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

ConditionMonkeypox
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adult individuals of ≥18 years old.

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

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

Disqualifiers

None

Trial 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)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: MKP vaccination for pre-exposure prophylaxis (HIV positive)
Group B: MKP vaccination for pre-exposure prophylaxis (seronegative individuals)

Trial outcomes

Primary outcomes

1

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

Time frame
Between day 29 - 90
2

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

Secondary outcomes

1

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)
2

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)
3

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)
4

To compare neutralization capacity between HIV negative and HIV positive individuals

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

IrsiCaixa

Collaborator

BCN Checkpoint

Collaborator

Source ClinicalTrials.gov
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