Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study of the Safety and Efficacy of BPL-1357 Against H1N1 Influenza Virus Challenge
National Institute of Allergy and Infectious Diseases (NIAID)
Summary
Background: Influenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics. Objective: To test an experimental flu vaccine. Eligibility: Healthy people aged 18 to 55 years. Design: The study will last 5 to 8 months and has 2 phases, A and B. The study vaccine will be given either as a shot in the arm or as a nasal spray. Participants will receive 1 of 3 combinations: (1) study vaccine in the nose and placebo in the arm; (2) placebo in the nose and study vaccine in the arm; or (3) placebo in the nose and placebo in the arm. A placebo is just like the real vaccine but contains no active ingredients. Phase A: Participants will have 5 clinic visits over 56 days. They will receive a shot and a nasal spray at 2 of the visits, 28 days apart. At each visit, they will have a physical exam, with tests of their blood, urine, and nasal secretions. They will check their temperature at home and record any symptoms for 7 days after each vaccine. Phase B: Participants will stay in the hospital for at least 9 days. They will be infected with a flu virus. They will provide blood, urine, and nasal fluid samples. They will have tests of their heart function. They will remain in the hospital until they test negative for the flu 2 days in a row. They will have 2 follow-up visits, 4 and 8 weeks after leaving the hospital. ...
Description
Study Description: This is a randomized, double-blinded, placebo-controlled, multicenter, phase 2 clinical trial of beta-propiolactone (BPL)-inactivated quadruple influenza virus cocktail vaccine (BPL-1357) administered intramuscularly (IM) or intranasally (IN) in 2 doses 28 days apart. The study has 2 phases: a vaccination phase (Phase A) and a challenge phase (Phase B). In phase A participants will be randomized to 1 of 3 groups for treatment assignment: group A IM BPL-1357 plus IN placebo, group B IM placebo plus IN BPL-1357, or group C IM placebo and IN placebo. In phase B, participants w…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
* INCLUSION CRITERIA: Individuals must meet all of the following criteria to be eligible for study participation: 1. Adults \>=18 and \<= 55 years of age at the time of consent. 2. Able to provide written informed consent. 3. Non-smoker (i.e., tobacco and cannabis) and does not use vape or e-cigarette products currently. Also, must not have used any of these products extensively in the past (regular use more than 5 times per week, more than 6 months lifetime total). 4. Has not received influenza vaccination of any type within 6 months prior to enrollment and consents to not receive influenza…
Interventions
- BiologicalBPL-1357 IM
Quadrivalent, inactivated, whole-virus vaccine containing 4 different wild-type avian viruses given intramuscularly.
- BiologicalBPL-1357 IN
Quadrivalent, inactivated, whole-virus vaccine containing 4 different wild-type avian viruses given intranasally.
- OtherPlacebo IM
Placebo given intramuscularly.
- OtherPlacebo IN
Placebo given intranasally.
Locations (2)
- National Institutes of Health Clinical CenterBethesda, Maryland
- University of Texas Medical Branch, GalvestonGalveston, Texas