Clinical Research Directory

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

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.

Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC

This study aims to validate the clinical performance of a newly developed isothermal nucleic acid amplification bioassay module for EBOV. A retrospective studies will be conducted using biobanked patient samples such as plasma samples and buccal swabs already collected by the Institut National de Recherches Biomédicales (INRB) in Kinshasa, DRC as part of their surveillance and outbreak activities. The diagnostic sensitivity and specificity of the EBOV bioassay module will be compared to the gold-standard reverse transcriptase polymerase chain reaction (RT-PCR) technologies used in the national reference lab.