Universal Flu Vaccine Enters Clinical Trial

The National Institutes of Health recently announced it is beginning its phase one trial for a universal flu vaccine. Currently, the yearly seasonal flu shot only covers certain strains of the virus. However, scientists are now studying a vaccine that could protect against all flu strains.

A phase 1 clinical trial for a “universal” influenza A vaccine candidate, BPL-1357, is now underway at the National Institutes of Health (NIH) Clinical Center, the agency announced.

In an animal study not yet peer reviewed, mice and ferrets that received the vaccine survived lethal doses of 6 different flu strains, including subtypes not included in the 4 noninfectious, inactivated, avian flu virus strains that make up the experimental vaccine.

The trial will randomly assign up to 100 healthy adults aged 18 to 55 years to receive 2 doses, 28 days apart, of an active intramuscular vaccine and an intranasal placebo, an intranasal vaccine and intramuscular placebo, or 2 placebos.

Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) developed the whole-virus vaccine candidate to induce a comprehensive cellular and mucosal immune response similar to natural infection. Blood and nasal mucosal samples taken monthly for 7 months will allow assessment of mucosal immunity’s role, if any, in protecting against infection and whether inducing both cellular and mucosal immunity increases protection.

Worldwide, influenza causes about 3 million to 5 million severe illnesses and up to 650 000 deaths annually. Pandemics of new influenza strains to which populations have no immunity—such as the 1918 outbreak that caused at least 50 million deaths—are potentially exponentially more lethal than seasonal outbreaks.

If successful in humans, “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,” NIAID Director Anthony S. Fauci, MD, said in the NIH announcement.

Source: American Medical Association, USA.

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