Flu Vaccine for Influenza

No longer recruiting at 19 trial locations

Overseen By Jeffrey McGuckin, MHS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biomedical Advanced Research and Development Authority

Must not be taking: Glucocorticoids, Anticancer chemotherapy

Disqualifiers: HIV, Hepatitis B/C, Schizophrenia, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new flu vaccine to evaluate its safety and effectiveness in boosting the immune system against the flu. It examines various doses of an A/H5 influenza vaccine combined with adjuvants, which enhance the body's response to the vaccine. Researchers divide participants into several groups to receive different doses and adjuvant combinations. Adults in stable health, including those with chronic conditions, may qualify if interested in joining. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, certain conditions like long-term use of high-dose steroids or recent vaccination may affect eligibility, so it's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past research has shown that A/H5 influenza vaccines with AS03A and MF59 additives are safe and generally well-tolerated. Studies indicate these vaccines generate strong immune responses and maintain a good safety record. Participants reported mostly mild side effects, such as soreness at the injection site or a mild fever.

For the AS03A-added vaccine, research shows a good safety record with only minor side effects. One study found it effective and well-tolerated in children.

The MF59-added vaccine has also undergone testing in various studies. It was found to be safe, with mild side effects similar to those of the AS03A vaccine. These vaccines have been used in other settings and consistently demonstrated safety.

Both additives, AS03A and MF59, enhance vaccine effectiveness without major safety concerns. Participants can feel reassured that these vaccines have undergone thorough testing to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore new formulations of the influenza vaccine targeting the A/H5N8 and A/H5N1 strains, using specific adjuvants like AS03A and MF59 to potentially enhance immune response. Unlike current standard flu vaccines that typically target seasonal strains, this approach aims to address avian influenza, which presents a significant pandemic risk. The use of different dosages and adjuvant combinations may boost the body's defense mechanisms more effectively, providing broader and longer-lasting protection against these specific flu strains. This innovative approach could pave the way for more robust vaccines that guard against a wider range of influenza viruses.

What evidence suggests that this trial's treatments could be effective for influenza?

This trial will evaluate different formulations of the A/H5 influenza vaccine, each combined with adjuvants like AS03 or MF59, to enhance the body's defense against the flu virus. Studies have shown that these adjuvants help the body produce more antibodies, which fight off viruses. Specifically, the AS03 adjuvant helps maintain protective antibodies for longer and increases the number of immune cells targeting the virus. Similarly, the MF59 adjuvant enables more people to develop a noticeable immune response. These findings suggest that the vaccines have strong potential to effectively prevent influenza caused by H5 strains. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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

My chronic conditions are stable and well-managed.

I can attend all study visits and won't move away during the study.

Willing and able to provide written informed consent prior to initiation of study procedures

Exclusion Criteria

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

I have been using glucocorticoids regularly for the last month.

My lab tests or health conditions won't affect the study's safety or results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two doses of adjuvanted vaccine separated by 21 days

6 weeks

2 visits (in-person)

Safety Assessment

Safety assessments based on solicited AEs, unsolicited TEAEs, and treatment-emergent SAEs, pIMDs, and MAAEs

29 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• A/H5 Influenza Vaccine

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Group O Experimental Treatment 1 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 N Experimental Treatment 1 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 M Experimental Treatment 1 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 L Experimental Treatment 1 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 K Experimental Treatment 1 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 J Experimental Treatment 1 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 I Experimental Treatment 1 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 H Experimental Treatment 1 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 G Experimental Treatment 1 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 F Experimental Treatment 1 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 E Experimental Treatment 1 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 D Experimental Treatment 1 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 C Experimental Treatment 1 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 B Experimental Treatment 1 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 A Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Biomedical Advanced Research and Development Authority

Lead Sponsor

Trials

108

Recruited

574,000+

Rho Federal Systems Division, Inc.

Industry Sponsor

Trials

44

Recruited

15,000+

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

Published Research Related to This Trial

Annual influenza vaccination is the largest vaccination effort in the USA, with ongoing discussions about moving towards universal vaccination strategies.

While there is substantial safety data, rare serious adverse events, such as Guillain-Barré syndrome linked to the 1976-1977 vaccine and oculorespiratory syndrome in Canada, highlight the need for continuous monitoring of vaccine safety, especially during pandemic situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring the safety of annual and pandemic influenza vaccines: lessons from the US experience. Iskander, J., Broder, K.[2008]

The A/H5N2 live attenuated influenza vaccine was found to be safe and well tolerated in a phase I clinical trial with 40 healthy volunteers, showing no increased rates of adverse events.

The vaccine demonstrated strong immunogenicity, with 96.6% of participants showing an immune response and significant seroconversion rates (37.9% and 48.3%) four weeks after the second dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical testing of pre-pandemic live attenuated A/H5N2 influenza candidate vaccine in adult volunteers: results from a placebo-controlled, randomized double-blind phase I study. Rudenko, L., Kiseleva, I., Stukova, M., et al.[2022]

Both paper-based and web-based surveys reported similar rates of local and systemic adverse events following influenza vaccination, indicating that the method of data collection does not significantly affect the safety outcomes reported.

The paper-based survey, which recruited participants through general practitioners, was more representative of the elderly population targeted for influenza vaccination, suggesting that combining recruitment methods could enhance the accuracy of safety monitoring during mass vaccination campaigns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of different collection methods for reported adverse events following pandemic and seasonal influenza vaccination. Kemmeren, J., Honsbeek, M., Dijkstra, F., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3132412/

H5N1 Influenza Vaccine Formulated with AS03A Induces ... Adjuvantation of the vaccine led to better persistence of neutralizing and hemagglutination-inhibiting antibodies and higher frequencies of antigen-specific ...

2. medrxiv.org medrxiv.org/content/10.1101/2025.02.12.25322044v1.full.pdf

Inactivated Zoonotic Influenza A(H5N8) Vaccine Induces ... Inactivated Zoonotic Influenza A(H5N8) Vaccine Induces Robust Antibody Responses Against Recent. Highly Pathogenic Avian Influenza Clade ...

3. nature.com nature.com/articles/s41541-018-0076-2

AS03-adjuvanted H5N1 vaccine promotes antibody ... Adjuvants significantly increased virus neutralizing titers. We performed comprehensive analyses of polyclonal antibody responses following FDA- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9612011/

AddaVax-Adjuvanted H5N8 Inactivated Vaccine Induces ... The results indicated that the H5N8 vaccines combined with AddaVax elicited significantly higher immunity compared to other groups, and NI antibody titers of ...

5. mdpi.com mdpi.com/2076-393X/11/8/1391

Advances in Adjuvanted Influenza Vaccines The addition of Matrix MTM to the H5N1 vaccine induced a sufficient antibody response against both homologous and heterologous H5N1 influenza virus [79,80].

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8357047/

Immunogenicity and Safety of AS03-adjuvanted H5N1 ... Immunogenicity and Safety of AS03-adjuvanted H5N1 Influenza Vaccine in Children 6–35 Months of Age. Results From a Phase 2, Randomized, Observer-blind ...

7. fda.gov fda.gov/files/vaccines,%20blood%20&%20biologics/published/Statistical-Clinical-Review---Influenza-A-(H5N1)-Virus-Monovalent-Vaccine--Adjuvanted.pdf

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted analysis of safety data, per vaccine actually administered at the first dose. Page 8. STN: 125419/39. Page 8. According to protocol cohort for ...

8. researchgate.net researchgate.net/publication/49799870_Cross-clade_immunogenicity_and_safety_of_an_AS03A_adjuvanted_prepandemic_H5N1_influenza_vaccine_in_Hong_Kong/download

(PDF) Cross-clade immunogenicity and safety of an AS03A ... The AS03(A)-adjuvanted H5N1 prepandemic influenza vaccine demonstrated good immunogenicity and an acceptable safety profile in Hong Kong.

9. withpower.com withpower.com/trial/phase-2-influenza-human-7-2024-afef1

Flu Vaccine for Influenza · Info for Participants Trial Overview 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 ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3071280/

Safety and Immunogenicity of Influenza A H5 Subunit Vaccines The investigational vaccine was essentially identical to the A/Vietnam/04 clade 1 H5N1 vaccine, except for the following: it contains the A/Indonesia/05/2005 ...