MedTrace Logo

A Study to Evaluate the Immunogenicity, Safety and Tolerability of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants

NCT02543268 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 329

Last updated 2025-06-22

No results posted yet for this study

Summary

The purpose of this study is to compare the humoral immune response induced by 3 different batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Ad26.ZEBOV-Batch #1

Ad26.ZEBOV - Batch #1, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1

BIOLOGICAL

Ad26.ZEBOV-Batch #2

Ad26.ZEBOV - Batch #2, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1

BIOLOGICAL

Ad26.ZEBOV-Batch #3

Ad26.ZEBOV - Batch #3, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1

BIOLOGICAL

MVA-BN-Filo

MVA-BN-Filo- live replication incompetent vaccine, 0.5 mL IM injection of 1\*10\^8 Infectious Unit \[Inf. U.\] once on Day 57.

BIOLOGICAL

Placebo

One 0.5 ml IM injection of 0.9% saline once on Day 1 and Day 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
2015-09-21
Primary Completion
2016-01-22
Completion
2016-07-20
FDA Drug
Yes

Countries

  • United States

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 NCT02543268 on ClinicalTrials.gov