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Trial Shows Nasal Vaccine Reduces Whooping Cough Bacteria

Child examined by clinician with stethoscope

(Semevent, Pixabay.

5 Sept. 2023. Results of a clinical trial show a vaccine delivered as a nasal spray protects healthy people against infection from the bacteria causing whooping cough infections. The biotechnology company ILiAD Biotechnologies LLC, developer of the vaccine code-named BPZE1, announced findings from the challenge study, which are not yet peer-reviewed, in a statement today.

Whooping cough is a highly contagious respiratory disease, caused by infections from the Bordetella pertussis bacteria. The disease, also known as pertussis, results from the bacteria attaching to tiny hairs called cilia that line the upper respiratory organs, and releasing toxins that damage the lining of lungs and airways. Whooping cough spreads from person to person easily through coughs or sneezes carrying the bacteria. Infants infected with whooping cough can develop violent repeated coughing fits that last as long as 10 weeks.

Vaccines are available and recommended for young children, as well as preventive antibiotics for people exposed to the bacteria. As a result, according to Centers for Disease Control and Prevention, occurrence of whooping cough has largely receded in the U.S. since the 1920s, except for a brief recent period when some parents skipped vaccinations for their children. Nonetheless, children under one year remain those most likely to become infected with whooping cough.

Immune response in the nasal passages

ILiAD Biotechnologies in Weston, Florida develops vaccines and treatments for respiratory diseases, beginning with whooping cough. BPZE1 is the company’s lead product, designed as a live but weakened form of Bordetella pertussis bacteria, administered as a nasal spray to invoke an immune response in the nasal passages, where humans first encounter the bacteria. ILiAD Bio says its preclinical studies show one dose of BPZE1 works quickly to stimulate antibodies and T-cells that clear the bacteria and prevent disease, with four early- and mid-stage clinical trials inducing immune responses in humans without serious vaccine-related  adverse effects. The company says its vaccine is aimed for adolescents and adults.

The recent clinical trial is a mid-stage study enrolling 53 healthy adults at two sites in the U.K. Participants were randomly assigned to receive a single nasal spray dose of BPZE1 or a placebo, then two to four months later exposed to enough Bordetella pertussis bacteria to cause disease. After that exposure, participants were quarantined at a clinic for 17 days, and given antibiotics if whooping cough symptoms developed, with antibiotics also given to those participants not developing symptoms at the end of the monitoring period. The study team from University of Oxford and University Hospital Southampton followed up with participants three and six months later.

ILiAD Bio says results show participants receiving BPZE1 with 98 percent less bacteria burden, measured as bacterial colony forming units or CFUs, than placebo recipients. In addition, BPZE1 recipients develop more antibodies in their mucous membranes and blood serum than placebo recipients. The company says BPZE1 was well tolerated, with mild symptom reactions of short duration, comparable to placebo recipients, and no serious adverse effects.

“The dramatic reduction in quantitative CFU counts in BPZE1 vaccinated participants compared to placebo,” says ILiAD Bio chief medical officer Stephanie Noviello in a company statement released through BusinessWire, “over the duration of post-challenge days, reinforces the potential clinical benefit of BPZE1, confirming previously published BPZE1 results in preclinical and attenuated human challenge studies.” Noviello adds that the company plans to present the findings to the World Vaccine Congress in Barcelona, Spain next month.

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