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A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults

NCT02416453 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2021-02-08

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens.

Conditions

  • Ebola Viral Disease

Interventions

BIOLOGICAL

MVA-BN-Filo

One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit \[Inf. U.\] on Day 29, 57, or 85.

BIOLOGICAL

Ad26.ZEBOV

One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.

BIOLOGICAL

Placebo

One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • University of Oxford

    collaborator OTHER

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

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

  • Inserm Clinical Trials · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-15
Primary Completion
2018-01-19
Completion
2018-01-19
FDA Drug
Yes

Countries

  • France
  • United Kingdom

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 NCT02416453 on ClinicalTrials.gov