Evaluating the Human Immune Response to the JYNNEOS Vaccine

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Apr 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how the human immune system responds to the JYNNEOS vaccine, which protects against viruses like smallpox and monkeypox. Researchers want to learn more about how strong and lasting this immune response is in different parts of the body, including the blood, lungs, skin, and bone marrow. The trial is currently looking for healthy adults aged 18 to 60 to participate.

To be eligible, participants should not have any serious health conditions, such as a recent organ transplant or active cancer, and they must not have received certain vaccines or had monkeypox before. Those who join the study will undergo various tests and procedures over the course of the trial, which lasts for at least 42 days. It's important to know that participants will need to provide informed consent, meaning they agree to take part in the study after understanding what it involves. This research could help improve future vaccines and our understanding of how they work in the body.

Gender

ALL

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