*Pertussis challenge study in adults vaccinated with BPZE1
Research type
Research Study
Full title
A Phase 2b, Placebo-Controlled, Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy Adults to Assess Protection Against Colonization Following Challenge with Virulent Wild-Type Bordetella pertussis
IRAS ID
1005086
Contact name
André Morais Campos
Contact email
Sponsor organisation
ILiAD Biotechnologies, LLC
Eudract number
2022-000616-63
Clinicaltrials.gov Identifier
Research summary
Summary of Research
Bordetella pertussis is a bacterium (germ) that causes infection in the upper airway and the lungs, often known as “whooping cough”. It is a serious infection that is easily passed to others via coughing, sneezing, talking, or breathing during the early infectious period. While whooping cough is a dangerous disease for the youngest infants, the natural reservoir of infection is increasingly recognised as being in adolescents and adults. Current vaccines do not prevent human-to-human transmission.
Acellular pertussis vaccines (aPVs) were introduced into most developed countries 2 decades ago. Despite a high vaccination rate in children, there has been a resurgence of whooping cough in recent years. Direct evidence that acellular pertussis vaccines (aPVs) do not alter the B. pertussis infectious period (e.g., colonisation of the upper airway) has been demonstrated in non-human studies and it has been generally agreed that there is a need for new and more effective vaccines.
BPZE1 is an experimental, intranasal vaccine, that belongs to a group of vaccines known as live attenuated (modified) vaccines. Live vaccines use a weakened (or attenuated) form of the germ that causes a disease. Previous studies have shown that BPZE1 can result in BPZE1 colonising the nose and throat, but without causing any disease symptoms.
In this study, healthy adults will be vaccinated with BPZE1 to stimulate a protective immune response; then after 2–4 months exposed to actual non-weakened B. pertussis bacteria to assess whether people’s bodies defend against the non-weakened pertussis bacteria.
44 people aged 18 to 50 years old, will take part in the study for up to 8 months. In addition to receiving BPZE1 and exposure to actual non-weakened B. pertussis bacteria, the study will involve procedures such as blood, urine and nasal sample collection, physical exams, ECG, overnight stays in clinic and completing diaries.
Summary of Results
BPZE1, a live attenuated intranasal pertussis vaccine, is designed to prevent Bordetella pertussis (Bp) infection (colonisation), disease and transmission to address shortcomings of current pertussis vaccines. This study assessed BPZE1-mediated protection against colonisation following challenge with 10^5 colony-forming units (CFU) of virulent Bp, previously modelled to colonise 80% of volunteers. Healthy adults were randomised 1:1 to 10^9 CFU BPZE1 or placebo administered intranasally via mucosal atomization device. After 2-4 months, participants were intranasally administered 10^5 CFU of virulent Bp and admitted to the challenge unit for 17 days. The primary endpoint was proportion of participants not colonised by Bp on post-challenge days 9, 11 and 14, as determined by nasal wash culture. Modified intent-to-treat (mITT) and per-protocol adequate inoculum (PPAI) (inoculum dose ≥5x10^4 CFU) analysis sets were used. Safety data was collected. 45 participants were evaluable after challenge, of whom 36 received an adequate challenge inoculum. Prevention of colonising infection was demonstrated in the pre-specified sensitivity analysis of BPZE1-vaccinated compared with placebo-vaccinated participants in the PPAI set (p=0.03); this primary endpoint showed comparable trends in the mITT analysis set. BPZE1 vaccination reduced nasal wash Bp densities by 98.7% vs placebo. BPZE1 group had no serious adverse events (AEs) or AEs leading to discontinuation; AEs were similar between groups. Intranasal BPZE1 vaccination protected against experimental virulent Bp colonisation with a consistent favourable safety profile. These results support the potential of BPZE1 to thereby reduce Bp transmission and disease.
REC name
London - Central Research Ethics Committee
REC reference
22/FT/0066
Date of REC Opinion
11 May 2022
REC opinion
Further Information Favourable Opinion