At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2A Partially-Blind Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Live Attenuated, Intranasal B. Pertussis Vaccine (BPZE1) in Healthy Adults
In Brief
A Phase 2 clinical trial evaluating BPZE1 and Placebo for Pertussis and Pertussis Immunisation. Completed, enrolled 50 participants across 1 site.
Detailed Summary
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 following treatment groups in a 3:3:3:1 ratio: 10\^7 colony forming units (CFU) of BPZE1 administered by VaxINator device, 10\^9 CFU of BPZE1 administered by VaxINator device, placebo administered by VaxINator device, 10\^9 CFU of BPZE1 administered by needleless tuberculin syringe. 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.
Study Details
Timeline
Interventions
Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of either 10\^7 colony forming units (CFU) or 10\^9 CFU.
The placebo consists of the same constituents in the same quantities as the BPZE1 investigational vaccines, absent the attenuated B. pertussis cells, reconstituted with sterile water for injection (SWFI).