Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) an Observational Prospective Cohort Study

Last updated: March 7, 2025
Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05562323
MoVIHvax
  • Ages > 18
  • All Genders

Study Summary

This observational study has been designed to characterize humoral and cellular immune responses after vaccination against monkeypox (MKP) in HIV positive and negative individuals at high risk of MKP infection during the vaccination campaign in the current monkeypox outbreak.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult individuals of ≥18 years old.

  2. Willing to comply with the requirements of the protocol and available for follow-upfor the planned duration of the trial.

  3. Has understood the information provided and capable of giving informed consent.

Exclusion

Exclusion Criteria:

  1. Participant has any medical condition and/or finding that in the investigatoropinion might increase participant risks, interfere with the study or impairinterpretation of study data.

Study Design

Total Participants: 100
Study Start date:
September 14, 2022
Estimated Completion Date:
August 31, 2026

Study Description

Of the 23,837 cases of monkeypox reported in the European Region of the WHO, 7.037 have been identified in Spain, according to the National Epidemiological Surveillance Network (RENAVE). Most of diagnosed individuals are men born in Spain, being nearly 40% HIV positive. The clinical evolution was satisfactory, although 3-7% of cases required hospitalization.

Given the limited number of available doses of the MVA-BN vaccine, it has been recently approved its use as a single intradermal dose. However, this posology can be more reactogenic than subcutaneous injection and there is limited data on its immunogenicity and effectiveness in people living with HIV (PLWH), which account for about half of the monkeypox cases in the current outbreak.

The present observational study has been designed to investigate the humoral and cellular immune responses following monkeypox vaccination in PLWH.

Connect with a study center

  • Germans Trias i Pujol Hospital

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • BCN Checkpoint

    Barcelona, 08015
    Spain

    Active - Recruiting

  • VALLE HEBRÓN HOSPITAL/Centro Salud Internacional y Enfermedades Transmisibles Drassanes

    Barcelona, 08035
    Spain

    Site Not Available

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