What side effects are associated with this type of intervention?

Common treatments for the flu, such as oseltamivir (Tamiflu) and baloxavir, have known side effects. Oseltamivir can cause gastrointestinal symptoms like nausea and vomiting, and in rare cases, neuropsychiatric effects such as delirium and hallucinations, particularly in children. Baloxavir is generally well tolerated but can cause diarrhea and vomiting, with rare hypersensitivity reactions like anaphylaxis. Flu vaccines, especially those with adjuvants like AS03, are generally safe but can cause local reactions at the injection site, mild fever, and muscle aches. Serious side effects are rare but can include severe allergic reactions.

What prior FDA approvals exist?

The FDA has approved several antiviral drugs for the treatment of influenza, including neuraminidase inhibitors such as oseltamivir (Tamiflu) and zanamivir (Relenza). These drugs work by inhibiting the neuraminidase enzyme, which is essential for the replication of the influenza virus. Additionally, baloxavir marboxil (Xofluza) has been approved as a single-dose antiviral treatment that inhibits the cap-dependent endonuclease protein. For prevention, the FDA has approved various influenza vaccines, including quadrivalent vaccines that protect against four strains of the virus. The Monovalent Influenza A/Astrakhan/3212/2020-like Virus Vaccine with AS03 Adjuvant System is being studied to enhance the immune response, similar to how adjuvanted vaccines like Fluad, which contains the MF59 adjuvant, have been used to boost immunogenicity in older adults.

What other types of research exist?

Promising novel alternatives for flu patients in 2024 include: 1) mRNA-based influenza vaccines, which have shown high efficacy and rapid adaptability to new strains; 2) Universal influenza vaccines targeting conserved viral components to provide broader protection; 3) Nanoparticle vaccines that enhance immune response and stability; 4) Intranasal vaccines offering needle-free administration and mucosal immunity. These alternatives are in various stages of clinical development and have demonstrated potential in recent studies.

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Virus Therapy

H5N8 Flu Vaccine + AS03 Adjuvant for Flu

Phase 1 & 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Administration of long-acting immune-modifying drugs at any time during the study period.

Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose and through the entire study period. For corticosteroids, this will mean prednisone equivalent >=20 milligrams/day for 14 days or a total of >=280 mg of prednisone equivalent dose in any 14-day period. Inhaled and topical steroids are allowed.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days after the second study intervention dose (administered at day 22)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new flu vaccine for adults aged 18 and older. The vaccine includes a booster ingredient to help the body fight the flu better. Researchers want to see if the vaccine is safe and effective.

Who is the study for?

Adults aged 18 or older who are medically stable and can give informed consent. Eligible participants must not have immune system problems, a recent history of cancer (except certain cases), or be receiving immunosuppressive treatments. Pregnant or breastfeeding women, those planning to become pregnant soon, and individuals with a history of severe vaccine reactions are excluded.

What is being tested?

The trial is testing the safety and effectiveness of two different formulations of an H5N8 influenza vaccine combined with AS03 adjuvant in adults. The goal is to determine how well these vaccines generate an immune response against the flu virus.

What are the potential side effects?

Potential side effects may include typical vaccine-related reactions such as soreness at the injection site, fatigue, headache, muscle pain, feverish feelings, and possible allergic responses to components within the vaccine.

Eligibility Criteria

Exclusion Criteria

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

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I will not take long-acting immune-modifying drugs during the study.

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I haven't taken strong immune system drugs for 3 months before getting the first vaccine dose.

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I haven't used any experimental treatments in the last 30 days and won't during the study.

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I have a condition that weakens my immune system.

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I am bedridden.

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I have had Guillain-Barré syndrome in the past.

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My recent lab tests show no major health issues.

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I have received vaccines for public health emergencies like COVID-19 or mpox.

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I have uncontrolled seizures or neurological disorders.

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I do not have uncontrolled heart, lung, liver, or kidney diseases.

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I have an autoimmune disorder, but it's not Hashimoto's causing hypothyroidism.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days after the second study intervention dose (administered at day 22)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days after the second study intervention dose (administered at day 22)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after the second study intervention dose (administered at day 22) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Geometric mean fold rise (GMFR) of serum HI antibody titers against vaccine-homologous H5N8

Hemagglutination-inhibiting (HI) antibody titers against vaccine-homologous H5N8

Percentage of participants reporting MAEs

+9 more

Secondary study objectives

GMFR of serum HI antibody titers against vaccine-homologous H5N8

HI antibody titers against vaccine-homologous H5N8

Microneutralization (MN) antibody titers for a subset of participants

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Active Control

Group I: FLU Q-PAN H5N8 Formulation 2_A GroupActive Control2 Interventions

Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.

Group II: FLU Q-PAN H5N8 Formulation 1_B GroupActive Control2 Interventions

Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.

Group III: FLU Q-PAN H5N8 Formulation 1_A GroupActive Control2 Interventions

Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.

Group IV: FLU Q-PAN H5N8 Formulation 2_B GroupActive Control2 Interventions

Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.

0 / 11Eligibility 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 treatments include antiviral agents and vaccines. Antiviral agents like oseltamivir inhibit the neuraminidase enzyme, preventing the release of new viral particles and limiting the virus's spread. Vaccines stimulate the immune system to recognize and combat the influenza virus. The AS03 adjuvant system in vaccines enhances the immune response by boosting antibody production and activating immune cells, providing stronger and longer-lasting immunity. This is crucial for flu patients as it reduces illness severity, prevents complications, and decreases transmission.

Association between influenza vaccination, all-cause mortality and cardiovascular mortality: a protocol for a living systematic review and prospective meta-analysis.Influenza in solid organ transplant recipients: epidemiology, management, and outcomes.Microarray Gene Expression Dataset Re-analysis Reveals Variability in Influenza Infection and Vaccination.