BPZE1 Pertussis Vaccine Description
BPZE1 is an intranasal vaccine candidate that consists of a live, attenuated form of the pertussis bacterium. The BPZE1 strain was developed at the Institute Pasteur de Lille and Inserm by a team of scientists led by Dr. Camille Locht.
The ILiAD Biotechnologies BPZE1 vaccine is designed to protect against Bordetella pertussis nasal infection (colonization) and active disease through the induction of broad and sustained mucosal and systemic immunity. BPZE1 is currently being developed as a booster vaccine with future development investigating its application as a primary vaccination in infants.
The U.S. FDA cleared an Investigational New Drug Application for the Phase 2a BPZE1 study at the Vanderbilt Vaccine and Treatment Evaluation Unit, sponsored by the National Institute of Allergy and Infectious Disease at the National Institute of Health.
On September 29, 2020, ILiAD announced its Phase 2b study met primary endpoints of overall safety and induction of mucosal immunity, and BPZE1 prevented colonization from re-vaccination/challenge in 90% of subjects with no vaccine-related serious adverse events.
ILiAD Biotechnologies, LLC. is utilizing its B-Tech technology to develop next-generation vaccines to prevent infectious diseases and improve lives.
BPZE1 Pertussis Vaccine Indication
BPZE1 is indicated to prevent pertussis. Pertussis, known as whooping cough, is a life-threatening disease caused by the highly contagious respiratory bacterium, Bordetella pertussis. Pertussis is highly contagious, and an infected person can transmit B. pertussis to as many as 15 other people.
Pertussis can lead to serious illness in people of all ages and can be life-threatening in young infants.
According to the U.S. Centers for Disease Control and Prevention (CDC), pertussis affects approximately 16 million people each year globally, accounting for nearly 200,000 deaths.
BPZE1 Pertussis Vaccine Dosage
BPZE1 is given as a mist into the nose, rather than a shot in the arm.
BPZE1 Pertussis Vaccine News
September 29, 2020 - ILiAD Biotechnologies presented positive topline Phase 2b trial results of its lead pertussis vaccine candidate BPZE1 at the virtual World Vaccine Congress. BPZE1, a live attenuated pertussis vaccine, met both primary endpoints of overall safety and induction of mucosal immunity.
September 24, 2020 - ILiAD Biotechnologies, LLC. announced that it will be presenting new data from its Phase 2b clinical trial of lead pertussis vaccine candidate, BPZE1, at the World Vaccine Congress to be held virtually September 28 – October 1, 2020.
October 3, 2019 - ILiAD Biotechnologies completed subject enrollment in its IB-200P multicenter, randomized, placebo-controlled, and observer-blinded study of BPZE1. BPZE1 is a live attenuated intranasal pertussis vaccine being studied in healthy adults to assess the immunological response and safety profile of single-dose and two-dose vaccination schedules. The study has now randomly assigned 300 subjects in a 2:1 ratio to a first (primary) vaccination, with 200 subjects assigned to BPZE1 vaccination and 100 subjects to Boostrix™ (currently marketed vaccine). The study design includes a second (boost) vaccination 3 months after subjects receive their primary dose. For the second dose, half the subjects will receive a boost dose of BPZE1 and half will receive an intranasal placebo.
December 19, 2018 - LiAD Biotechnologies announced the initial closing of a Class C financing, which will provide ILiAD with up to $20 million of proceeds. The initial closing includes commitments to fund $12.8 million. These funds will enable the company to conduct a Phase 2b BPZE1 clinical study following the Phase 2a study currently in progress at the Vanderbilt Vaccine Research Program.
BPZE1 Pertussis Clinical Trials
More than 360 healthy adults have now received intranasal administration of a range of doses of BPZE1 in two Phase 1 and two Phase 2 clinical studies without any vaccine-related serious adverse events and a clean overall safety profile said the company.
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-center, 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
- The 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.