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 range
18 Years – 42 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines TPOXX taken orally for a full 28 days alongside the JYNNEOS vaccine — how does taking an antiviral and a vaccine together like this differ from either treatment on its own, and what does that mean for my safety?
2Since this is a Phase 2 trial, what do we actually know so far about how safe and effective this TPOXX-plus-JYNNEOS combination is, and what are the unknowns that Phase 2 is still trying to work out?
3The trial is actively running but no longer enrolling new participants — does that mean there are any findings emerging from it that my doctor has access to, and how might those findings be relevant to my situation?
4The study is measuring both adverse events and immune response — what kinds of side effects have been associated with TPOXX or JYNNEOS individually, and are there any that might be more likely when they're given together?
5Given that this trial focuses on smallpox, which is not currently circulating, would my doctor consider this combination approach relevant to my specific circumstances, or is there a more standard path that might make more sense for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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 weighs 120 kg or more.
. 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.