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Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo

NCT02598388 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 578

Last updated 2025-02-04

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults.

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 percent (%) saline.

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • 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
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-10
Primary Completion
2018-12-12
Completion
2018-12-12

Countries

  • United States
  • Kenya
  • Mozambique
  • Nigeria
  • Tanzania
  • 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 NCT02598388 on ClinicalTrials.gov