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Active Not Recruiting
NCT06366672
Evaluating the Human Immune Response to the JYNNEOS Vaccine
Conditions: Vaccinia, Virus Diseases
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Phase: EARLY_PHASE1
Enrollment: 20
Sponsor: Washington University School of Medicine
Location: Washington University in Saint Louis School of Medicine Emergency Care and Research Core St Louis Missouri
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.
Eligibility Criteria
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 study enrollment or on the day of bronchoscopy
* Any significant infiltrate or pleural effusion on upright posterior-anterior and lateral chest x-ray imaging performed on the day of bronchoscopy
* International Normalized Ratio value greater than 1.4 or a Partial Thromboplastin Time value of greater than 40 seconds at study enrollment
* Platelet count of less than 100,000 at study enrollment
Source: ClinicalTrials.gov (NCT06366672). StuddyBuddy aggregates publicly available trial information.