Comparing 5 approaches for pertussis (whooping cough)

Exclusion

• −Known allergy to macrolides including azithromycin or erythromycin, history of Clostridium difficile within last 2 months.
• −Immunocompromised (with HIV/AIDS-positive or receiving immunosuppressive therapy involving steroids) or with any medical condition or medication that leads to a compromised immune system.
• −Positive for hepatitis B or C by blood test.
• −Participants with ANY of the following criteria at the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more → will be excluded:
• −Underlying chronic medical condition requiring ongoing follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → and monitoring by a physician (e.g., diabetes, seizure disorder).
• −Underlying cardiac and/or pulmonary disease including hypertension, angina, prior myocardial infarction, asthma, emphysema, chronic bronchitis, and pulmonary tuberculosis.
• −Moderate or severe symptoms of health anxiety, anxiety, and mood symptoms. Self-reported current diagnosis of a major psychiatric illness, including a schizophrenia spectrum disorder, bipolar disorder, posttraumatic stress disorder, obsessive compulsive disorder, substance use, or eating disorder.
• −QT prolongation on electrocardiogram (EKG).
• −Vaccinated against pertussis within previous 5 years and/or \>7 cumulative doses from infancy to date of screening.
• −Reported history of laboratory-confirmed pertussis infection, including having been exposed to B. pertussis in a Controlled Human Infection Model
• −Antibody titer to pertussis toxin \>20 IU/mL (2x the lower limit of quantification (LLOQ)).
• −Detection of B. pertussis in nasal samples prior to challenge using culture isolation and/or PCR detection, or detection of other respiratory infection.
• −Note: Household members whose vaccination is not current will be offered or directed to a pertussis-containing vaccine, as recommended and funded by the Nova Scotia Department of Health and Wellness.
• −Any contraindication to receiving azithromycin.
• −Taking any systemic antibiotic currently or within the previous 2 weeks.
• −Currently taking terfenadine, astemizole, theophylline, or cimetidine.
• −Poor venous access, as defined by inability to obtain venous blood after 3 venipuncture attempts.
• −Receipt of any investigational drug or vaccine within 6 months prior to challenge. An investigational vaccine is defined as a vaccine that is still being tested in clinical trials or one that has not yet been authorized for use in Canada for administration by public vaccine programs.
• −Receipt of any authorized vaccines within 2 weeks prior to challenge with B. pertussis in this study. (This is to avoid attributing any AEs from these vaccines to the B. pertussis challenge, which would skew the study results.)
• −Previous moderate or severe respiratory infection that required hospitalization.
• −Head trauma (e.g., fracture of the cribriform plate) within 1 year of screening.
• −Any other finding that the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → considers will make the participant unsuitable for the study or unable to comply with the study requirements.
• −Symptoms indicative of acute respiratory illness (such as fever, cough, difficulty breathing) identified during the physical examination done on Day -1 (check-in) or Study Day 1 before a participant is challenged.
• −History of Bell's Palsy and/or facial paralysis.
• −Receipt of facial cosmetic filler in the past 3 months.
• −Pregnant (known before or established at the time of screening using a urine-based test) or breastfeeding.
• −Living or working with (any form of close contact) any of the at-risk/vulnerable groups who are not up to date on their vaccination, specifically children \<1 year of age, pregnant woman who have not yet received their maternal Tdap vaccine, immunocompromised individuals, adults \>65 years of age who have not received a dose of Tdap vaccine within the past 10 years, or other at risk persons, as applicable, up to Day 57.
• −Recent (within 6 months) nasal or sinus surgery, recent use of intranasal steroids (4 weeks), or diagnosis with nasal polyps.
• −History of everyday smoking/vaping in the last 2 years and/or current smoking/vaping more than once per week.