Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59

Completed · Phase 2

Conditions studied: Influenza

In brief

This BARDA-sponsored, randomized, double-blind, phase 2 study is designed to assess safety and immunogenicity of A/H5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with AS03 or MF59.

Key facts

Study ID

NCT06560151

Run by

Biomedical Advanced Research and Development Authority

People needed

1380

Starts

2024-08-21

Expected to finish

2025-06-11

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or non-pregnant female, 18 years of age or older at the time of screening and informed consent.
• Willing and able to provide written informed consent prior to initiation of study procedures.
• Agrees to have specimens collected during this trial specifically for the purpose of future research stored for future research use.
• In relatively stable health, as determined by medical history and physical examination.
• a. Any chronic medical diagnoses or conditions should be stable and well managed, with no significant changes expected during the study period, and in the opinion of the site investigator, will not impact the ability to assess safety and/or immunogenicity per the study design.
• If a female of childbearing potential who is sexually active, agrees to use an adequate method of birth control from Screening through 4 weeks following the last study vaccination and has used an adequate birth control method for at least 2 months prior to Screening.
• a. Female of childbearing potential is defined as post onset menarche and pre-menopausal person capable of becoming pregnant. This does not include females who meet any of the following conditions:
• i. menopausal >2 years
• ii. tubal ligation >1 year
• iii. bilateral salpingo-oophorectomy
• iv. hysterectomy.
• b. Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example: oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; the female participant has exclusively female sexual partners; male partner is sterile or otherwise unable to produce sperm (information on the person's sterility can come from the site personnel's review of the participant's medical records or interview with the participant regarding her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); or male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).
• Available for all study visits, willing to participate in all study procedures, and not planning to relocate from the area for the duration of the study.

You may not qualify if…

• Has an acute illness, as determined by the site investigator, within 72 hours prior to vaccination.
• a. An acute illness that is nearly resolved, with only minor residual symptoms remaining, is allowable if, in the opinion of the site investigator, the residual symptoms will not interfere with the ability of study staff to assess safety parameters as required by the protocol.
• Has a history of severe reaction to any influenza vaccine.
• Has a known allergy to squalene-based adjuvants.
• Female of childbearing potential who has a positive urine pregnancy test or who is currently breastfeeding.
• Has a body mass index >35 kg/m2 .
• Has known human immunodeficiency virus, hepatitis B, or hepatitis C infection (based on medical history).
• Has a history of any pIMDs (list provided in Protocol Appendix 3), neuralgia, paresthesia, neuritis, convulsions, or encephalomyelitis within 90 days prior to Screening, or a family history of Guillain-Barré syndrome.
• Has narcolepsy or a first degree relative with narcolepsy.
• Has a history of alcohol or drug abuse within 5 years prior to Screening.
• Has any diagnosis, current or past, of schizophrenia, bipolar disease, or any other psychiatric diagnosis that may, in the opinion of the site investigator, interfere with participant compliance or safety evaluations.
• Is immunosuppressed due to an underlying disease or medication, use of anticancer chemotherapy (cytotoxic), or radiation therapy.
• With the exception of basal or squamous cell skin cancer, has known active neoplastic disease, including hematologic malignancy.
• Has long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or prednisone equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate or equivalent) within 1 month prior to screening in this study. However, participants on low-dose inhaled steroids (≤800 µg/day of beclomethasone dipropionate or equivalent) or topical steroids are not excluded.
• Has received immunoglobulin or other blood product (with the exception of Rho[D] immune globulin) within the 90 days prior to screening in this study.
• Has received any (licensed or under Emergency Use Authorization [EUA]) live vaccines within 4 weeks or inactivated, messenger RNA (mRNA), or recombinant protein vaccines within 2 weeks prior to screening, or plans to receive such vaccines (including seasonal influenza and COVID-19 vaccines) from screening through 22 days following the second dose of the study vaccine, inclusive of the vaccination day (Screening Visit through Day 43).
• Is participating or plans to participate in another interventional clinical trial (either active or follow-up phase) during the study period.
• Has participated in an A(H5) influenza vaccine study in the past or has a history of A(H5) influenza infection prior to vaccination in this study. This includes, but is not limited to, influenza sub-types A(H5N1), A(H5N8), and A(H5N6).
• Has any laboratory test result or clinical findings (including vital signs) that singly or in combination are likely to unfavorably alter the risks of participant participation or to confound study safety or immunogenicity results, in the opinion of the site investigator. Additionally, the following are exclusionary:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN), or
• Bilirubin >1.5 times the ULN unless isolated Gilbert's syndrome.
• Has any disease or medical condition that, in the opinion of the site investigator, might confound interpretation of safety or immunogenicity.

Where it is running

• DelRicht Research - Atlanta — Atlanta, Georgia, United States
• Javara Research - Privia Medical Group Georgia — Savannah, Georgia, United States
• Accellacare - Duly Health and Care - Oak Lawn — Oak Lawn, Illinois, United States
• Johnson County Clin-Trials (JCCT) — Lenexa, Kansas, United States
• Alliance for Multispecialty Research - Wichita East - Heartland Research Associates — Wichita, Kansas, United States
• Alliance for Multispecialty Research - Lexington — Lexington, Kentucky, United States
• DelRicht Research - New Orleans - Prytania Street — New Orleans, Louisiana, United States
• DelRicht Research - Prairieville — Prairieville, Louisiana, United States
• Rochester Clinical Research — New York, New York, United States
• Accellacare - Cary — Cary, North Carolina, United States
• Accellacare of Hickory — Hickory, North Carolina, United States
• Accellacare - Piedmont Healthcare — Statesville, North Carolina, United States
• Accellacare - Tradd Court — Wilmington, North Carolina, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• DelRicht Research - Tulsa — Tulsa, Oklahoma, United States
• Tekton Research - Oklahoma - Primary Health Partners — Yukon, Oklahoma, United States
• Tekton Research - Austin — Austin, Texas, United States
• Javara Research - Privia Medical Group Gulf Coast — Conroe, Texas, United States
• Tekton Research - San Antonio — San Antonio, Texas, United States
• DelRicht Research - Virgina — Sterling, Virginia, United States

Full record on ClinicalTrials.gov

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