NCT05734508

Brief Summary

The goal of this observational study is to monitor and assess the safety profile of the MVA-BN vaccine among staff and study personnel of the PALM-007 study in the Democratic Republic of the Congo. The main questions it aims to answer are:

  • To estimate the incidence of serious adverse events (SAEs) in all individuals vaccinated with the MVA-BN vaccine
  • To estimate the incidence of adverse events (AEs) after each dose of MVA-BN vaccine. Participants will receive two doses of vaccine and will be actively followed up to the 28th day after their last dose of MVA-BN vaccine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 12, 2026

Completed
Last Updated

February 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

February 7, 2023

Results QC Date

January 5, 2026

Last Update Submit

January 27, 2026

Conditions

Monkeypox

Outcome Measures

Primary Outcomes (4)

  • Frequency of SAEs After First Dose of MVA-BN Vaccine

    Number of participants with an SAE up to 14 days after dose

    Within 14 days of first vaccine dose

  • Frequency of SAEs After Second Dose of MVA-BN Vaccine

    Number of participants with an SAE up to 14 days after dose

    Within 14 days of second vaccine dose

  • Frequency of AEs After First Dose of MVA-BN Vaccine

    Number of participants with an AE within 14 days of first vaccine dose

    Within 14 days of first vaccine dose

  • Frequency of AEs After Second MVA-BN Vaccine Dose

    Number of participants with an AE up to 28 days after second vaccine dose

    Within 28 days of second vaccine dose

Study Arms (1)

MVA-BN vaccine

EXPERIMENTAL

2 doses of 0.5 mL MVA-BN vaccine injected subcutaneously and given at least 28 days apart

Biological: MVA-BN vaccine

Interventions

MVA-BN vaccineBIOLOGICAL

A live vaccine produced from the Modified Vaccinia Ankara-Bavarian Nordic strain (MVA-BN), an attenuated and non-replicating orthopox virus

Also known as: JYNNEOS
MVA-BN vaccine

Eligibility Criteria

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

You may qualify if:

  • Provides written informed consent
  • years of age or older
  • At high risk for Monkeypox infections
  • Personnel and staff associated with the PALM 007-Monkeypox study sites in the DRC
  • Willingness and ability to communicate AEs to study personnel

You may not qualify if:

  • Allergy to MVA-BN or any of its components
  • Pregnant or breastfeeding women
  • Fever (axillary temperature ≥37.5°celsius)
  • People who have already received the MVA-BN vaccine (in routine vaccination or another study involving this vaccine)
  • Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study
  • Individuals with any condition or circumstance that would render them unable to comply with study procedures (e.g., not reachable by phone)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut National de Rescherche Biomédicale (INRB)

Kinshasa, Democratic Republic of the Congo

Location

L'Hôpital Général de Référence de Kole

Kole, Democratic Republic of the Congo

Location

L'Hôpital Général de Référence de Tunda

Tunda, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Mpox, Monkeypox

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsPrimate DiseasesAnimal DiseasesRodent Diseases

Results Point of Contact

Title
Nsengi Ntamabyaliro
Organization
National Institute of Biomedical Research, Democratic Republic of the Congo
nntamabyaliro@palm-rdc.com
+243815171991

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 21, 2023

Study Start

March 23, 2023

Primary Completion

June 28, 2024

Study Completion

June 28, 2024

Last Updated

February 12, 2026

Results First Posted

February 12, 2026

Record last verified: 2026-01

Locations

DE(3)