Phase 2/3 Trial of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in DRC

NCT07842107 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: UA-TUMAINI-2026-01
• Study Type: interventional
• Target: 3,810
• Locations: 1 country
• Sites: 1

Brief 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, double-blind, 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 crossover 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.

Conditions

Ebola Hemorrhagic Fever; Bundibugyo Virus Disease

Keywords

Filovirus; Orthoebolavirus; Viral hemorrhagic fever; Bundibugyo ebolavirus

Outcome Measures

Primary Outcomes (2)

• Phase 2: Proportion of participants experiencing unsolicited Grade 3 or 4 adverse events, serious adverse events, SUSARs, adverse events of special interest, or medically attended adverse events

  Proportion of vaccine recipients who experience unsolicited Grade 3 or 4 adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), adverse events of special interest (AESIs), or medically attended adverse events (MAAEs), assessed using severity and causality assessments. Events are summarized with counts, percentages and exact 95% confidence intervals.

  Day 1 to Day 181

• Phase 3: Vaccine efficacy against PCR-confirmed symptomatic Bundibugyo virus disease with symptom onset 10 to 29 days after vaccination

  Vaccine efficacy estimated by comparing the number of PCR-confirmed symptomatic Bundibugyo virus disease cases with symptom onset 10 to 29 days after randomization in each candidate vaccine arm with the comparator arm. The primary analysis is per-protocol.

  Day 10 to Day 29 after vaccination

Secondary Outcomes (4)

• Phase 2: Seroconversion rate measured by ELISA for IgM and IgG titres

  Days 1, 15, 29, 43, 57 and 181

• Phase 3: Number of confirmed Bundibugyo virus disease deaths in each arm

  Day 0 to Day 29 after vaccination

• Phase 3: Number of PCR-confirmed symptomatic Bundibugyo virus disease cases with symptom onset 10 to 29 days after vaccination, modified intention-to-treat

  Day 10 to Day 29 after vaccination

• Phase 3: Number of PCR-confirmed symptomatic Bundibugyo virus disease cases with symptom onset 0 to 9 days after vaccination

  Day 0 to Day 9 after vaccination

Study Arms (2)

Candidate BDBV vaccine, then a comparator

EXPERIMENTAL

Participants randomized to this arm receive a single dose of a candidate Bundibugyo virus (BDBV) vaccine on Day 1, administered at the location where the participant resides at the time of vaccination. Eligibility criteria are reconfirmed and body temperature measured before the dose is administered. Participants are observed for 30 minutes after vaccination for immediate adverse events. On Day 29 participants in this arm receive the comparator as a crossover intervention. Dose, formulation and route are candidate-specific and are specified in the vaccine-specific appendix for each candidate entering the platform. Safety follow-up continues to Day 181 in the Phase 2 component and to Day 29 in the Phase 3 component.

Biological: Candidate BDBV vaccine; Biological: Active comparator

Comparator, then candidate BDBV vaccine

ACTIVE COMPARATOR

Participants randomized to this arm receive a single dose of comparator, administered at the location where the participant resides at the time of vaccination. Eligibility criteria are reconfirmed and body temperature measured before the dose is administered. Participants are observed for 30 minutes after administration for immediate adverse events. On Day 29 participants in this arm receive the corresponding candidate BDBV vaccine as a crossover intervention. Safety follow-up continues to Day 181 in the Phase 2 component and to Day 29 in the Phase 3 component.

Biological: Candidate BDBV vaccine; Biological: Active comparator

Interventions

Candidate BDBV vaccine BIOLOGICAL

Candidate BDBV vaccine - A candidate Bundibugyo virus vaccine recommended for prioritization by the independent WHO 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.

Candidate BDBV vaccine, then a comparator; Comparator, then candidate BDBV vaccine

Active comparator BIOLOGICAL

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.

Also known as: Comparator

Candidate BDBV vaccine, then a comparator; Comparator, then candidate BDBV vaccine

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A contact of a newly confirmed Bundibugyo virus disease (BVD) index case, occurring within the previous 21 days of enrollment. A contact is defined as a person who, within the previous 21 days, lived in the same household as the index case; OR visited or was visited by the index case at or after the onset of symptoms; OR, without using adequate personal protective equipment, provided the index case with care, was in close physical contact with the patient's body, body fluids, linen or clothes, or prepared the body for, or was exposed to the body at, a funeral ceremony.
• Adults, adolescents, and children aged 12 years and older at the time of enrollment.
• Capable of giving signed informed consent or assent, or having a parent or legal guardian capable of giving signed or witnessed verbal informed consent, in accordance with applicable country regulations.

You may not qualify if:

• History of laboratory-confirmed Bundibugyo virus disease.
• History of anaphylaxis from a vaccine or a component of a vaccine.
• Serious bed-confining illness requiring hospitalization at the time of vaccination.
• Receipt of monoclonal antibodies as post-exposure prophylaxis (PEP) within 21 days prior to vaccination, or planned receipt after vaccination.
• Use of any other experimental drug, other than antivirals or monoclonal antibodies used for BVD prophylaxis, within 28 days prior to vaccination.
• Currently enrolled in, or planning to participate in, another investigational or interventional study during this study. Observational and registry studies are permitted.
• Living in an area deemed inaccessible by the Investigator, for reasons of distance or security.
• Symptoms consistent with BVD, defined as inexplicable bleeding, OR high fever together with at least three of the following: headache, lethargy, anorexia or loss of appetite, aching muscles or joints, stomach pain, difficulty swallowing, vomiting, difficulty breathing, diarrhea, hiccups.

Sponsors & Collaborators

• Jean-Pierre Van geertruyden: lead
• Institute of Tropical Medicine, Belgium: collaborator
• Epicentre: collaborator
• CEPI: collaborator
• Médecins Sans Frontières, Belgium: collaborator
• World Health Organization: collaborator
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator

Study Sites (1)

Bunia

Bunia, Ituri, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Central Study Contacts

Maha Salloum

CONTACT

+32495931677; maha.salloum@uantwerpen.be

Lucie Kwizera

CONTACT

+32492054863; Lucie.Kwizera@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual participant data and supporting information will become available after publication of the primary study results and following completion of the trial. No end date is set. Data will remain available for as long as the trial data set is maintained by the Sponsor and Co-Sponsors, consistent with the record retention period of 25 years after the end of the trial.
• Access Criteria: Anonymized data sharing will occur in accordance with the WHO Policy Statement on Data Sharing in the Context of Public Health Emergencies. Requests for de-identified individual participant data will be assessed on a case-by-case basis by the Sponsor and Co-Sponsors, subject to applicable ethical, regulatory and data-sharing requirements. Vaccine developers will receive data only for their own investigational product and the comparator, in accordance with the signed Letter of Agreement with each Sponsor. Requests should be directed to the central contact listed for this record.

Locations

DE (1)