After proving the efficacy of a pertussis vaccine in preventing infection, ILiAD Biotechnologies’ next challenge was to add the shot to a Trojan horse lineup of childhood vaccines to see whether they can be co-administered.
The Florida-based biotech has demonstrated just that in a phase 2b trial called SUPER (Stand Up to Pertussis). BPZE1 was tested in 366 healthy school-age children in the U.K., Australia and Costa Rica. The randomized study assessed the immunological response and safety of a single dose of the nasal vaccine with and without co-administration of tetanus, diphtheria and acellular pertussis vaccines (Tdap or Boostrix).
The primary goal was met, with BPZE1 achieving induction of broad pertussis mucosal secretory immunoglobulin A (S-IgA) immunity 29 days post-vaccination, according to a Tuesday release. Children who received BPZE1 alone and in combination with the other vaccines had 3.8-fold and 3.4-fold increases, respectively, of baseline S-IgA levels against B. pertussis. Children who received Tdap alone had a 1.2-fold increase from baseline.
ILiAD’s shot spurred broad systemic immunological antibody responses when given alone. The shot also did not seem to interfere with the induction of tetanus or diphtheria antibody responses.
Safety was tracked for the seven days after administration to assess signs of reactivity, with no red flags and a favorable profile consistent with five previous adult clinical trials.
ILiAD CEO Keith Rubin, M.D., noted that similar efficacy results had previously been established in adult populations, but, now, the biotech has the data to prove the same is true 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,” Rubin said in a Tuesday statement.
The trial helped show BPZE1 can be worked into existing vaccination schedules for children.
Also known as whooping cough, pertussis is caused by a highly contagious bacteria and affects 16 million people annually. Vaccines exist to protect against the disease, but ILiAD said there remains an unmet need to address the potentially life-threatening disease.