Pertussis Vaccine Candidate Launches Phase 2b Study
A clinical stage biotech company announced the initiation of a Phase 2b study of BPZE1, a live attenuated intranasal pertussis vaccine.
ILiAD Biotechnologies said in a press release on June 25, 2019, that ‘BPZE1 is the most advanced next-generation pertussis vaccine in the world.’
ILiAd said ‘BPZE1 is designed to overcome the deficiencies of current pertussis vaccines, including poor durability and failure to prevent nasopharyngeal Bordetella pertussis infections that lead to escape mutants and transmission to vulnerable infants.’
In addition, current pertussis vaccines do not fully protect infants under age 6 months, since immunization requires multiple injections, usually at 2, 4 and 6 months.
The BPZE1 vaccine is being studied in 300 healthy adults to assess the immunological response and safety profile of a single dose and two dose vaccination schedules.
The primary immunogenicity outcome of the phase 2b study is the proportion of subjects who achieve seroconversion against at least 1 pertussis antigen in nasal secretions on Day 29 or 113 (prime or prime + boost).
In 2018, a Phase 2a BPZE1 study was initiated at the Vanderbilt Vaccine and Treatment Evaluation Unit (VTEU), sponsored by the National Institute of Allergy and Infectious Disease (NIAID).
Prior to the Phase 2a, two Phase 1 studies have been completed at the Karolinska University Hospital in Stockholm.
Dr. Keith Rubin, Chief Executive Officer of ILiAd, said “The need for a safe and more effective pertussis vaccine is well recognized, and BPZE1’s ability to induce robust mucosal and systemic immunity continues to be supported by ongoing evidence, giving us further confidence that we can deliver on our mission to eradicate disease due to B. pertussis.”
While ILiAD is currently focused on developing a pertussis vaccine to directly protect adults and adolescents and to indirectly protect vulnerable infants, future development aims to immunize neonates directly.
Pertussis, commonly known as whooping cough, is a life-threatening disease caused by the highly contagious respiratory bacterium Bordetella pertussis. According to the Centers for Disease Control and Prevention (CDC), a recent worldwide publication modeling pertussis cases and deaths estimates that there were 24.1 million pertussis cases and 160,700 deaths in children younger than 5 years in 2014.
ILiAD Biotechnologies is a privately held, clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis.