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Monkeypox (Mpox)Phase 2NCT07199569

Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells

A Phase 2 study testing Jynneos and MVA-BN (Quail) in people with Monkeypox (Mpox), run by Bavarian Nordic at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Randomized, double-blind, phase 2b trial to assess comparability in immunogenicity, safety, and reactogenicity of MVA-BN vaccine manufactured in primary chicken embryo fibroblast (CEF) cells and the CCX.E10 quail cell line in adults Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Monkeypox (Mpox)
What is being tested?
Jynneos and MVA-BN (Quail)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
970 participants
Where
10 sitesUnited States
Study dates
27 Oct 2025to 30 Nov 2026
Phase
Phase 2
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 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 to 49 years of age
  • Informed consent form (ICF) signed and dated by the participant after reading the form and being advised of the risks and benefits of the trial in a language understood by the participant and before performance of any trial-specific procedures
  • General good health, without clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator that would interfere with the trial
  • Body mass index (BMI) ≥18.5 and ≤35 (calculated as [body weight in kg]/[body height in m]2 )
  • Agreement by female participants of childbearing potential and male participants who are sexually active with a female partner of childbearing potential to use a highly effective method of birth control from at least 30 days prior to administration of the MVA-BN vaccine until 30 days after last vaccination
  • Medically acceptable methods of contraception that may be used by the participant and/or partner include combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), combined use of 2 barrier birth control methods (male condom with female diaphragm, male condom with cervical cap), bilateral tubal occlusion, vasectomy, or abstinence (acceptable only if refraining from heterosexual intercourse during the entire period of 30 days prior to administration of the MVA-BN vaccine until 30 days after last vaccination
  • Female participants or partners are not considered to be of childbearing potential if they are at least 1 year postmenopausal

Who cannot join

  • Pregnancy or breastfeeding
  • Acute or chronic condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of responses including, but not limited to, neurologic, cardiovascular, respiratory, hepatic, hematologic, rheumatologic, endocrine, gastrointestinal, renal, autoimmune, or immunosuppressive conditions
  • History of or active autoimmune disease (vitiligo or thyroid disease requiring thyroid replacement are not exclusions), history of Guillain-Barré syndrome or Reye's syndrome
  • Known immunodeficiency syndrome or known or suspected impairment of immunologic functions including, but not limited to, clinically significant liver disease, diabetes mellitus type I, or moderate to severe kidney impairment; HIV infection under stable HAART regimen (no change within the last 3 months) and CD4 count is >500/µL is not considered immunodeficient
  • Known or reported previous smallpox vaccination or vaccination with any licensed or investigational poxvirus-based vaccine
  • History of monkeypox, cowpox, or vaccinia infection
Show all 24Show fewer
  • Close contact in the 3 weeks prior to signing the ICF with anyone known to have mpox
  • History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure
  • Clinically significant mental disorder not adequately controlled by medical treatment
  • Active or recent (within 6 months before screening) chronic alcohol abuse and/or intravenous and/or nasal drug abuse
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, eg, tris(hydroxymethyl)-amino methane, including history of allergic asthma
  • Known allergy to aminoglycosides or quinolones
  • History of anaphylaxis or severe allergic reaction to any vaccine
  • Receipt of or plans to receive any licensed live vaccine from 30 days prior to the trial vaccination until 30 days after last trial vaccination
  • Receipt of or plans to receive any licensed nonlive vaccine from 14 days prior to the trial vaccination until 14 days after last trial vaccination
  • Use of any investigational or nonregistered agent within 30 days prior to vaccination or plans to receive an investigational agent during the trial
  • Recent blood donation (including platelets, plasma, and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active trial period
  • Chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day or any other immune-modifying drugs from 3 months prior to the first trial vaccination to the visit at the end of the active trial period (use of topical, inhaled, ophthalmic, and nasal glucocorticoids is allowed)
  • History of organ transplantation whether or not chronic immunosuppressive therapy is being administered
  • Abnormal troponin I level >upper limit of normal (ULN)
  • Administration or planned administration of immunoglobulins and/or any blood products from 3 months prior to the first trial vaccination until the visit at the end of the active trial period (packed red blood cells given for an emergency indication in an otherwise healthy person and not required as ongoing treatment is not exclusionary [eg, packed red blood cells given in an emergency during elective surgery])
  • History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, significant arrhythmia with or without corrective/ablative surgery, or any other heart condition under the care of a doctor
  • Employment with the investigator or trial site, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial site, or relationship to the investigator or trial site employee
  • Relationship with Bavarian Nordic as an employee or employee family member, contractor, agent, or business partner or a financial interest in the outcome of the trial

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Accellacare and McFarland Clinic

    Ames, Iowa, 50010

  • Avacare

    Austin, Texas, 78705

  • Accellacare of Cary - Cary Medical Group

    Cary, North Carolina, 27518

  • Avacare

    Fort Worth, Texas, 76135

  • Accellacare - Knoxville

    Knoxville, Tennessee, 37938

  • Johnson County ClinTrials, LLC

    Lenexa, Kansas, 66219

  • Accellacare of Charleston

    Mt. Pleasant, South Carolina, 29464

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609

  • Accellacare Research of Salisbury

    Salisbury, North Carolina, 28144

  • Velocity Clinical Research

    Suffolk, Virginia, 23435

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Phase 2b Comparability Trial in Adults 18 to 49 Years of Age to Assess Immunogenicity, Safety, and Reactogenicity of the MVA-BN Vaccine Manufactured in Different Production Cells

Randomized, double-blind, phase 2b trial to assess comparability in immunogenicity, safety, and reactogenicity of MVA-BN vaccine manufactured in primary chicken embryo fibroblast (CEF) cells and the CCX.E10 quail cell line in adults

Being tested
Jynneos, MVA-BN (Quail)
Medical subject headings
Mpox, Monkeypox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JynneosBiological

    MVA-BN manufactured in primary CEF cells. MVA-BN (CEF) vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U and is an LF suspension to be administered subcutaneously into the deltoid muscle of the upper arm (preferably the nondominant arm). Participant will receive 2 doses 4 weeks apart (Day 1 and Day 29).

  • MVA-BN (Quail)Biological

    MVA-BN manufactured in CCX.E10 quail cell line. Vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U. and is a LF suspension to be administered subcutaneously into the deltoid muscle of the upper arm (preferably the nondominant arm). Participant will receive 2 doses 4 weeks apart (Day 1 and Day 29).

Study groups in NCT07199569
Study groupRoleWhat they receive
Group 1Active comparatorMVA-BN (CEF)
Receives: Biological: Jynneos
Group 2ExperimentalMVA-BN (Quail)
Receives: Biological: MVA-BN (Quail)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity of 2 doses of MVA-BN

    Titer of serum neutralizing antibodies against vaccinia virus as measured by plaque reduction neutralization tests (PRNTs)

    Measured: 2 weeks after the second MVA-BN vaccination

  2. Number of Participants with Serious Adverse Events (SAE)

    Number and percentage of study participants reporting any serious adverse events at any time during the trial period

    Measured: From vaccination through study termination, up to 7 months

  3. Number of Participants with Adverse Events of Special Interest (AESI)

    Number and percentage of study participants reporting any Adverse Events of Special Interest (AESI)

    Measured: From vaccination through study termination, up to 7 months

  4. Number of Participants with Medically Attended Adverse Events (MAAE)

    Number and percentage of study participants reporting any Medically Attended Adverse Events (MAAE)

    Measured: From vaccination through study termination, up to 7 months

  5. Number of Participants with a Grade 3 or higher adverse event (AE)

    Number and percentage of study participants reporting any grade 3 or higher unsolicited adverse event (AE) assessed as related to trial vaccine

    Measured: The day of or within 28 days after either vaccination

  6. Number of Participants with Solicited Local AE

    Number and percentage of study participants reporting any solicited local AE (pain, swelling, pruritus, erythema, induration)

    Measured: The day of or within 7 days after either vaccination

  7. Number of Participants with Solicited Systemic AE (body temperature, headache, fatigue, myalgia, nausea, chills)

    Number and percentage of study participants reporting any solicited systemic AE (body temperature, headache, fatigue, myalgia, nausea, chills)

    Measured: The day of or within 7 days after either vaccination

  8. Number of Participants with Unsolicited AE

    Number and percentage of study participants reporting any unsolicited AE

    Measured: The day of or within 28 days after either vaccination

Secondary outcomes (4)

  1. Titer of Serum Neutralizing Antibodies against Vaccinia Virus

    GMTs of serum neutralizing antibodies against vaccinia virus as measured by PRNT

    Measured: 4 weeks after the first MVA-BN vaccination and 6 months after the last MVA-BN vaccination

  2. Seroconversion in Neutralizing Antibodies

    Percentage of participants with seroconversion in neutralizing antibodies against vaccinia virus as determined by PRNT. Seroconversion is defined as either the appearance of antibody titer at or above the lower limit of quantitation [LLOQ] for participants with baseline values below the LLOQ or doubling or more of the antibody titer compared to baseline for participants with a baseline antibody titer at or above the LLOQ

    Measured: 4 weeks after the first MVA-BN vaccination, 2 weeks and 6 months after the second MVA-BN vaccination

  3. Titer of Total Antibodies against Vaccinia Virus

    GMTs of total antibodies against vaccinia virus as determined by enzyme-linked immunosorbent assay (ELISA)

    Measured: 4 weeks after the first MVA-BN vaccination, 2 weeks and 6 months after the second MVA-BN vaccination

  4. Seroconversion in Total Antibodies against Vaccinia Virus

    Percentage of participants with seroconversion in total antibodies against vaccinia virus as determined by ELISA Seroconversion is defined as either the appearance of total antibody at or above the LLOQ for participants with baseline values below the LLOQ, or a 4-fold increase of total antibodies against vaccinia virus compared to pre-immunization baseline values for participants with baseline values at or above the LLOQ

    Measured: 4 weeks after the first MVA-BN vaccination, 2 weeks and 6 months after the second MVA-BN vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2025
  2. Study start27 Oct 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
970 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07199569
Sponsor's protocol ID
POX-MVA-046
Status last verified
Apr 2026
First submitted
22 Sep 2025
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Jynneos and MVA-BN (Quail) in people with Monkeypox (Mpox), run by Bavarian Nordic at 10 sites 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 7 inclusion and 24 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Immunogenicity of 2 doses of MVA-BN (time frame: 2 weeks after the second MVA-BN vaccination). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07199569.

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 8 Apr 2026.

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