What is the mechanism of action of this treatment?

Common flu prevention treatments, such as the INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), work by stimulating the immune system to recognize and combat the influenza virus. These vaccines introduce antigens, like the hemagglutinin protein, which trigger the body to produce antibodies. This immune response helps the body to quickly identify and neutralize the virus upon future exposures, thereby reducing the risk of infection and severity of illness. This mechanism is crucial for flu prevention patients as it provides a proactive defense, minimizing the incidence and impact of influenza outbreaks.

What side effects are associated with this type of intervention?

The most common side effects of influenza vaccines, including those similar to the INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), typically include local reactions at the injection site such as pain, redness, and swelling. Systemic reactions may include fever, headache, muscle aches, and fatigue. These side effects are generally mild and resolve within a few days. Severe allergic reactions are rare. Adjuvanted vaccines, which include substances like aluminum hydroxide to enhance the immune response, may have similar side effects but can sometimes cause more pronounced local reactions.

What prior FDA approvals exist?

The FDA has approved several vaccines for the prevention of influenza, including traditional inactivated influenza vaccines (IIVs) and live attenuated influenza vaccines (LAIVs). These vaccines work by stimulating the immune system to recognize and fight the influenza virus. Similar to the INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA) being studied, which aims to enhance immune response, other innovative approaches like the multimeric-001 (M-001) vaccine have shown promise in inducing significant cellular and humoral immune responses against multiple influenza strains. These advancements represent ongoing efforts to improve the efficacy and breadth of flu vaccines.

What other types of research exist?

Promising novel alternatives to the INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA) for flu prevention include: 1) A candidate influenza B vaccine targeting two adjacent HA stem sites, which has shown a >104-fold reduction in pulmonary viral load. 2) The 4xM2e.HSP70c fusion protein vaccine, which has fully protected mice against lethal doses of H1, H3, and H9 influenza A isolates, demonstrating higher lung viral clearance compared to conventional vaccines.

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Virus Therapy

Universal Influenza Vaccine for Flu Prevention

Phase 1 & 2

Waitlist Available

Research Sponsored by Janssen Vaccines & Prevention B.V.

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Must not have

History of acute polyneuropathy or chronic idiopathic demyelinating polyneuropathy

Clinically significant acute illness or temperature >= 38.0 degree Celsius within 24 hours prior to the planned first dose of study vaccine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 8, 29, 57, 64, 85, 238 and 365

Summary

This trial tests a new flu vaccine in healthy adults. The vaccine uses a small part of the flu virus protein to help the body build immunity, and it may include an extra substance to boost the immune response.

Who is the study for?

Healthy adults aged 18-45 can join this trial. Women must use approved birth control and have negative pregnancy tests. Participants should not have had recent vaccines, investigational drugs/devices, or immune system issues. They also shouldn't be pregnant, breastfeeding, or planning to become pregnant soon.

What is being tested?

The study is testing a new flu vaccine called INFLUENZA G1 mHA with or without an added ingredient (Al(OH)3 adjuvant). It's compared against a placebo to see how safe it is and how the body reacts to it in healthy adults.

What are the potential side effects?

Possible side effects may include reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, allergic responses to vaccine components, and other potential immune-related effects.

Eligibility Criteria

Exclusion Criteria

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

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I have a history of severe nerve damage.

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I haven't had a fever or serious illness in the last 24 hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 8, 29, 57, 64, 85, 238 and 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 8, 29, 57, 64, 85, 238 and 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 8, 29, 57, 64, 85, 238 and 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of Solicited Local AEs at 7 Days Post-vaccination 1

Duration of Solicited Local AEs at 7 Days Post-vaccination 2

Duration of Solicited Systemic AEs at 7 Days Post-vaccination 1

+21 more

Secondary study objectives

Quantification of Antibody Binding to Hemagglutinin (HA) Stem or Full-length Hemagglutinin as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 + PlaceboExperimental Treatment2 Interventions

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Day 1 and placebo on Day 57 in Cohort 2.

Group II: INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3Experimental Treatment2 Interventions

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Days 1 and 57 in Cohort 2.

Group III: INFLUENZA G1 mHA Dose Level 2 + PlaceboExperimental Treatment1 Intervention

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Day 1 and placebo on Day 57 in Cohort 2.

Group IV: INFLUENZA G1 mHA Dose Level 2Experimental Treatment1 Intervention

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Days 1 and 57 in Cohort 2.

Group V: INFLUENZA G1 mHA Dose Level 1 along with Al(OH)3Experimental Treatment2 Interventions

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 1 with Aluminum Hydroxide (Al\[OH\])3 adjuvant on Days 1 and 57 in Cohort 1.

Group VI: INFLUENZA G1 mHA Dose Level 1Experimental Treatment1 Intervention

Participants will receive single intramuscular (IM) injection of INFLUENZA G1 mHA Dose level 1 on Days 1 and 57 in Cohort 1.

Group VII: PlaceboPlacebo Group1 Intervention

Participants will receive IM injection of placebo on Days 1 and 57 in Cohorts 1 and 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Al(OH)3

2023

Completed Phase 2

~170

INFLUENZA G1 mHA

2023

Completed Phase 2

~170

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common flu prevention treatments, such as the INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), work by stimulating the immune system to recognize and combat the influenza virus. These vaccines introduce antigens, like the hemagglutinin protein, which trigger the body to produce antibodies. This immune response helps the body to quickly identify and neutralize the virus upon future exposures, thereby reducing the risk of infection and severity of illness. This mechanism is crucial for flu prevention patients as it provides a proactive defense, minimizing the incidence and impact of influenza outbreaks.

Association between antibody titers and protection against influenza virus infection within households.