Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
ID07499739

Mpox Biology, Outcome, Transmission and Epidemiology - Tracking the Immune Response After Mpox Vaccination in Kinshasa, Democratic Republic of the Congo

Led by Institute of Tropical Medicine, Belgium · Updated on 2026-06-01

300

Participants Needed

3

Research Sites

104 weeks

Total Duration

On this page

Sponsors

I

Institute of Tropical Medicine, Belgium

Lead Sponsor

I

Institut National de Recherche Biomédicale (INRB). Kinshasa, Democratic Republic of Congo

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to assess the immune responses in people vaccinated against mpox with either the MVA-BN or LC16m8 vaccine during a routine vaccination campaign in Kinshasa, Democratic Republic of the Congo. About 150 participants vaccinated with MVA-BN and 150 vaccinated with LC16m8 will be included. The study focuses on understanding how the immune response develops and lasts over time. Participants will have blood samples collected at six visits over a 24-month period: on the day of vaccination (day 0), 28 days later, 59 days later, and then at 8, 16, and 24 months. At each visit, 10 mL of blood will be taken, with an additional 20 mL collected from a subgroup of participants. The study evaluates the presence and levels of neutralizing and binding antibodies against the mpox virus. During the study, participants will be monitored through scheduled visits to collect blood samples and assess immune responses. The main outcome measured is the rate of seroconversion for neutralizing antibodies 28 days after vaccination. Other measures include antibody levels at various time points up to 24 months and vaccine tolerability. The study also tracks any mpox infections after vaccination and factors influencing immune response strength.

CONDITIONS

Brief Title

Mpox Biology, Outcome, Transmission and Epidemiology - Tracking the Immune Response After mpoX vaCcination (MBOTE-TRAXX): Clinical Study to Monitor the Immunological Response Following Mpox Vaccination in the City of Kinshasa, Democratic Republic of the Congo

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Any person aged 18 years or older at the time of giving informed consent
  • Participant received the MVA-BN or LC16m8 mpox vaccine as part of the national vaccination campaign
  • Participant has the capacity and willingness to give informed written consent
  • Participant agrees to adhere to the study's follow-up schedule
Not Eligible

You will not qualify if you...

  • None explicitly listed in the eligibility criteria

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 months

Participants vaccinated with MVA-BN or LC16m8 receive blood sample collections to monitor their immune response following vaccination.

6 visits over 24 months (Day 0, Day 28, Day 59, Month 8, Month 16, Month 24)

Trial Site Locations

Total: 3 locations

1

Centre Convivial Kasa-Vubu

Kinshasa, Democratic Republic of the Congo

Actively Recruiting

2

Kinoise

Kinshasa, Democratic Republic of the Congo

Actively Recruiting

3

Kokolo

Kinshasa, Democratic Republic of the Congo

Actively Recruiting

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Research Team

L

Laurens Liesenborghs

S

Stefanie Bracke

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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