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COMPLETED
NCT04186000
PHASE2

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

Sponsor: Universiteit Antwerpen

View on ClinicalTrials.gov

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.

Official title: Open-label Phase 2 Study to Evaluate the Immunogenicity and Safety of a Prophylactic Vaccination of Health Care Providers by Administration of a Heterologous Vaccine Regimen Against Ebola in the Democratic Republic of the Congo

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

699

Start Date

2019-12-18

Completion Date

2022-10-12

Last Updated

2026-07-14

Healthy Volunteers

Yes

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.

Locations (1)

Hôpital Général de Référence de Boende

Boende, Province de La Tshuapa, Democratic Republic of the Congo