Evaluating the Human Immune Response to the JYNNEOS Vaccine

NCT06366672 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 202312043
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaccinia; Virus Diseases

Keywords

T cell; neutralizing antibody; mucosal immunity

Outcome Measures

Primary Outcomes (2)

• Change in magnitude of the MVA-BN antigen-specific T cell response in the blood

  Change from day 42 to day 395

• Change in magnitude of the MVA-BN antigen-specific antibody response in blood plasma

  Change from day 42 to day 395

Secondary Outcomes (2)

• Change in magnitude of the MVA-BN antigen-specific T cell response in the lower airways

  Change from day 42 to day 395

• Change in magnitude of the MVA-BN antigen-specific antibody response in bronchoalveolar lavage fluid

  Change from day 42 to day 395

Other Outcomes (2)

• Evaluate the magnitude and surface phenotype of T cells in the blood, airspace, and skin over time

  Through study completion on day 395

• Evaluate the magnitude and surface phenotype of B cells in the blood and bone marrow over time.

  Through study completion on day 395

Study Arms (1)

MVA-BN vaccinated

EXPERIMENTAL

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

Biological: JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection; Procedure: Phlebotomy; Procedure: Research bronchoscopy; Procedure: Skin punch biopsy; Procedure: Bone marrow aspiration

Interventions

JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection BIOLOGICAL

live, nonreplicating vaccine delivered according to the FDA approved package insert

MVA-BN vaccinated

Phlebotomy PROCEDURE

Research blood draw

MVA-BN vaccinated

Research bronchoscopy PROCEDURE

Outpatient research bronchoscopy with bronchoalveolar lavage and endobronchial biopsy performed with conscious sedation.

MVA-BN vaccinated

Skin punch biopsy PROCEDURE

Skin punch biopsy performed with topical anesthesia.

MVA-BN vaccinated

Bone marrow aspiration PROCEDURE

Bone marrow aspiration performed with local anesthesia.

MVA-BN vaccinated

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• year old otherwise healthy participants

You may not qualify if:

• 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.
• Pulse oxygen saturation value of 92% or less on room air at study enrollment or on the day of bronchoscopy

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in Saint Louis School of Medicine Emergency Care and Research Core

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Vaccinia; Virus Diseases

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic; Smallpox Vaccine; Suspensions; Injections, Subcutaneous; Phlebotomy

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Colloids; Dosage Forms; Pharmaceutical Preparations; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philip Mudd, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be vaccinated with MVA-BN according to the FDA-approved labeling and immune responses in the blood, lung mucosa, skin, and bone marrow will be monitored prior to and following vaccination using phlebotomy, research bronchoscopy, skin punch biopsy, and bone marrow aspiration procedures.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 16, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)