Prospective Follow-up After MVA-BN Booster Vaccination

N/ANot Yet RecruitingNCT07342829

Institute of Tropical Medicine, Belgium95 enrolled

Overview

POQS-Boosted is a prospective observational study during which individuals who received Booster vaccination against mpox with the MVA-BN vaccine will be invited to provide biological samples at multiple times over the course of two years.

Mpox caused a worldwide outbreak in 2022 and continues to circulate worldwide and causes sporadic cases in Belgium and elsewhere. In the last 10 days, the first cases infected with the probably more virulent clade Ib MPXV have been reported from men who have sex with men in Belgium, the Netherlands, and elsewhere, indicating circulating this viral clade in sexual networks. In Belgium, vaccination against mpox was ceased at the end of 2022 and evidence showed that antibody levels against MPXV have decreased since then, raising questions about sustained protectiveness and the potential for a new mpox outbreak to emerge. POQS-Boosted is a prospective observational study during which individuals who received Booster vaccination against mpox with the MVA-BN vaccine will be invited to provide biological samples at multiple times over the course of two years.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Monkeypox (Mpox)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Is scheduled to receive a booster dose of MVA-BN 2. ≥18 years 3. Willingness to provide written informed consent 4. Willingness to follow the study schedule Exclusion Criteria: 1\. Past or current MPXV infection

Locations (1)

Institute of Tropical Medicine

Antwerp, Belgium

Outcomes

Primary Outcomes

Orthopoxvirus-specific serum binding and neutralising antibody titre

To describe the evolution of the orthopoxvirus-specific serum antibody response up to two years after MVA-BN booster vaccination

Time frame: from enrollment to the end of follow up at 2 years

Secondary Outcomes

Orthopoxvirus-specific systemic T- and B cell-mediated immune responses to MPXV

To describe the evolution of the orthopoxvirus-specific systemic cellular immune response up to two years after MVA-BN booster vaccination

Time frame: from enrollment up to 2 years

MPXV-specific IgA in saliva and anorectal samples; T and B cell-mediated immune responses to MPXV, measured on saliva and anorectal samples

To describe the evolution of the orthopoxvirus-specific mucosal antibody \& cellular immune response up to two years after MVA-BN booster vaccination

Time frame: from enrolment up to two years

Central Contacts

Christophe Van Dijck, PhD

CONTACT

+32 3 345 58 65 cvandijck@itg.be

Clinical Trials Unit Antwerp

CONTACT

+32 3 247 66 66 studies@itg.be

Data from ClinicalTrials.gov

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