Trial protocol

The EBO-PEP project

Full trial title:

Evaluation of the effectiveness of a post-exposure prophylaxis (PEP) strategy in high-risk contacts of Ebola Virus Disease (EVD): EBO-PEP Trial

Short title – Sponsor Trial Number: ANRS 0515s EBO-PEP

Sponsor: Inserm – ANRS MIE

For further information, please consult :
Clinicaltrials
PACTR

Coordinating Investigators

Pr. Placide Mbala

Institut National de Recherche Biomédicale (INRB)
Avenue de la démocratie, Kinshasa Gombe, République Démocratique du Congo
mbalaplacide@gmail.com

Dr. Marie Jaspard

Hôpital Saint-Antoine, Service des maladies infectieuses et tropicales,
Inserm UMR-1136 IPLESP
184 rue Faubourg Saint-Antoine, 75012, Paris, France
marie.jaspard@aphp.fr

Graphique traitement EBOPEP double traitement

The trial will only be conducted if an EVD outbreak is officially declared.

Participants are randomized (1:1) into one of two study arms:

  • ERV : Ervebo on Day 1 (D1)
  • ERV+IMZ : on D1 and D56 + Inmazeb on D1


Tous les participants ont un suivi quotidien pendant 21 jours avec une durée totale de suivi de 60 jours.
Les participants du bras ERV+IMZ bénéficient d’une visite à J56 en présentiel afin d’être revaccinés avec le vaccin Ervebo pour pallier une possible diminution de la réponse vaccinale quand le vaccin est administré concomitamment à l’Inmazeb.

Inclusion criteria

  • Have had a high-risk exposure within the previous 5 days
  • Having no symptoms of EVD
  • Provide a signed and dated informed consent to participate in the trial

Number of participants

81 participants per arm, for a total of 162 participants.

The number of participants may be re-evaluated during the trial based on the secondary attack rate observed in the control arm.

Definition of high risk exposure:

  • Direct contact with a person with PCR-confirmed EVD presenting diarrhea, vomiting, or external hemorrhage (“wet symptoms”), or with their bodily fluids;
  • Direct contact with the body of a person with confirmed or probable EVD;
  • Needlestick injury with a syringe contaminated with the blood of a person with confirmed or probable EVD;
  • Or an infant born to or breastfed by a person with EVD.

Provisional calendar

2024

June 2024

Test set-up start date
2025

Q2 2025

Expected date of first inclusion (depending on epidemic)
2025-2027
  • Expected duration of inclusion: 2 years (depending on epidemics)
  • Maximum follow-up time per trial participant: 60 days
  • Total trial duration: 3 years (1 year preparation and 2 years running)
2027

Q2 2027

Expected date of last participant’s visit (depending on epidemics)
Q2 2028

Q2 2028

Expected trial end date