Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections

NCT06549530 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: POX-MVA-045
• Study Type: interventional
• Target: 460
• Locations: 2 countries
• Sites: 3

Brief Summary

All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen). Serum samples for assessment of immune response will be collected at baseline (visit of first vaccination) and at 2 weeks (week 6), 6 months (week 30), and 1 year after the second (last) vaccination.

Conditions

Monkeypox (Mpox)

Outcome Measures

Primary Outcomes (2)

• Immunogenicity of 2 doses of MVA BN

  Titer of serum neutralizing antibodies against vaccinia virus as measured by plaque reduction neutralization tests (PRNTs) 2 weeks after the second MVA BN vaccination

  2 weeks after the second MVA-BN vaccination

• Occurrence of Safety Adverse Events (SAE) & Adverse of Event of Special Interest (AESI) events

  Occurrence of any SAE at any time during the trial period Occurrence of any AESI at any time during the trial period

  Day 0 to week 56

Secondary Outcomes (2)

• Neutralizing antibody response

  From day zero to two weeks after the second vaccination

• Neutralizing antibody response durability

  Six months and one year after the second vaccination

Study Arms (1)

MVA-BN

EXPERIMENTAL

Participants will receive 2 vaccinations at the standard dose of MVA-BN vaccine 4 weeks apart.

Drug: MVA-BN

Interventions

MVA-BN DRUG

All participants will receive 2 vaccinations of the same dose of MVA-BN vaccine 4 weeks apart (standard regimen).

MVA-BN

Eligibility Criteria

• Age: 2 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• To be eligible to participate in this trial, an adult individual must meet all the following criteria:
• Age 18 to 50 years at screening
• Male or female sex
• 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
• Body mass index (BMI) ≥18.5 and ≤35 (calculated as \[body weight in kilograms\] /\[body height in meters\] 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), bilateral tubal occlusion, vasectomy, or abstinence (abstinence only acceptable 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 post-menopausal (amenorrhea \>12 months and follicle stimulating hormone according to local lab values) at screening.
• Willingness to comply with the requirements of the protocol, in the judgment of the investigator
• Pediatric Cohort
• To be eligible to participate in this trial, a child must meet all the following criteria:
• Age ≥2 and \<12 years at screening
• Male or female sex
• Informed consent form signed and dated by a parent/guardian after reading the form and being advised of the risks and benefits or the trial in a language understood by the parent/guardian and before performance of any trial-specific procedures

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this trial:
• For female participants: Pregnancy or breastfeeding
• Acute or chronic medical 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
• 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. Human immunodeficiency virus (HIV) infection under stable Highly active antiretroviral therapy (HAART) (no change within the last three month) and CD4 count \>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
• 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 of 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 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

Sponsors & Collaborators

• Bavarian Nordic: lead
• Coalition for Epidemic Preparedness Innovations: collaborator

Study Sites (3)

University of Kinshasa

Kinshasa, Democratic Republic of the Congo

Location

Uganda Virus Research Institute

Entebbe, Uganda

Location

Epicentre Mbarara Research Centre

Mbarara, Uganda

Location

MeSH Terms

Conditions

Mpox, Monkeypox

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 12, 2024
• Study Start: October 21, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 7, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); UG (2)