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NOT YET RECRUITING
NCT07842107
PHASE2/PHASE3

Study of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in the Democratic Republic of the Congo

Sponsor: Jean-Pierre Van geertruyden

View on ClinicalTrials.gov

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

BIOLOGICAL

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.

BIOLOGICAL

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