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

NCT06560151 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: BP-I-23-001
• Study Type: interventional
• Target: 1,380
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Influenza

Keywords

A/H5; H5; Inactivated; Monovalent; Influenza; Vaccines; AS03; MF59

Outcome Measures

Primary Outcomes (3)

• The percentage of participants who experience any solicited local reactogenicity symptom occurring within 8 days of each vaccination, inclusive of the vaccination day.

  Day 1 through Day 8 and Day 22 through Day 29

• The percentage of participants who experience any solicited systemic reactogenicity symptom occurring within 8 days of each vaccination, inclusive of the vaccination day.

  Day 1 through Day 8 and Day 22 through Day 29

• The percentage of participants achieving seroprotection at Day 43 based on serum HAI antibody titers (≥1:40) to A/Astrakhan (H5N8).

  Day 43

Secondary Outcomes (37)

• The percentage of participants who experience any unsolicited TEAE within 22 days of each vaccination, inclusive of the vaccination day.

  Day 1 through Day 22 and Day 22 through Day 43

• The percentage of participants who experience any treatment-emergent SAE.

  Day 1 through Day 203

• The percentage of participants who experience any treatment-emergent MAAE.

  Day 1 through Day 203

• The percentage of participants who experience any treatment-emergent pIMD.

  Day 1 through Day 203

• The percentage of participants achieving seroprotection at Day 43 based on serum HAI antibody titers (≥1:40) to A/bar-headed goose (H5N1).

  Day 43

Study Arms (15)

Treatment Group A

EXPERIMENTAL

This treatment group of 60 participants (ages 18-64) in Treatment Group A will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose of AS03A.

Biological: 3.75 µg H5N8 antigen plus full dose AS03A

Treatment Group B

EXPERIMENTAL

This treatment group of 120 participants (60 participants ages 18-64 and 60 participants ages ≥65) in Treatment Group B will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a full dose of AS03A.

Biological: 7.5 µg H5N8 antigen plus full dose AS03A

Treatment Group C

EXPERIMENTAL

This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a full dose of AS03A.

Biological: 15 µg H5N8 antigen plus full dose AS03A

Treatment Group D

EXPERIMENTAL

This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A.

Biological: 3.75 µg H5N8 antigen plus half dose AS03A

Treatment Group E

EXPERIMENTAL

This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A.

Biological: 7.5 µg H5N8 antigen plus half dose AS03A

Treatment Group F

EXPERIMENTAL

This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65 will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A.

Biological: 15 µg H5N8 antigen plus half dose AS03A

Treatment Group G

EXPERIMENTAL

This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59.

Biological: 3.75 µg H5N8 antigen plus MF59

Treatment Group H

EXPERIMENTAL

This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59.

Biological: 7.5 µg H5N8 antigen plus MF59

Treatment Group I

EXPERIMENTAL

This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59.

Biological: 15 µg H5N8 antigen plus MF59

Treatment Group J

EXPERIMENTAL

This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A.

Biological: 3.75 µg H5N1 antigen plus full dose AS03A

Treatment Group K

EXPERIMENTAL

This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A.

Biological: 7.5 µg H5N1 antigen plus full dose AS03A

Treatment Group L

EXPERIMENTAL

This treatment group of 60 participants (ages ≥65) will receive 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A.

Biological: 15 µg H5N1 antigen plus full dose AS03A

Treatment Group M

EXPERIMENTAL

This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59.

Biological: 3.75 µg H5N1 antigen plus MF59

Treatment Group N

EXPERIMENTAL

This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59.

Biological: 7.5 µg H5N1 antigen plus MF59

Treatment Group O

EXPERIMENTAL

This treatment group of 60 participants (age ≥65) will receive 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59.

Biological: 15 µg H5N1 antigen plus MF59

Interventions

3.75 µg H5N8 antigen plus full dose AS03A BIOLOGICAL

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

Treatment Group A

7.5 µg H5N8 antigen plus full dose AS03A BIOLOGICAL

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

Treatment Group B

15 µg H5N8 antigen plus full dose AS03A BIOLOGICAL

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

Treatment Group C

3.75 µg H5N8 antigen plus half dose AS03A BIOLOGICAL

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

Treatment Group D

7.5 µg H5N8 antigen plus half dose AS03A BIOLOGICAL

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

Treatment Group E

15 µg H5N8 antigen plus half dose AS03A BIOLOGICAL

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

Treatment Group F

3.75 µg H5N8 antigen plus MF59 BIOLOGICAL

Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.

Treatment Group G

7.5 µg H5N8 antigen plus MF59 BIOLOGICAL

Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.

Treatment Group H

3.75 µg H5N1 antigen plus full dose AS03A BIOLOGICAL

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.

Treatment Group J

7.5 µg H5N1 antigen plus full dose AS03A BIOLOGICAL

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.

Treatment Group K

15 µg H5N1 antigen plus full dose AS03A BIOLOGICAL

Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.

Treatment Group L

3.75 µg H5N1 antigen plus MF59 BIOLOGICAL

Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.

Treatment Group M

7.5 µg H5N1 antigen plus MF59 BIOLOGICAL

Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.

Treatment Group N

15 µg H5N1 antigen plus MF59 BIOLOGICAL

Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.

Treatment Group O

15 µg H5N8 antigen plus MF59 BIOLOGICAL

Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.

Treatment Group I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Rho Federal Systems Division, Inc.: collaborator
• ICON plc: collaborator
• Biomedical Advanced Research and Development Authority: lead

Study Sites (20)

DelRicht Research - Atlanta

Atlanta, Georgia, 30329, United States

Location

Javara Research - Privia Medical Group Georgia

Savannah, Georgia, 31406, United States

Location

Accellacare - Duly Health and Care - Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

Johnson County Clin-Trials (JCCT)

Lenexa, Kansas, 66219, United States

Location

Alliance for Multispecialty Research - Wichita East - Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Alliance for Multispecialty Research - Lexington

Lexington, Kentucky, 40509, United States

Location

DelRicht Research - New Orleans - Prytania Street

New Orleans, Louisiana, 70115, United States

Location

DelRicht Research - Prairieville

Prairieville, Louisiana, 70769, United States

Location

Rochester Clinical Research

New York, New York, 14609, United States

Location

Accellacare - Cary

Cary, North Carolina, 27518, United States

Location

Accellacare of Hickory

Hickory, North Carolina, 28601, United States

Location

Accellacare - Piedmont Healthcare

Statesville, North Carolina, 28625, United States

Location

Accellacare - Tradd Court

Wilmington, North Carolina, 28401, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

DelRicht Research - Tulsa

Tulsa, Oklahoma, 74133, United States

Location

Tekton Research - Oklahoma - Primary Health Partners

Yukon, Oklahoma, 73099, United States

Location

Tekton Research - Austin

Austin, Texas, 78745, United States

Location

Javara Research - Privia Medical Group Gulf Coast

Conroe, Texas, 77384, United States

Location

Tekton Research - San Antonio

San Antonio, Texas, 78229, United States

Location

DelRicht Research - Virgina

Sterling, Virginia, 20166, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

MF59 oil emulsion

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: August 21, 2024
• Primary Completion: January 2, 2025
• Study Completion: June 11, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

US (20)