Clinical trial NCT05562323: Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) An Observational Prospective Cohort Study
Official title: Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) An Observational Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Monkeypox
Keywords: Monkeypox vaccine
Immune responses
HIV
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Sponsor class: OTHER
Collaborators: name: IrsiCaixa
name: BCN Checkpoint
First posted: 2022-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 individuals who have been/will be vaccinated against MKP as pre-exposuire profilaxis following the National Vaccination Plan (40-50/50-60% of HIV negative and HIV positive individuals)

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.

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.

Primary outcomes:
measure: Proportion of participants with detectable anti-orthopox antibodies
timeFrame: Between day 29 - 90
measure: Quantification of anti-orthopox antibodies
timeFrame: Between day 29 - 90
Secondary outcomes:
measure: Changes of the immunogenicity after the first vaccine dose
timeFrame: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
measure: To compare immunogenicity between HIV negative and HIV positive individuals
timeFrame: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
measure: Neutralization capacity of anti-orthopox antibodies
timeFrame: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
measure: To compare neutralization capacity between HIV negative and HIV positive individuals
timeFrame: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Trias i Pujol Hospital
state: Barcelona
city: Barcelona
country: Spain
facility: BCN Checkpoint
city: Barcelona
country: Spain
facility: VALLE HEBRÓN HOSPITAL/Centro Salud Internacional y Enfermedades Transmisibles Drassanes
Study officials:
References: