Clinical trial of NIH candidate mRNA universal flu vaccine begins

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Clinical trial of NIH candidate mRNA universal flu vaccine begins

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Clinical trial of NIH candidate mRNA universal flu vaccine begins

A clinical trial of an experimental universal flu vaccine developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) has begun recruiting volunteers at Duke University in Durham, North Carolina.

The Phase 1 trial will test the safety of the experimental vaccine, called H1ssF-3928 mRNA-LNP, and its ability to elicit an immune response.

Influenza A virus (H3N2)

The trial will enroll 50 healthy volunteers aged 18 to 49.

Three groups of study participants (10 each) will receive 10, 25 and 50 micrograms of the experimental vaccine.

After the data have been evaluated to determine the optimal dose, an additional 10 participants will be recruited to receive the optimal dose.

The study will also include a cohort of participants who will receive the current quadrivalent seasonal influenza vaccine.

This will allow researchers to directly compare the immunogenicity and safety of the candidate vaccine with existing seasonal flu vaccines.

Participants will be assessed periodically to assess the vaccine’s safety (and secondarily, its effectiveness) and will be followed for up to 1 year after vaccination.

Seasonal influenza, or the flu, kills tens of thousands of people in the United States each year.

The U.S. Centers for Disease Control and Prevention estimates that between 2010 and 2020, between 12,000 and 52,000 people died from the flu each year in the U.S. (link is external).

Although annual seasonal flu vaccines are valuable tools for controlling the spread and severity of flu, they do not provide immunity against every flu strain.

Every year, before the flu season begins, scientific experts must predict which flu strains are likely to be most common in the coming months and then choose three or four of those strains to include in the next seasonal flu shot.

Vaccine makers then need time to produce and distribute a vaccine — during which time the dominant virus strain can change unexpectedly, potentially reducing the vaccine’s effectiveness.

These problems could be eliminated with an effective universal flu vaccine, which protects recipients against various strains of the virus and ideally provides long-lasting, long-lasting immunity so people don’t need to be vaccinated every year.

“A universal flu vaccine would be a major public health achievement that would eliminate the need to develop a seasonal flu vaccine each year, and the need for patients to get an annual flu shot,” said NIAID Acting Director Hugh Auchincloss, M.D., “In addition, Some influenza strains have high pandemic potential. A universal influenza vaccine can serve as an important line of defense against the spread of future influenza pandemics.”

This early trial was conducted through the Collaborative Influenza Vaccine Innovation Centers (CIVICs) (link is external) program, created by NIAID in 2019 to support the development of broadly protective and longer-lasting influenza vaccines.

This is the first investigational universal influenza vaccine candidate tested by the CIVICs program and is produced at the facilities of Duke University’s Human Vaccine Institute (DHVI), which is part of the CIVICs program.

A similar vaccine developed by researchers at NIAID’s VRC has shown positive results in early clinical trials.

Both vaccines use a specific part of the influenza protein, called hemagglutinin (HA), to induce a broad immune response to influenza.

While one part of the HA protein, the so-called head, tends to change as the flu virus spreads and evolves, a more stable part, the so-called stem, evolves very slowly in many different types of flu viruses very similar.

By using the HA stem as the basis for a vaccine, the researchers hope to induce long-term immunity against a wide range of influenza viruses.

Unlike VRC’s earlier vaccines, the H1ssF-3928 mRNA-LNP vaccine candidate uses a messenger RNA (mRNA) platform.

By developing and testing a variety of different universal flu vaccine platforms, researchers have a better chance of finding a vaccine that is safe and provides robust and broad immunity against a variety of strains.

Clinical trial of NIH candidate mRNA universal flu vaccine begins

(source:internet, reference only)

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