More than 360 healthy adults have now received intranasal administration of a range of doses of BPZE1 in two Phase 1 and two Phase 2 clinical studies without any vaccine-related serious adverse events (SAE) and a clean overall safety profile.
Phase 2 Studies: A multi-center Phase 2b study comparing 1 or 2 doses of lyophilized BPZE1 to Boostrix (Tdap vaccine, GSK) in 300 subjects, sponsored by ILiAD, has been completed and has demonstrated the ability for BPZE1 to transiently colonize the majority of subjects previously vaccinated with Boostrix only 3 months earlier. In comparison, vaccination with intranasal BPZE1 demonstrated the ability to prevent 90% of subjects from colonizing with a second dose of BPZE1 3 months later. BPZE1 demonstrated induction of broad mucosal immunity against whole cell extract (WCE) and pertussis-specific protein antibodies. Durability was sustained until the end of the study (9 months) and BPZE1 induced both IgG and IgA systemic immunity using WCE and pertussis-specific protein assays, with durability of response measured until the end of the study (9 months). For Phase 2 studies, intranasal administration was performed using the VaxINator(TM) atomization device (Teleflex, Morrisville, NC). A 50 subject Phase 2a clinical study comparing lyophilized BPZE1 (107 CFU or 109 CFU) to placebo has completed follow-up at the Vanderbilt University School of Medicine Vaccine Research Program and is awaiting serological assay testing. 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).
Phase 1 Studies: In addition to a 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 at the same Swedish institution, evaluating higher volume and higher doses, has also 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.