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NIH launches phase I trial of a novel universal flu vaccine

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Dr Veena Aggarwal, Consultant Women Health, CMD and Editor-in-Chief, IJCP Group & Medtalks Trustee, Dr KK's Heart Care Foundation of India    01 July 2022

The National Institutes of Health has launched the phase I clinical trial of a novel universal influenza vaccine candidate BPL-1357 to study its safety and efficacy in healthy adult volunteers. The placebo-controlled trial will recruit about 100 candidates, aged 18 to 55 years. The single-site trial will be carried out at the NIH Clinical Center in Bethesda, Maryland.

BPL-1357 is an inactivated, whole-virus vaccine and contains four strains of avian influenza viruses (A /Environment /Maryland/261/2006 H7N3, A/Mallard /Maryland/802/2007 H5N1, A/Pintail/Ohio /339/1987 H3N8, and A/Mallard/Ohio /265/1987 H1N9). In pre-clinical studies, the vaccine was protective against the six different influenza virus strains, including subtypes that were not included in the vaccine.

The participants will be randomized into three groups (A, B and C) in a 1:1:1 ratio. They will receive two doses of either the vaccine or a placebo in a gap of 28 days. The new BPL-1357 vaccine will be administered via intramuscular route in Group A along with intranasal saline placebo, while those in Group B would receive the vaccine intranasally plus IM placebo. Participants in Group C will receive the placebo administered IM and intranasally. The study duration is around 7 months.

Those who have taken a flu vaccine within 8 weeks of enrollment are excluded from the trial. The selected participants are required to abstain from taking a flu vaccine for two months after the second dose of the vaccine or the placebo. The immune response would be assessed by blood and nasal mucosal samples to be collected on seven visits separate from the two visits to receive the vaccine or the placebo.

 (Source: National Institutes of Health, June 28, 2022)

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