Evaluating the Human Immune Response to the JYNNEOS Vaccine

Virus Diseases Clinical Trial

Official title:

Evaluating the Durability of the Human Immune Response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06366672
• Other study ID #: 202312043
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Philip Mudd, MD, PhD
• Phone: 314-273-1576
• Email: pmudd[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaccinia
• Virus Diseases

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Washington University in Saint Louis School of Medicine Emergency Care and Research Core	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate the magnitude and surface phenotype of T cells in the blood, airspace, and skin over time		Through study completion on day 395
Other	Evaluate the magnitude and surface phenotype of B cells in the blood and bone marrow over time.		Through study completion on day 395
Primary	Change in magnitude of the MVA-BN antigen-specific T cell response in the blood		Change from day 42 to day 395
Primary	Change in magnitude of the MVA-BN antigen-specific antibody response in blood plasma		Change from day 42 to day 395
Secondary	Change in magnitude of the MVA-BN antigen-specific T cell response in the lower airways		Change from day 42 to day 395
Secondary	Change in magnitude of the MVA-BN antigen-specific antibody response in bronchoalveolar lavage fluid		Change from day 42 to day 395