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Effectiveness and Safety of a Heterologous, Two-dose Ebola Vaccine in the DRC

NCT04152486 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20426

Last updated 2021-11-23

No results posted yet for this study

Summary

A single arm, open-label, non-randomized, interventional phase 3 study to measure safety and effectiveness of a heterologous, two dose preventative vaccine (Ad26. ZEBOV, MVA-BN®-Filo) against Ebola Virus Disease.

Conditions

  • Ebola Virus Disease

Interventions

BIOLOGICAL

Ad26.ZEBOV, MVA-BN-Filo vaccine

Ad26.ZEBOV: a monovalent vaccine expressing the full-length glycoprotein (GP) from Ebola virus (EBOV) Mayinga. The vaccine is produced in the human cell line PER.C6®. MVA-mBN226B: further referred to as Modified Vaccinia Ankara (MVA)-BN®-Filo. This is a multivalent vaccine expressing the EBOV GP, the Sudan virus (SUDV) GP, the Marburg virus (MARV) Musoke GP, and the Taï Forest virus (TAFV, formerly known as Côte d'Ivoire ebolavirus) nucleoprotein (NP). The EBOV GP expressed by MVA BN Filo has 100% homology with the one expressed by Ad26.ZEBOV.

Sponsors & Collaborators

  • Epicentre

    collaborator OTHER

  • Ministère de la Santé de la RDC

    collaborator UNKNOWN

  • Médecins Sans Frontières, France

    collaborator OTHER

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • Janssen Vaccines & Prevention B.V.

    collaborator INDUSTRY

  • Public Health England

    collaborator OTHER_GOV

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Jean-Jacques Muyembe-Tamfum, MD, PhD · L'Institut National de Recherche Biomédicale RDC

  • Daniel Bausch, MD, PhD · London School of Hygiene and Tropical Medicine

  • Deborah Watson-Jones, MD, PhD · London School of Hygiene and Tropical Medicine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-14
Primary Completion
2022-01-31
Completion
2022-02-28

Countries

  • Democratic Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04152486 on ClinicalTrials.gov