VacciniaEarly Phase 1NCT06366672
Evaluating the Human Immune Response to the JYNNEOS Vaccine
A Early Phase 1 study testing JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection, Phlebotomy and Research bronchoscopy in people with Vaccinia and Virus Diseases, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccinia, Virus Diseases
- What is being tested?
- JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection, Phlebotomy and Research bronchoscopy
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to Oct 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 year old otherwise healthy participants
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in Saint Louis School of Medicine Emergency Care and Research Core
St Louis, Missouri, 63110
About this study
Official title: Evaluating the Durability of the Human Immune Response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine
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.
Read the 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
- Vaccinia, Virus Diseases
- Being tested
- JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection, Phlebotomy, Research bronchoscopy, Skin punch biopsy, Bone marrow aspiration
- Keywords
- T cell, neutralizing antibody, mucosal immunity
- Medical subject headings
- Vaccinia, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injectionBiological
live, nonreplicating vaccine delivered according to the FDA approved package insert
PhlebotomyProcedure or surgery
Research blood draw
Research bronchoscopyProcedure or surgery
Outpatient research bronchoscopy with bronchoalveolar lavage and endobronchial biopsy performed with conscious sedation.
Skin punch biopsyProcedure or surgery
Skin punch biopsy performed with topical anesthesia.
Bone marrow aspirationProcedure or surgery
Bone marrow aspiration performed with local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in magnitude of the MVA-BN antigen-specific T cell response in the blood
Measured: Change from day 42 to day 395
Change in magnitude of the MVA-BN antigen-specific antibody response in blood plasma
Measured: 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
Measured: Change from day 42 to day 395
Change in magnitude of the MVA-BN antigen-specific antibody response in bronchoalveolar lavage fluid
Measured: Change from day 42 to day 395
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start10 Jun 2024
- Primary completion25 Sep 2026
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VacciniaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Mudd, Washington University School of Medicine
- Investigators
- Philip Mudd, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366672
- Sponsor's protocol ID
- 202312043
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Durability of the Human Immune Response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine
- ClinicalTrials.gov ID
- NCT06366672
- Acronym / sponsor ID
- 202312043
- Conditions
- Vaccinia, Virus Diseases
- Keywords
- T cell, neutralizing antibody, mucosal immunity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- Oct 2027 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MVA-BN vaccinated | Experimental | Biological: JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection, Procedure: Phlebotomy, Procedure: Research bronchoscopy, Procedure: Skin punch biopsy, Procedure: Bone marrow aspirationMVA-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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-60 year old otherwise healthy participants
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injectionlive, nonreplicating vaccine delivered according to the FDA approved package insert | Biological | MVA-BN vaccinated |
| PhlebotomyResearch blood draw | Procedure or surgery | MVA-BN vaccinated |
| Research bronchoscopyOutpatient research bronchoscopy with bronchoalveolar lavage and endobronchial biopsy performed with conscious sedation. | Procedure or surgery | MVA-BN vaccinated |
| Skin punch biopsySkin punch biopsy performed with topical anesthesia. | Procedure or surgery | MVA-BN vaccinated |
| Bone marrow aspirationBone marrow aspiration performed with local anesthesia. | Procedure or surgery | MVA-BN vaccinated |
Primary outcome
Change in magnitude of the MVA-BN antigen-specific T cell response in the blood
Time frame: Change from day 42 to day 395
Change in magnitude of the MVA-BN antigen-specific antibody response in blood plasma
Time frame: Change from day 42 to day 395
2 secondary outcomes
Change in magnitude of the MVA-BN antigen-specific T cell response in the lower airways
Time frame: Change from day 42 to day 395
Change in magnitude of the MVA-BN antigen-specific antibody response in bronchoalveolar lavage fluid
Time frame: Change from day 42 to day 395
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Mudd, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection, Phlebotomy and Research bronchoscopy in people with Vaccinia and Virus Diseases, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in magnitude of the MVA-BN antigen-specific T cell response in the blood (time frame: Change from day 42 to day 395). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.