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Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo

NCT02509494 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1023

Last updated 2022-07-18

Study results available
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Summary

The purpose of this study is the evaluation of the safety and immunogenicity of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a 2-dose heterologous regimen.

Conditions

  • Ebola Virus Disease

Interventions

BIOLOGICAL

Ad26.ZEBOV

Ebola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles.

BIOLOGICAL

MVA-BN-Filo

MVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1\*10\^8 Infectious Unit (Inf. U.).

BIOLOGICAL

MenACWY

MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.

BIOLOGICAL

Placebo

0.9% saline for injection.

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Ministry of Health and Sanitation, Sierra Leone

    collaborator OTHER_GOV

  • University of Sierra Leone

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Grameen Foundation

    collaborator OTHER

  • World Vision, Ireland

    collaborator OTHER

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-06-28
Completion
2019-07-03

Countries

  • Sierra Leone

Study Locations

More Related Trials

Entities

Drugs

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 NCT02509494 on ClinicalTrials.gov