Influenza PreventionPhase 1/2NCT05901636

A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults

A Phase 1/2 study testing INFLUENZA G1 mHA and Al(OH)3 in people with Influenza Prevention, run by Janssen Vaccines & Prevention B.V. at 4 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 primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (>=) 18 to less than or equal to (<=) 45 years of age. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Influenza Prevention
What is being tested?: INFLUENZA G1 mHA and Al(OH)3
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 170 participants
Where: 4 sitesUnited States
Study dates: 17 May 2023to 19 Aug 2024
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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Must be healthy as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening
Contraceptive (birth control) use by female participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies. Before randomization, participants who were born female must be either: a) not of childbearing potential; b) of childbearing potential and practicing a highly effective method of contraception and agreeing to remain on such a method of contraception from signing the informed consent until 3 months after the last dose of study vaccine. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Highly effective methods for this study include: hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion/ligation procedures, vasectomized partner (the vasectomized partner should be the sole partner for that participant), and sexual abstinence
All female participants of childbearing potential must: a) have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; b) have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
Must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the US FDA toxicity scale 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

Who cannot join

Contraindication to IM injections and blood draws, example, bleeding disorders
Clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
History of severe allergic reaction (for example, anaphylaxis) or other serious adverse reactions to vaccines or vaccine excipients (specifically the excipients of the study vaccine[s])
Abnormal function of the immune system resulting from: a) clinical conditions (example, autoimmune disease or immunodeficiency) or their treatments expected to have an impact on the immune response elicited by the study vaccine; b) chronic or recurrent use of systemic corticosteroids within 2 months before administration of study vaccine and during the study; c) administration of antineoplastic and immunomodulating agents or radiotherapy expected to have an impact on the immune response elicited by the study vaccine within 6 months before administration of study vaccine and during the study
History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
Received treatment with immunoglobulins (including monoclonal antibodies) expected to impact the vaccine-induced immune response in the 2 months or blood products in the 3 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study.

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Received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine, or received an investigational biological product within 3 months or 5 half-lives, whichever is longer, before the planned study intervention, or is currently enrolled or plans to participate in another investigational study or observational clinical study during the course of this study
Pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study vaccine. Oocyte donation is prohibited while enrolled in this study
Received or plans to receive: licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccination[s]; other licensed (not live) vaccines (not including seasonal influenza vaccines) - within 14 days before or after planned administration of the first or subsequent study vaccination[s]; seasonal influenza vaccines - within 4 months before planned administration of the first study vaccination until the end of the study (that is, any individual who requires a seasonal influenza vaccination for occupational or other reasons will be excluded)
Has received a pandemic influenza vaccine (other than Hemagglutinin Type 1 and Neuraminidase Type 1 [H1N1]) in a previous pandemic influenza vaccine study at any time prior to randomization

Trial locations and contacts

4 sites in 1 country.

United States4 sites

CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Clinical Trials Managements, LLC
Metairie, Louisiana, 70006
Floridian Clinical Research LLC
Miami Lakes, Florida, 33016

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of a Universal Influenza (Uniflu) Vaccine With INFLUENZA G1 mHA in Healthy Adults

Conditions: Influenza Prevention
Being tested: INFLUENZA G1 mHA, Placebo, Al(OH)3

What participants receive

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

INFLUENZA G1 mHABiological
INFLUENZA G1 mHA will be administered intramuscularly.
PlaceboBiological
Placebo will be administered intramuscularly.
Al(OH)3Biological
Al(OH)3 will be administered intramuscularly.

Study groups in NCT05901636
Study group	Role	What they receive
INFLUENZA G1 mHA Dose Level 1	Experimental	Participants will receive single intramuscular (IM) injection of INFLUENZA G1 mHA Dose level 1 on Days 1 and 57 in Cohort 1. Receives: Biological: INFLUENZA G1 mHA
INFLUENZA G1 mHA Dose Level 1 along with Al(OH)3	Experimental	Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 1 with Aluminum Hydroxide (Al[OH])3 adjuvant on Days 1 and 57 in Cohort 1. Receives: Biological: INFLUENZA G1 mHA; Biological: Al(OH)3
Placebo	Placebo comparator	Participants will receive IM injection of placebo on Days 1 and 57 in Cohorts 1 and 2. Receives: Biological: Placebo
INFLUENZA G1 mHA Dose Level 2	Experimental	Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Days 1 and 57 in Cohort 2. Receives: Biological: INFLUENZA G1 mHA
INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3	Experimental	Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Days 1 and 57 in Cohort 2. Receives: Biological: INFLUENZA G1 mHA; Biological: Al(OH)3
INFLUENZA G1 mHA Dose Level 2 + Placebo	Experimental	Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Day 1 and placebo on Day 57 in Cohort 2. Receives: Biological: INFLUENZA G1 mHA
INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 + Placebo	Experimental	Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Day 1 and placebo on Day 57 in Cohort 2. Receives: Biological: INFLUENZA G1 mHA; Biological: Al(OH)3

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) Within 7 Days After Vaccination 1
An AE was 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 the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Measured: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2
An AE was 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 the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Measured: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1
AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using food and drug administration (FDA) toxicity grading scale- Pain: Grade (G) 1 (mild; does not interfere with activity); G2 (moderate; requires modification in activity/use of medications); G3 (severe; inability to do usual activities/use of narcotic pain reliever); G4 (life threatening; hospitalization), Erythema and swelling: G 1 (mild; 25 -50 millimeter [mm]); G2 (moderate; 51 -100 mm); G3 (severe; greater than [>] 100 mm); G4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).
Measured: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2
AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using FDA toxicity grading scale- Pain: Grade 1 (mild; does not interfere with activity); Grade 2 (moderate; requires modification in activity/use of medications); Grade 3 (severe; inability to do usual activities/use of narcotic pain reliever); Grade 4 (life threatening; hospitalization), Erythema and swelling: Grade 1 (mild; 25 -50 mm); Grade 2 (moderate; 51 -100 mm); Grade 3 (severe; >100 mm); Grade 4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).
Measured: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was 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 the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Measured: From Day 1 up to Day 365
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was 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 the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Measured: From Day 57 up to Day 365
Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1
An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2
An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1
AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius [C]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).
Measured: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2
AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius [C]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).
Measured: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: From Day 1 up to Day 365
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: From Day 57 up to Day 365
Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1
An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.
Measured: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2
An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.
Measured: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Measured: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Measured: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).
Measured: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).
Measured: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1
Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 1 are reported below.
Measured: From Day 1 up to Day 365
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 2 are reported below.
Measured: From Day 57 up to Day 365
Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.
Measured: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.
Measured: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine
An AE was 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 the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with SAEs and SAEs related to study vaccine were reported.
Measured: From first vaccination (Day 1) up to Day 365

Secondary outcomes (1)

Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Geometric mean concentration of antibodies binding to HA stem or full-length HA protein as measured by ELISA (H5-ELISA and mHA ELISA) was reported. HA stem derived protein vaccine antigen (mHA) derived from H1N1 A/California/07/2009 virus strain. Per-protocol Immunogenicity population was denoted as PPI. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
Measured: Days 29 and 85

Timeline

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

17 May 202319 Aug 2024

First posted13 Jun 2023
Study start17 May 2023
Primary completion19 Aug 2024
Study completion19 Aug 2024

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 Influenza PreventionStudies 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: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05901636
Sponsor's protocol ID: CR108777
Other IDs: VAC21148FLZ1001, 2019-004635-23, 2019
Status last verified: Aug 2025
First submitted: 5 Jun 2023
Last updated: 8 Sep 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

Publications

Hertoghs N, Tang C, van Paassen V, Jongeneelen M, Tolboom J, Yieh L, Wang M, Kaszas K, McLean C, van den Berg S, Lowson D, Hu W, Aguilar Z, Hendriks J, Kuipers H, Kulke S, Sadoff J, Brandenburg B, Zahn R. A group 1 hemagglutinin stem vaccine elicits broad humoral responses against influenza in phase 1/2a study. Nat Commun. 2026 Apr 13;17(1):3451. doi: 10.1038/s41467-026-70396-1.
PubMed 41974675

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of a Universal Influenza (Uniflu) Vaccine With INFLUENZA G1 mHA in Healthy Adults
ClinicalTrials.gov ID: NCT05901636
Acronym / sponsor ID: CR108777
Conditions: Influenza Prevention
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Collaborators: Biomedical Advanced Research and Development Authority
Study start: 17 May 2023 (actual)
Primary completion: 19 Aug 2024 (actual)
Study completion: 19 Aug 2024 (actual)
First posted: 13 Jun 2023 (actual)
Results: Posted 8 Sep 2025

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
INFLUENZA G1 mHA Dose Level 1	Experimental	Biological: INFLUENZA G1 mHAParticipants will receive single intramuscular (IM) injection of INFLUENZA G1 mHA Dose level 1 on Days 1 and 57 in Cohort 1.
INFLUENZA G1 mHA Dose Level 1 along with Al(OH)3	Experimental	Biological: INFLUENZA G1 mHA, Biological: Al(OH)3Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 1 with Aluminum Hydroxide (Al[OH])3 adjuvant on Days 1 and 57 in Cohort 1.
Placebo	Placebo comparator	Biological: PlaceboParticipants will receive IM injection of placebo on Days 1 and 57 in Cohorts 1 and 2.
INFLUENZA G1 mHA Dose Level 2	Experimental	Biological: INFLUENZA G1 mHAParticipants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Days 1 and 57 in Cohort 2.
INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3	Experimental	Biological: INFLUENZA G1 mHA, Biological: Al(OH)3Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Days 1 and 57 in Cohort 2.
INFLUENZA G1 mHA Dose Level 2 + Placebo	Experimental	Biological: INFLUENZA G1 mHAParticipants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Day 1 and placebo on Day 57 in Cohort 2.
INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 + Placebo	Experimental	Biological: INFLUENZA G1 mHA, Biological: Al(OH)3Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Day 1 and placebo on Day 57 in Cohort 2.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Must be healthy as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening
Contraceptive (birth control) use by female participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies. Before randomization, participants who were born female must be either: a) not of childbearing potential; b) of childbearing potential and practicing a highly effective method of contraception and agreeing to remain on such a method of contraception from signing the informed consent until 3 months after the last dose of study vaccine. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Highly effective methods for this study include: hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion/ligation procedures, vasectomized partner (the vasectomized partner should be the sole partner for that participant), and sexual abstinence
All female participants of childbearing potential must: a) have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; b) have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
Must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the US FDA toxicity scale 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

Key exclusion criteria (10 listed)

Contraindication to IM injections and blood draws, example, bleeding disorders
Clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
History of severe allergic reaction (for example, anaphylaxis) or other serious adverse reactions to vaccines or vaccine excipients (specifically the excipients of the study vaccine[s])
Abnormal function of the immune system resulting from: a) clinical conditions (example, autoimmune disease or immunodeficiency) or their treatments expected to have an impact on the immune response elicited by the study vaccine; b) chronic or recurrent use of systemic corticosteroids within 2 months before administration of study vaccine and during the study; c) administration of antineoplastic and immunomodulating agents or radiotherapy expected to have an impact on the immune response elicited by the study vaccine within 6 months before administration of study vaccine and during the study
History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy

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
INFLUENZA G1 mHAINFLUENZA G1 mHA will be administered intramuscularly.	Biological	INFLUENZA G1 mHA Dose Level 1, INFLUENZA G1 mHA Dose Level 1 along with Al(OH)3, INFLUENZA G1 mHA Dose Level 2, INFLUENZA G1 mHA Dose Level 2 + Placebo, INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3, INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 + Placebo
PlaceboPlacebo will be administered intramuscularly.	Biological	Placebo
Al(OH)3Al(OH)3 will be administered intramuscularly.	Biological	INFLUENZA G1 mHA Dose Level 1 along with Al(OH)3, INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3, INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 + Placebo

Primary outcome

Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
An AE was 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 the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
An AE was 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 the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using food and drug administration (FDA) toxicity grading scale- Pain: Grade (G) 1 (mild; does not interfere with activity); G2 (moderate; requires modification in activity/use of medications); G3 (severe; inability to do usual activities/use of narcotic pain reliever); G4 (life threatening; hospitalization), Erythema and swelling: G 1 (mild; 25 -50 millimeter [mm]); G2 (moderate; 51 -100 mm); G3 (severe; greater than [>] 100 mm); G4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).
Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using FDA toxicity grading scale- Pain: Grade 1 (mild; does not interfere with activity); Grade 2 (moderate; requires modification in activity/use of medications); Grade 3 (severe; inability to do usual activities/use of narcotic pain reliever); Grade 4 (life threatening; hospitalization), Erythema and swelling: Grade 1 (mild; 25 -50 mm); Grade 2 (moderate; 51 -100 mm); Grade 3 (severe; >100 mm); Grade 4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1
Time frame: From Day 1 up to Day 365
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was 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 the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2
Time frame: From Day 57 up to Day 365
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was 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 the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius [C]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).
Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius [C]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1
Time frame: From Day 1 up to Day 365
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2
Time frame: From Day 57 up to Day 365
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.
Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
An AE was 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 the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.
Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1
Time frame: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2
Time frame: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1
Time frame: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).
Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2
Time frame: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1
Time frame: From Day 1 up to Day 365
Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 1 are reported below.
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Time frame: From Day 57 up to Day 365
Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 2 are reported below.
Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1
Time frame: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.
Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2
Time frame: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.
Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine
Time frame: From first vaccination (Day 1) up to Day 365
An AE was 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 the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with SAEs and SAEs related to study vaccine were reported.

1 secondary outcome

Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Days 29 and 85

Results and safety

Results posted to the registry on 8 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)	25	24
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)	25	23
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)	25	22
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)	25	22
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)	25	23
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)	25	21
Group 3 and Group 8: Placebo (Two Doses)	20	17

Primary outcome: Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1

Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8). Count of participants. Unit: Participants

Measure	Group 1: Influenza A G1 mHA 45 mcg (Two Doses) n = 25	Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) n = 25	Group 4: Influenza A G1 mHA 135 mcg (Two Doses) n = 25	Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) n = 25	Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) n = 25	Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) n = 25	Group 3 and Group 8: Placebo (Two Doses) n = 20
Value	5	12	3	13	6	14	1

Population analysed: Full analysis set (FAS) included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.

Primary outcome: Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2

Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64). Count of participants. Unit: Participants

Measure	Group 1: Influenza A G1 mHA 45 mcg (Two Doses) n = 24	Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) n = 23	Group 4: Influenza A G1 mHA 135 mcg (Two Doses) n = 23	Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) n = 25	Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) n = 23	Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) n = 24	Group 3 and Group 8: Placebo (Two Doses) n = 20
Value	5	9	5	8	2	5	2

Population analysed: FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.

Primary outcome: Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1

Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8). Count of participants. Unit: Participants

Measure	Group 1: Influenza A G1 mHA 45 mcg (Two Doses) n = 25	Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) n = 25	Group 4: Influenza A G1 mHA 135 mcg (Two Doses) n = 25	Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) n = 25	Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) n = 25	Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) n = 25	Group 3 and Group 8: Placebo (Two Doses) n = 20
Value	0	1	0	0	0	0	0

Population analysed: FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.

Primary outcome: Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2

Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64). Count of participants. Unit: Participants

Measure	Group 1: Influenza A G1 mHA 45 mcg (Two Doses) n = 24	Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) n = 23	Group 4: Influenza A G1 mHA 135 mcg (Two Doses) n = 23	Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) n = 25	Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) n = 23	Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) n = 24	Group 3 and Group 8: Placebo (Two Doses) n = 20
Value	0	0	0	0	0	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Influenza A G1 mHA 45 mcg (Two Doses)	0 of 25 (0%)	9 of 25 (36%)	0 of 25
Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses)	0 of 25 (0%)	16 of 25 (64%)	0 of 25
Group 4: Influenza A G1 mHA 135 mcg (Two Doses)	0 of 25 (0%)	8 of 25 (32%)	0 of 25
Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses)	2 of 25 (8%)	18 of 25 (72%)	0 of 25
Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose)	0 of 25 (0%)	9 of 25 (36%)	0 of 25
Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose)	0 of 25 (0%)	16 of 25 (64%)	0 of 25
Group 3 and Group 8: Placebo (Two Doses)	0 of 20 (0%)	9 of 20 (45%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41974675Hertoghs N, Tang C, van Paassen V, Jongeneelen M, Tolboom J, Yieh L, Wang M, Kaszas K, McLean C, van den Berg S, Lowson D, Hu W, Aguilar Z, Hendriks J, Kuipers H, Kulke S, Sadoff J, Brandenburg B, Zahn R. A group 1 hemagglutinin stem vaccine elicits broad humoral responses against influenza in phase 1/2a study. Nat Commun. 2026 Apr 13;17(1):3451. doi: 10.1038/s41467-026-70396-1.
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

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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.

4 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 INFLUENZA G1 mHA and Al(OH)3 in people with Influenza Prevention, run by Janssen Vaccines & Prevention B.V. at 4 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 4 inclusion and 10 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 8 Sep 2025). 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) Within 7 Days After Vaccination 1 (time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)). The study lists 23 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 NCT05901636, 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 8 Sep 2025.