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

NCT ID: NCT05562323

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2026-08-31

Brief 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.

Detailed 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.

Conditions

Monkeypox

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MKP vaccination for pre-exposure prophylaxis (HIV positive)

HIV positive individuals who receive MKP vaccination for pre-exposure prophylaxis

No interventions assigned to this group

MKP vaccination for pre-exposure prophylaxis (seronegative individuals)

HIV seronegative individuals who receive MKP vaccination for pre-exposure prophylaxis

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Adult individuals of ≥18 years old.

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

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IrsiCaixa

OTHER

Sponsor Role: collaborator

BCN Checkpoint

INDUSTRY

Sponsor Role: collaborator

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Germans Trias i Pujol Hospital

Badalona, Barcelona, Spain

Site Status: RECRUITING

BCN Checkpoint

Barcelona, Barcelona, Spain

Site Status: RECRUITING

VALLE HEBRÓN HOSPITAL/Centro Salud Internacional y Enfermedades Transmisibles Drassanes

Barcelona, Barcelona, Spain

Site Status: NOT_YET_RECRUITING

Countries

Spain

Central Contacts

Beatriz Mothe, PhD, MD

Role: CONTACT

bmothe@irsicaixa.es

676142408

Susana Benet, PhD, MD

Role: CONTACT

sbenet@lluita.org

676142408

Facility Contacts

Ángel Rivero Calaf, MD,PhD

Role: primary

arivero@lluita.org

Vicente Descalzo Jorro, MD,PhD

Role: primary

Other Identifiers

MoVIHvax

Identifier Type: -

Identifier Source: org_study_id