In May 2024, ILiAD Biotechnologies reported positive topline interim results for BPZE1 in the Stand Up to Pertussis (SUPER) trial. The school-age trial involves 366 participants in the UK, Australia, and Costa Rica; it is the first multi-centre, placebo-controlled, randomised study of BPZE1 in healthy children aged 6-17. It is assessing the immunological response and safety of a single intranasal dose of BPZE1 both with and without coadministration of tetanus, diphtheria, and acellular pertussis.
BPZE1 in trial
BPZE1 is a “technologically advanced” pertussis vaccine containing genetic modifications to “eliminate, attenuate, or inactivate” three different B. pertussis toxins:
- Inactivated pertussis toxin
- Deleted dermonecrotic toxin
- Marked reduction in tracheal cytotoxin
The primary immunogenicity objective of the trial is to demonstrate induction of broad pertussis mucosal secretory immunoglobulin A (S-IgA) immunity 29 days after vaccination with the candidate alone or when administered with Tdap. A “key” secondary objective is to demonstrate non-interference of serum immunoglobulin G (IgG) responses against Tdap-containing antigens at Day 29 after coadministration.
Findings
Children who were intranasally vaccinated with BPZE1 alone and in combination with intramuscular administration of Tdap had 3.8-fold and 3.4-fold increases from baseline levels of S-IgA against whole cell B. pertussis extract. This compares with children vaccinated with Tdap alone, who had “minimal increase” (1.2-fold from baseline).
BPZE1 also induced “broad systemic immunological antibody responses” when delivered alone. In combination with Tdap, it induced systemic IgG responses “equal to or greater than responses induced by Tdap alone”. Furthermore, coadministration with Tdap “did not interfere” with induction of tetanus or diphtheria antibody responses, and “minimal reactogenicity” was observed across all groups.
An effective vaccine
Dr Keith Rubin, Cheif Executive Officer and Founder of ILiAD, stated that BPZE1 has “once again” demonstrated “its unique ability to safely induce potent mucosal and systemic immunity”.
“We now have substantial evidence that the same can be said of BPZE1’s ability to safely induce potent immune responses against B. pertussis in 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.”
Dr Rubin suggested that the trial “also provides evidence” that the vaccine could be “flexibly integrated” into current vaccination schedules, thanking “everyone who contributed to this study”. Dr Stephanie Noviello is ILiAD’s Chief Medical Officer, and highlights that “school-age children are a segment of the population who have experienced an escalating rate” of disease and become a “vector for transmission to vulnerable infants”.
“We need a vaccine that can effectively stop the spread of pertussis.”
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