NCT07499739

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

Mpox Biology, Outcome, Transmission and Epidemiology - Tracking the Immune Response After mpoX vaCcination

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study Mbote-TRAXX evaluates humoral and cellular immune responses in individuals vaccinated against mpox with the MVA-BN or LC16m8 vaccine administered as part of routine mpox vaccination campaigns in Kinshasa, Democratic Republic of the Congo (DRC). Participants will be followed at multiple time points after vaccination in order to assess the kinetics and durability of the immune response by collection of blood samples. We plan to include approximately 150 participants vaccinated with MVA-BN and 150 participants vaccinated with LC16m8.

Detailed description

The study Mbote-TRAXX evaluates humoral and cellular immune responses in individuals vaccinated against mpox with the MVA-BN or LC16m8 vaccine administered as part of routine mpox vaccination campaigns in Kinshasa, Democratic Republic of the Congo (DRC). Participants will be followed at multiple time points after vaccination in order to assess the kinetics and durability of the immune response. We plan to include approximately 150 participants vaccinated with MVA-BN and 150 participants vaccinated with LC16m8. Participants will be followed in the clinical trial for a period of 24 months with 6 visits: visit 1 (day 0), visit 2 (day 0 + 28 days), visit 3 (day 0 + 59 days), visit 4 (day 0 + 8 months), visit 5 (day 0 + 16 months) and visit 6 (day 0 + 24 months). The study intervention consists of blood samples. At each visit, 10 mL of blood will be collected, and additional blood samples (20 mL per visit) will be taken from a subgroup of participants.

Conditions

• Mpox

Interventions

Type	Name	Description
PROCEDURE	blood sample collection	10 mL of blood will be collected at every visit and additional 20 mL blood samples will be taken from a subgroup of participants at every visit.

Timeline

• Start date: 2026-04-15
• Primary completion: 2026-11-15
• Completion: 2028-11-15
• First posted: 2026-03-30
• Last updated: 2026-03-30