The National Institutes of Health (NIH) has launched a Phase I clinical trial for a potential universal flu vaccine.
The trial will assess the vaccine candidate BPL-1357 which has been developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID). The candidate is a whole-virus vaccine made up of four strains of non-infectious chemically inactivated, low-pathogenicity avian flu virus.
An animal study of the candidate1 showed that mice receiving two doses of the vaccine survived later exposure to lethal doses of each of six different influenza virus strains, including subtypes that were not included in the vaccine.
The trial, which is taking place at the NIH’s Clinical Center in Bethesda, Maryland, will enrol up to 100 people aged from 18-55 to assess the safety a flu vaccine candidate and its ability to prompt immune responses.
During the trial, volunteers will be randomised into three groups and receive two doses of the vaccine, or a placebo spaced 28 days apart.
Each patient will take part in the study for seven months and will be asked to return to the clinic seven times to provide blood and nasal mucosal samples that will be used by the investigators to detect and characterise immune responses.
“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 NIAID Director Anthony S. Fauci, M.D. “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 pre-clinical studies and we look forward to learning how it performs in people.”
“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,” said Dr. 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.”
“Our study will examine the safety of BPL-1357 and also will allow us to assess the importance of mucosal immunity against flu and whether a strategy of inducing both the cellular and antibody arms of the immune system can provide broader protection against the ever-changing influenza virus,” he added.