Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- None explicitly listed in the eligibility criteria
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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