BPZE1 is a live, attenuated form of the pertussis bacterium.
BPZE1 is indicated to prevent pertussis
BPZE1 is given as a mist into the nose, rather than a shot in the arm.
ILiAD Biotechnologies, LLC (ILiAD) is providing the vaccine.
FDA has cleared the Investigational New Drug (IND) application for a Phase 2a BPZE1 study at the Vanderbilt Vaccine and Treatment Evaluation Unit (VTEU), sponsored by the National Institute of Allergy and Infectious Disease (NIAID) at the National Institute of Health (NIH).
Clinical Trial NCT01188512: First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine
- The purpose of this study is to evaluate the safety and immunogenicity of a new live attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating, placebo-controlled study on a genetically modified B. pertussis strain given as a single intranasal dose to healthy adult male volunteers.
Clinical Trial NCT03541499: Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults
This is a randomized, partially blind, placebo-controlled, clinical trial evaluating a single intranasal dose of BPZE1 in healthy adults.
The study will evaluate a lyophilized formulation of the product, with the goal of testing for the optimal dose for subsequent clinical trials.
Fifty healthy adults, 18-49 years of age will be randomized to one of the four treatment groups
Study duration will be approximately 12 months with a subject participation duration of approximately 6 months.
The primary objective of this study is to assess the safety and tolerability of a single intranasal dose of either 10^7 or 10^9 CFU of lyophilized BPZE1 vaccine.