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Not yet recruitingNCT07842107TUMAINIUpdated Oct 5, 2026

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

A Phase 2/3 interventional study of Candidate BDBV vaccine and Active comparator in Ebola Hemorrhagic Fever and Bundibugyo Virus Disease, sponsored by Jean-Pierre Van geertruyden. Not yet recruiting at 1 site in Democratic Republic of the Congo. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Jean-Pierre Van geertruyden · Phase 2/3, Interventional, and Prevention

Updated Oct 5, 2026Enrollment updatedEligibility revised+5 moreGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
3,620
Allocation
Randomized
Ages
1 Year and older
Sex
All
01

Study 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, 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.

02

Conditions studied

  • Ebola Hemorrhagic Fever
  • Bundibugyo Virus Disease

Keywords

  • Filovirus
  • Orthoebolavirus
  • Viral hemorrhagic fever
  • Bundibugyo ebolavirus
  • Democratic Republic of the Congo
  • Adaptive platform trial
03

In context

Hemorrhagic Fever, Ebola

104 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.

This study's planned enrollment of 3,620 is above the median of 94 across 81 interventional studies indexed under Hemorrhagic Fever, Ebola.

Browse Hemorrhagic Fever, Ebola studies →

Lead sponsor

Jean-Pierre Van geertruyden is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 5, 2026. See what changed

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 , 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.

Exclusion criteria

Exclusion Criteria:

  • History of laboratory-confirmed Bundibugyo virus disease.
  • Previous vaccination against Bundibugyo virus. Note: prior receipt of an Ebola or Marburg 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.
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
3,620 participants (estimated)

Study arms

  • Experimental
    Candidate BDBV vaccine, then a comparator

    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).

    Biological: Candidate BDBV vaccine · Biological: Active comparator

  • Active comparator
    Comparator, then candidate BDBV vaccine

    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).

    Biological: Candidate BDBV vaccine · Biological: Active comparator

Interventions

  • BiologicalCandidate BDBV vaccine

    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.

  • BiologicalActive 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.

    Also known as: Comparator

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 to Day 181 (+/- 14 days)

  2. 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.

    Time frame: Day 10 to Day 29 after vaccination

  3. 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.

    Time frame: Day 1 to Day 29 (+/- 2 days); to Day 57 (+/- 2 days) for comparator recipients, timed from their Day 29 vaccination

Secondary outcomes

  1. 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.

    Time frame: 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

  2. 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.

    Time frame: Day 1 to Day 29 after vaccination

  3. 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.

    Time frame: Day 10 to Day 29 after vaccination

  4. 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.

    Time frame: Day 1 to Day 9 after vaccination

  5. 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.

    Time frame: 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

07

Study locations

1 site
  • Bunia
    Bunia, Ituri, Democratic Republic of the Congo
    • L'Institut National de Recherche Biomédicale (INRB) · Contactinfo@inrb.cd · +243815183977
    • Hugo Kavunga, MD, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

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: Pseudonymized data sharing will occur in accordance with the WHO Policy Statement on Data Sharing in the Context of Public Health Emergencies. Requests for pseudonymized individual participant data will be reviewed on a case-by-case basis by a designated Data Access Committee or equivalent governance body, and assessed for scientific merit, ethical appropriateness, alignment with participant consent, and compliance with applicable national regulations and institutional policies. Access is subject to a data use agreement. 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.

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Enrollment
3810→3620
Oct 5, 2026
Eligibility
Minimum age 12 Years→1 Year; 3 inclusion criteria added, 2 removed; 4 exclusion criteria edited
What changed in the criteria
Inclusion criteria
  • RemovedAdults, adolescents, and children aged 12 years and older at the time of enrollment.
  • RemovedCapable 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.
  • AddedAdults, 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.
  • AddedCapable 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.
  • AddedWilling to provide verifiable identification, such as iris scanning or a participant card where feasible, and able to be contacted by telephone number or address.
Exclusion criteria
  • ChangedBefore Serious bed-confining illness requiring hospitalization at the time of vaccination.Now Acute unstable illness at the time of vaccination, including organ failure, severe ongoing infection, or any acute condition requiring hospitalization.
  • EditedOngoing 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. Note: if PEP becomes standard of care, it is non-exclusionary.
  • ChangedBefore Living in an area deemed inaccessible by the Investigator, for reasons of distance or security.Now 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.
  • EditedSymptoms consistent with BVD at screening, defined as sudden onset of fever (measured or reported, 38.0 degrees Celsius or above); OR 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.
Oct 5, 2026
Primary outcomes
2 edited, 1 added
What changed in the outcomes
  • EditedPhase 2: Proportion of participants experiencing unsolicited Grade 3 or 4 adverse events, serious adverse events, SUSARssuspected unexpected serious adverse reactions, adverse events of special interest, or medically attended adverse eventsTime frame: Day 1 to Day 181 → Day 1 to Day 181 (+/- 14 days)
  • EditedPhase 3: Vaccine efficacy against polymerase chain reaction (PCR)-confirmed symptomatic Bundibugyo virus disease with symptom onset 10 to 29 days after vaccinationTime frame: Day 10 to Day 29 after vaccination
  • AddedPhase 2: Proportion of participants experiencing unsolicited adverse events, Grade 1 to Grade 4Time frame: Day 1 to Day 29 (+/- 2 days); to Day 57 (+/- 2 days) for comparator recipients, timed from their Day 29 vaccination
Oct 5, 2026
Secondary outcomes
2 edited, 1 time frame changed, 2 added, 1 removed, 1 description edited
What changed in the outcomes
  • EditedPhase 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-treatTime frame: Day 10 to Day 29 after vaccination
  • EditedPhase 3: Number of polymerase chain reaction (PCR)-confirmed symptomatic Bundibugyo virus disease cases with symptom onset 0 to 9 days after vaccinationTime frame: Day 0 to Day 9 after vaccination → Day 1 to Day 9 after vaccination
  • AddedPhase 2: Seropositivity and seroconversion rates measured by Bundibugyo virus glycoprotein-specific immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) and pseudovirus neutralization assay (pVNA)Time frame: 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
  • AddedPhase 2: Magnitude and kinetics of antibody responses to candidate Bundibugyo virus (BDBV) vaccinesTime frame: 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
  • RemovedPhase 2: Seroconversion rate measured by ELISA for IgM and IgG titresTime frame: Days 1, 15, 29, 43, 57 and 181
  • Time framePhase 3: Number of confirmed Bundibugyo virus disease deaths in each armDay 0 to Day 29 after vaccination → Day 1 to Day 29 after vaccination
  • DescriptionPhase 3: Number of confirmed Bundibugyo virus disease deaths in each arm: how it is measured was reworded
Oct 5, 2026
Contact
Study contact changed: m•••@uantwerpen.be · •••1677→t•••@uantwerpen.be · •••1800; removed L•••@uantwerpen.be · •••4863. See the current contact
Oct 5, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Bunia · Bunia, Democratic Republic of the CongoContact h•••@gmail.com · •••5153→i•••@inrb.cd · •••3977Contact person changed (no phone or email listed)
Oct 5, 2026
Title
Phase 2/3 TrialStudy of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in DRCthe Democratic Republic of the Congo
Oct 5, 2026
Sponsor
Collaborators added: Coalition for Epidemic Preparedness Innovations; collaborators removed: CEPI
Oct 5, 2026
Registered
First appeared on the registry
Sep 25, 2026
Show all 2 updates
  1. Oct 5, 2026
    Enrollment 3810→3620
    Eligibility Minimum age 12 Years→1 Year; 3 inclusion criteria added, 2 removed; 4 exclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • RemovedAdults, adolescents, and children aged 12 years and older at the time of enrollment.
    • RemovedCapable 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.
    • AddedAdults, 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.
    • AddedCapable 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.
    • AddedWilling to provide verifiable identification, such as iris scanning or a participant card where feasible, and able to be contacted by telephone number or address.
    Exclusion criteria
    • ChangedBefore Serious bed-confining illness requiring hospitalization at the time of vaccination.Now Acute unstable illness at the time of vaccination, including organ failure, severe ongoing infection, or any acute condition requiring hospitalization.
    • EditedOngoing 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. Note: if PEP becomes standard of care, it is non-exclusionary.
    • ChangedBefore Living in an area deemed inaccessible by the Investigator, for reasons of distance or security.Now 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.
    • EditedSymptoms consistent with BVD at screening, defined as sudden onset of fever (measured or reported, 38.0 degrees Celsius or above); OR 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.
    Primary outcomes 2 edited, 1 added
    What changed in the outcomes
    • EditedPhase 2: Proportion of participants experiencing unsolicited Grade 3 or 4 adverse events, serious adverse events, SUSARssuspected unexpected serious adverse reactions, adverse events of special interest, or medically attended adverse eventsTime frame: Day 1 to Day 181 → Day 1 to Day 181 (+/- 14 days)
    • EditedPhase 3: Vaccine efficacy against polymerase chain reaction (PCR)-confirmed symptomatic Bundibugyo virus disease with symptom onset 10 to 29 days after vaccinationTime frame: Day 10 to Day 29 after vaccination
    • AddedPhase 2: Proportion of participants experiencing unsolicited adverse events, Grade 1 to Grade 4Time frame: Day 1 to Day 29 (+/- 2 days); to Day 57 (+/- 2 days) for comparator recipients, timed from their Day 29 vaccination
    Secondary outcomes 2 edited, 1 time frame changed, 2 added, 1 removed, 1 description edited
    What changed in the outcomes
    • EditedPhase 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-treatTime frame: Day 10 to Day 29 after vaccination
    • EditedPhase 3: Number of polymerase chain reaction (PCR)-confirmed symptomatic Bundibugyo virus disease cases with symptom onset 0 to 9 days after vaccinationTime frame: Day 0 to Day 9 after vaccination → Day 1 to Day 9 after vaccination
    • AddedPhase 2: Seropositivity and seroconversion rates measured by Bundibugyo virus glycoprotein-specific immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) and pseudovirus neutralization assay (pVNA)Time frame: 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
    • AddedPhase 2: Magnitude and kinetics of antibody responses to candidate Bundibugyo virus (BDBV) vaccinesTime frame: 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
    • RemovedPhase 2: Seroconversion rate measured by ELISA for IgM and IgG titresTime frame: Days 1, 15, 29, 43, 57 and 181
    • Time framePhase 3: Number of confirmed Bundibugyo virus disease deaths in each armDay 0 to Day 29 after vaccination → Day 1 to Day 29 after vaccination
    • DescriptionPhase 3: Number of confirmed Bundibugyo virus disease deaths in each arm: how it is measured was reworded
    Sponsor Collaborators added: Coalition for Epidemic Preparedness Innovations; collaborators removed: CEPI
    Contact Study contact changed: m•••@uantwerpen.be · •••1677→t•••@uantwerpen.be · •••1800; removed L•••@uantwerpen.be · •••4863. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Bunia · Bunia, Democratic Republic of the CongoContact h•••@gmail.com · •••5153→i•••@inrb.cd · •••3977Contact person changed (no phone or email listed)
    Title Phase 2/3 TrialStudy of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in DRCthe Democratic Republic of the Congo
    + 4 other changes: description, conditions, arm descriptions and data sharing statement
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07842107
Lead sponsor
Jean-Pierre Van geertruyden
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
Jean-Pierre Van geertruyden (Sponsor, Universiteit Antwerpen) — Sponsor-investigator
First posted
Sep 25, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 5, 2026

Study contacts

Study Coordinator
Contact
tumaini@uantwerpen.be
+3232651800

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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