Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With… (NCT04957485) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS
United States100 participantsStarted 2022-04-05
Plain-language summary
This study is designed to evaluate the immunogenicity profile of JYNNEOS® when 2 doses are administered subcutaneously (SC) 4 weeks apart; and potential immunological interference while concomitantly administering TPOXX or placebo orally twice daily (BID) for 28 days.
Who can participate
Age range18 Years – 42 Years
SexALL
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Inclusion criteria
✓. Subject is a healthy male or female between 18 and 42 years of age, inclusive, at the time of informed consent.
✓. Subject has a resting heart rate \>40 beats per minute (bpm) or \<110 bpm at screening.
✓. Subject has negative test for HIV antibodies, hepatitis B surface antigen, and hepatitis C virus antibody.
✓. Subject has white blood cells ≥2500/mm3 and \<11,000/mm3.
✓. Subject has hemoglobin within normal limits.
✓. Subject has platelets ≥ lower normal limits.
✓. Subject has adequate renal function defined as a calculated creatinine clearance \>60 mL/min as estimated by the Cockcroft-Gault equation.
✓. Creatinine in males ≤1.7 mg/dL and in females ≤1.4 mg/dL (1.3 times the upper laboratory reference range).
Exclusion criteria
✕. Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the second JYNNEOS injection.
✕. Subject has a history or suspected exposure of smallpox, monkeypox or cowpox disease, or previous vaccination with any poxvirus-based vaccine.
✕. Subject has received any vaccinations within 28 days prior to Day 1 or plans to receive a vaccination at any time during the treatment period or within 28 days after Day 29.
✕. Subject has been administered or plans to be administered immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at trial conclusion.
✕. Subject has used any investigational or nonregistered drug or vaccine other than the trial vaccines within 28 days preceding the first dose of the trial vaccine or planned administration of such a drug /vaccine during the trial period, including the COVID-19 vaccine prior to marketing approval by the FDA.
✕. Subject has a known or suspected history of smallpox vaccination defined as visible vaccination scar or documentation of smallpox vaccination or as reported by the subject.
✕. Subject has had a previous anaphylactic reaction, severe systemic response, or serious hypersensitivity to a prior immunization.