ILiAD Biotechnologies Announces Positive Phase 2b Results for BPZE1 Pertussis Vaccine Trial

In a recent announcement, iLiAD Biotechnologies, LLC (ILiAD) shared promising interim results from the SUPER (Stand Up to Pertussis) trial, which tested the next-generation pertussis vaccine, BPZE1, in children. This trial included 366 participants from the United Kingdom, Australia, and Costa Rica and is the first multi-center, placebo-controlled, randomized study of BPZE1 involving healthy children aged 6-17. The aim was to evaluate the immune response and safety of a single intranasal dose of BPZE1, administered both with and without a tetanus, diphtheria, and acellular pertussis vaccine (Tdap, Boostrix®).

The trial's primary goal was to measure the induction of broad pertussis mucosal secretory immunoglobulin A (S-IgA) immunity 29 days following vaccination. The safety of BPZE1, both alone and in conjunction with Tdap, was assessed by tracking reactogenicity within seven days post-vaccination. A key secondary goal was to confirm that the combined administration of BPZE1 and Tdap did not interfere with serum immunoglobulin G (IgG) responses to Tdap antigens, including diphtheria, tetanus, pertussis toxin (PT), filamentous hemagglutinin (FHA), and pertactin (PRN).

The results were encouraging: children vaccinated with BPZE1 alone showed a 3.8-fold increase in S-IgA against whole cell B. pertussis extract, while those who received both BPZE1 and Tdap had a 3.4-fold increase. In contrast, children vaccinated with Tdap alone showed only a 1.2-fold increase. BPZE1 also induced broad systemic immunological antibody responses when administered alone, and when combined with Tdap, it produced systemic IgG responses equal to or greater than those induced by Tdap alone. Importantly, the combination of BPZE1 and Tdap did not interfere with the induction of tetanus or diphtheria antibody responses. Safety profiles were favorable across all groups, reflecting minimal reactogenicity, consistent with previous adult trials.

Keith Rubin, M.D., ILiAD’s CEO and Founder, expressed optimism about the results, stating that BPZE1 has demonstrated its capacity to safely induce strong mucosal and systemic immunity. He noted that while similar results had been observed in adult trials, this study provided substantial evidence of BPZE1’s efficacy in children. Rubin highlighted the potential of BPZE1 to protect not just school-aged children but also their vulnerable contacts, particularly infants. He also mentioned that the trial offered evidence of the vaccine's flexibility within the current immunization schedule.

This trial marked the first time BPZE1 was studied in children who had received the diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in infancy. Previous trials had focused on adults who had received the first-generation whole cell pertussis (wP) vaccine, which is associated with more side effects than DTaP.

Stephanie Noviello, M.D., ILiAD’s Chief Medical Officer, emphasized the importance of the findings, noting the increasing rates of pertussis among school-aged children and their role in transmitting the disease to infants. She highlighted the need for a vaccine that could effectively curb the spread of pertussis and pointed out that BPZE1 demonstrated mucosal immunity induction in children, supporting its potential to break the cycle of B. pertussis transmission.

Pertussis, or whooping cough, remains a serious global health issue, affecting around 16 million people annually and causing nearly 200,000 deaths. Despite an 84% global vaccination coverage, current vaccines have not fully controlled the outbreaks.

BPZE1 is a live-attenuated pertussis vaccine designed to provide comprehensive and long-lasting protection against B. pertussis infection and disease. Developed by the Institut Pasteur de Lille in France, BPZE1 aims to prevent colonization of the nasal passages and transmission of the bacteria, potentially protecting both vaccinated individuals and vulnerable populations like infants. ILiAD Biotechnologies, a clinical-stage biotechnology company, continues to develop this innovative vaccine and aims to validate its efficacy through further clinical trials.