This is a randomised, double-blinded, placebo-controlled trial of BPZE1 that includes virulent B. pertussis challenge followed by a safety follow-up.
This Phase 2b challenge study will investigate colonisation rates, immunologic response, and the safety of BPZE1 vaccination to potentially protect against colonising, virulent wild-type B. pertussis infection in healthy adults using a virulent challenge model. Consenting, eligible participants will receive a single dose of BPZE1 or placebo. 2-4 months later they will be challenged with B. pertussis and admitted to a challenge unit. Participants will remain in the challenge unit for a total of 17 days and 16 nights during which time they will be monitored closely. If a participant develops symptoms of pertussis (per investigator discretion), antibiotic (azithromycin) will be started and the participant will remain in the unit for 3 additional days of observation before discharge. If symptoms of pertussis do not develop, then participants will receive antibiotic (azithromycin) from Days 14-16 of the challenge unit stay. Participants will undergo safety follow-up for at least 6 months post-vaccination and at least 3 months post-challenge, for a total follow-up of 6-7 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
53
Oxford Vaccine Group
Oxford, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Number of Participants Colonized Following Virulent Challenge
Participants by treatment group (BPZE1 and placebo) colonized on any day (Challenge Day 9, 11 or 14) following virulent challenge as determined by culture.
Time frame: Challenge Day 9, 11 or 14
GMFR of Mucosal Anti-pertussis S-IgA Antibody
The geometric mean fold rise (GMFR) of mucosal anti-pertussis S-IgA antibody (whole cell extract \[WCE\], FHA, PRN, PT and fimbriae types 2 and 3 \[FIM2/3\]) from baseline to Day 28 (BPZE1 and placebo). Secretory IgA to be normalized (\[specific S-IgA\]/\[total S-IgA\])
Time frame: Day 28
GMFR of Serum IgA Antibody
The GMFR of serum IgA antibody (WCE, FHA, PRN, PT and FIM2/3) from baseline to Day 28 (BPZE1 and placebo)
Time frame: Day 28
GMFR of Serum IgG Antibody
The GMFR of serum IgG antibody (WCE, FHA, PRN, PT and FIM2/3) from baseline to Day 28 (BPZE1 and placebo)
Time frame: Day 28
Safety: Number of Participants With Solicited AEs for Reactogenicity
Occurrence and intensity of solicited AEs for nasal/respiratory and systemic reactogenicity through 7 days following vaccination by treatment group (BPZE1 and placebo)
Time frame: Day 7
Safety: Number of Participants With Treatment Emergent Adverse Events
Occurrence and intensity of TEAEs through 28 days following study vaccination and following challenge by treatment group (BPZE1 and placebo)
Time frame: Day 28
Safety: Number of Participants With TEAEs Related to Vaccination or Related to Challenge
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Challenge Strain
Occurrence and intensity of TEAEs related to vaccination from time of vaccination to challenge or related to challenge for 3 months after challenge by treatment group (BPZE1 and placebo)
Time frame: Day 60-120 post vaccination and Day 90 post challenge
Safety: Number of Participants With AESI and SAE
Occurrence, intensity, and relationship to study vaccine of AESIs and SAEs from vaccination through end of study (EOS) by treatment group (BPZE1 and placebo)
Time frame: Day 180