In short
Inactivated influenza virus H3N2 hemagglutinin is a protein-based vaccine component studied for the prevention of influenza disease. It is being investigated in one authorised Phase 1/2 trial with 250 healthy participants. The trial compares an extemporaneously mixed combination vaccine containing this hemagglutinin together with OVX836 against several reference vaccines, including Vaxigrip.
Key points
- Inactivated influenza virus H3N2 hemagglutinin is a protein-based vaccine antigen studied for influenza disease.
- One Phase 1/2 trial is authorised and plans to enrol 250 healthy participants.
- The trial is randomised, double-blind and reference-controlled, with intramuscular administration.
- The study assesses safety and immunogenicity of a combination vaccine containing this hemagglutinin and OVX836.
- Primary outcomes include solicited local and systemic reactions during seven days after vaccination.
- The trial also records unsolicited adverse events during 28 days and serious adverse events throughout the study.
What is inactivated influenza virus H3N2 hemagglutinin?
Inactivated influenza virus H3N2 hemagglutinin is a protein-based vaccine antigen derived from the influenza A virus. Hemagglutinin is a surface protein of the influenza virus that allows the virus to attach to and enter host cells. In the trial described here, the hemagglutinin is used in an inactivated form at a dose of 15 micrograms per strain as part of an inactivated influenza vaccine called GC-IIV. The substance is an investigational vaccine component with no marketing authorisation mentioned in the available records.
How does inactivated influenza virus H3N2 hemagglutinin work?
Hemagglutinin is the main target of protective antibodies against influenza. When given as an inactivated vaccine component, it is intended to stimulate the immune system to produce antibodies that recognise the hemagglutinin protein on the surface of influenza viruses. These antibodies are expected to help the body defend itself if it later encounters the influenza virus. The trial investigates whether the immune response is maintained when the hemagglutinin-containing vaccine is mixed with OVX836, a candidate vaccine based on the nucleoprotein of the influenza virus.
Which conditions is it used or studied for?
- Influenza disease — the trial studies the vaccine component in healthy participants to assess safety and immunogenicity against influenza disease.
How is inactivated influenza virus H3N2 hemagglutinin given?
In the trial, the hemagglutinin is given as part of an inactivated influenza vaccine administered by intramuscular injection. The study includes an extemporaneously mixed combination vaccine containing GC-IIV (15 micrograms of each hemagglutinin, including H3N2) and OVX836 (480 micrograms), as well as separate injections of GC-IIV alone and OVX836 alone for comparison.
What do the clinical trials show?
One authorised Phase 1/2 trial is available in the registry. It is a first-in-human, randomised, double-blind, reference-controlled study that plans to enrol 250 healthy participants. The trial compares the extemporaneously mixed combination vaccine against GC-IIV alone, OVX836 alone, GC-IIV and OVX836 given concomitantly, and a licensed trivalent inactivated influenza vaccine (Vaxigrip). The primary outcomes focus on safety and reactogenicity: solicited local and systemic signs and symptoms during seven days after vaccination, unsolicited adverse events during 28 days, serious adverse events, adverse events of special interest and new-onset chronic diseases throughout the study, and safety laboratory test deviations during 28 days. The study is authorised but not yet reported as completed, so no efficacy or immunogenicity results are available.
What side effects are known?
The available sources do not report side effects for this specific hemagglutinin component. The trial is designed to measure solicited local and systemic reactions, unsolicited adverse events, serious adverse events and safety laboratory changes, but no results have been published in the provided data.