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Virus Therapy

Flu Vaccine for Influenza

Phase 2

Recruiting

Research Sponsored by Biomedical Advanced Research and Development Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or non-pregnant female, 18 years of age or older at the time of screening and informed consent

Be older than 18 years old

Must not have

Has received immunoglobulin or other blood product within the 90 days prior to screening in this study

Female of childbearing potential who has a positive urine pregnancy test or who is currently breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of different doses of a flu vaccine with added ingredients to see how well it works in preventing the A/H5 strain of influenza.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical vaccine reactions such as soreness at the injection site, fever, fatigue, headache, muscle pain, joint pain, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am pregnant or breastfeeding.

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I have narcolepsy or a close family member does.

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

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I have been using glucocorticoids regularly for the last month.

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

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

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My BMI is over 35.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 10Eligibility criteria met