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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202502853321394 Date of Registration: 14/02/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the efficacy of post-exposure prophylaxis (PEP) strategy in contacts at high risk of developing Ebola virus disease
Official scientific title Evaluation of the efficacy of post-exposure prophylaxis (PEP) strategy in contacts at high risk of developing Ebola virus disease : EBO-PEP trial
Brief summary describing the background and objectives of the trial Ebola virus disease (EVD) remains a significant public health challenge due to its high mortality rates and potential for rapid transmission among close contacts of infected individuals. Despite advances in treatment and prevention, including the development of the Ervebo vaccine (ERV), there is a critical need to optimize post-exposure prophylaxis (PEP) strategies to protect high-risk contacts, such as those with direct exposure to bodily fluids of symptomatic cases or corpses of confirmed or probable cases. The EBOPEP trial seeks to evaluate whether combining ERV with Inmazeb (IMZ), a monoclonal antibody cocktail, or Obeldesivir (ODV), an antiviral agent, offers enhanced protection compared to ERV alone. The trial's main objective is to compare the efficacy of two combination PEP strategies (ERV+IMZ and ERV+ODV) against ERV alone in reducing the incidence of EVD at Day 21 among high-risk contacts. The secondary objectives include assessing the safety and tolerance of the three PEP strategies, comparing the severity of EVD cases among the intervention arms, evaluating the proportion of deaths attributable to EVD in each group, and describing the progression of viral load in participants with confirmed EVD. These objectives aim to provide a comprehensive understanding of the clinical and epidemiological benefits of the proposed PEP strategies.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EBO PEP
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Prevention
Anticipated trial start date 01/07/2025
Actual trial start date 01/06/2025
Anticipated date of last follow up 01/06/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants)
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 Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group EBO PEP ERV arm: Ervebo (72 million PFU IM) ERV arm: Ervebo at D1 Participants will be randomized (1:1:1) into one of three trial arms : - Arm 1: Control arm : ERV - Arm 2: ERV on Day 0 + Inmazeb IV on Day 0+ ERV on Day 56 (Revaccination) - Arm 3: ERV on Day 0 +Obeldesivir oral on Day 0 to 9) 80 Active-Treatment of Control Group
Experimental Group EBO PEP ERV+IMZ arm: Ervebo (72 million PFU IM) + Inmazeb IV (150 mg/kg) ERV+ODV arm: Ervebo (72 million PFU IM) + oral obeldesivir (350 mg BID) ERV+IMZ arm: Ervebo at D1 and D56 + Inmazeb IV (150 mg/kg) D1 ERV+ODV arm: Ervebo D1+ oral obeldesivir (350 mg BID D1-J10) Participants will be randomized (1:1:1) into one of three trial arms : - Arm 1: Control arm : ERV - Arm 2: ERV on Day 0 + Inmazeb IV on Day 0+ ERV on Day 56 (Revaccination) - Arm 3: ERV on Day 0 +Obeldesivir oral on Day 0 to 9) 160
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Last high-risk contact within the last 5 days No signs or symptoms of EVD Age ≥ 12 years Signed and dated informed consent to take part in the trial Previous vaccination with Ervebo or any other EVD vaccine less than 5 years ago (declared by the participant) History of confirmed EVD less than 5 years ago (declared by the participant) Pregnant women (positive pregnancy test) Breastfeeding women Hypersensitivity to one of the investigational medicinal products (IMP) or to their excipients (declared by the participant) Declared severe renal or hepatic insufficiency Participation in another therapeutic or vaccination trial for EVD Any other reason which, at the investigator's discretion, would compromise the participant's safety and cooperation in the trial. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 80 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
No 10/02/2025 National Health Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Local 5, Commune/ Kasa-vubu Kinshasa 012 Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the rate of EVD at 21 days in contacts at high risk of EVD receiving a PEP strategy Ervebo + Inmazeb or obeldesivir vs. Ervebo alone Proportion of participants with symptomatic and PCR-confirmed EVD between D1 and D21
Secondary Outcome Comparing safety and tolerance Compare the severity of EVD Compare the proportion of deaths Describe changes in viral load Estimating cost-effectiveness Day1 and Day 21 or at the end of hospitalisation for EVD if this continues after Day21
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
BENI EBO PEP CENTER Hospital street BENI Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP3 Toison dor Street / Guldeen Vlieslaan 56-60 Brussels Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Inserm ANRS MIE 2, Rue Oradour-sur-Glane Paris PARIS 75015 France Research funding and grant
COLLABORATORS
Name Street address City Postal code Country
Centre de Recherche et de Formation en Infectiologie de Guinee Donka, bloc des professeurs Conakry Guinea
Agence Nationale de Securite Sanitaire Cite chemin de fer, Almamya Kaloum Conakry Guinea
Institut National de Recherche Biomedicale Avenue de la democratie, 5345 Kinshasa Democratic Republic of the Congo
Alliance for International Medical Action Urban station, 1 rue Philidor Paris 75020 France
Barcelone Institute for Global Health C Rosselo 132 Planta 05 Barcelone 08036 Spain
Cheikh Anta Diop University Avenue Martin Luther King Dakar Senegal
PACCI Research Center CHU Treichville, 18 Abidjan BP 1954 Cote Divoire
Bordeaux University 146, Leo Saignat street Bordeaux 33076 France
French National Agency for Research into AIDS viral hepatitis and emerging infectious diseases PariSante Campus 2 Oradour sur Glane street Paris 75015 France
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marie Jaspard marie.jaspard@aphp.fr +33658809012 184 rue Faubourg Saint-Antoine
City Postal code Country Position/Affiliation
Paris 75012 France INSERM
Role Name Email Phone Street address
Public Enquiries Alice Montoyo alice.montoyo@coral.alima.ngo +3306601629 Centre Urban Station,1 rue Philidor,
City Postal code Country Position/Affiliation
Paris 75020 France International Project Manager ALIMA
Role Name Email Phone Street address
Scientific Enquiries Placide Mbalaa mbalaplacide@gmail.com +243815205343 Democratic avenue, 5345
City Postal code Country Position/Affiliation
Kinshasa Democratic Republic of the Congo Coordinating Investigator INRB
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study data will be processed by PAC-CI and Inserm-ANRS|MIE, with registration ensured under CNIL regulations. Participant data will remain anonymized, with no identifying details included. Each participant will receive a unique identification code for all study-related materials and electronic records. Access to IPD will be limited to authorized personnel for data verification purposes, under strict confidentiality. This process complies with legal and ethical standards to protect participant privacy. Study Protocol Data will be made available, at the sponsor's discretion, at the end of the study. Access to the study data is strictly controlled and must be based on a formal request addressed to the COPIL or the sponsor.
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 Anticipated trial start date 11/02/2025 TYPO ERROR 01 Jun 2025 01 Jul 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 11/02/2025 TYPO ERROR 01 Jun 2024 01 Jun 2025
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 11/02/2025 TYPO ERROR Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 11/02/2025 Response to querry Control Group, EBO PEP, ERV arm: Ervebo (72 million PFU IM) , ERV arm: Ervebo at D1 , To compare the rate of EVD at 21 days in contacts at high risk of EVD receiving a PEP strategy Ervebo + Inmazeb or obeldesivir vs. Ervebo alone, 80, Active-Treatment of Control Group Control Group, EBO PEP, ERV arm: Ervebo (72 million PFU IM) , ERV arm: Ervebo at D1 , Participants will be randomized (1:1:1) into one of three trial arms : - Arm 1: Control arm : ERV - Arm 2: ERV on Day 0 + Inmazeb IV on Day 0+ ERV on Day 56 (Revaccination) - Arm 3: ERV on Day 0 +Obeldesivir oral on Day 0 to 9), 80, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 11/02/2025 Response to querry Experimental Group, EBO PEP, ERV+IMZ arm: Ervebo (72 million PFU IM) + Inmazeb IV (150 mg/kg) ERV+ODV arm: Ervebo (72 million PFU IM) + oral obeldesivir (350 mg BID) , ERV+IMZ arm: Ervebo at D1 and D56 + Inmazeb IV (150 mg/kg) D1 ERV+ODV arm: Ervebo D1+ oral obeldesivir (350 mg BID D1-J10) , To compare the rate of EVD at 21 days in contacts at high risk of EVD receiving a PEP strategy Ervebo + Inmazeb or obeldesivir vs. Ervebo alone, 160, Experimental Group, EBO PEP, ERV+IMZ arm: Ervebo (72 million PFU IM) + Inmazeb IV (150 mg/kg) ERV+ODV arm: Ervebo (72 million PFU IM) + oral obeldesivir (350 mg BID) , ERV+IMZ arm: Ervebo at D1 and D56 + Inmazeb IV (150 mg/kg) D1 ERV+ODV arm: Ervebo D1+ oral obeldesivir (350 mg BID D1-J10) , Participants will be randomized (1:1:1) into one of three trial arms : - Arm 1: Control arm : ERV - Arm 2: ERV on Day 0 + Inmazeb IV on Day 0+ ERV on Day 56 (Revaccination) - Arm 3: ERV on Day 0 +Obeldesivir oral on Day 0 to 9), 160,