ILiAD Biotechnologies has initiated the Phase IIb IB-200P clinical trial of BPZE1, a live attenuated intranasal vaccine to treat pertussis, a life-threatening disease caused by the highly contagious respiratory bacterium Bordetella pertussis.
The multi-centre, randomised, placebo-controlled, and observer-blinded study will study BPZE1 in healthy adults to assess the immunological response and safety profile of single and two dose vaccination schedules.
For this trial, ILiAD will enrol about 300 subjects who will be randomly assigned 2:1 for the first (primary) vaccination.
Out of the total subjects, 200 of them will be assigned to BPZE1 vaccination and 100 to Boostrix.
In each primary vaccination group, half of the patients will be given a second (boosting) BPZE1 vaccination and half will receive a placebo.
The trial’s primary immunogenicity outcome is the proportion of subjects who achieve seroconversion against at least one pertussis antigen in nasal secretions on day 29 or 113.
Global contract research organisation Pharmaceutical Product Development (PPD) is leading the study through its vaccines development group that supported more than 145 vaccine clinical trials across more than 50 countries during the past five years.
ILiAD Biotechnologies CEO Dr Keith Rubin said: “Advancing BPZE1 to Phase IIb is another important milestone for ILiAD, and a promising step forward for global health.
“The need for a safe and more effective pertussis vaccine is well recognised, and BPZE1’s ability to induce robust mucosal and systemic immunity continues to be supported by ongoing evidence, giving us further confidence that we can deliver on our mission to eradicate disease due to B. pertussis.”
BPZE1 has been designed to overcome the deficiencies of current vaccines, including poor durability and failure to prevent nasopharyngeal Bordetella pertussis infections.
Prior to the Phase IIa trial of the vaccine, two Phase I studies were concluded at the Karolinska University Hospital in Stockholm.