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Vaccination to prevent Mpox Infection (MPOX-VAX Study)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507881-19-00
Enrollment
300
Registered
2024-03-08
Start date
2024-06-29
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mpox infection

Brief summary

Mean geometric MVA-specific antibody titres at week 48, Mean rate of change in MVA-specific antibody titres post week 6 to week 48

Detailed description

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

Interventions

DRUGIMVANEX suspension for injection Smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)

Sponsors

University College Dublin
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Ireland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026