ERVEBO vaccination for frontline workers during the 2026 Bundibugyo outbreak in the DRC
Official title: BRAVO Study - Bundibugyo: Répondre Avec la Vaccination, " On Est Ensemble " Prospective Evaluation Embedded in the Bundibugyo Virus Disease Outbreak Response in the Democratic Republic of Congo
Run by Epicentre · NCT07903350 · Data updated 2026-11-12
This study tests whether giving the ERVEBO vaccine to frontline workers during the Bundibugyo virus outbreak helps protect them and reduces severe disease and death.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20000 (estimated) |
| Sponsor | Epicentre Academic / other |
| Locations | 1 site (Bunia) |
| Status | Recruiting |
| Started | September 19, 2026 |
| Main results expected | June 2027 |
| Study ends | September 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07903350 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older who work in healthcare facilities, Ebola treatment centers, laboratories, or community outbreak response teams in BVD-affected areas and have potential exposure to infectious materials.
✕Probably not a fit
Some participants may not derive direct benefit if cross-protection from ERVEBO against Bundibugyo virus is limited or if exposure risk is low.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
BRAVO is an outbreak-focused, phased study in the Democratic Republic of the Congo that evaluates the use of ERVEBO vaccination among frontline workers during the 2026 Bundibugyo virus disease outbreak. Step A examines vaccination under routine operational conditions and compares outcomes across different vaccination statuses. The study aims to generate evidence to inform public health decisions on protecting workers and guiding future BVD vaccination strategies, with safety and effectiveness as key endpoints. The trial enrolls adults in healthcare, outbreak response, and related settings who may have exposure to infectious material or affected communities. It is conducted by Epicentre with INRB, MSF, and national partners.
Why it matters
Potential benefit: If successful, frontline workers could gain protection against Bundibugyo virus and experience reduced risk of severe disease and mortality.
How similar studies have gone: Previous ERVEBO studies have demonstrated safety and cross-protection signals for related viruses, supporting further evaluation in this outbreak setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Eligibility criteria for enrolment in the BRAVO cohort Inclusion criteria: The following FLWs will be eligible for enrolment in the study: * Aged 18 years or older * Currently working, or holding a signed work assignment to work, in the following settings within BVD-affected study areas: * Ebola health facilities, including physicians, nurses, nurse assistants, laboratory technicians, pharmacists, IPC personnel, environmental hygiene and waste management personnel, mental health and psychosocial support staff, cleaners, security personnel, administrative and any other potentially exposed staff * Health facilities providing non Ebola clinical care, including but not restricted to services such as emergency care, general outpatient or inpatient care, surgery, laboratory services, maternity, haematology, infectious diseases, paediatrics * Community based or outbreak response activities, including surveillance and contact tracing teams, drivers and ambulance teams, vaccination teams, community health workers and personnel responsible for post mortem swabbing or burial related activities * Any other personnel whose duties involve direct contact with suspected or confirmed Ebola cases, their bodily fluids, contaminated materials, or environments where Ebola transmission may occur. * Able and willing to complete the informed consent process and comply with study procedures Exclusion criteria : There are no exclusion criteria to participate in the BRAVO cohort. If a FLW chooses to not receive the ERVEBO vaccine, they can be enrolled as part of the control group. To be part of the vaccinated group, additional criteria apply as below: Eligibility criteria specific to vaccination Inclusion criteria: * Enrolled in the BRAVO study (eligible and gave informed consent) * Voluntary chooses to receive vaccination Exclusion criteria: * Voluntarily chooses not to receive vaccination * Self reported clinically significant immunodeficiency (e.g. a known immunodeficiency condition that, in the judgment of the study clinician, may affect the safety and effectiveness of ERVEBO® vaccination, such as HIV infection with an AIDS-defining illness, CD4+ T-lymphocyte count \<200 cells/mm³, HIV/AIDS or another severe immunocompromising condition). Stable HIV infection on antiretroviral therapy with preserved immune function is not a contra-indication) * History of severe allergic reaction or anaphylaxis associated with a vaccine or vaccine component * Any other condition or reason not otherwise specified in the protocol which, in the opinion of the investigator or delegated clinician, would contraindicate administration of ERVEBO® or make vaccination inappropriate. Any decision to withhold vaccination on this basis will be documented, including the rationale for exclusion.
Where it's running
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Laboratoire Provincial de Santé et CTE
Bunia, Democratic Republic of the Congo Recruiting
Study contacts
- Study coordinator: Lise Denoeud
- Email: Lise-Anne.DENOEUD@EPICENTRE.MSF.ORG
- Phone: +33 (0)1 40 21 55 55
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.