HealthyPhase 1/2NCT03502707

A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older

A Phase 1/2 study testing RSV preF Protein 50 mcg, RSV preF Protein 150 mcg and Ad26.RSV.preF 1*10^11 vp in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study for: Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: RSV preF Protein 50 mcg, RSV preF Protein 150 mcg and Ad26.RSV.preF 1*10^11 vp
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 669 participants
Where: 6 sitesUnited States
Study dates: 6 Jul 2018to 16 May 2022
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Before randomization, a woman must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
For participants in Cohorts 1 and 2 only: Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the United States (US) Food and Drug Administration (FDA) toxicity, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
From the time of each vaccination through 3 months after each vaccination, participant agrees not to donate blood
Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Who cannot join

Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
Participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
Participant has a known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
Participant has received respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study at any time prior to randomization

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Optimal Research
Austin, Texas, 78705
Optimal Research
Huntsville, Alabama, 35802
Optimal Research
Melbourne, Florida, 32934
Optimal Research
Peoria, Illinois, 61614
Optimal Research
Rockville, Maryland, 20850
Optimal Research
San Diego, California, 92108

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About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older

The purpose of this study for:

Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3.

Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen.

Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.

Conditions: Healthy
Being tested: Placebo, RSV preF Protein 50 mcg, RSV preF Protein 150 mcg, Ad26.RSV.preF 1*10^11 vp, Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboBiological
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
RSV preF Protein 50 mcgBiological
Also called JNJ-64213175
RSV preF will be administered as a solution for intramuscular injection at a dose of 50 mcg.
RSV preF Protein 150 mcgBiological
Also called JNJ-64213175
RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
Ad26.RSV.preF 1*10^11 vpBiological
Also called JNJ-64400141
Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1*10^11 vp.
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcgBiological
Mixture of Ad26.RSV.preF (5*10^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcgBiological
Mixture of Ad26.RSV.preF (5*10^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcgBiological
Mixture of Ad26.RSV.preF (1*10^11 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcgBiological
Mixture of Ad26.RSV.preF (1*10^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
Selected RegimenBiological
A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.

Study groups in NCT03502707
Study group	Role	What they receive
Cohort (C)1 Group (G)1: Placebo for RSV preF Protein	Placebo comparator	Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12. Receives: Biological: Placebo
C1 G2: RSV preF Protein	Experimental	Participants will receive intramuscular injection of 50 microgram (mcg) RSV preF protein on Day 1, Day 57 and at Month 12. Receives: Biological: RSV preF Protein 50 mcg
C1 G3: Placebo for Ad26.RSV.preF/RSV preF or RSV preF Protein	Placebo comparator	Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12. Receives: Biological: Placebo
C1 G4: Mixture of Ad26.RSV.preF/RSV preF Protein	Experimental	Participants will receive intramuscular injection of a mixture of 510^10 viral particles (vp) of Ad26.RSV.preF/RSV preF 50 mcg protein on Day 1, Day 57 and at Month 12. Receives: Biological: Mixture of Ad26.RSV.preF 510^10 vp Plus RSV preF Protein 50 mcg
C1 G5: RSV preF Protein	Experimental	Participants will receive intramuscular injection of 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12. Receives: Biological: RSV preF Protein 150 mcg
C1 G6: Mixture of Placebo for Ad26.RSV.preF/RSV preF Protein	Placebo comparator	Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12. Receives: Biological: Placebo
C1 G7: Mixture of Ad26.RSV.preF/RSV preF Protein	Experimental	Participants will receive intramuscular injection of a mixture of 510^10 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12. Receives: Biological: Mixture of Ad26.RSV.preF 510^10 vp Plus RSV preF Protein 150 mcg
C1 G8: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein	Placebo comparator	Participants will receive intramuscular injection of placebo on Day 1 and at Month 12 and in only 1 arm on Day 57. Receives: Biological: Placebo
C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Participants will receive intramuscular injection of a mixture of 110^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and at Month 12 and placebo in another arm on Day 1 and at Month 12. Receives: Biological: Placebo; Biological: Mixture of Ad26.RSV.preF 110^11 vp Plus RSV preF Protein 150 mcg
C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo	Experimental	Participants will receive separate intramuscular injections of 110^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and at Month 12 and placebo in 1 arm on Day 57. Receives: Biological: Placebo; Biological: RSV preF Protein 150 mcg; Biological: Ad26.RSV.preF 110^11 vp
C2 G11: Ad26.RSV.preF and Placebo	Experimental	Participants will receive intramuscular injection of 110^11 vp of Ad26.RSV.preF in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57. Receives: Biological: Placebo; Biological: Ad26.RSV.preF 110^11 vp
C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Participants will receive intramuscular injection of a mixture of 510^10 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57. Receives: Biological: Placebo; Biological: Mixture of Ad26.RSV.preF 510^10 vp Plus RSV preF Protein 50 mcg
C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Participants will receive intramuscular injection of a mixture of 110^11 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57. Receives: Biological: Placebo; Biological: Mixture of Ad26.RSV.preF 110^11 vp Plus RSV preF Protein 50 mcg
C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Participants will receive intramuscular injection of a mixture of 110^11 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57. Receives: Biological: Placebo; Biological: Mixture of Ad26.RSV.preF 110^11 vp Plus RSV preF Protein 150 mcg
C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Participants will receive intramuscular injection of a mixture of 510^10 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57. Receives: Biological: Placebo; Biological: Mixture of Ad26.RSV.preF 510^10 vp Plus RSV preF Protein 150 mcg
C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo	Experimental	Data from C1 G10 will be pooled with those of C2 G16. Participants will receive separate intramuscular injections of 110^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and placebo in 1 arm on Day 57. Receives: Biological: Placebo; Biological: RSV preF Protein 150 mcg; Biological: Ad26.RSV.preF 110^11 vp
C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Data from C1 G9 will be pooled with those of C2 G17. Participants will receive intramuscular injection of a mixture of 110^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and placebo in another arm on Day 1. Receives: Biological: Placebo; Biological: Mixture of Ad26.RSV.preF 110^11 vp Plus RSV preF Protein 150 mcg
C2 G18: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein	Placebo comparator	Participants will receive intramuscular injection of placebo in separate arms on Day 1 and in only 1 arm on Day 57. Receives: Biological: Placebo
C3 G19: Selected Regimen (SR)	Experimental	If a one-dose regimen is selected, participants in this group will receive SR on Day 1 and a booster (the SR) at Month 12 and month 24. The participants who are randomized to two-dose regimen will receive SR on Day 1 and Day 57, and a booster (the selected regimen) at Month 12. Receives: Biological: Selected Regimen
C3 G20: SR + Placebo for SR	Experimental	If a one-dose regimen is selected, participants in this group will receive SR on Day 1 and Month 24, and a placebo at Month 12. The participants who are randomized to two-dose regimen will receive selected regimen on Day 1 and Day 57, and a placebo at Month 12. Receives: Biological: Placebo; Biological: Selected Regimen
C3 G21: Placebo for SR	Placebo comparator	If a one-dose regimen is selected, participants in this group will receive placebo for SR on Day 1 and at Month 12 and Month 24. The participants who are randomized to two-dose regimen will receive placebo for SR on Day 1, Day 57, and Month 12. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Measured: From Day 1 up to Day 730
Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Measured: From Day 1 up to Day 730
Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Measured: From Day 1 up to Day 1095
Cohort 3: Number of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Measured: From Day 1 up to Day 1095
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Measured: 7 days post-vaccination 1 on Day 1 (Day 8)
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: 7 days post-vaccination 2 on Day 57 (Day 64)
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: 7 days post-vaccination 3 on Day 365 (Day 372)
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: 7 days post-vaccination 1 on Day 1 (Day 8)
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: 7 days post-vaccination 2 on Day 57 (Day 64)
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: 7 days post-vaccination 1 on Day 1 (Day 8)
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: 7 days post-vaccination 2 on Day 365 (Day 372)
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: 7 days post-vaccination 3 on Day 730 (Day 737)
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measured: 28 days post-vaccination 1 on Day 1 (Day 29)
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measured: 28 days post-vaccination 2 on Day 57 (Day 85)
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measured: 28 days post-vaccination 3 on Day 365 (Day 393)
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measured: 28 days post-vaccination 1 on Day 1 (Day 29)
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measured: 28 days post-vaccination 2 on Day 57 (Day 85)
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measured: 28 days post-vaccination 1 on Day 1 (Day 29)
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measured: 28 days post-vaccination 2 on Day 365 (Day 393)
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measured: 28 days post-vaccination 3 on Day 730 (Day 758)
Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29
RSV A2 Strain neutralization antibody titers on Day 29 was reported. Geometric mean titers (GMTs) of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be analyzed for specified arms only.
Measured: Day 29

Secondary outcomes (12)

Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 1 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
Measured: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 3 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
Measured: Days 1, 15, 29, 57, 85, 183, 365, 393, 547, 730, 744, 758
Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29
RSV A2 strain neutralization antibody titers on Day 29 in Group 16 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only.
Measured: Day 29
Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85
RSV A2 strain neutralization antibody titers on Day 85 in Group 17 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only.
Measured: Day 85
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (ELISA units per liter [EU/L]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 1 were reported.
Measured: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (ELISA units per liter [EU/L]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 2 were reported.
Measured: Days 1, 15, 29, 57, 85, 183, 365, and 547
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 1 were reported.
Measured: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 2 were reported.
Measured: Days 1, 15, 29, 57, 85, 183, 365, and 547
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 1 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was Spot forming units (SFU)/10^6 peripheral blood mononuclear cells (PBMCs).
Measured: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 3 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was SFU/10^6 PBMCs.
Measured: Days 1, 15, 29, 57, 85, 183, 365, 393, 730, 744, and 758
Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot Assay on Day 29 in Groups 11-16 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only.
Measured: Day 29
Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85
Breadth of IFN-gamma T-Cells responses analyzed by ELISpot assay on Day 85 in Group 17 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only.
Measured: Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 201816 May 2022

First posted19 Apr 2018
Study start6 Jul 2018
Primary completion16 May 2022
Study completion16 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 669 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03502707
Sponsor's protocol ID: CR108456
Other IDs: VAC18193RSV1004
Status last verified: May 2025
First submitted: 11 Apr 2018
Last updated: 25 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Comeaux CA, Bart S, Bastian AR, Klyashtornyy V, De Paepe E, Omoruyi E, van der Fits L, van Heesbeen R, Heijnen E, Callendret B, Sadoff J. Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-Based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. J Infect Dis. 2024 Jan 12;229(1):19-29. doi: 10.1093/infdis/jiad220.
PubMed 37433021

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Study at a glance

From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
ClinicalTrials.gov ID: NCT03502707
Acronym / sponsor ID: CR108456
Conditions: Healthy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 669 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Study start: 6 Jul 2018 (actual)
Primary completion: 16 May 2022 (actual)
Study completion: 16 May 2022 (actual)
First posted: 19 Apr 2018 (actual)
Results: Posted 13 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study for:

Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3.

Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 21

Arm	Type	Receives
Cohort (C)1 Group (G)1: Placebo for RSV preF Protein	Placebo comparator	Biological: PlaceboParticipants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
C1 G2: RSV preF Protein	Experimental	Biological: RSV preF Protein 50 mcgParticipants will receive intramuscular injection of 50 microgram (mcg) RSV preF protein on Day 1, Day 57 and at Month 12.
C1 G3: Placebo for Ad26.RSV.preF/RSV preF or RSV preF Protein	Placebo comparator	Biological: PlaceboParticipants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
C1 G4: Mixture of Ad26.RSV.preF/RSV preF Protein	Experimental	Biological: Mixture of Ad26.RSV.preF 510^10 vp Plus RSV preF Protein 50 mcgParticipants will receive intramuscular injection of a mixture of 510^10 viral particles (vp) of Ad26.RSV.preF/RSV preF 50 mcg protein on Day 1, Day 57 and at Month 12.
C1 G5: RSV preF Protein	Experimental	Biological: RSV preF Protein 150 mcgParticipants will receive intramuscular injection of 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.
C1 G6: Mixture of Placebo for Ad26.RSV.preF/RSV preF Protein	Placebo comparator	Biological: PlaceboParticipants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
C1 G7: Mixture of Ad26.RSV.preF/RSV preF Protein	Experimental	Biological: Mixture of Ad26.RSV.preF 510^10 vp Plus RSV preF Protein 150 mcgParticipants will receive intramuscular injection of a mixture of 510^10 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.
C1 G8: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein	Placebo comparator	Biological: PlaceboParticipants will receive intramuscular injection of placebo on Day 1 and at Month 12 and in only 1 arm on Day 57.
C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Biological: Placebo, Biological: Mixture of Ad26.RSV.preF 110^11 vp Plus RSV preF Protein 150 mcgParticipants will receive intramuscular injection of a mixture of 110^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and at Month 12 and placebo in another arm on Day 1 and at Month 12.
C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo	Experimental	Biological: Placebo, Biological: RSV preF Protein 150 mcg, Biological: Ad26.RSV.preF 110^11 vpParticipants will receive separate intramuscular injections of 110^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and at Month 12 and placebo in 1 arm on Day 57.
C2 G11: Ad26.RSV.preF and Placebo	Experimental	Biological: Placebo, Biological: Ad26.RSV.preF 110^11 vpParticipants will receive intramuscular injection of 110^11 vp of Ad26.RSV.preF in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Biological: Placebo, Biological: Mixture of Ad26.RSV.preF 510^10 vp Plus RSV preF Protein 50 mcgParticipants will receive intramuscular injection of a mixture of 510^10 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Biological: Placebo, Biological: Mixture of Ad26.RSV.preF 110^11 vp Plus RSV preF Protein 50 mcgParticipants will receive intramuscular injection of a mixture of 110^11 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Biological: Placebo, Biological: Mixture of Ad26.RSV.preF 110^11 vp Plus RSV preF Protein 150 mcgParticipants will receive intramuscular injection of a mixture of 110^11 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Biological: Placebo, Biological: Mixture of Ad26.RSV.preF 510^10 vp Plus RSV preF Protein 150 mcgParticipants will receive intramuscular injection of a mixture of 510^10 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo	Experimental	Biological: Placebo, Biological: RSV preF Protein 150 mcg, Biological: Ad26.RSV.preF 110^11 vpData from C1 G10 will be pooled with those of C2 G16. Participants will receive separate intramuscular injections of 110^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and placebo in 1 arm on Day 57.
C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo	Experimental	Biological: Placebo, Biological: Mixture of Ad26.RSV.preF 110^11 vp Plus RSV preF Protein 150 mcgData from C1 G9 will be pooled with those of C2 G17. Participants will receive intramuscular injection of a mixture of 110^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and placebo in another arm on Day 1.
C2 G18: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein	Placebo comparator	Biological: PlaceboParticipants will receive intramuscular injection of placebo in separate arms on Day 1 and in only 1 arm on Day 57.
C3 G19: Selected Regimen (SR)	Experimental	Biological: Selected RegimenIf a one-dose regimen is selected, participants in this group will receive SR on Day 1 and a booster (the SR) at Month 12 and month 24. The participants who are randomized to two-dose regimen will receive SR on Day 1 and Day 57, and a booster (the selected regimen) at Month 12.
C3 G20: SR + Placebo for SR	Experimental	Biological: Placebo, Biological: Selected RegimenIf a one-dose regimen is selected, participants in this group will receive SR on Day 1 and Month 24, and a placebo at Month 12. The participants who are randomized to two-dose regimen will receive selected regimen on Day 1 and Day 57, and a placebo at Month 12.
C3 G21: Placebo for SR	Placebo comparator	Biological: PlaceboIf a one-dose regimen is selected, participants in this group will receive placebo for SR on Day 1 and at Month 12 and Month 24. The participants who are randomized to two-dose regimen will receive placebo for SR on Day 1, Day 57, and Month 12.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Before randomization, a woman must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
For participants in Cohorts 1 and 2 only: Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the United States (US) Food and Drug Administration (FDA) toxicity, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
From the time of each vaccination through 3 months after each vaccination, participant agrees not to donate blood
Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Key exclusion criteria (5 listed)

Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
Participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
Participant has a known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
Participant has received respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study at any time prior to randomization

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.	Biological	C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo, C1 G3: Placebo for Ad26.RSV.preF/RSV preF or RSV preF Protein, C1 G6: Mixture of Placebo for Ad26.RSV.preF/RSV preF Protein, C1 G8: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein, C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo, C2 G11: Ad26.RSV.preF and Placebo, C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo, C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo, C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo, C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo, C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo, C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo, C2 G18: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein, C3 G20: SR + Placebo for SR, C3 G21: Placebo for SR, Cohort (C)1 Group (G)1: Placebo for RSV preF Protein
RSV preF Protein 50 mcgAlso: JNJ-64213175RSV preF will be administered as a solution for intramuscular injection at a dose of 50 mcg.	Biological	C1 G2: RSV preF Protein
RSV preF Protein 150 mcgAlso: JNJ-64213175RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.	Biological	C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo, C1 G5: RSV preF Protein, C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
Ad26.RSV.preF 110^11 vpAlso: JNJ-64400141Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 110^11 vp.	Biological	C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo, C2 G11: Ad26.RSV.preF and Placebo, C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
Mixture of Ad26.RSV.preF 510^10 vp Plus RSV preF Protein 50 mcgMixture of Ad26.RSV.preF (510^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.	Biological	C1 G4: Mixture of Ad26.RSV.preF/RSV preF Protein, C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Mixture of Ad26.RSV.preF 510^10 vp Plus RSV preF Protein 150 mcgMixture of Ad26.RSV.preF (510^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.	Biological	C1 G7: Mixture of Ad26.RSV.preF/RSV preF Protein, C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Mixture of Ad26.RSV.preF 110^11 vp Plus RSV preF Protein 50 mcgMixture of Ad26.RSV.preF (110^11 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.	Biological	C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Mixture of Ad26.RSV.preF 110^11 vp Plus RSV preF Protein 150 mcgMixture of Ad26.RSV.preF (110^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.	Biological	C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo, C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo, C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Selected RegimenA regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.	Biological	C3 G19: Selected Regimen (SR), C3 G20: SR + Placebo for SR

Primary outcome

Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 730
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 730
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 1095
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Cohort 3: Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 1095
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Time frame: 7 days post-vaccination 1 on Day 1 (Day 8)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Time frame: 7 days post-vaccination 2 on Day 57 (Day 64)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Time frame: 7 days post-vaccination 3 on Day 365 (Day 372)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Time frame: 7 days post-vaccination 1 on Day 1 (Day 8)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Time frame: 7 days post-vaccination 2 on Day 57 (Day 64)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Time frame: 7 days post-vaccination 1 on Day 1 (Day 8)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Time frame: 7 days post-vaccination 2 on Day 365 (Day 372)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Time frame: 7 days post-vaccination 3 on Day 730 (Day 737)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Time frame: 28 days post-vaccination 1 on Day 1 (Day 29)
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Time frame: 28 days post-vaccination 2 on Day 57 (Day 85)
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Time frame: 28 days post-vaccination 3 on Day 365 (Day 393)
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Time frame: 28 days post-vaccination 1 on Day 1 (Day 29)
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Time frame: 28 days post-vaccination 2 on Day 57 (Day 85)
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Time frame: 28 days post-vaccination 1 on Day 1 (Day 29)
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Time frame: 28 days post-vaccination 2 on Day 365 (Day 393)
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Time frame: 28 days post-vaccination 3 on Day 730 (Day 758)
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29
Time frame: Day 29
RSV A2 Strain neutralization antibody titers on Day 29 was reported. Geometric mean titers (GMTs) of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be analyzed for specified arms only.

12 secondary outcomes

Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, 547, 730, 744, 758
Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29
Time frame: Day 29
Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85
Time frame: Day 85
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
Time frame: Days 1, 15, 29, 57, 85, 183, 365, and 547
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
Time frame: Days 1, 15, 29, 57, 85, 183, 365, and 547
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, 730, 744, and 758
Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29
Time frame: Day 29
Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85
Time frame: Day 85

Results and safety

Results posted to the registry on 13 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Pooled Placebo	16	14
Cohort 1: RSV preF Protein 50 mcg	8	7
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)	8	8
Cohort 1: RSV preF Protein 150 mcg	8	7
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)	8	8
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo	8	6
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone	8	8
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone	24	16
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone	42	37
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone	42	34
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone	42	27
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone	43	17
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone	36	29
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo	36	32
Cohort 2: Pooled Placebo	24	20
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)	135	76
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo	136	75
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen	45	24

Primary outcome: Cohort 1: Number of Participants With Serious Adverse Events (SAEs)

Time frame: From Day 1 up to Day 730. Count of participants. Unit: Participants

Measure	Cohort 1: Pooled Placebo n = 16	Cohort 1: RSV preF Protein 50 mcg n = 8	Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) n = 8	Cohort 1: RSV preF Protein 150 mcg n = 8	Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) n = 8	Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n = 8	Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone n = 8
Value	3	0	0	2	3	0	0

Population analysed: The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.

Primary outcome: Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs)

Time frame: From Day 1 up to Day 730. Count of participants. Unit: Participants

Measure	Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone n = 24	Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone n = 42	Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone n = 42	Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone n = 36	Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n = 36	Cohort 2: Pooled Placebo n = 24
Value	0	5	5	7	3	4

Primary outcome: Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)

Time frame: From Day 1 up to Day 1095. Count of participants. Unit: Participants

Measure	Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n = 42	Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n = 42
Value	4	5

Population analysed: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.

Primary outcome: Cohort 3: Number of Participants With Serious Adverse Events (SAEs)

Time frame: From Day 1 up to Day 1095. Count of participants. Unit: Participants

Measure	Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) n = 135	Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo n = 136	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n = 44
Value	14	16	3

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 up to 1095 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Pooled Placebo	3 of 16 (18.8%)	5 of 16 (31.3%)	0 of 16
Cohort 1: RSV preF Protein 50 mcg	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Cohort 1: RSV preF Protein 150 mcg	2 of 8 (25%)	2 of 8 (25%)	1 of 8
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)	3 of 8 (37.5%)	4 of 8 (50%)	0 of 8
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone	0 of 8 (0%)	4 of 8 (50%)	0 of 8
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone	0 of 24 (0%)	12 of 24 (50%)	0 of 24
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone	5 of 42 (11.9%)	14 of 42 (33.3%)	1 of 42
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone	5 of 42 (11.9%)	14 of 42 (33.3%)	1 of 42
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone	4 of 42 (9.5%)	15 of 42 (35.7%)	0 of 42
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone	5 of 42 (11.9%)	10 of 42 (23.8%)	0 of 42
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone	7 of 36 (19.4%)	10 of 36 (27.8%)	1 of 36
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo	3 of 36 (8.3%)	15 of 36 (41.7%)	0 of 36
Cohort 2: Pooled Placebo

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37433021Comeaux CA, Bart S, Bastian AR, Klyashtornyy V, De Paepe E, Omoruyi E, van der Fits L, van Heesbeen R, Heijnen E, Callendret B, Sadoff J. Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-Based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. J Infect Dis. 2024 Jan 12;229(1):19-29. doi: 10.1093/infdis/jiad220.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Vaccines & Prevention B.V. Clinical Trial study director

Janssen Vaccines & Prevention B.V.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RSV preF Protein 50 mcg, RSV preF Protein 150 mcg and Ad26.RSV.preF 1*10^11 vp in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Number of Participants With Serious Adverse Events (SAEs) (time frame: From Day 1 up to Day 730). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03502707, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.