ILiAD's pertussis vaccine enters phase 2 of childhood immunization trials

ILiAD Biotechnologies has made significant strides in the development of a pertussis vaccine, BPZE1, which has been shown to prevent infection. Their next objective was to determine if BPZE1 could be integrated into the existing lineup of childhood vaccines without compromising immunological responses to other diseases.

The Florida-based biotech company achieved a milestone with a phase 2b trial known as SUPER (Stand Up to Pertussis). Conducted in the U.K., Australia, and Costa Rica, the study involved 366 healthy school-age children. This randomized trial aimed to evaluate the immunological efficacy and safety of a single dose of the BPZE1 nasal vaccine, both on its own and in combination with tetanus, diphtheria, and acellular pertussis vaccines (Tdap or Boostrix).

The primary objective of the study was fulfilled, with BPZE1 inducing a broad mucosal secretory immunoglobulin A (S-IgA) response against pertussis 29 days post-vaccination, as detailed in a recent press release. Children who received BPZE1 alone exhibited a 3.8-fold increase in baseline S-IgA levels against B. pertussis, while those who received the vaccine in conjunction with Tdap showed a 3.4-fold increase. In contrast, children who were administered Tdap alone demonstrated a mere 1.2-fold rise from baseline levels.

Furthermore, the BPZE1 vaccine stimulated a comprehensive systemic immunological antibody response when given independently. Crucially, the vaccine did not appear to disrupt the immune responses to tetanus or diphtheria when co-administered with other vaccines.

Safety monitoring for the seven days following vaccination revealed no significant adverse reactions, aligning with the favorable safety profile observed in five previous adult clinical trials. Dr. Keith Rubin, CEO of ILiAD, highlighted that similar efficacy had already been confirmed in adults, and now, data shows that the same holds true for children.

"This immunity and potential ability to prevent transmission may one day protect not only school-age children around the world but also their vulnerable contacts, particularly infants," Rubin stated.

The implications of this trial are far-reaching, demonstrating that BPZE1 can be seamlessly incorporated into existing childhood vaccination schedules. Pertussis, commonly known as whooping cough, is a highly contagious bacterial infection that impacts approximately 16 million people annually. While vaccines are available to mitigate the disease, ILiAD asserts that there remains a critical need to address this potentially fatal illness more effectively.

In summary, ILiAD Biotechnologies has successfully validated that their pertussis vaccine, BPZE1, can be co-administered with other vaccines without compromising immunological responses. This achievement marks a significant step toward enhancing protection against whooping cough for school-age children and their communities worldwide.