Active — Not RecruitingPhase 2

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

Democratic Republic of the Congo, Uganda460 participantsStarted 2024-10-21

Plain-language 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.

Who can participate

Age range2 Years – 50 Years

SexALL

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Inclusion 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.

Exclusion criteria

What they're measuring

Immunogenicity of 2 doses of MVA BN

Timeframe: 2 weeks after the second MVA-BN vaccination

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

Timeframe: Day 0 to week 56

Trial details

NCT IDNCT06549530

SponsorBavarian Nordic

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-01

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