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Safety, Tolerability and Immunogenicity Study of 3 Prime-boost Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo in Healthy Adults, Children and Human Immunodeficiency Virus Positive (HIV+) Adults

NCT02564523 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1075

Last updated 2022-03-07

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata.

Conditions

  • Hemorrhagic Fever, Ebola

Interventions

BIOLOGICAL

Ad26.ZEBOV

One 0.5 mL intramuscular (IM) injection of (5x10\*10 viral particles)

BIOLOGICAL

MVA-BN-Filo

One 0.5 mL IM injection of (1x10\*8 infectious units)

BIOLOGICAL

Placebo

One 0.5 mL IM injection of 0.9% saline

Sponsors & Collaborators

  • EBOVAC2 Consortium

    collaborator INDUSTRY

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

    collaborator OTHER_GOV

  • Centre Muraz

    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
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-06
Primary Completion
2019-02-12
Completion
2019-02-12

Countries

  • Burkina Faso
  • Côte d’Ivoire
  • Kenya
  • Uganda

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 NCT02564523 on ClinicalTrials.gov