Evaluating the Human Immune Response to the JYNNEOS Vaccine (NCT06366672) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Evaluating the Human Immune Response to the JYNNEOS Vaccine
United States20 participantsStarted 2024-06-10
Plain-language summary
This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* 18-60 year old otherwise healthy participants
Exclusion Criteria:
* Prisoners
* Participants unable to provide full written informed consent
* Previous receipt of a smallpox or monkeypox vaccine
* Previous infection with monkeypox
* Receipt of any vaccine in the 28 days prior to the first study procedure or planned receipt of any vaccine outside of those provided in the current study before completion of the study day 42 visit.
* Immunocompromise (primary or secondary due to other medical conditions or medications)
* Previous organ transplant
* Active malignancy
* Pregnancy
* \< 4 weeks post-partum or actively breastfeeding
* Female participants who are not actively on hormonal contraception or do not have an intrauterine device in place
* Body Mass Index \> 40
* Current smokers
* History of a known chronic pulmonary, cardiovascular, renal, hepatic, hematologic or metabolic disorder. Participants with isolated treated hypertension as the only cardiovascular disorder may be included in the study.
* History of a chronic neurologic or neurodevelopmental condition. This does not exclude potential participants with chronic back pain or previous disk herniation/back surgery, only participants with documented weakness, quadriplegia or paraplegia. This exclusion criterion also does not exclude from the study participants with recurrent migraine headaches as the only chronic neurologic condition.
* Pulse oxygen saturation value of 92% or less on room air at st…
What they're measuring
1
Change in magnitude of the MVA-BN antigen-specific T cell response in the blood
Timeframe: Change from day 42 to day 395
2
Change in magnitude of the MVA-BN antigen-specific antibody response in blood plasma