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Study of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in the Democratic Republic of the Congo
Sponsor: Jean-Pierre Van geertruyden
Summary
Bundibugyo virus (BDBV) causes severe and often fatal outbreaks of Bundibugyo virus disease (BVD). No vaccine against BDBV is licensed. There is an urgent need to identify vaccines that are safe, immunogenic, and effective in preventing disease among people at highest risk of infection. This is a Phase 2/3 randomized, blinded, active-controlled adaptive platform trial evaluating candidate BDBV vaccines in contacts of confirmed BVD cases, co-sponsored by the University of Antwerp and the National Institute of Biomedical Research (INRB), Kinshasa. The contacts of each confirmed index case form a "ring". Eligible contacts are individually randomized to a candidate vaccine or an active comparator on Day 1, and on Day 29 all participants receive the alternative intervention, so that every participant is offered a candidate vaccine while the comparison between groups remains blinded. The platform allows additional candidates to enter as they are prioritized and allows evaluation of a candidate to be discontinued for futility, with an independent Data Monitoring Committee reviewing accumulating data throughout. The overall aim is to generate robust evidence to support the use of BDBV vaccines for outbreak response and future epidemic preparedness.
Official title: A Phase 2/3 Randomized, Controlled, Adaptive Platform Trial to Evaluate the Efficacy, Safety, and Immunogenicity of Vaccine Candidates Against Bundibugyo Virus Disease (BVD) in Contacts of Cases
Key Details
Gender
All
Age Range
1 Year - Any
Study Type
INTERVENTIONAL
Enrollment
3620
Start Date
2026-10-20
Completion Date
2027-06
Last Updated
2026-10-05
Healthy Volunteers
Yes
Interventions
Candidate BDBV vaccine
Candidate Bundibugyo Virus (BDBV) vaccine - A candidate Bundibugyo virus vaccine recommended for prioritization by the independent World Health Organization Technical Advisory Group on Candidate Vaccines Prioritization. Administered as a single dose. Dose, formulation and route are candidate-specific and are specified in the vaccine-specific appendix for each candidate entering the platform. Additional candidate vaccines may be added to the platform as they become available and meet the inclusion criteria.
Active comparator
Active comparator, Typhoid vaccine. All study interventions are reconstituted and dispensed by an uninvolved third party, such as a trial pharmacist, so that allocation remains masked.
Locations (1)
Bunia
Bunia, Ituri, Democratic Republic of the Congo