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African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola

NCT03031912 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2026-01-12

Study results available
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Summary

This is a randomized, placebo-controlled, multi-site, double-blind trial of V920 (rVSVΔG-ZEBOV-GP) Ebola Virus vaccine candidate in subjects with HIV infection to be conducted in conformance with Good Clinical Practices. The study will take place at 2 Canadian sites (Centre Hospitalier de l'Université de Montréal and Ottawa General Hospital) and 2 African sites (Centre MURAZ, Burkina Faso and Centre Hospitalier National Aristide Le Dantec, Dakar, Senegal). The Duration of Study: 365 days for each participant not including screening.

Conditions

  • Ebola

Interventions

BIOLOGICAL

V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine

The rVSVΔG-ZEBOV-GP vaccine is a live attenuated recombinant virus consisting of a single recombinant VSV isolate (11481 nt, strain Indiana) with the gene for the Zaire ebolavirus GP (ZEBOV GP), Kikwit strain replacing the gene for the VSV GP, which has been deleted. This results in a VSV backbone with the ZEBOV GP constituting the envelope of the virus.

OTHER

Saline

Normal saline (0.9%) has been chosen as an inert substance to serve as placebo control.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • International Development Research Centre, Canada

    collaborator OTHER_GOV

  • Dalhousie University

    collaborator OTHER

  • Université de Montréal

    collaborator OTHER

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • University of Ottawa

    collaborator OTHER

  • Centre Muraz

    collaborator OTHER

  • Institute for Health Research - Epidemiological Surveillance and Training (IRESSEF)

    collaborator UNKNOWN

  • Canadian Immunization Research Network

    lead NETWORK

Principal Investigators

  • Cecile Tremblay, MD · CHUM

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2023-03-03
Completion
2023-03-03
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT03031912 on ClinicalTrials.gov