Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults
Condition: Pertussis; Pertussis Immunisation
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is a phase 2a, single center, randomized, partially blind, placebo controlled, clinical
      trial evaluating a single intranasal dose of either 10^7 colony forming units (CFU) or 10^9
      CFU 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 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. The secondary objectives of this study are: 1)
      to assess the humoral immunogenicity of lyophilized BPZE1 vaccine at Day 15, Day 29 and Day
      181 following receipt of one intranasal dose of 10^7 or 10^9 CFU of BPZE1; 2) to assess
      mucosal immunogenicity of lyophilized BPZE1 vaccine at Day 29 and Day 181 following receipt
      of one intranasal dose of 10^7 or 10^9 CFU of BPZE1; 3) to evaluate nasal clearance of BPZE1
      by culture at Day 29 (and if still positive, at Day 46) following receipt of one intranasal
      dose of lyophilized BPZE1 vaccine of 10^7 or 10^9 CFU of BPZE1.
    

Intervention name(s): BPZE1; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: B. pertussis Vaccine; BPZE1; Immunogenicity; Safety