Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202608542565174 Date of Registration: 18/08/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A phase 1b randomised double-blinded placebo-controlled study of a Bundibugyo virus disease vaccine, ChAdOx1 Ebola BDBV Vaccine (Recombinant), in healthy participants aged 18 – 55 years in Uganda.
Official scientific title A phase 1b randomised double-blinded placebo-controlled study of a Bundibugyo virus disease vaccine, ChAdOx1 Ebola BDBV Vaccine (Recombinant), in healthy participants aged 18 – 55 years in Uganda.
Brief summary describing the background and objectives of the trial This is a Phase 1b clinical trial evaluating the safety, tolerability and immunogenicity of the ChAdOx1 Ebola BDBV Vaccine (Recombinant) in 110 healthy Ugandan adults aged 18–55 years. Sponsored by the University of Oxford, the study will be conducted at the MRC/UVRI & LSHTM Uganda Research Unit, Masaka Research Station, following an initial Phase 1a first-in-human study in the United Kingdom. Bundibugyo virus (BDBV) causes a severe form of Ebola virus disease with high mortality and has caused outbreaks in Uganda and the Democratic Republic of the Congo. Despite the ongoing public health threat, there are currently no licensed vaccines specifically targeting BDBV. The investigational ChAdOx1 Ebola BDBV Vaccine (Recombinant) is based on the well-established ChAdOx1 platform and is designed to induce immunity against BDBV without containing live virus. Participants will be enrolled into three cohorts: a randomised, double-blind, placebo-controlled cohort receiving a single vaccine dose or placebo (n=50); an open-label cohort receiving a single dose followed by a booster at six months (n=20); and an open-label cohort of individuals previously vaccinated against Ebola who will receive a single vaccine dose (n=40). Participants will be followed for 12 months, during which safety assessments, adverse event monitoring, clinical evaluations and blood sampling for immunological analyses will be undertaken. The primary objective is to assess the safety and tolerability of a single vaccine dose, while secondary and exploratory objectives are to evaluate humoral and cellular immune responses, including responses following booster vaccination and in individuals previously vaccinated against Ebola. The study will generate critical early clinical evidence to support the development of a vaccine against Bundibugyo virus disease for future outbreak preparedness and response.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BD-Ebov-02
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 03/08/2026
Actual trial start date 03/08/2026
Anticipated date of last follow up 03/08/2027
Actual Last follow-up date 01/09/2027
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants) 110
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ChAdOx1 Ebola BDBV Vaccine The vaccine is administered IM as a single dose. A booster dose at 6 months will be administered to participants in cohort 2 only The vaccine is administered IM as a single dose. A booster dose at 6 months will be administered to participants in cohort 2 only 5 x 1010 vp per administration 100
Control Group sodium chloride The placebo consists of 0.9% sodium chloride administered intramuscularly into the deltoid region of the arm once in Cohort 1 and 3 and twice in cohort 2. The placebo is administered IM as a single dose. A booster dose at 6 months will be administered to participants in cohort 2 only 5 x 1010 vp per administration 10 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults aged between 18 to 55 years (inclusive) at the time of screening. Medically healthy, such that according to investigator judgement, hospitalisation within the study period is not anticipated, and the participant appears likely to be able to remain a study participant through the end of protocol-specified follow-up. Planned elective procedures for pre-existing conditions are allowable. Able to attend the scheduled visits and to comply with all study procedures. Willing and able to give informed consent for participation in the study. Able to provide a reliable past medical history confirmed where necessary, at the investigator’s discretion, by the participant’s usual health care provider. Willing to allow usual health care provider, if appropriate, to be notified of participation in the study. Agreement to refrain from planned blood donation during the study (see also section 8.6). For participants of childbearing potential only (as defined by protocol section 11.9): willing to use highly effective contraception for the duration of the study AND to have a pregnancy test on the day of screening and vaccination days and at the end of study. Highly effective methods include contraceptive implant, injectable contraception, intrauterine device/system, surgical sterilisation, or another method judged by the Investigator to be highly effective. The pregnancy tests taken prior to vaccination must be negative. For cohort 3 only: Have previously received at least one dose of rVSV-ZEBOV-GP or rVSV-SEBOV-GP. Receipt of an investigational product within 12 weeks prior to enrolment or planned within the trial period. Participation in another research study, in which procedures performed could compromise the integrity of this study such as exposure to a different study IMP or significant volumes of blood taken, or are planning to do so within the trial period. History of previous confirmed or suspected filovirus infection. History of travel within 42 days of enrolment, or planned travel within the study period, to the Democratic Republic of the Congo. For cohorts 1 and 2 only: Prior receipt of a vaccine targeting filoviruses, including licensed and investigational vaccines, confirmed by participant recall. Prior receipt of a ChAdOx1- or ChAdOx2-vectored vaccine within 2 years of enrolment as confirmed by participant recall Administration of immunoglobulins and/or any blood products within three months preceding the planned administration of the vaccine candidate. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; severe infection(s); receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months, or long-term systemic corticosteroid therapy (including for more than 7 consecutive days within three months preceding the planned administration of the vaccine candidate). History of anaphylaxis or severe reaction in relation to vaccination. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including hypersensitivity to the active substance or to any of the excipients of the IMP. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). History of any serious psychiatric condition likely to affect participation in the study. Participants who are pregnant, breastfeeding or lactating, or are planning pregnancy during the study. History of a bleeding disorder (e.g., Factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture. History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism); history of antiphospholipid syndrome, or history of heparin induced thrombocytopenia. History of capillary leak syndrome. History of Guillian-Barre syndrome, transverse myelitis or other neuroinflammatory syndrome. History of currently active autoimmune conditions of any severity requiring treatment or on-going medical follow-up. Moderate, severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, haematological (including sickle cell disease), immunological, endocrine disorder, or neurological illness. Well-controlled co-morbidities in a healthy participant are acceptable as judged by the Investigator. Suspected or known current alcohol abuse, as per investigator’s discretion. Suspected or known injecting drug use within the 5 years preceding enrolment. Acute or chronic hepatitis B or hepatitis C infection. Any clinically significant finding on screening that does not resolve (for example on repeat testing at the discretion of an Investigator) within the recruitment timeline of the study*. Any other significant disease, disorder or finding which may significantly increase the risk to the participant if included in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data. Study staff or a partner or dependent child of study staff. Use of traditional medicine within 3 months of enrolment in the study which, in the opinion of the investigator, could impact the integrity of the trial. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/08/2026 Uganda Virus Research Institute Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 Nakiwogo Road, Entebbe Uganda Entebbe 256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination. Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination. Occurrence of abnormal safety laboratory measures for duration of the study period. Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) for duration of the study period. 0 to 12-month follow-up period
Secondary Outcome Assessment of immunogenicity response after one dose immunisation through a) BDBV-specific IgG enyme-linked immunosorbent assay (ELISA) and/or b) BDBV-specific interferon gamma T cell enzyme-linked immunospot assay (ELISpot) Cohort Day 0 - Day 365 Cohort Day 0-Day 84
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MRCUVRI and LSHTM Uganda Research Unit Plot 2-5, Ntikko Road, Masaka, Uganda Masaka 256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Coalition for Epidemic Preparedness Innovations Skoyen Atrium Askekroken 11 Oslo 0277 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Boundary Brook House, Churchill Drive, Headington Oxford United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eugene Ruzagira Eugene.Ruzagira@mrcuganda.org +256701030782 Plot 51-59, Nakiwogo Road, Entebbe, Uganda
City Postal code Country Position/Affiliation
Entebbe Uganda Associate Professor
Role Name Email Phone Street address
Public Enquiries Zacchaeus Anywaine Zacchaeus.Anywaine@mrcuganda.org +256772823705 Plot 2-5, Ntikko Road, Masaka, Uganda
City Postal code Country Position/Affiliation
Masaka Uganda Scientist
Role Name Email Phone Street address
Scientific Enquiries Andrew Obuku Ekii Andrew.Obuku@mrcuganda.org +256773623473 Plot 51-59, Nakiwogo Road, Entebbe, Uganda
City Postal code Country Position/Affiliation
Entebbe Uganda Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) underlying the results reported in publications, including participant-level demographic, clinical, safety and immunogenicity data, will be made available upon reasonable request. Data will be shared in a pseudonymised format with qualified researchers whose proposed use has been approved by the Sponsor and the study investigators, subject to applicable ethical approvals, data sharing agreements, and relevant institutional and regulatory requirements. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 12 months after publication of the primary study results and ending 5 years thereafter. Access to de-identified individual participant data will be granted to qualified researchers upon submission of a scientifically sound research proposal. Requests will be reviewed and approved by the Sponsor and study investigators based on scientific merit, ethical considerations, protection of participant confidentiality, and compliance with applicable laws, regulations, and institutional requirements. Approved requestors will be required to complete a data sharing agreement prior to access, and data may only be used for the approved research purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 30/07/2026 Updated as per the recomendantion by the reviewer This is a Phase 1b clinical trial to evaluate the safety, tolerability and immunogenicity of ChAdOx1 Ebola BDBV Vaccine (Recombinant) in 110 healthy Ugandan adults aged 18–55 years. The study is sponsored by the University of Oxford and will be conducted at the MRC/UVRI & LSHTM Uganda Research Unit, Masaka Research Station. It follows an initial Phase 1a first-in-human study of the same vaccine being conducted in the United Kingdom (BD-Ebov-01). The study has been developed in response to the ongoing Bundibugyo virus disease (BVD) outbreak in the Democratic Republic of the Congo and Uganda. There are currently no licensed vaccines specifically targeting Bundibugyo virus disease, and this study aims to support development of a safe and effective vaccine for future outbreak response. Participants will be enrolled into one of three cohorts: • Cohort 1 (n=50) is a randomised, double-blind, placebo-controlled cohort receiving either a single dose of ChAdOx1 Ebola BDBV Vaccine (Recombinant) or saline placebo. • Cohort 2 (n=20) is an open-label cohort receiving a single vaccine dose followed by a booster dose six months later. • Cohort 3 (n=40) is an open-label cohort of individuals previously vaccinated with rVSV-ZEBOV-GP or rVSV-SUDV-GP who will receive a single dose of ChAdOx1 Ebola BDBV Vaccine (Recombinant). Participants will attend screening, vaccination and follow-up visits over 12 months. Study procedures include informed consent, medical assessment, vaccine/placebo administration, safety monitoring, collection of adverse events, blood sampling for clinical safety and immunological analyses, and completion of diary cards following vaccination. The primary objective is to evaluate the safety and tolerability of the vaccine, while secondary and exploratory objectives include assessment of humoral and cellular immune responses following vaccination, including responses following booster vaccination and in individuals previously vaccinated This is a Phase 1b clinical trial evaluating the safety, tolerability and immunogenicity of the ChAdOx1 Ebola BDBV Vaccine (Recombinant) in 110 healthy Ugandan adults aged 18–55 years. Sponsored by the University of Oxford, the study will be conducted at the MRC/UVRI & LSHTM Uganda Research Unit, Masaka Research Station, following an initial Phase 1a first-in-human study in the United Kingdom. Bundibugyo virus (BDBV) causes a severe form of Ebola virus disease with high mortality and has caused outbreaks in Uganda and the Democratic Republic of the Congo. Despite the ongoing public health threat, there are currently no licensed vaccines specifically targeting BDBV. The investigational ChAdOx1 Ebola BDBV Vaccine (Recombinant) is based on the well-established ChAdOx1 platform and is designed to induce immunity against BDBV without containing live virus. Participants will be enrolled into three cohorts: a randomised, double-blind, placebo-controlled cohort receiving a single vaccine dose or placebo (n=50); an open-label cohort receiving a single dose followed by a booster at six months (n=20); and an open-label cohort of individuals previously vaccinated against Ebola who will receive a single vaccine dose (n=40). Participants will be followed for 12 months, during which safety assessments, adverse event monitoring, clinical evaluations and blood sampling for immunological analyses will be undertaken. The primary objective is to assess the safety and tolerability of a single vaccine dose, while secondary and exploratory objectives are to evaluate humoral and cellular immune responses, including responses following booster vaccination and in individuals previously vaccinated against Ebola. The study will generate critical early clinical evidence to support the development of a vaccine against Bundibugyo virus disease for future outbreak preparedness and response.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 30/07/2026 Updated to include the maximum age of 55years Adult: 18 Year(s)-44 Year(s) Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/07/2026 Intervention number need to match the total study number as recomended by the reviewer Experimental Group, ChAdOx1 Ebola BDBV Vaccine , The vaccine is administered IM as a single dose. A booster dose at 6 months will be administered to participants in cohort 2 only , The vaccine is administered IM as a single dose. A booster dose at 6 months will be administered to participants in cohort 2 only , 5 x 1010 vp per administration, 100,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/07/2026 Updated as per the reviewer comment. The Intervention section has been revised to reflect 100 participants in the intervention group and 10 participants in the control group, corresponding to the final sample size of 110 participants. Control Group, sodium chloride, The placebo consists of 0.9% sodium chloride administered intramuscularly into the deltoid region of the arm once in Cohort 1 and 3 and twice in cohort 2., The placebo is administered IM as a single dose. A booster dose at 6 months will be administered to participants in cohort 2 only , 5 x 1010 vp per administration, 40, Placebo Control Group, sodium chloride, The placebo consists of 0.9% sodium chloride administered intramuscularly into the deltoid region of the arm once in Cohort 1 and 3 and twice in cohort 2., The placebo is administered IM as a single dose. A booster dose at 6 months will be administered to participants in cohort 2 only , 5 x 1010 vp per administration, 10, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 12/08/2026 The trial will be conducted at one site, not school and there is not any other site apart from the one mentioned above. MRCUVRI and LSHTM Uganda Research Unit , Plot 2-5, Ntikko Road, Masaka, Uganda, Masaka, , Uganda MRCUVRI and LSHTM Uganda Research Unit , Plot 2-5, Ntikko Road, Masaka, Uganda, Masaka, 256, Uganda
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/08/2026 PACTR Admin FALSE, Uganda Virus Research Institute Research Ethics Committee , Plot 51-59 Nakiwogo Road, Entebbe Uganda , Entebbe, 256, Uganda, 22 Jul 2026, , +256414321962, tlutalo@uvri.go.ug, FALSE, Uganda Virus Research Institute Research Ethics Committee , Plot 51-59 Nakiwogo Road, Entebbe Uganda , Entebbe, 256, Uganda, 22 Jul 2026, , +256414321962, tlutalo@uvri.go.ug, 43761_40076_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/08/2026 PACTR Admin FALSE, Uganda Virus Research Institute Research Ethics Committee , Plot 51-59 Nakiwogo Road, Entebbe Uganda , Entebbe, 256, Uganda, 22 Jul 2026, , +256414321962, tlutalo@uvri.go.ug, 43761_40076_4737.pdf TRUE, Uganda Virus Research Institute Research Ethics Committee , Plot 51-59 Nakiwogo Road, Entebbe Uganda , Entebbe, 256, Uganda, 22 Jul 2026, 17 Aug 2026, +256414321962, tlutalo@uvri.go.ug, 43761_40076_4737.pdf