Evaluating the Human Immune Response to the JYNNEOS Vaccine
NCT ID: NCT06366672
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2024-06-10
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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MVA-BN vaccinated
MVA-BN vaccine administered: day 0 and day 28 Phlebotomy: within 30 days prior to first vaccine dose, day 0, day 14, day 28, day 35, day 42, day 56, day 90, day 110, day 150, day 210, day 395 Research bronchoscopy: within 30 days prior to first vaccine dose, day 42, day 210, day 395 Skin punch biopsy: within 30 days prior to first vaccine dose, day 42, day 210, day 395 Bone marrow aspiration: within 30 days prior to first vaccine dose, day 56, day 110, day 210, day 395
JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection
live, nonreplicating vaccine delivered according to the FDA approved package insert
Phlebotomy
Research blood draw
Research bronchoscopy
Outpatient research bronchoscopy with bronchoalveolar lavage and endobronchial biopsy performed with conscious sedation.
Skin punch biopsy
Skin punch biopsy performed with topical anesthesia.
Bone marrow aspiration
Bone marrow aspiration performed with local anesthesia.
Interventions
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JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection
live, nonreplicating vaccine delivered according to the FDA approved package insert
Phlebotomy
Research blood draw
Research bronchoscopy
Outpatient research bronchoscopy with bronchoalveolar lavage and endobronchial biopsy performed with conscious sedation.
Skin punch biopsy
Skin punch biopsy performed with topical anesthesia.
Bone marrow aspiration
Bone marrow aspiration performed with local anesthesia.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Philip Mudd
Assistant Professor
Principal Investigators
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Philip Mudd, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University in Saint Louis School of Medicine Emergency Care and Research Core
St Louis, Missouri, United States
Countries
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Other Identifiers
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202312043
Identifier Type: -
Identifier Source: org_study_id
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