An experimental universal Flu vaccine trial has commenced at Duke University in Durham, North Carolina, led by NIAID’s Vaccine Research Center.
The H1ssF-3928 mRNA-LNP experimental vaccination will be examined in this Phase 1 trial for both safety and its capacity to elicit an immunological response.
Evaluating the Safety Of The Experimental Flu Vaccine
The trial aims to recruit a maximum of 50 healthy individuals aged 18 to 49 who will participate in the study. They will be divided into three groups, each consisting of 10 participants. The groups will receive doses of 10, 25, and 50 micrograms of the experimental vaccine
respectively.
An additional 10 individuals will be enlisted to receive the suggested dosage based on the analysis of the data to establish the optimal dosage. The study will also include a group of participants who will receive the currently available quadrivalent seasonal influenza vaccine.
This group will serve as a direct comparison to assess the immunogenicity and safety of the experimental vaccine in relation to the seasonal flu vaccines. The participants will undergo regular evaluations to assess the safety of the vaccine and, secondarily, its effectiveness. They will also have follow-up appointments for up to one year after receiving the vaccine.
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Promising Results from Previous Clinical Trials
Seasonal influenza, commonly known as the flu, causes the death of thousands of people in the United States annually. According to the Centers for Disease Control and Prevention (CDC), between 2010 and 2020, the estimated annual flu-related deaths ranged from 12,000 to 52,000 in the United States.
While annual seasonal flu vaccines are important for controlling the spread and severity of the flu, they do not provide immunity against all strains of the virus. Each year, experts must predict the most likely flu strains for the upcoming season and include them in the next vaccine.
However, the flu strains can change unexpectedly during vaccine production, potentially reducing the vaccine’s effectiveness. An effective universal flu vaccine could solve these issues by providing broad protection against a wide range of strains and long-lasting immunity, thereby eliminating the need for yearly vaccinations.
The early-stage trial is being conducted as part of the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program, established by NIAID in 2019 to support the development of broadly protective and longer-lasting flu vaccines.
This trial represents the first investigation of a universal flu vaccine candidate within the CIVICs program, and the vaccine was produced at the facilities of the Duke Human Vaccine Institute (DHVI), which is affiliated with the CIVICs program.
Researchers at NIAID’s VRC have already developed a similar vaccine that showed promising results in early clinical trials. Both vaccines utilize a specific section of a flu protein called hemagglutinin (HA) to stimulate a broad immune response against influenza.
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