Trial of a novel influenza vaccine commences at NIH

A promising influenza vaccine developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID) is now entering a Phase 1 clinical trial which will see up to 100 healthy adult volunteers inoculated. The vaccine is to be delivered either as a nasal spray or by intramuscular injection.

The vaccine candidate known as BPL-1357 is a multivalent, whole-virus vaccine containing beta-propiolactone (BPL)-inactivated copies of four strains of influenza: H1N9, H3N8, H5N1, and H7N3.

A preclinical study involving mice and ferrets found two doses of the experimental vaccine was fully protective against fatal doses of six different strains of influenza. These animal studies also demonstrated vaccine efficacy when administered as a nasal spray compared to intramuscular injection.

“Influenza vaccines that can provide long-lasting protection against a wide range of seasonal influenza viruses as well as those with pandemic potential would be invaluable public health tools,” said Anthony Fauci, NIAID Director. “The scientific community is making progress on this pressing global health priority: the BPL-1357 candidate influenza vaccine being tested in this clinical trial performed very well in preclinical studies and we look forward to learning how it performs in people.”

The Phase 1 trial at the National Institutes of Health (NIH) will run for seven months focusing on the immune responses and safety profiles from the BPL-1357 vaccine.

Intranasal or inhalable vaccines are under much scrutiny, owing to how they could potentially and effectively prevent respiratory viruses from taking hold at the point of entry into a human body.

“With the BPL-1357 vaccine, especially when given intranasally, we are attempting to induce a comprehensive immune response that closely mimics immunity gained following a natural influenza infection,” explained NIAID researcher Matthew Memoli. “This is very different than nearly all other vaccines for influenza or other respiratory viruses, which focus on inducing immunity to a single viral antigen and often do not induce mucosal immunity.”

Memoli hopes the trial will establish the potential for this vaccine candidate to not only generate broad antibody responses but also a more direct mucosal immune response in nasal cells exposed to the intranasal version of the vaccine.

Tags: Trial

Category: Features, Pharmaceuticals