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

NCT ID: NCT05901636

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2024-08-19

Brief 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.

Conditions

Influenza Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

INFLUENZA G1 mHA Dose Level 1

Participants will receive single intramuscular (IM) injection of INFLUENZA G1 mHA Dose level 1 on Days 1 and 57 in Cohort 1.

Group Type: EXPERIMENTAL

INFLUENZA G1 mHA

Intervention Type: BIOLOGICAL

INFLUENZA G1 mHA will be administered intramuscularly.

INFLUENZA G1 mHA Dose Level 1 along with Al(OH)3

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.

Group Type: EXPERIMENTAL

INFLUENZA G1 mHA

Intervention Type: BIOLOGICAL

INFLUENZA G1 mHA will be administered intramuscularly.

Al(OH)3

Intervention Type: BIOLOGICAL

Al(OH)3 will be administered intramuscularly.

Placebo

Participants will receive IM injection of placebo on Days 1 and 57 in Cohorts 1 and 2.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo will be administered intramuscularly.

INFLUENZA G1 mHA Dose Level 2

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Days 1 and 57 in Cohort 2.

Group Type: EXPERIMENTAL

INFLUENZA G1 mHA

Intervention Type: BIOLOGICAL

INFLUENZA G1 mHA will be administered intramuscularly.

INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3

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.

Group Type: EXPERIMENTAL

INFLUENZA G1 mHA

Intervention Type: BIOLOGICAL

INFLUENZA G1 mHA will be administered intramuscularly.

Al(OH)3

Intervention Type: BIOLOGICAL

Al(OH)3 will be administered intramuscularly.

INFLUENZA G1 mHA Dose Level 2 + Placebo

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Day 1 and placebo on Day 57 in Cohort 2.

Group Type: EXPERIMENTAL

INFLUENZA G1 mHA

Intervention Type: BIOLOGICAL

INFLUENZA G1 mHA will be administered intramuscularly.

INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 + Placebo

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.

Group Type: EXPERIMENTAL

INFLUENZA G1 mHA

Intervention Type: BIOLOGICAL

INFLUENZA G1 mHA will be administered intramuscularly.

Al(OH)3

Intervention Type: BIOLOGICAL

Al(OH)3 will be administered intramuscularly.

Interventions

INFLUENZA G1 mHA

INFLUENZA G1 mHA will be administered intramuscularly.

Intervention Type: BIOLOGICAL

Placebo

Placebo will be administered intramuscularly.

Intervention Type: BIOLOGICAL

Al(OH)3

Al(OH)3 will be administered intramuscularly.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Janssen Vaccines & Prevention B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

Floridian Clinical Research LLC

Miami Lakes, Florida, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Clinical Trials Managements, LLC

Metairie, Louisiana, United States

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VAC21148FLZ1001

Identifier Type: OTHER

Identifier Source: secondary_id

2019-004635-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108777

Identifier Type: -

Identifier Source: org_study_id