Toward Comprehensive Immunity: NIH Initiates Clinical Trials for the Definitive Influenza Vaccine

by Liam O'Connor
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universal flu vaccine

Transmission electron micrograph depiction of influenza A virus particles, which have been colorized in red and gold hues, isolated from a clinical sample and subsequently cultivated in cell culture. Influenza A has the potential to infect both human beings and animals, inclusive of birds and swine. Image Credit: NIAID

Vaccine Prospect FluMos-v2 Aims to Neutralize Six Influenza Strains

The National Institutes of Health’s Clinical Center in Bethesda, Maryland, has commenced a Phase 1 trial of an investigational universal flu vaccine candidate named FluMos-v2. Sponsored by the National Institute of Allergy and Infectious Diseases, the trial aims to assess the safety and immunogenicity of this vaccine. FluMos-v2, an enhancement of its predecessor FluMos-v1, is formulated to provide more extensive immunity against six variants of influenza viruses.

The initiation of the Phase 1 trial for a novel universal influenza vaccine candidate is now underway at the Clinical Center of the National Institutes of Health in Bethesda. The trial is overseen by the National Institute of Allergy and Infectious Diseases (NIAID), a constituent of the National Institutes of Health (NIH), and it will scrutinize the safety and efficacy of the investigational vaccine in eliciting an immune response.

Current State of Influenza Vaccines

At present, seasonal flu vaccines are adept at averting particular strains of the influenza virus. Annually, these vaccines undergo reassessment and modification to optimally align with the flu strains anticipated to predominate in the forthcoming flu season. While most seasonal flu vaccines are crafted to equip the immune system to thwart three or four prevalent flu strains, a universal flu vaccine could potentially offer protection against a broader range.

According to the Acting Director of NIAID, Dr. Hugh Auchincloss, “A consummate universal flu vaccine would necessitate fewer regular inoculations than the current annual regimen and would defend against an expansive range of influenza virus strains. Each new candidate for a universal influenza vaccine and its associated clinical trials moves us incrementally closer to that objective.”

About Vaccine Candidate FluMos-v2

FluMos-v2, the vaccine candidate under scrutiny, was engineered by scientists at NIAID’s Vaccine Research Center (VRC). This candidate is a modified version of the earlier universal flu vaccine, FluMos-v1, which initiated human testing in 2021 and is still under evaluation. The design of FluMos-v2 aims to stimulate antibody production against multiple strains of the influenza virus by showcasing segments of the influenza virus’s hemagglutinin (HA) protein in repeated configurations on nanoparticle scaffolding. Animal trials have demonstrated that this candidate vaccine generates robust antibody responses.

Unlike FluMos-v1, which includes HA from four flu strains, FluMos-v2 incorporates HA from six different strains: four from influenza A and two from influenza B viruses. Scientists expect this to extend the range of immunity, thereby offering a wider spectrum of protection against influenza viruses.

Details of the Clinical Trial and Subsequent Monitoring

The forthcoming clinical trial aims to enroll 24 healthy volunteers between the ages of 18 and 50. These participants will receive two intramuscular injections of the FluMos-v2 vaccine, spaced 16 weeks apart. Initially, enrollees will be administered a lower dosage of 60 mcg per vaccination. If the initial dose proves to be safe after being administered to a minimum of three participants, then recruitment will commence for the higher dosage group, at 180 mcg per vaccination. Each dosage group is expected to comprise 12 participants.

Following their first vaccination, participants will undergo regular telephone follow-ups and clinical examinations for a period of 40 weeks to monitor their immunological responses to the experimental vaccine. Blood samples will also be collected during the study visits to evaluate any elicited immune reactions to the vaccine candidate.

Frequently Asked Questions (FAQs) about universal flu vaccine

What is FluMos-v2?

FluMos-v2 is an investigational universal flu vaccine candidate that aims to provide broad immunity against six different strains of the influenza virus. The vaccine has been designed by researchers at the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center.

Who is sponsoring the Phase 1 clinical trials for FluMos-v2?

The Phase 1 clinical trials for FluMos-v2 are being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), which is a part of the National Institutes of Health (NIH).

Where are the clinical trials for FluMos-v2 taking place?

The clinical trials for FluMos-v2 are being conducted at the National Institutes of Health’s Clinical Center located in Bethesda, Maryland.

What is the primary aim of these clinical trials?

The primary objectives of the trials are to evaluate the safety and immunogenicity of the FluMos-v2 vaccine candidate. Immunogenicity refers to the vaccine’s ability to elicit an immune response.

How is FluMos-v2 different from the current seasonal flu vaccines?

Current seasonal flu vaccines are designed to protect against three or four prevalent strains of the flu. In contrast, FluMos-v2 aims to offer immunity against a broader range of six different influenza strains.

How many participants will be enrolled in the clinical trials?

The clinical trial aims to enroll 24 healthy volunteers, aged between 18 and 50 years. Participants will be divided into two dosage groups.

What is the dosage regimen for the trial participants?

The participants will receive two intramuscular injections of the FluMos-v2 vaccine, spaced 16 weeks apart. The trial will start with a lower dosage group of 60 mcg per vaccination and may proceed to a higher dosage group of 180 mcg per vaccination if safety is established.

What kind of follow-up can trial participants expect?

For 40 weeks after the initial vaccination, participants will receive regular follow-up phone calls and clinical examinations. Blood samples will also be taken to measure any immune responses elicited by the vaccine candidate.

What are the anticipated benefits of a universal flu vaccine like FluMos-v2?

A universal flu vaccine like FluMos-v2 could reduce the need for annual vaccinations and provide protection against a wider variety of influenza strains, making it more effective in flu prevention.

Who made the statement regarding the ideal universal flu vaccine?

The statement about an ideal universal flu vaccine was made by Dr. Hugh Auchincloss, the Acting Director of NIAID.

More about universal flu vaccine

  • National Institutes of Health (NIH) Official Website
  • NIAID Vaccine Research Center Overview
  • Current Status of Influenza Vaccines and Research
  • Influenza Virus: Types and Strains
  • Clinical Trial Phases Explained
  • The Need for a Universal Influenza Vaccine
  • Bethesda Clinical Center: Location and Facilities
  • Immunogenicity: What it Means and Why it Matters

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