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Study to Evaluate the Immunogenicity and Safety of a Heterologous Vaccine Regimen Against Ebola

NCT04186000 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 699

Last updated 2023-01-04

No results posted yet for this study

Summary

This Phase 2 study aims to improve preparedness for future Ebola outbreaks by vaccination of a well-known population at risk, ie, a cohort of health care providers (HCP) (such as primary, emergency, and community health care workers) who may be exposed to Ebola in the event of a future outbreak in the Democratic Republic of the Congo (DRC). This study will enhance the immunogenicity database by investigating the kinetics of the humoral immune response. The study will contribute to the safety database (serious adverse events) for VAC52150 following a heterologous vaccine regimen with Ad26.ZEBOV as first vaccine followed by second dose with MVA-BN-Filo administered 56 days later (Day 57). Additionally, after randomization (1:1), a booster vaccination with Ad26.ZEBOV will be executed at 1 year post first dose or 2 years post first dose.

Conditions

  • Ebola Virus Disease

Interventions

BIOLOGICAL

Ad26.ZEBOV vaccine

The booster vaccination with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Ace Africa

    collaborator OTHER

  • Innovative Medicines Initiative

    collaborator OTHER

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • University of Kinshasa

    collaborator OTHER

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Hypolite Mavoko Muhindo, Dr. · University of Kinshasa, Tropical Medicine Department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-18
Primary Completion
2020-04-25
Completion
2022-10-12

Countries

  • Democratic Republic of the Congo

Study Locations

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Entities

Companies

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 NCT04186000 on ClinicalTrials.gov