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Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine

NCT05027932 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-04-08

Study results available
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Summary

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.

Conditions

Interventions

OTHER

IN Placebo

The placebo is normal saline in two syringes administered IN.

OTHER

IM Placebo

The placebo is normal saline in a syringe administered IM.

DRUG

BPL-1357

BPL-1357 contains 4 whole inactivated avian influenza viruses: A /Environment /Maryland/261/2006 H7N3, A/Mallard /Maryland/802/2007 H5N1, A/Pintail/Ohio /339/1987 H3N8, and A/Mallard/Ohio /265/1987 H1N9. It is administered either IM or IN depending on the assigned treatment group.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Matthew J Memoli, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2023-06-13
Completion
2025-02-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05027932 on ClinicalTrials.gov