Prospective Follow-up After MVA-BN Booster Vaccination | NCT07342829

Studies
Prospective Follow-up After MVA-BN Booster Vaccination

NCT07342829

Sponsor

Institute of Tropical Medicine, Belgium

Status

Not yet recruiting

Last Update Posted

Jan 20, 2026Actual

Enrollment

95Estimated

Phase

Not provided

Conditions

Monkeypox (Mpox)

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2026Estimated

Primary Completion Date

Jun 30, 2028Estimated

Completion Date

Jun 30, 2028Estimated

First Submitted Date

Jan 6, 2026

First Submission Date that Met QC Criteria

Jan 6, 2026

First Posted Date

Jan 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2026

Last Update Posted Date

Jan 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

95Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	from enrollment to the end of follow up at 2 years

Secondary Outcomes

Measure	Description	Time Frame
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	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Is scheduled to receive a booster dose of MVA-BN
≥18 years
Willingness to provide written informed consent
Willingness to follow the study schedule

Exclusion Criteria:

1. Past or current MPXV infection

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individuals who received MVA-BN booster vaccination will be asked to participate in "POQS-Boosted"

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Laurens Liesenborghs, MD	Institute of Tropical Medicine Antwerp	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Tropical Medicine		Antwerp		2000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D045908	Mpox, Monkeypox

Ancestor Terms

ID	Term
D011213	Poxviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

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Browse Branches

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