The University of Southampton is recruiting for their whooping cough challenge study

The WHO reported 151,074 global cases of whooping cough cases in 2018, with an estimated 89,000 deaths. Whooping cough can affect people of all ages, but young babies are most vulnerable to serious complications and death.

Researchers are working to develop improved vaccines against whooping cough. The existing vaccines are generally effective, but some countries have seen increases in case rates over the past 20 years. In 2012 the UK experienced a nationwide outbreak, where there were over 9,300 cases in England alone – more

The Southampton NIHR Clinical Research Facility, located with Southampton University Hospital NHS Foundation Trust is looking for healthy volunteers to take part in a new trial to develop a new method of protecting people from Whooping cough. Challenge studies like this one inoculate volunteers with B. pertussis bacteria with the goal of establishing colonisation – when the bacteria live in the nose and throat without causing any disease. This can allow researchers to identify correlates of protection, (immunological signals that indicate protection from whooping cough), and help the development and testing of new, better vaccines.

If you are aged 18-55, in good health and not taking antibiotics, you may be eligible to participate. Participants are compensated up to £1000 for their time and travel during the study. Participation on the trial will last around 4-18 weeks with volunteers attending 7-10 visits.

To find out more,
To the Project Management team or call 023 8120 3853
Value:

Challenge studies can help us better understand the immune system mechanisms that support lasting protection against whooping cough. That understanding could accelerate the development of new, better vaccines.
Risks: Although the study aims to establish asymptomatic colonisation with B. pertussis, there is a possibility that participants may develop symptoms. Participants suspected to have whooping cough will be immediately treated with antibiotics, which will help stop the infection spreading to others, and usually (but not always) reduce the symptoms. However, it’s possible that participants given antibiotics even during the early phase of illness may go on to develop the cough. Coughing episodes may disturb sleep or result in vomiting, and occasionally cause whooping. Other complications are rare but still possible.

Risks:

Although the study aims to establish asymptomatic colonisation with B. pertussis, there is a possibility that participants may develop symptoms. Participants suspected to have whooping cough will be immediately treated with antibiotics, which will help stop the infection spreading to others, and usually (but not always) reduce the symptoms. However, it’s possible that participants given antibiotics even during the early phase of illness may go on to develop the cough. Coughing episodes may disturb sleep or result in vomiting, and occasionally cause whooping. Other complications are rare but still possible.

Infection Control Measures:

There is a possibility that participants may transmit B. pertussis and infect others, especially bedroom and household contacts. In order to reduce this possibility, participants and their bedroom contact will be required to follow infection control measures from Day 0 to Day 16 and (for those who decide to take part in the optional re-challenge) week 14 to week 16 + 2 days. Some of the infection control measures include:

  • Avoiding heavily crowded social environments such as crowded pubs and nightclubs
  • Avoiding close contact with babies and other vulnerable individuals
  • Intimate contact and bedroom sharing must be limited to one declared partner who will also attend follow up visits and be issued with antibiotics.

These measures are covered in detail in the volunteer information sheet and during the screening process. 

Treatments:

Prior to discharge, volunteers and bedroom contacts will be given a three day course of a common antibiotic called azithromycin to clear B. pertussis from the nose and throat.

Study Setting:

This study is outpatient and does not involve quarantine. Following the inoculation visit, there are follow-up visits at day 3, day 7, day 14, and day 28, and optional re-challenge visits at week 13, week 15, and week 16, with a final telephone call at week 18.

Support:

In addition to the resources provided by the study team, 1Day Sooner is standing by to support volunteers before, during, and after their trial experience. We can also connect you with volunteers who have already participated in challenge studies. Contact us at organizing@1daysooner.org to learn more!

For more Study details, check out our fact sheet and Southampton’s volunteer information sheet

For a deeper dive, you can view the protocol from the first phase of this study that developed the colonisation model, and visit the website for PERISCOPE, the consortium dedicated to the next generation of whooping cough vaccines.