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Sponsor: Dalhousie University
Conditions: Pertussis
Interventions: Adacel®
Countries: Canada
Recruitment of individuals primed during childhood with TdaP (tetanus, diphtheria , acellular pertussis) vaccine, and administration of an Adacel booster with blood sample collection at various time points before and after vaccination. Collection of blood sample volumes will be large enough to allow assessment and comparison of multiple assays that evaluate cell-mediated immune (CMI) responses and other biomarkers following the administration of pertussis vaccinations. The ultimate objective would be to utilize these validated assays for evaluation of pertussis clinical trial results or development of new pertussis vaccine formulations.
Sex: ALL
Age: 17 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Age ≥16years * Primed during infancy with an acellular pertussis vaccine * Good general health status, as determined by history no greater than 30 days prior to administration of the first test article * Written informed consent provided * If female of child-bearing potential, has a negative pregnancy test on the day of consent and has agreed to continue adequate contraception until after the last blood draw. Exclusion Criteria: * Not primed in infancy with an acellular pertussis vaccine * History of anemia * Underlying chronic medical condition requiring ongoing monitoring by a physician (e.g., diabetes, seizure disorder) * Underlying cardiac and/or pulmonary disease including hypertension, angina, prior myocardial infection, asthma, emphysema, chronic bronchitis, and pulmonary tuberculosis * Pregnant (known before or established at the time of screening using a urine-based test) * Immunocompromised (reporting HIV/AIDS positive or receiving immunosuppressive therapy involving steroids) * Vaccinated against pertussis within previous 5 years * Refusing to get an Adacel® (TdaP) vaccination dose
- Halifax, Nova Scotia, Canada