Date: 2016-02-19
Type of information: Completion of patient enrollment
phase: 1b
Announcement: completion of patient enrollment
Company: ILiAD Biotechnologies (USA - NY)
Product: BPZE1 Pertussis Vaccine
Action
mechanism: vaccine. BPZE1 is a next generation pertussis vaccine designed to induce comprehensive immunity and provide durable protection against whooping cough. BPZE1 has been developed to block B. pertussis from colonizing the adult nasal passage, potentially preventing transmission to infants. The vaccine was developed in the laboratory of Dr. Camille Locht and licensed to ILiAD from the French National Institute of Health and Medical Research (Inserm) and the Institut Pasteur de Lille (IPL) by Inserm Transfert and IPL. As part of a collaboration agreement with Inserm/IPL, ILiAD supports applied research in Dr. Locht’s lab and funds the Phase 1b trial.
Disease: Bordetella pertussis infection
Therapeutic area: Infectious diseases
Country: Sweden
Trial details:
Latest
news: * On February 19, 2016, ILiAD Biotechnologies announced that enrollment has been completed for three randomized groups of study subjects in a Phase 1b vaccine clinical trial being conducted in Stockholm, Sweden. The Phase 1b clinical trial is studying two higher doses and volumes of BPZE1, 108 CFU and 109 CFU, as a follow-up to a prior Phase 1 BPZE1 trial published in the journal PLOS One. The original study indicated that BPZE1 is safe in healthy adults at doses up to 107 CFU and can induce immune responses targeting Bordetella pertussis (B. pertussis) bacteria. The purpose of the current study is to demonstrate safety at higher doses, as well as to investigate whether a greater proportion of subjects attain BPZE1-induced immune responses by dose escalation. ILiAD has raised more than $5 million to date and, in addition to Phase 1b enrollment, has achieved several key milestones. BPZE1 technology is covered by 14 issued patents, with an additional 30 patents pending around the world. In a non-human primate model, ILiAD has demonstrated that BPZE1 effectively protects against both whooping cough and B. pertussis nasopharyngeal colonization.
