Vaccination to prevent Mpox Infection (MPOX-VAX Study)

Phase 1

Conditions: Mpox infection
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: CTIS2023-507881-19-00

Lead Sponsor: niversity College Dublin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

Be = 18 years old, ?Understand the study procedures, be able to comply with the procedures, and voluntarily agree to participate by giving written, informed consent for the trial, ?Eligible 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

Unable or unwilling to given informed consent, ?Have a contraindication to MVA vaccination, ?Have a documented, pre-existing allergy to any component of the vaccine, ?Have a clinical and/or laboratory diagnosis of Mpox prior to recruitment, ?Pregnant or breastfeeding women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary <br> To assess the rate of change of (durability) of, and factors associated with, MVA-specific antibodies after at W48 post vaccination with MVA;Secondary Objective: Development of MVA-specific antibodies at W6 after first dose, Neutralising capacity of vaccine-induced immune response for Mpox virus in vitro culture at week 6 and 48, Prevalence of asymptomatic Mpox seroconversion, Prevalence of active asymptomatic Mpox infection, Prevalence of active STIs at inclusion (HAV, HBV, HCV, Syphilis, Chlamydia and Gonorrhoea) and prevalence of participants with chronic HIV infection, HBV, HCV, Incidence of STIs at week 6,12 and 48;Primary end point(s): Mean geometric MVA-specific antibody titres at week 48, Mean rate of change in MVA-specific antibody titres post week 6 to week 48

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Absolute mean change from baseline in MVA-specific antibody 6 weeks post first vaccine;Secondary end point(s):Neutralising capacity of vaccine-induced immune response for Mpox virus in vitro culture at weeks 6 and 48;Secondary end point(s):Detection of Mpox-specific antibodies at week 0,2,6,12 and 48;Secondary end point(s):Detection of Mpox DNA on anorectal, throat or vaginal swabs at week 0, 2, 6, 12 and 48.;Secondary end point(s):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;Secondary end point(s):Incidence of STIs (HAV (IgM), HBV, HCV, HIV, Syphilis, Chlamydia and Gonorrhoea) at week 6,12 and 48