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NIH begins first-in-human trial for universal flu vaccine

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Anthony S. Fauci



The NIH announced a first-in-human clinical trial of a universal influenza vaccine candidate, developed by scientists at the National Institute of Allergy and Infectious Diseases, or NIAID.

The seasonal influenza vaccine reduces rates of influenza-related hospitalization and death and is the best way to protect against infection, experts agree. But it is generally only 40% to 60% effective at reducing influenza illness, and is often even less potent.

In 2018, the NIAID developed a “scientific blueprint” to aid researchers in the creation of a universal influenza vaccine, with the goal of providing all age groups long-lasting protection from various influenza subtypes, including those that can cause a pandemic.

The new experimental vaccine, currently named H1ssF_3928, was created using only the hemagglutinin stem of an H1N1 influenza virus, and not the head, which is what binds the influenza virus to human host cells, making it a natural target for seasonal vaccines.

A universal influenza vaccine candidate being tested by the NIH targets the stem of the hemagglutinin . Source: CDC/Illustrator: Dan Higgins

But the head mutates frequently — the reason that seasonal vaccines must be updated every year — and many scientists believe that focusing on the stem could induce broader and longer lasting immunity, the NIH noted. The experimental vaccine is designed to elicit a response to diverse influenza subtypes.

According to the release, researchers hope the trial also will help them understand how age and previous exposure to different influenza variants impact immune responses to the vaccine. They will gradually enroll at least 53 healthy adults aged 18 to 70 years, and categorize them into four age groups, with each group consisting of 12 participants.

The first five participants will be aged 18 to 40 years and will receive a single 20-µg intramuscular injection of the experimental vaccine, whereas the other 48 participants will receive two 60-µg vaccinations 16 weeks apart. For 1 week after each injection, participants will record their temperature and any experienced symptoms. At various time points, they will provide blood samples, which will be tested “to characterize and measure levels of anti-influenza antibodies,” according to the release. Nine to 11 follow-up visits are expected over 12 to 15 months, and participants will not be exposed to any influenza virus as part of the trial.

“Seasonal influenza is a perpetual public health challenge, and we continually face the possibility of an influenza pandemic resulting from the emergence and spread of novel influenza viruses,” NIAID director Anthony S. Fauci, MD, said in the release. “This phase 1 clinical trial is a step forward in our efforts to develop a durable and broadly protective universal influenza vaccine.” – by Marley Ghizzone

Disclosure: Fauci reports no relevant financial disclosures.