Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine
Recruiting
National Institute of Allergy and Infectious Diseases (NIAID)
Phase 1
2022-06-27
Background:
Influenza (flu) is a virus that infects people of all ages. Some people may have mild flu
symptoms. Others may get very sick and even die from the flu. Flu vaccines help protect
people against the flu, but if the flu strains in the vaccine are not a good match with the
strains circulating in the community, the vaccine is not as effective. Researchers want to
make flu vaccines that protect against changing flu strains.
Objective:
To test if a new flu vaccine is safe and if it creates an immune response.
Eligibility:
Healthy adults ages 18-55 who do not smoke and have not received a flu vaccine in the 8 weeks
prior or a COVID-19 vaccine in the 4 weeks prior to enrollment.
Design:
Participants will be screened on a separate protocol.
Participants will have 9 visits over 7 months. They will get a combination of study vaccine
and/or placebo, both as a shot in the arm and as a spray into the nose, at 2 visits. For 7
days after getting the vaccines, they will take their temperature and complete online surveys
at home to record any symptoms.
At each visit, participants will have a physical exam and medical history. They will give
blood and urine samples. They will have nasal testing. For this, a thin absorptive strip will
be inserted into their nostril for 1 minute to collect mucus. At some visits, the inside of
their nose will be wiped with a small brush to collect cells. For this, their nostril will be
numbed to make it more comfortable. Some blood and nasal samples will be used for genetic
testing. Participants who get flu-like symptoms during the study will be asked to collect
nasal samples at home and send these samples back to NIH to test if they actually have the
flu.
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