A Phase 2b, Placebo-Controlled, Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy Adults to Assess Protection Against Colonization Following Challenge with Virulent Wild-Type Bordetella pertussis (CHAMPION-1 study)

In this study, we are trying to find out how we can best protect people against pertussis (more commonly known as whooping cough). Pertussis is a highly contagious infection of the lungs and airways, caused by bacteria (small organisms which can reproduce and cause illness) called Bordetella pertussis (B. pertussis). The groups of people most severely affected by pertussis are babies, the elderly, people with chronic medical conditions that affect the lungs and heart, and people who are immunocompromised (unable to respond normally to an infection). It is estimated that pertussis causes 160,000 deaths in the world each year, with half of these deaths happening in children under 1 year of age.

How will the study be carried out?

The study will take place at the Oxford Vaccine Group and University Hospital Southampton in the United Kingdom. Across the whole study, approximately 44 people aged 18 to 50 years old will take part. You will be enrolled in the study for up to 8 months. This includes the following:

• A screening phase of up to 30 days prior to enrolment
• A vaccination phase lasting up to 120 days after vaccination
• A challenge phase which involves a 17-day and 16-night stay at the challenge unit
• A safety follow-up phase lasting up to 120 days following administration of the challenge agent.

Why am I being asked to take part?

As a healthy volunteer we are asking you to take part in this study so we can investigate the safety and immune response of BPZE1. To take part in the study you must do the following:

1. Agree (consent) to take part in the study and sign and date this form
2. Understand the purpose of the study and the study procedures
3. Be generally healthy and be 18 to 50 years of age
4. Not be pregnant or breastfeeding
5. Be a non-smoker at the time of enrolment
6. Have been vaccinated against COVID-19 (minimum of 2 doses) more than 14 days before vaccination with BPZE1 in this study
7. Be able to understand and comply with planned study procedures including staying at the  challenge unit for 17 days and 16 nights between 2 and 4 months after being vaccinated, being exposed to the bacteria B. pertussis and be willing to take antibiotics as required in the study
8. Be willing to provide written agreement to and abide by infection control rules

Email: info@ovg.ox.ac.uk

Tel: 01865 611400

CHAMPION study website: https://champion1.co.uk/