NCT05562323

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Sep 2022Aug 2026

Study Start

First participant enrolled

September 14, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

3.8 years

First QC Date

September 27, 2022

Last Update Submit

March 7, 2025

Conditions

Monkeypox

Keywords

Monkeypox vaccineImmune responsesHIV

Outcome Measures

Primary Outcomes (2)

  • 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

  • Quantification of anti-orthopox antibodies

    Quantification of anti-orthopox antibodies at 29 - 90 days following first MVA-BN vaccination

    Between day 29 - 90

Secondary Outcomes (4)

  • Changes of the immunogenicity after the first vaccine dose

    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

    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

    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

    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)

Study Arms (2)

MKP vaccination for pre-exposure prophylaxis (HIV positive)

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

MKP vaccination for pre-exposure prophylaxis (seronegative individuals)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

RECRUITING

BCN Checkpoint

Barcelona, Barcelona, 08015, Spain

RECRUITING

VALLE HEBRÓN HOSPITAL/Centro Salud Internacional y Enfermedades Transmisibles Drassanes

Barcelona, Barcelona, 08035, Spain

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples: PBMC, plasma and whole blood in PaxGene

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsPrimate DiseasesAnimal DiseasesRodent Diseases

Central Study Contacts

Beatriz Mothe, PhD, MD

CONTACT

676142408bmothe@irsicaixa.es

Susana Benet, PhD, MD

CONTACT

676142408sbenet@lluita.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

September 30, 2022

Study Start

September 14, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)