Whooping cough nasal vaccine shows promise in phase II trial

Researchers reported that participants who were given BPZE1 and then exposed to the whooping cough bacteria were unlikely to pass the infection on to others after day 14 post-challenge.
A woman coughs

A pertussis nasal spray vaccine can stop the bacteria that causes whooping cough from living in the nose and throat, according to the results of a randomised, phase II trial.

Publishing the findings of the CHAMPION-1 study in the The Lancet Microbe on 1 December 2025, researchers analysed data from 53 adult volunteers who either were given BPZE1 — a weakened version of the whooping cough bacteria — as a single spray into the nose or a placebo, then two to four months later were exposed to the bacteria in a controlled setting.

Of those participants who completed the trial per protocol, the researchers observed that nearly two-thirds (60%, n=12/20) in the BPZE1 group and one-quarter (25%, n=4/16) in the placebo group had no detectable colonisation by Bordetella pertussis B1917 on days 9, 11, and 14 post-challenge (P=0.033), which means they would be unlikely to pass the infection on to others.

The authors also revealed that the vaccine was safe and well tolerated, with no serious side effects and a similar frequency of mild adverse effects reported in both groups.

The study was sponsored by ILiAD Biotechnologies and supported by the National Institute of Health Research (NIHR).

Ashifa Trivedi, senior paediatrics pharmacist and vice-chair of the Neonatal and Paediatrics Pharmacists Group, commented: “The early findings from this nasal vaccine study are encouraging, particularly the potential to reduce how easily whooping cough spreads. That could have real benefit for vulnerable babies, who are most at risk of severe illness.

“It is also a timely reminder of how important it is to keep uptake of our existing vaccines high. Maternal vaccination during pregnancy and the routine infant schedule remain the most effective ways we have to protect babies right now.

“This new vaccine is still in the very early stages of research, so we need much larger trials to understand its safety and effectiveness in real-world settings, including for children and pregnant women. If future studies confirm these results, a vaccine that reduces transmission could add an important extra layer of protection.”

Annual data published by the UK Health Security Agency on 27 November 2025 show that in 2024, there were 14,879 pertussis cases — the highest number of reported cases in England since enhanced surveillance started in 1994.

In 2024, there were 11 deaths among babies caused by pertussis and 11 additional deaths among older people linked to pertussis, the data revealed.

The data also show that the majority of infant deaths from pertussis were born to mothers who did not have the prenatal vaccine, which is estimated to provide 91% protection against infant death from whooping cough but does not provide lifelong protection, nor does it not stop people from carrying or spreading the bacteria.

In a press release, published on 3 December 2025, NIHR said that ILiAD Biotechnologies plans to conduct more preclinical studies and, later, clinical trials to support the use of BPZE1 during pregnancy.

Nigel Gooding, consultant pharmacist in neonates and paediatrics at Cambridge University Hospitals NHS Foundation Trust, commented: “We know that immunisation rates of pregnant women is not as high as would be expected for pertussis. This potentially means that babies born to mothers who were are not immunised antenatally are at higher risk of severe pertussis and possibly death. Infants in this group also remain at high risk if they are not subsequently vaccinated through the infant vaccination programme.

“This nasal pertussis vaccination will also potentially offer much longer lasting protection due to its mechanism of action.

“I welcome the further studies planned to support the use of this new vaccine in pregnancy which could significantly reduce the impact of this awful disease in newborns and infants and relieve pressure on limited paediatric intensive care beds required to treat these patients.”

In March 2025, NHS England announced plans to commission community pharmacies to provide whooping cough vaccinations.

Last updated
Citation
The Pharmaceutical Journal, PJ December 2025, Vol 317, No 8004;317(8004)::DOI:10.1211/PJ.2025.1.389236

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