A total of 78 healthy adults have now received intranasal administration of a range of doses of BPZE1 in two Phase 1 clinical studies without any vaccine-related serious adverse events (SAE) and no marked difference in minor adverse events compared to placebo controls. Building on a previously published BPZE1 Phase 1a study conducted at the Karolinska University Hospital (Sweden) that demonstrated safety and induction of immune responses at lower doses, a 54-subject Phase 1b Swedish study evaluating higher volume and higher doses has been completed. While maintaining an excellent safety profile, > 80% of BPZE1 vaccinated subjects (including all dose groups) had transiently positive nasopharyngeal BPZE1 colonization, the first step to inducing a protective immune response. Serum antibody measurements demonstrated > 90% of all subjects receiving BPZE1 had a seropositive response to ≥ 1 of the main antigens tested (pertussis toxin, pertactin, FHA, and fimbriae) post vaccination. In the highest BPZE1 dose group, > 90% of subjects had a seropositive immunological response to ≥ 2 antigens.
A Phase 2a clinical study start is planned for the first half of 2018 at the Vanderbilt University School of Medicine Vaccine Research Program. The Vanderbilt Vaccine Research Program is one of nine Vaccine Treatment and Evaluation Units (VTEUs), sponsored by the Division of Microbiology and Infectious Diseases (DMID) in the National Institute of Allergy and Infectious Disease (NIAID) within the National Institute of Health (NIH).