Ebola Hemorrhagic FeverPhase 2/3TUMAININCT07842107
Study of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in the Democratic Republic of the Congo
A Phase 2/3 study testing Candidate BDBV vaccine and Active comparator in people with Ebola Hemorrhagic Fever and Bundibugyo Virus Disease, run by Jean-Pierre Van geertruyden at 1 site in Democratic Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Ebola Hemorrhagic Fever, Bundibugyo Virus Disease
- What is being tested?
- Candidate BDBV vaccine and Active comparator
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,620 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 20 Oct 2026to Jun 2027
- Phase
- Phase 2/3
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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 1 year and older at the time of enrollment. Where a candidate vaccine has an age indication that does not cover the full age range, enrollment for that candidate is limited to its age indication and compared with the same age group in the comparator arm. The lower age limit for any age band is determined by the age indication of both the candidate vaccine and the comparator.
- Capable of giving written informed consent, or having a parent, legal guardian or legally authorized representative capable of giving written informed consent on the participant's behalf, in accordance with applicable country regulations. Where permitted by local regulations, witnessed verbal consent may be obtained for participants unable to provide written consent, documented in the presence of an impartial witness independent of the study team. Participants for whom assent is required under local regulations or ethics committee requirements must additionally provide informed assent.
- Willing to provide verifiable identification, such as iris scanning or a participant card where feasible, and able to be contacted by telephone number or address.
Who cannot join
- History of laboratory-confirmed Bundibugyo virus disease.
- Previous vaccination against Bundibugyo virus. Note: prior receipt of an Ebola or Marburg investigational or licensed vaccine is non-exclusionary provided that any prior vaccination was administered more than 28 days before enrollment and is documented.
- History of anaphylaxis from a vaccine or a component of a vaccine.
- Acute unstable illness at the time of vaccination, including organ failure, severe ongoing infection, or any acute condition requiring hospitalization.
- Receipt of monoclonal antibodies as post-exposure prophylaxis (PEP) within 21 days prior to vaccination, or planned receipt after vaccination.
- Ongoing treatment with antiviral PEP from at least six days prior to vaccination until the time of vaccination. Note: prior receipt of a licensed or experimental antiviral candidate for BVD PEP is acceptable provided the course was completed at least six days prior to vaccination.
Show all 10Show fewer
- 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. Inaccessibility is defined as: no usable road or river access for the vehicles available to the team; or an active security incident or armed clash affecting the locality within the preceding 7 days, or a formal instruction from local authorities not to deploy.
- Symptoms consistent with BVD at screening, defined as sudden onset of fever (measured or reported, 38.0 degrees Celsius or above); OR inexplicable bleeding; OR 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.
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
Bunia
Bunia, Ituri
L'Institut National de Recherche Biomédicale (INRB), +243815183977, info@inrb.cd
Hugo Kavunga, MD, PhD
About this study
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
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.
- Conditions
- Ebola Hemorrhagic Fever, Bundibugyo Virus Disease
- Being tested
- Candidate BDBV vaccine, Active comparator
- Keywords
- Filovirus, Orthoebolavirus, Viral hemorrhagic fever, Bundibugyo ebolavirus, Democratic Republic of the Congo, Adaptive platform trial
- Medical subject headings
- Hemorrhagic Fever, Ebola, Hemorrhagic Fevers, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candidate BDBV vaccineBiological
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.
Active comparatorBiological
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 (+/- 1 day), 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 (+/- 2 days) participants in this arm receive the comparator as the alternative 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 (+/- 14 days) in the Phase 2 component. In the Phase 3 component, active safety follow-up continues to Day 36 (+/- 2 days), with passive safety follow-up to Day 181 (+/- 14 days). Receives: 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 on Day 1 (+/- 1 day), 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 (+/- 2 days) participants in this arm receive the corresponding candidate Bundibugyo virus (BDBV) vaccine as the alternative intervention. Safety follow-up continues to Day 181 (+/- 14 days) in the Phase 2 component. In the Phase 3 component, active safety follow-up continues to Day 36 (+/- 2 days), with passive safety follow-up to Day 181 (+/- 14 days). Receives: Biological: Candidate BDBV vaccine; Biological: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2: Proportion of participants experiencing serious adverse events, suspected unexpected serious adverse reactions, adverse events of special interest, or medically attended adverse events
Proportion of vaccine recipients who experience 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.
Measured: Day 1 to Day 181 (+/- 14 days)
Phase 3: Vaccine efficacy against polymerase chain reaction (PCR)-confirmed symptomatic Bundibugyo virus disease with symptom onset 10 to 29 days after vaccination
Vaccine efficacy estimated by comparing the number of polymerase chain reaction (PCR)-confirmed symptomatic Bundibugyo virus disease cases with symptom onset 10 to 29 days after vaccination in each candidate vaccine arm with the comparator arm. The primary analysis is per-protocol.
Measured: Day 10 to Day 29 after vaccination
Phase 2: Proportion of participants experiencing unsolicited adverse events, Grade 1 to Grade 4
Proportion of vaccine recipients who experience unsolicited adverse events of any grade (Grade 1 to Grade 4), assessed using severity and causality assessments. Events are summarized with counts, percentages and exact 95% confidence intervals.
Measured: Day 1 to Day 29 (+/- 2 days); to Day 57 (+/- 2 days) for comparator recipients, timed from their Day 29 vaccination
Secondary outcomes (5)
Phase 2: Seropositivity and seroconversion rates measured by Bundibugyo virus glycoprotein-specific immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) and pseudovirus neutralization assay (pVNA)
Seropositivity and seroconversion rates assessed in all participants in each candidate vaccine arm and in the comparator group randomized alongside that candidate. Endpoints are Bundibugyo virus (BDBV) glycoprotein-specific immunoglobulin G (IgG) concentrations measured by enzyme-linked immunosorbent assay (ELISA), and functional titers measured by pseudovirus neutralization assay (pVNA). Samples are collected from all participants at every time point to preserve masking. Analysis is aligned to the timing of candidate vaccine receipt in each group.
Measured: Days 1 (+/- 1 day), 15 (+/- 2 days) and 29 (+/- 2 days); Days 29, 43 and 57 (+/- 2 days) for comparator recipients, timed from their Day 29 vaccination
Phase 3: Number of confirmed Bundibugyo virus disease deaths in each arm
Number of deaths from confirmed Bundibugyo virus disease in each arm, compared between each candidate vaccine arm and the comparator arm. The denominator for each arm is the number of participants randomized to that arm.
Measured: Day 1 to Day 29 after vaccination
Phase 3: Number of polymerase chain reaction (PCR)-confirmed symptomatic Bundibugyo virus disease cases with symptom onset 10 to 29 days after vaccination, modified intention-to-treat
Number of polymerase chain reaction (PCR)-confirmed symptomatic Bundibugyo virus disease cases with symptom onset 10 to 29 days after vaccination in each arm, analyzed as modified intention-to-treat, to estimate vaccine efficacy between each candidate vaccine arm and the comparator arm.
Measured: Day 10 to Day 29 after vaccination
Phase 3: Number of polymerase chain reaction (PCR)-confirmed symptomatic Bundibugyo virus disease cases with symptom onset 0 to 9 days after vaccination
Number of polymerase chain reaction (PCR)-confirmed symptomatic Bundibugyo virus disease cases with symptom onset 0 to 9 days after vaccination in each arm, used to estimate vaccine efficacy in the period before protection is expected to be established.
Measured: Day 1 to Day 9 after vaccination
Phase 2: Magnitude and kinetics of antibody responses to candidate Bundibugyo virus (BDBV) vaccines
Antibody titers and concentrations analyzed longitudinally for each candidate vaccine arm, to describe the magnitude and kinetics of the antibody response up to Day 181.
Measured: Days 1 (+/- 1 day), 15 (+/- 2 days), 29 (+/- 2 days) and 181 (+/- 14 days); Days 29, 43, 57 (+/- 2 days) and 181 (+/- 14 days) for comparator recipients, timed from their Day 29 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola Hemorrhagic FeverStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jean-Pierre Van geertruyden
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium, Institut National de Recherche Biomedicale (INRB), Epicentre, Médecins Sans Frontières, Belgium, World Health Organization, Coalition for Epidemic Preparedness Innovations
- Responsible party
- Sponsor-investigator, Jean-Pierre Van geertruyden, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842107
- Sponsor's protocol ID
- UA-TUMAINI-2026-01
- Acronym
- TUMAINI
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary results will be made publicly available through publications and trial reporting. Results will be made publicly available within six months of the last visit of the last participant for collection of primary outcome data, and earlier where appropriate during a public health emergency. Access to additional pseudonymized individual participant data may be considered on a case-by-case basis, subject to applicable ethical, regulatory and data-sharing requirements.