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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain
RECRUITINGBCN Checkpoint
Barcelona, Barcelona, Spain
RECRUITINGVALLE HEBRÓN HOSPITAL/Centro Salud Internacional y Enfermedades Transmisibles Drassanes
Barcelona, Barcelona, Spain
NOT_YET_RECRUITINGProportion of participants with detectable anti-orthopox antibodies
Proportion of participants with detectable anti-orthopox antibodies at 29 - 90 days following first MVA-BN vaccination
Time frame: Between day 29 - 90
Quantification of anti-orthopox antibodies
Quantification of anti-orthopox antibodies at 29 - 90 days following first MVA-BN vaccination
Time frame: Between day 29 - 90
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)
Time frame: 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)
To compare immunogenicity between HIV negative and HIV positive individuals
To compare the GMFR between HIV negative and HIV positive individuals
Time frame: 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)
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.
Time frame: 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)
To compare neutralization capacity between HIV negative and HIV positive individuals
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To compare ID50 between HIV negative and HIV positive individuals
Time frame: 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)