Trials / Active Not Recruiting
Active Not RecruitingNCT06366672
Evaluating the Human 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
- Status
- Active Not Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Orthopoxvirus vaccination leads to very high magnitude antigen-specific T cell responses and neutralizing antibody responses that can be detected in blood decades after vaccination. Despite a large number of previous studies of human immune responses to Modified Vaccinia Ankara (MVA) vaccination in blood, very few of these previous studies evaluate the human mucosal immune response to MVA in the lung and skin, or the immune response to MVA vaccination in the bone marrow. The development of methods to explore human immune responses in these key immunologic compartments now allows the evaluation of the induction of immune responses in these human tissues using the MVA vaccine system.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection | live, nonreplicating vaccine delivered according to the FDA approved package insert |
| PROCEDURE | Phlebotomy | Research blood draw |
| PROCEDURE | Research bronchoscopy | Outpatient research bronchoscopy with bronchoalveolar lavage and endobronchial biopsy performed with conscious sedation. |
| PROCEDURE | Skin punch biopsy | Skin punch biopsy performed with topical anesthesia. |
| PROCEDURE | Bone marrow aspiration | Bone marrow aspiration performed with local anesthesia. |
Timeline
- Start date
- 2024-06-10
- Primary completion
- 2026-09-01
- Completion
- 2026-12-01
- First posted
- 2024-04-16
- Last updated
- 2025-10-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06366672. Inclusion in this directory is not an endorsement.