Below are the abbreviated inclusion and exclusion criteria for this trial. Please don’t hesitate to reach out to the site for more information or clarification about them.
Each participant must meet the following criteria:
- Provide consent to be in the study.
- Understand the purpose of the study and the study procedures.
- Be 18 to 50 years of age and generally healthy.
- Not be pregnant or breastfeeding.
- Be a non-smoker at the time of enrolment.
- Have been vaccinated against COVID-19 more than 14 days before vaccination with BPZE1 in this study.
- Be able to comply with planned study procedures including staying at the challenge unit for 17 days and 16 nights between 2 to 4 months after being vaccinated, being exposed to the non-weakened bacteria pertussis and be willing to take antibiotics as required in the study.
- Be willing to provide written agreement to and abide by infection control rules.
Participants meeting any of the following criteria (by review of medical history and participant intake) will be excluded from the study:
- Participation in any other drug studies. This is to protect you from possible interactions between research drugs and prevent you from giving too many blood samples.
- Use of any illegal drugs.
- Unable to follow the alcohol consumption requirements for the study.
- Use of smoking products (including vaping) and unwilling to refrain from use for the required duration of the study.
- Uses nasal sprays (including steroid sprays) or washes for 28 days (four weeks) after both the vaccination and leaving the challenge unit.
- Repeated close contact with or is currently living in a household with an immunocompromised individual.
- Repeated contact, living with or working with the following groups of people from study vaccination to challenge and approximately 1 week after leaving the challenge unit:
- Infants less than 1 year of age
- Partially immunised infants
- Pregnant women
- Adults older than 65 years who have not been vaccinated against pertussis in the last 10 years