Volunteers will trial a new way to prevent whooping cough in a study launching in Southampton, following a sharp rise in cases in recent years.
The research is testing a new type of vaccine for whooping cough as the current vaccines become less effective.
Healthy volunteers will be compensated up to £3,775 to take part in the study that involves several visits to University Hospital Southampton and a 16-night stay at a hotel.
The study, known as a ‘human challenge’ trial, will involve a nasal spray of the new vaccine, or placebo, followed three months later by controlled infection with the bacterium that causes whooping cough.
Why is a vaccine needed?
A vaccine for whooping cough, or pertussis, is currently offered in the UK to all babies. However, it does not offer lifelong protection, cannot stop upper airway infections and does not prevent people from spreading it.
The current vaccine was first introduced 17 years ago, and we now know that it is less effective than the old vaccine that it replaced which had side effects. This has contributed to a four-fold rise in UK cases in recent years, from 6,216 in the years 2005-2011 to 25,891 between 2012-2018.
Whooping cough can cause persistent coughing and breathing difficulties for up to three months. Whilst adults can have no symptoms, mild cold-like symptoms or sometimes a prolonged cough, the effects on babies under six months can be severe and even life-threatening.
Caused by the bacteria Bordetella pertussis, it is highly infectious and spread through coughs and sneezes. The bacteria can infect the upper airway without causing disease symptoms, so adults can spread it without knowing they have it. It is estimated to cause 160,000 deaths worldwide each year, half of which are in children less than a year old.
It is therefore generally agreed that there is a need for new and more effective vaccines. A better vaccine might be able to reduce rates by protecting against the spread of the disease.
What does taking part involve?
In previous studies, researchers gave participants nose drops containing the vaccine BPZE1 – a weakened version of the bacteria that causes whooping cough. They found it infected their nose and throat without causing any disease symptoms, and produced an immune response.
The results of this study, CHAMPION-1, will help researchers find out if the BPZE1 vaccine can protect people from being infected with the disease-causing bacteria. It is what is known as a ‘challenge’ study. An atomiser, which is similar to a nasal spray, will be used to deliver either the vaccine or a placebo into the nose of the participant. After 2–4 months participants will then be deliberately infected with the bacteria that causes whooping cough, to see if they are protected. This will be done in the controlled environment of the research clinic.
After this they will then stay at the study hotel for 16 nights. Before they leave, they will be given a course of antibiotics to clear the bacteria from their nose.
In summary, the study involves attending seven clinic visits over approximately six to eight months, including a 16-night stay at the study hotel in Southampton. Participants, who must be aged between 18-50 years and in good health, will be compensated up to £3,775 for their time and inconvenience.
‘Sharp increase in cases’
The research is led by Professor Robert Read, Director of the NIHR Southampton Biomedical Research Centre, and sponsored by ILiAD Biotechnologies. It is being delivered by the NIHR Southampton Clinical Research Facility based in University Hospital Southampton Foundation NHS Trust.
Professor Read says: “Despite the dramatic decline in whooping cough during the 20th century, there has been a sharp increase in cases in recent decades. There is an important need for new and more effective vaccines. We are inviting people in the Southampton area to become part of this journey to best protect people against this life-threatening bacteria.”
To find out more, please visit champion1.co.uk.