A Phase 1 clinical trial of a novel influenza vaccine has begun inoculating healthy adult volunteers at the National Institutes of Health Clinical Center in Bethesda, Maryland.
The placebo-controlled trial will test the safety of a candidate vaccine, BPL-1357, and its ability to prompt immune responses. The vaccine candidate was developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID). The single-site trial can enroll up to 100 people aged 18 to 55 years and is led by NIAID investigator Matthew J. Memoli, M.D.
BPL-1357 is a whole-virus vaccine made up of four strains of non-infectious, chemically inactivated, low-pathogenicity avian flu virus.
In the Phase 1 trial, volunteers will be randomized in a 1:1:1 ratio into three groups and will receive two doses of placebo or vaccine spaced 28 days apart. Group A participants receive BPL-1357 intramuscularly along with intranasal saline placebo; Group B will receive doses of the candidate vaccine intranasally along with intramuscular placebo; volunteers in Group C receive intramuscularly and intranasally delivered placebo at both visits to the clinic. Neither the study clinicians nor the volunteers know the group assignments. Volunteers must not have received any type of flu vaccination in the eight weeks prior to enrollment and must agree to forego seasonal flu vaccination for approximately two months after the second vaccine (or placebo) dose.
The study duration for each participant is approximately seven months. In addition to the two clinic visits to receive vaccine (or placebo), volunteers 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 characterize immune responses.
