EbolaPhase 4BRAVONCT07903350
BRAVO is a Phased Outbreak-response Study in the DRC Evaluating ERVEBO® Vaccination in ~20,000 Frontline Workers During the 2026 BDV Outbreak, Step A Assesses Real-world Effectiveness, Safety, and Impact on Severe Disease and Mortality, While Generating Evidence for Future BDV Vaccination Strategies
A Phase 4 study testing ERVEBO Vaccination in people with Ebola and Bundibugyo Virus Disease (BVD), run by Epicentre at 1 site in Democratic Republic of the Congo.
Trial summary
The BRAVO study (Bundibugyo: Respondre Avec la Vaccination, "On est ensemble") was developed in response to the 2026 Bundibugyo virus disease (BVD) outbreak in the Democratic Republic of the Congo (DRC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ebola, Bundibugyo Virus Disease (BVD)
- What is being tested?
- ERVEBO Vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 19 Sep 2026to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
- Enrolled in the BRAVO study (eligible and gave informed consent)
- Voluntary chooses to receive vaccination
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Democratic Republic of the Congo1 site, 1 recruiting
- Recruiting
Laboratoire Provincial de Santé et CTE
Bunia
Youssouf KABORE INVESTIGATEUR SITE, 0842683765, youssouf.kabore@epicentre.msf.org
About this study
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
The BRAVO study (Bundibugyo: Respondre Avec la Vaccination, "On est ensemble") was developed in response to the 2026 Bundibugyo virus disease (BVD) outbreak in the Democratic Republic of the Congo (DRC). The study focuses on frontline workers (FLWs), who are at increased risk of infection because of their involvement in patient care, outbreak response activities, and contact with affected communities. Protecting this population is critical for maintaining healthcare services and strengthening outbreak control efforts.
Currently, there is no licensed vaccine specifically targeting Bundibugyo virus (BDBV) for broad use. However, ERVEBO®, a vaccine licensed against Zaire ebolavirus, is available and has demonstrated a favorable safety profile. Although preclinical and immunological evidence suggests that ERVEBO® may provide some degree of cross-protection against BDBV, the extent of protection remains uncertain. BRAVO therefore aims both to support rapid vaccination of frontline workers during the outbreak and to generate evidence that can inform future vaccine policy and preparedness strategies.
Read more
BRAVO is designed as a phased study embedded within the public health response. The study population includes adults aged 18 years and older working in Ebola treatment centers, healthcare facilities, or community-based outbreak response activities in affected areas. Both clinical and non-clinical personnel may participate if their duties place them at risk of exposure to infected individuals, infectious materials, or affected communities.
The study consists of three steps:
Step A: Immediate deployment and evaluation of ERVEBO® during the outbreak. Step B: Potential future evaluation of heterologous prime-boost vaccination strategies if additional vaccines become available and remain relevant.
Step C: Potential contribution to evaluation of future Bundibugyo virus-specific vaccines.
The primary focus of the current study is Step A, which is a prospective cohort study conducted under real-world outbreak conditions. The main objective is to assess the effectiveness of ERVEBO® vaccination against Bundibugyo virus disease, severe disease outcomes, and death. The primary effectiveness endpoint is whether vaccination reduces case fatality among laboratory-confirmed BVD cases hospitalized in Ebola treatment facilities.
Secondary objectives include evaluating whether vaccination reduces:
BVD-related mortality in the cohort, Incidence of symptomatic laboratory-confirmed BVD, Indicators of severe disease among confirmed cases.
Safety is also an important component of the study. Serious adverse events occurring within one month after vaccination will be documented, and pregnancy outcomes among enrolled pregnant participants will be monitored.
Participants may be enrolled regardless of vaccination status, allowing comparisons between vaccinated and unvaccinated frontline workers as vaccine deployment progresses according to operational feasibility and risk prioritization. Written informed consent will be obtained before enrollment and vaccination. The consent process will clearly communicate that protection against Bundibugyo virus has not been established and that additional vaccine options may become available in the future.
Participants will generally be followed for six months after enrollment, or until the end of the outbreak if it occurs earlier. Pregnant participants will be followed through pregnancy outcomes. An additional component within Ebola treatment centers will collect information on frontline workers presenting with symptoms compatible with BVD, supporting supplementary analyses of vaccine effectiveness using routinely collected clinical and laboratory data.
Step A aims to vaccinate approximately 20,000 frontline workers during the first six months of implementation. Based on projected outbreak assumptions, the study may generate sufficient confirmed BVD cases to provide meaningful estimates of vaccine effectiveness, particularly regarding protection against death.
Beyond evaluating the immediate impact of vaccination, BRAVO is expected to strengthen outbreak preparedness by establishing systems for vaccination delivery, pharmacovigilance, data collection, and participant communication. The study is designed to provide decision-relevant evidence during the outbreak rather than after it, helping guide future recommendations for Bundibugyo virus vaccine strategies.
Enrollment and vaccination are planned from September through December 2026, with follow-up continuing through June 2027. Final analysis and reporting are expected in September 2027.
Read the detailed description
BRAVO (Bundibugyo: Respondre Avec la Vaccination, "On est ensemble") is a phased study conducted during the 2026 Bundibugyo virus disease (BVD) outbreak in the Democratic Republic of the Congo. The study aims to evaluate the effectiveness and safety of ERVEBO® vaccination among frontline workers (FLWs) and to generate evidence to support public health decision-making for BVD prevention and outbreak response.
Frontline workers are at increased risk of Bundibugyo virus exposure through clinical care, outbreak response activities, and interactions with affected communities. Although no vaccine specifically licensed for Bundibugyo virus is currently available for broad use, ERVEBO®, a vaccine licensed against Zaire ebolavirus, is available and may provide cross-reactive protection against Bundibugyo virus. The extent of such protection is not yet established.
The study population includes adults aged 18 years and older working in healthcare facilities, Ebola treatment centers, laboratories, or community-based outbreak response activities within affected areas. Both clinical and non-clinical personnel may be eligible if their roles involve potential exposure to patients, infectious materials, or affected communities.
The study consists of three planned phases. Step A, the primary focus of the current outbreak response, evaluates the deployment of ERVEBO® under routine operational conditions. Participants may be enrolled regardless of vaccination status, allowing comparison of outcomes between vaccinated and unvaccinated frontline workers over time.
The primary objective of Step A is to assess the effectiveness of ERVEBO® vaccination in reducing mortality among laboratory-confirmed BVD cases. Secondary objectives include evaluating the impact of vaccination on BVD-related mortality, incidence of symptomatic laboratory-confirmed disease, and indicators of severe disease among confirmed cases. Safety assessments include monitoring serious adverse events for one month following vaccination and documenting pregnancy outcomes among enrolled pregnant participants.
Participants will generally be followed for six months after enrollment or until the end of the outbreak, whichever occurs first. If the outbreak continues beyond the planned follow-up period, follow-up may be extended. Data collected during routine outbreak response activities, including information from Ebola treatment facilities, may support additional analyses of vaccine effectiveness among symptomatic frontline workers tested for BVD.
The study is also intended to strengthen operational preparedness by supporting vaccination delivery systems, pharmacovigilance activities, outbreak data collection, and risk communication processes. Future protocol amendments may allow evaluation of heterologous prime-boost vaccination strategies (Step B) or participation in assessments of future Bundibugyo virus-specific vaccines (Step C) if such vaccines become available. The study is expected to provide timely evidence to inform interim and long-term vaccination strategies for Bundibugyo virus disease.
- Conditions
- Ebola, Bundibugyo Virus Disease (BVD)
- Being tested
- ERVEBO Vaccination
- Keywords
- Bundibugyo virus disease, BVD, Bundibugyo ebolavirus, ERVEBO, Ebola virus disease, Frontline workers, Ebola vaccine, Democratic Republic of the Congo, Emerging infectious diseases, Outbreak vaccination, Epidemic preparedness, Ebola treatment centers
- Medical subject headings
- Hemorrhagic Fever, Ebola, Communicable Diseases, Emerging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERVEBO VaccinationBiological
Frontline workers who receive ERVEBO® as part of the outbreak vaccination program
| Study group | Role | What they receive |
|---|---|---|
| Unvaccinated Frontline Workers | No intervention | Frontline workers who do not receive ERVEBO® during the observation period and are followed for outcome assessment. |
| ERVEBO Vaccination | Experimental | Frontline workers who receive ERVEBO® as part of the outbreak vaccination program Receives: Biological: ERVEBO Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Case fatality among laboratory-confirmed BVD cases hospitalized in Ebola health facilities
Effectiveness of ERVEBO® in reducing case fatality among laboratory-confirmed Bundibugyo virus disease (BVD) cases hospitalized in Ebola health facilities.
Measured: Up to 6 months after enrolment
Secondary outcomes (6)
Incidence of BVD-attributable death
Incidence of BVD-attributable death among enrolled frontline workers during follow-up, including deaths occurring in Ebola health facilities and in the community
Measured: Up to 6 months after enrollment
Cumulative incidence of laboratory-confirmed BVD
Cumulative incidence of symptomatic laboratory-confirmed BVD among vaccinated versus unvaccinated frontline workers.
Measured: Up to 6 months
Test-negative vaccine effectiveness
Proportion of vaccinated frontline workers among laboratory-confirmed BVD cases compared with BVD-negative symptomatic frontline workers presenting to Ebola health facilities.
Measured: Up to 12 months
Severe disease among confirmed BVD cases
Proportion of laboratory-confirmed BVD cases presenting with high viral load at admission, measured by low PCR cycle-threshold (Ct) value, a marker of severe disease and mortality.
Measured: Day 1
Serious adverse events (SAEs)
Proportion of vaccinated participants experiencing at least one serious adverse event (SAE) during the safety follow-up period.
Measured: 1 month after vaccination
Pregnancy and delivery outcomes among pregnant participants receiving ERVEBO®
Proportion of pregnancies with at least one adverse pregnancy or delivery outcome among pregnant participants receiving ERVEBO®. Adverse outcomes include spontaneous abortion, stillbirth, elective termination, congenital anomalies, neonatal death and maternal death.
Measured: 2 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start19 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EbolaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-Randomized, open label
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Médecins Sans Frontières, France, Programme Elargi de Vaccination de République Démocratique du Congo, Institut national de santé publique, RDC, University of Kinshasa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903350
- Sponsor's protocol ID
- BRAVO-Ebola
- Acronym
- BRAVO
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07903350
- Acronym / sponsor ID
- BRAVO / BRAVO-Ebola
- Conditions
- Ebola, Bundibugyo Virus Disease (BVD)
- Keywords
- Bundibugyo virus disease, BVD, Bundibugyo ebolavirus, ERVEBO, Ebola virus disease, Frontline workers, Ebola vaccine, Democratic Republic of the Congo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Médecins Sans Frontières, France, Programme Elargi de Vaccination de République Démocratique du Congo, Institut national de santé publique, RDC, University of Kinshasa
- Study start
- 19 Sep 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The BRAVO study (Bundibugyo: Respondre Avec la Vaccination, "On est ensemble") was developed in response to the 2026 Bundibugyo virus disease (BVD) outbreak in the Democratic Republic of the Congo (DRC). The study focuses on frontline workers (FLWs), who are at increased risk of infection because of their involvement in patient care, outbreak response activities, and contact with affected communities. Protecting this population is critical for maintaining healthcare services and strengthening outbreak control efforts.
Currently, there is no licensed vaccine specifically targeting Bundibugyo virus (BDBV) for broad use. However, ERVEBO®, a vaccine licensed against Zaire ebolavirus, is available and has demonstrated a favorable safety profile. Although preclinical and immunological evidence suggests that ERVEBO® may provide some degree of cross-protection against BDBV, the extent of protection remains uncertain. BRAVO therefore aims both to support rapid vaccination of frontline workers during the outbreak and to generate evidence that can inform future vaccine policy and preparedness strategies.
BRAVO is designed as a phased study embedded within the public health response. The study population includes adults aged 18 years and older working in Ebola treatment centers, healthcare facilities, or community-based outbreak response activities in affected areas. Both clinical and non-clinical personnel may participate if their duties place them at risk of exposure to infected individuals, infectious materials, or affected communities.
The study consists of three steps:
Step A: Immediate deployment and evaluation of ERVEBO® during the outbreak. Step B: Potential future evaluation of heterologous prime-boost vaccination strategies if additional vaccines become available and remain relevant.
Step C: Potential contribution to evaluation of future Bundibugyo virus-specific vaccines.
The primary focus of the current study is Step A, which is a prospective cohort study conducted under real-world outbreak conditions. The main objective is to assess the effectiveness of ERVEBO® vaccination against Bundibugyo virus disease, severe disease outcomes, and death. The primary effectiveness endpoint is whether vaccination reduces case fatality among laboratory-confirmed BVD cases hospitalized in Ebola treatment facilities.
Secondary objectives include evaluating whether vaccination reduces:
BVD-related mortality in the cohort, Incidence of symptomatic laboratory-confirmed BVD, Indicators of severe disease among confirmed cases.
Safety is also an important component of the study. Serious adverse events occurring within one month after vaccination will be documented, and pregnancy outcomes among enrolled pregnant participants will be monitored.
Participants may be enrolled regardless of vaccination status, allowing comparisons between vaccinated and unvaccinated frontline workers as vaccine deployment progresses according to operational feasibility and risk prioritization. Written informed consent will be obtained before enrollment and vaccination. The consent process will clearly communicate that protection against Bundibugyo virus has not been established and that additional vaccine options may become available in the future.
Participants will generally be followed for six months after enrollment, or until the end of the outbreak if it occurs earlier. Pregnant participants will be followed through pregnancy outcomes. An additional component within Ebola treatment centers will collect information on frontline workers presenting with symptoms compatible with BVD, supporting supplementary analyses of vaccine effectiveness using routinely collected clinical and laboratory data.
Step A aims to vaccinate approximately 20,000 frontline workers during the first six months of implementation. Based on projected outbreak assumptions, the study may generate sufficient confirmed BVD cases to provide meaningful estimates of vaccine effectiveness, particularly regarding protection against death.
Beyond evaluating the immediate impact of vaccination, BRAVO is expected to strengthen outbreak preparedness by establishing systems for vaccination delivery, pharmacovigilance, data collection, and participant communication. The study is designed to provide decision-relevant evidence during the outbreak rather than after it, helping guide future recommendations for Bundibugyo virus vaccine strategies.
Enrollment and vaccination are planned from September through December 2026, with follow-up continuing through June 2027. Final analysis and reporting are expected in September 2027.
Detailed description
BRAVO (Bundibugyo: Respondre Avec la Vaccination, "On est ensemble") is a phased study conducted during the 2026 Bundibugyo virus disease (BVD) outbreak in the Democratic Republic of the Congo. The study aims to evaluate the effectiveness and safety of ERVEBO® vaccination among frontline workers (FLWs) and to generate evidence to support public health decision-making for BVD prevention and outbreak response.
Frontline workers are at increased risk of Bundibugyo virus exposure through clinical care, outbreak response activities, and interactions with affected communities. Although no vaccine specifically licensed for Bundibugyo virus is currently available for broad use, ERVEBO®, a vaccine licensed against Zaire ebolavirus, is available and may provide cross-reactive protection against Bundibugyo virus. The extent of such protection is not yet established.
The study population includes adults aged 18 years and older working in healthcare facilities, Ebola treatment centers, laboratories, or community-based outbreak response activities within affected areas. Both clinical and non-clinical personnel may be eligible if their roles involve potential exposure to patients, infectious materials, or affected communities.
The study consists of three planned phases. Step A, the primary focus of the current outbreak response, evaluates the deployment of ERVEBO® under routine operational conditions. Participants may be enrolled regardless of vaccination status, allowing comparison of outcomes between vaccinated and unvaccinated frontline workers over time.
The primary objective of Step A is to assess the effectiveness of ERVEBO® vaccination in reducing mortality among laboratory-confirmed BVD cases. Secondary objectives include evaluating the impact of vaccination on BVD-related mortality, incidence of symptomatic laboratory-confirmed disease, and indicators of severe disease among confirmed cases. Safety assessments include monitoring serious adverse events for one month following vaccination and documenting pregnancy outcomes among enrolled pregnant participants.
Participants will generally be followed for six months after enrollment or until the end of the outbreak, whichever occurs first. If the outbreak continues beyond the planned follow-up period, follow-up may be extended. Data collected during routine outbreak response activities, including information from Ebola treatment facilities, may support additional analyses of vaccine effectiveness among symptomatic frontline workers tested for BVD.
The study is also intended to strengthen operational preparedness by supporting vaccination delivery systems, pharmacovigilance activities, outbreak data collection, and risk communication processes. Future protocol amendments may allow evaluation of heterologous prime-boost vaccination strategies (Step B) or participation in assessments of future Bundibugyo virus-specific vaccines (Step C) if such vaccines become available. The study is expected to provide timely evidence to inform interim and long-term vaccination strategies for Bundibugyo virus disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-Randomized, open label
| Arm | Type | Receives |
|---|---|---|
| Unvaccinated Frontline Workers | No intervention | –Frontline workers who do not receive ERVEBO® during the observation period and are followed for outcome assessment. |
| ERVEBO Vaccination | Experimental | Biological: ERVEBO VaccinationFrontline workers who receive ERVEBO® as part of the outbreak vaccination program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 years or older
- Currently working, or holding a signed work assignment to work, in the following settings within BVD-affected study areas:
- Able and willing to complete the informed consent process and comply with study procedures
- Enrolled in the BRAVO study (eligible and gave informed consent)
- Voluntary chooses to receive vaccination
Key exclusion criteria (7 listed)
- 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.
- Eligibility criteria specific to vaccination
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERVEBO VaccinationFrontline workers who receive ERVEBO® as part of the outbreak vaccination program | Biological | ERVEBO Vaccination |
Primary outcome
Case fatality among laboratory-confirmed BVD cases hospitalized in Ebola health facilities
Time frame: Up to 6 months after enrolment
Effectiveness of ERVEBO® in reducing case fatality among laboratory-confirmed Bundibugyo virus disease (BVD) cases hospitalized in Ebola health facilities.
6 secondary outcomes
Incidence of BVD-attributable death
Time frame: Up to 6 months after enrollment
Cumulative incidence of laboratory-confirmed BVD
Time frame: Up to 6 months
Test-negative vaccine effectiveness
Time frame: Up to 12 months
Severe disease among confirmed BVD cases
Time frame: Day 1
Serious adverse events (SAEs)
Time frame: 1 month after vaccination
Pregnancy and delivery outcomes among pregnant participants receiving ERVEBO®
Time frame: 2 months after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ERVEBO Vaccination in people with Ebola and Bundibugyo Virus Disease (BVD), run by Epicentre at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Denoeud (+33 (0)1 40 21 55 55, Lise-Anne.DENOEUD@EPICENTRE.MSF.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Case fatality among laboratory-confirmed BVD cases hospitalized in Ebola health facilities (time frame: Up to 6 months after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.