MODIFIED VACCINIA ANKARA – BAVARIAN NORDIC LIVE VIRUS for Mpox infection

Inclusion criteria

• {"criterion_text":"- Be ≥ 18 years old\n- ●\tUnderstand the study procedures, be able to comply with the procedures, and voluntarily agree to participate by giving written, informed consent for the trial\n- ●\tEligible for 1 or 2 doses of MVA for Mpox prevention as per NIAC guidelines OR have received first dose of MVA <28 days previously for Mpox prevention"}

Exclusion criteria

• {"criterion_text":"- Unable or unwilling to given informed consent\n- ●\tHave a contraindication to MVA vaccination\n- ●\tHave a documented, pre-existing allergy to any component of the vaccine\n- ●\tHave a clinical and/or laboratory diagnosis of Mpox prior to recruitment\n- ●\tPregnant or breastfeeding women"}

Primary endpoints

• {"endpoint_text":"- Mean geometric MVA-specific antibody titres at week 48","definition_or_measurement_approach":"Measurement of MVA-specific antibody titres at week 48 (geometric mean titres)."}
• {"endpoint_text":"- Mean rate of change in MVA-specific antibody titres post week 6 to week 48","definition_or_measurement_approach":"Calculation of the mean rate of change in MVA-specific antibody titres between week 6 and week 48."}

Secondary endpoints

• {"endpoint_text":"- Absolute mean change from baseline in MVA-specific antibody 6 weeks post first vaccine","definition_or_measurement_approach":"Absolute mean change from baseline to week 6 in MVA-specific antibody titres."}
• {"endpoint_text":"- Neutralising capacity of vaccine-induced immune response for Mpox virus in vitro culture at weeks 6 and 48","definition_or_measurement_approach":"In vitro neutralisation assay measuring neutralising capacity at weeks 6 and 48."}
• {"endpoint_text":"- Detection of Mpox-specific antibodies at week 0,2,6,12 and 48","definition_or_measurement_approach":"Serological assays for Mpox-specific antibodies at weeks 0, 2, 6, 12 and 48."}
• {"endpoint_text":"- Detection of Mpox DNA on anorectal, throat or vaginal swabs at week 0, 2, 6, 12 and 48.","definition_or_measurement_approach":"PCR detection of Mpox DNA on anorectal, throat or vaginal swabs at specified timepoints."}
• {"endpoint_text":"- Frequency of active STIs at inclusion (HAV (IgM), HBV, HCV, Syphilis, Chlamydia and Gonorrhoea and frequency of participants with chronic HIV infection, HBV or HCV","definition_or_measurement_approach":"Clinical/laboratory testing for listed STIs at inclusion to determine frequency/prevalence."}
• {"endpoint_text":"- Incidence of STIs (HAV (IgM), HBV, HCV, HIV, Syphilis, Chlamydia and Gonorrhoea) at week 6,12 and 48","definition_or_measurement_approach":"Laboratory-confirmed incidence of listed STIs at weeks 6, 12 and 48."}

Methods

• Advertisements and video materials: Documents include 'Mpox Advertisement Plan', 'MPOX VIDEO AD SCRIPT v1 01 Nov 2024', 'K2_Recruitment material Video Script V2 13 Feb 2025' and translated materials (Spanish, Portuguese) indicating use of advertisement/video materials for recruitment (documents in repository).
• Site-based recruitment at participating Infectious Diseases clinics (Beaumont Hospital; Mater Misericordiae University Hospital; St Vincent's University Hospital; Cork University Hospital; University Hospital Galway; St James's Hospital) in Ireland using clinic referrals and local site recruitment procedures (document: NREC-CT-Recruitment-and-informed-consent-procedure-MPOXVAX).

Ireland

Latest Decision Or Authorization Date

04-02-2026

Number Of Sites

6

Number Of Participants

218

Primary sponsor

Full Name

University College Dublin

Organisation Type

Educational Institution

Country Of Registered Address

Ireland