Evaluating the immune response to the JYNNEOS vaccine
Evaluating the Durability of the Human Immune Response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine
This study is testing how well the JYNNEOS vaccine works on the immune system by looking at responses in different parts of the body, like blood and skin, in people who receive the vaccine.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT06366672 on ClinicalTrials.gov |
What this trial studies
This study assesses how the human immune system responds to the JYNNEOS vaccine, specifically focusing on T cell and antibody responses in various tissues including blood, lung mucosa, skin, and bone marrow. It aims to fill the gap in understanding the mucosal immune response and the immune response in bone marrow, which have been less studied compared to blood responses. Participants will receive the vaccine and undergo procedures such as phlebotomy, bronchoscopy, skin biopsies, and bone marrow aspiration to evaluate immune responses over time.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-60 who have not previously received smallpox or monkeypox vaccines.
Not a fit: Patients with a history of smallpox or monkeypox vaccination, immunocompromised individuals, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of immune responses to the JYNNEOS vaccine, potentially leading to improved vaccination strategies against orthopoxvirus diseases.
How similar studies have performed: While there have been many studies on immune responses to vaccines, this specific focus on mucosal and bone marrow responses to the JYNNEOS vaccine is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Saint Louis, Missouri
- Washington University in Saint Louis School of Medicine Emergency Care and Research Core — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Philip Mudd, MD, PhD — Washington University School of Medicine
- Study coordinator: Philip Mudd, MD, PhD
- Email: pmudd@wustl.edu
- Phone: 314-273-1576
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.