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Only 172 spots left

~172 spots leftby May 2025

Flu Vaccine for Influenza

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Biomedical Advanced Research and Development Authority

Stay on your current meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18, in stable health, who can consent to the study and agree to have samples stored for future research. Women of childbearing age must use effective birth control. Those with chronic conditions can join if their health is expected to remain stable.

Inclusion Criteria

I am 18 or older and not pregnant.

Exclusion Criteria

I have received a blood product or immunoglobulin within the last 3 months.

I am pregnant or breastfeeding.

I have narcolepsy or a close family member does.

I am immunosuppressed due to a condition, medication, chemotherapy, or radiation.

I have been using glucocorticoids regularly for the last month.

I have been in an A(H5) flu vaccine study or had A(H5) flu before.

I have been sick within the last 3 days before getting a vaccine.

My BMI is over 35.

I haven't had nerve issues or a family history of Guillain-Barré syndrome in the last 3 months.

Participant Groups

The trial tests various doses of H5N8 and H5N1 influenza vaccines combined with AS03 or MF59 adjuvants. It's a phase 2 study assessing safety and how well these vaccines work at different dose levels.

15Treatment groups

Experimental Treatment

Group I: Treatment Group OExperimental Treatment1 Intervention

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.

Group II: Treatment Group NExperimental Treatment1 Intervention

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.

Group III: Treatment Group MExperimental Treatment1 Intervention

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.

Group IV: Treatment Group LExperimental Treatment1 Intervention

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

Group V: Treatment Group KExperimental Treatment1 Intervention

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.

Group VI: Treatment Group JExperimental Treatment1 Intervention

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.

Group VII: Treatment Group IExperimental Treatment1 Intervention

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.

Group VIII: Treatment Group HExperimental Treatment1 Intervention

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.

Group IX: Treatment Group GExperimental Treatment1 Intervention

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

Group X: Treatment Group FExperimental Treatment1 Intervention

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.

Group XI: Treatment Group EExperimental Treatment1 Intervention

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.

Group XII: Treatment Group DExperimental Treatment1 Intervention

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.

Group XIII: Treatment Group CExperimental Treatment1 Intervention

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.

Group XIV: Treatment Group BExperimental Treatment1 Intervention

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.

Group XV: Treatment Group AExperimental Treatment1 Intervention

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.