* Phase 2b trial of BPZE1 Nasal Spray Vaccine in Healthy Children
Research type
Research Study
Full title
A Phase 2b, Multi-Center, Placebo-Controlled, Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy School-Age Children to Assess the Immunological Response and Safety Profile of a Single Dose BPZE1 With and Without Co-Administration of Tetanus, Diphtheria, and Acellular Pertussis (Boostrix™)
IRAS ID
297587
Contact name
Saul Faust
Contact email
Sponsor organisation
ILiAD Biotechnologies
Eudract number
2020-005937-34
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Research Summary
Bordetella pertussis is a bacteria (germ) that causes infection in the upper airway and the lungs, often known as“whooping cough”. A serious infection that is easily passed to others, with effects lasting up to 100 days.
Currently available pertussis vaccines do not provide mucosal immunity or alter B. pertussis acquisition.
While whooping cough is a dangerous disease for the youngest infants, the natural reservoir of infection is increasingly recognized as being in teenagers and young adults. Current vaccines do not prevent human-to-human transmission.
Acellular pertussis (aP) vaccines were introduced into most developed countries 2 decades ago. Despite a high vaccination rate in children, there has been a resurgence of Bordetella pertussis (B. pertussis) in these countries. The resurge is hypothesised to be in part due to the sole use of aP vaccines, which do not alter B. pertussis acquisition and have limited durability.
BPZE1 is an experimental vaccine, that belongs to a group of vaccines known as live attenuated (modified) pertussis vaccine. Live vaccines use a weakened (or attenuated) form of the germ that causes a disease.
BPZE1 has been studied in 4 adult trials (over 350 adults have received this product). In a Phase 2b study, BPZE1, unlike Boostrix™ (a current pertussis vaccine), induced mucosal immunity which was associated with protection from B. pertussis acquisition. A single vaccination appeared sufficient to induce both mucosal and systemic responses in this population.
This is the first study in school-age children. The purpose of this study is to look at serum and mucosal antibodies the body makes following vaccination with BPZE1 or Boostrix™ (a current pertussis vaccine used as a control in this study) or both vaccines. Boostrix is a currently used vaccine that protects participants against tetanus, diphtheria and pertussis. This study will also monitor for safety of the vaccines delivered and the nasal delivery device used for vaccination (VaxINator).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 investigated BPZE1-induced immune responses in a background of DTaP or Tdap (ie, aP-vaccine primed children), with the last pertussis-containing booster occurring more than 3 years prior. BPZE1 alone as well as co-administration with Boostrix (Tdap) were investigated to test safety and determine whether augmenting/broadening mucosal immune responses are possible in an aP-vaccine primed-only population. Furthermore, the testing of interference of BPZE1 with all components found in Boostrix was investigated as a key secondary objective. As this population had never received a whole-cell pertussis (wP) vaccination, this was the first time that a broader immunization against B. pertussis was provided. The study met the primary endpoint demonstrating that BPZE1 induced significant nasal mucosal immune response (secretory immunoglobulin) against whole cell extract in both the BPZE1 and BPZE1+Boostrix groups. Additionally, no interference was found with co-administration of BPZE1 with Boostrix. In addition, when BPZE1 was administered with Boostrix, no interference of BPZE1 on the serum antibody responses to antigens in Boostrix (PT, FHA and PRN) was observed. No unexpected safety concerns emerged. BPZE1 with or without Boostrix was well tolerated with mainly mild FDA toxicity scoring of nasal/respiratory, systemic and local (arm) reactogenicity, which was of similar incidence and intensity to Boostrix. There were no SAEs or AEs leading to discontinuation attributed to vaccination and unsolicited TEAEs were similar between the 3 vaccine groups for both Day 1 and Day 85 (open-label BPZE1) vaccinations.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0348
Date of REC Opinion
18 Jun 2021
REC opinion
Further Information Favourable Opinion