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A Study to Assess the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

NCT02376400 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2016-12-08

No results posted yet for this study

Summary

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult participants.

Conditions

  • Healthy

Interventions

BIOLOGICAL

MVA-BN-Filo

One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1, 29 or 57.

BIOLOGICAL

Ad26.ZEBOV

One 0.5 mL IM injection of 5\*10\^10 viral particles (vp) on Day 1, 29 or 57.

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Crucell Holland BV Clinical Trial · Crucell Holland BV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-12-31
Completion
2016-09-30

Countries

  • 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 NCT02376400 on ClinicalTrials.gov