Evaluating the Human Immune Response to the JYNNEOS Vaccine

Description

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

Study Overview

Study Details

Study overview

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.

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

Evaluating the Human Immune Response to the JYNNEOS Vaccine

Condition
Vaccinia
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University in Saint Louis School of Medicine Emergency Care and Research Core, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18-60 year old otherwise healthy participants
  • * 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

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Washington University School of Medicine,

Philip Mudd, MD, PhD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

2025-12