Respiratory Syncytial VirusesPhase 1/2NCT03303625
A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age
A Phase 1/2 study testing Ad26.RSV.preF (1*10^11 vp) and Ad26.RSV.preF (5*10^10 vp) in people with Respiratory Syncytial Viruses and Respiratory Tract Infections, run by Janssen Vaccines & Prevention B.V. at 7 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1*10^11 viral particles [vp]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein [pre-F]… Read more about this study
- Who is it for?
- Ages 12 months to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Viruses, Respiratory Tract Infections
- What is being tested?
- Ad26.RSV.preF (1*10^11 vp) and Ad26.RSV.preF (5*10^10 vp)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 29 Nov 2017to 21 Apr 2020
- 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 12 months to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adults Participants:
- Participant must be in good health, without significant medical illness, on the basis of physical examination, medical history, and vital signs measurement
- 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 local laboratory normal reference ranges and additionally within the limits of toxicity Grade 1 according to the United stated (US) Food and Drug Administration (FDA) toxicity tables, 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
- All women of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and a negative urine Beta-hCG pregnancy test immediately prior to each study vaccine administration
- Pediatric Participants:
- Participant is the product of a normal term pregnancy greater than and equal to (>=) 37 weeks, with a minimum birth weight of 2.5 kilogram (kg)
- Participants must be in good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening
Who cannot join
- Adults Participants:
- Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature >=38.0 ºC (degree celsius)/100.4 °F (fahrenheit) within 24 hours prior to the first dose of study vaccine
- Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Pediatric Participants:
- Participant's weight is below 10th percentile according to World Health Organization (WHO) pediatric growth and weight charts
- Participant has any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation: example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, systemic infections, congenital heart disease, history of any pulmonary condition requiring medication, atopy, reactive airway disease, medically-confirmed wheezing, bronchoconstriction or treatment with a beta2 agonist, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea, hospitalization for respiratory illness, or mechanical ventilation for respiratory illness
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Finland3 sites
Järvenpään rokotetutkimusklinikka
Jarvenpaa, 04400
University of Tampere/Vaccine Research Center
Tampere, 33100
University of Tampere/Vaccine Research Center
Turku, 20520
United Kingdom3 sites
Royal Manchester Children's Hospital
Manchester, M13 9WL
Oxford Vaccine Group
Oxford, OX3 7LE
University Hospital Southampton NHS Foundation Trust
Southampton, SO166YD
United States1 site
Heartland Research Associates, LLC
Newton, Kansas, 67114
About this study
Official title: A Randomized, Double-blind, Phase 1/2a Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF in Adults 18 to 50 Years of Age, RSV-seropositive Toddlers 12 to 24 Months of Age
The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1*10^11 viral particles [vp]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein [pre-F] [Ad26.RSV.preF]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.
Read the detailed description
The study, designed to assess the safety and tolerability of two doses given one month apart of Ad26.RSV.preF, an investigational RSV vaccine candidate based on a Ad26 vector expressing the RSV F protein, will be conducted in a double blinded manner. The study will be divided in two sequential cohorts: cohort 0 (18-50 year-old adults) and cohort 1 (12-24 month-old RSV seropositive toddlers). The vaccine safety will be monitored by reporting solicited and unsolicited adverse events (AEs) and all serious adverse events (SAEs). The data will be reviewed by an independent data monitoring committee (IDMC) to assess safety data and to ensure the continuing safety of the participants enrolled in this study. The safety will be monitored throughout the study.
- Being tested
- Ad26.RSV.preF (1*10^11 vp), Ad26.RSV.preF (5*10^10 vp), Placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.RSV.preF (1*10^11 vp)Biological
Also called JNJ-64400141
Participants will receive two doses of 0.5 milliliter (mL) (1*10^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.
Ad26.RSV.preF (5*10^10 vp)Biological
Also called JNJ-64400141
RSV seropositive participants will receive two doses of 0.25 mL (5*10^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.
PlaceboDrug
Participants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 0: Adults (Ad26.RSV.preF) | Experimental | Participants aged greater than or equal to (>=) 18 to lesser than or equal to (<=) 50 years will receive vector Ad26.RSV.preF at 1*10^11 viral particles (vp) via intramuscular (IM) route (Group 1) on Day 1 and 29. Receives: Biological: Ad26.RSV.preF (1*10^11 vp) |
| Cohort 0: Adults (Placebo) | Placebo comparator | Participants aged >= 18 to <= 50 years will receive placebo via IM route (Group 2) on Day 1 and 29. Receives: Drug: Placebo |
| Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF) | Experimental | RSV seropositive participants aged >=12 to <=24 months will receive Ad26.RSV.preF at 5*10^10 vp via IM route (Group 3) on Day 1 and 29. Receives: Biological: Ad26.RSV.preF (5*10^10 vp) |
| Cohort 1: RSV seropositive Toddlers (Placebo) | Placebo comparator | RSV seropositive participants aged >= 12 to <= 24 months will receive placebo via IM route (Group 4) on Day 1 and 29. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
Measured: For 7 days after first vaccination on Day 1 (Up to Day 7)
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
Measured: For 7 days after second vaccination on Day 29 (Up to Day 35)
Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C).
Measured: For 7 days after first vaccination on Day 1 (Up to Day 7)
Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C).
Measured: For 7 days after second vaccination on Day 29 (Up to Day 35)
Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
Measured: For 28 days after first vaccination on Day 1 (Up to Day 28)
Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
Measured: For 28 days after second vaccination on Day 29 (Up to Day 56)
Number of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measured: From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months)
Secondary outcomes (4)
Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
Measured: Day 1 (predose), Post-dose on Days 29, 57 and 211
Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211
GMT (ELISA units per liter [EU/L]) of RSV F protein in pre-fusion form as assessed by ELISA was reported.
Measured: Pre-fusion on Days 1, 29, 57 and 211
Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211
GMT (ELISA units per liter [EU/L]) of RSV F protein in post-fusion form as assessed by ELISA was reported.
Measured: Post-fusion on Days 1, 29, 57 and 211
Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57
Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines.
Measured: Day 1 (predose) and Post-dose on Days, 29, and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start29 Nov 2017
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
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.
- Other trials for Respiratory Syncytial VirusesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303625
- Sponsor's protocol ID
- CR108371
- Other IDs
- 2017-001345-27, VAC18194RSV2001, 2017
- Status last verified
- May 2025
- First submitted
- 3 Oct 2017
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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, Phase 1/2a Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF in Adults 18 to 50 Years of Age, RSV-seropositive Toddlers 12 to 24 Months of Age
- ClinicalTrials.gov ID
- NCT03303625
- Acronym / sponsor ID
- CR108371
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Posted 23 Jun 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 is to assess the safety and tolerability of an intramuscular regimen of two doses (1*10^11 viral particles [vp]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein [pre-F] [Ad26.RSV.preF]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.
Detailed description
The study, designed to assess the safety and tolerability of two doses given one month apart of Ad26.RSV.preF, an investigational RSV vaccine candidate based on a Ad26 vector expressing the RSV F protein, will be conducted in a double blinded manner. The study will be divided in two sequential cohorts: cohort 0 (18-50 year-old adults) and cohort 1 (12-24 month-old RSV seropositive toddlers). The vaccine safety will be monitored by reporting solicited and unsolicited adverse events (AEs) and all serious adverse events (SAEs). The data will be reviewed by an independent data monitoring committee (IDMC) to assess safety data and to ensure the continuing safety of the participants enrolled in this study. The safety will be monitored throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 0: Adults (Ad26.RSV.preF) | Experimental | Biological: Ad26.RSV.preF (1*10^11 vp)Participants aged greater than or equal to (>=) 18 to lesser than or equal to (<=) 50 years will receive vector Ad26.RSV.preF at 1*10^11 viral particles (vp) via intramuscular (IM) route (Group 1) on Day 1 and 29. |
| Cohort 0: Adults (Placebo) | Placebo comparator | Drug: PlaceboParticipants aged >= 18 to <= 50 years will receive placebo via IM route (Group 2) on Day 1 and 29. |
| Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF) | Experimental | Biological: Ad26.RSV.preF (5*10^10 vp)RSV seropositive participants aged >=12 to <=24 months will receive Ad26.RSV.preF at 5*10^10 vp via IM route (Group 3) on Day 1 and 29. |
| Cohort 1: RSV seropositive Toddlers (Placebo) | Placebo comparator | Drug: PlaceboRSV seropositive participants aged >= 12 to <= 24 months will receive placebo via IM route (Group 4) on Day 1 and 29. |
Who may qualify
- Ages
- 12 months to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Participant must be in good health, without significant medical illness, on the basis of physical examination, medical history, and vital signs measurement
- 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 local laboratory normal reference ranges and additionally within the limits of toxicity Grade 1 according to the United stated (US) Food and Drug Administration (FDA) toxicity tables, 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
- All women of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and a negative urine Beta-hCG pregnancy test immediately prior to each study vaccine administration
- Participant is the product of a normal term pregnancy greater than and equal to (>=) 37 weeks, with a minimum birth weight of 2.5 kilogram (kg)
- Participants must be in good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening
Key exclusion criteria (7 listed)
- Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature >=38.0 ºC (degree celsius)/100.4 °F (fahrenheit) within 24 hours prior to the first dose of study vaccine
- Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Participant's weight is below 10th percentile according to World Health Organization (WHO) pediatric growth and weight charts
- Participant has any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation: example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, systemic infections, congenital heart disease, history of any pulmonary condition requiring medication, atopy, reactive airway disease, medically-confirmed wheezing, bronchoconstriction or treatment with a beta2 agonist, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea, hospitalization for respiratory illness, or mechanical ventilation for respiratory illness
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 |
|---|---|---|
| Ad26.RSV.preF (1*10^11 vp)Also: JNJ-64400141Participants will receive two doses of 0.5 milliliter (mL) (1*10^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF. | Biological | Cohort 0: Adults (Ad26.RSV.preF) |
| Ad26.RSV.preF (5*10^10 vp)Also: JNJ-64400141RSV seropositive participants will receive two doses of 0.25 mL (5*10^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF. | Biological | Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF) |
| PlaceboParticipants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29. | Drug | Cohort 0: Adults (Placebo), Cohort 1: RSV seropositive Toddlers (Placebo) |
Primary outcome
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination
Time frame: For 7 days after first vaccination on Day 1 (Up to Day 7)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination
Time frame: For 7 days after second vaccination on Day 29 (Up to Day 35)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination
Time frame: For 7 days after first vaccination on Day 1 (Up to Day 7)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C).
Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination
Time frame: For 7 days after second vaccination on Day 29 (Up to Day 35)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C).
Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination
Time frame: For 28 days after first vaccination on Day 1 (Up to Day 28)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination
Time frame: For 28 days after second vaccination on Day 29 (Up to Day 56)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
4 secondary outcomes
Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211
Time frame: Day 1 (predose), Post-dose on Days 29, 57 and 211
Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211
Time frame: Pre-fusion on Days 1, 29, 57 and 211
Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211
Time frame: Post-fusion on Days 1, 29, 57 and 211
Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57
Time frame: Day 1 (predose) and Post-dose on Days, 29, and 57
Results and safety
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.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Related trials for Respiratory Syncytial Viruses
Not yet recruitingObservational study
ELderly REspiratory VIral Cohort
Influenza Viruses, Respiratory Syncytial Virus (RSV)
Active, not recruitingObservational study
A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Disease
Respiratory Syncytial Viruses
Active, not recruitingObservational study
Effectiveness of ABRYSVO® Maternal Respiratory Syncytial Virus (RSV) Vaccine Against RSV in Infants in Western Pennsylvania
Respiratory Syncytial Viruses
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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ad26.RSV.preF (1*10^11 vp) and Ad26.RSV.preF (5*10^10 vp) in people with Respiratory Syncytial Viruses and Respiratory Tract Infections, run by Janssen Vaccines & Prevention B.V. at 7 sites in 3 countries.
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 7 inclusion and 7 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 7 sites in Finland, United Kingdom, 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 23 Jun 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?
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination (time frame: For 7 days after first vaccination on Day 1 (Up to Day 7)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 27 Oct 2026.