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

Monkeypox Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05562323
• Other study ID #: MoVIHvax
• Status: Active, not recruiting
• Start date: September 14, 2022
• Est. completion date: March 20, 2026

Study information

• Verified date: December 2023
• Source: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 20, 2026
• Est. primary completion date: June 23, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Monkeypox

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol Hospital	Badalona	Barcelona
Spain	BCN Checkpoint	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	BCN Checkpoint, IrsiCaixa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with detectable anti-orthopox antibodies	Proportion of participants with detectable anti-orthopox antibodies at 29 - 90 days following first MVA-BN vaccination	Between day 29 - 90
Primary	Quantification of anti-orthopox antibodies	Quantification of anti-orthopox antibodies at 29 - 90 days following first MVA-BN vaccination	Between day 29 - 90
Secondary	Changes of the immunogenicity after the first vaccine dose	The geometric mean fold rise (GMFR) in anti-orthopox antibody titers from baseline to Day 29-90 and 150-180 after the first dose of MVA-BN and to 29-90 and 150-180 after the second dose (if applicable)	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)
Secondary	To compare immunogenicity between HIV negative and HIV positive individuals	To compare the GMFR between HIV negative and HIV positive individuals	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)
Secondary	Neutralization capacity of anti-orthopox antibodies	Neutralization titers measured as the reciprocal dilution inhibiting 50% of the infection (ID50) will be reported using a live virus assay (VNA) to measure cytopathic effect in Vero E6 cells after the first dose of MVA-BN.	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)
Secondary	To compare neutralization capacity between HIV negative and HIV positive individuals	To compare ID50 between HIV negative and HIV positive individuals	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)