Controlled Human Infection Model (pertussis)
CCfV is looking for healthy adult volunteers to participate in Canada’s first human challenge trial to better understand pertussis (whooping cough).
Why is this study being done?
Pertussis, commonly called whooping cough, is a highly contagious infectious disease that is still common, though vaccines have been available for decades. CCfV is conducting a human challenge trial to help determine why long-term immunity is not acquired after natural infection or immunization.
Healthy, informed, and consenting participants spend 16-21 days and nights in the CCfV Challenge Unit, an isolated and controlled environment. They will be exposed to a small amount of Bordetella pertussis (the bacteria that causes whooping cough) and monitored continually for symptoms over the study period. Participants will receive treatment (antibiotic) to resolve symptoms.
Am I eligible?
You may be eligible if:
- You are 18-40 years of age.
- You are available for the entire residential stay in the Challenge Unit and during the outpatient period.
- You are in good health.
- Your physical examination and blood test at the screening visit are within normal limits.
- You feel you will be able to stay in the Challenge Unit for the full 16-21 days and nights.
What will I have to do?
Participation will include the initial screening visit, the inpatient stay followed by one year of outpatient (study clinic) visits after being admitted to the Challenge Unit (inpatient). The inpatient period will last 16 – 21 days depending on your post-challenge outcome.
The inpatient period depends on whether you develop symptoms or not. If you do not develop symptoms you are expected to remain an inpatient the longest, as antibiotic therapy will not be started until Day 16. The inpatient period for participants who develop symptoms will depend on which day they develop symptoms and are positive for the bacteria in their nose, how long there are mild symptoms, and when they start the 5-day course of the antibiotic treatment.
Commonly called whooping cough, pertussis is an acute and highly contagious bacterial respiratory tract infection of Bordetella pertussis. The illness is named for the characteristic “whoop” noise caused by a sudden inhalation of air after a coughing fit that often occurs and is associated with the disease. There are 20–40 million cases of pertussis reported globally each year, 400,000 of those being fatal. Though illness in adults can be mild, symptoms can become severe in under-vaccinated and unvaccinated infants.
Vaccination programs for pertussis have been available for decades; however, vaccination and immunity provided by natural infection are not protective for life. There is limited understanding of pertussis’ ability to establish an infection or which pertussis antigens are the most effective targets for vaccines or what type and amount of antibodies are needed to protect adults and children.
Waning immunity is important to understand as older individuals who are only partially immune due to previous illness or fading vaccination immunity are a major source of infection for infants who are at particular risk for pertussis-related complications and death.
To further understand how pertussis infects the body and answer other gaps in knowledge such as pathogenesis, vaccine infectivity, and the immune response to the infection, CCfV is enrolling healthy, informed, and consenting adults in the first controlled human infection model study in Canada.
Controlled human infection models, also known as human challenge trials/studies, are a specialized type of clinical trial where healthy, informed, and consenting adults are intentionally exposed to a pathogen (virus or bacteria) in a controlled environment with healthcare support. Establishing a controlled human infection model of B. pertussis necessitates two consecutive studies.
In the first study, volunteers spend approximately 16-21 days in CCfV’s Challenge Unit, a highly specialized 10-bed hospital unit designed to fully contain respiratory infections. Healthcare support is continually available to assist with and monitor participant safety and wellness.
The primary objective of the first study is to determine the amount of B. pertussis (dose) that results in only mild symptoms (similar to a common cold) among 70-90% of those who received that dose. All participants will receive appropriate antibiotic treatment to prevent severe illness. Five days after appropriate treatment, participants are no longer contagious.
The primary objective of the second study is to confirm the dose that achieved only mild symptoms in the first study and to better describe the clinical course of pertussis disease.
No contact information available.