ZEBOVAC (Ebola Vaccine Trial, Ad26.ZEBOV/MVA-BN-Filo)

Phase 2

Completed

• Conditions: Ebola Virus Disease
• Interventions: Drug: Ad26.ZEBOV/MVA-BN-Filo

• Registration Number: NCT04028349
• Lead Sponsor: MRC/UVRI and LSHTM Uganda Research Unit

Brief Summary

An open-label, single arm phase II study of the candidate Ebola Vaccine Ad26.ZEBOV/MVA-BN®-Filo

Detailed Description

This is an interventional, single arm, open-label, non-randomized, phase II study to accumulate additional data on immunogenicity and safety of Ad26.ZEBOV/MVA-BN®-Filo against Ebola virus disease.

It also has a qualitative component to better understand knowledge about Ebola virus disease and the perception and attitudes towards the vaccine amongst participants (Healthcare and Frontline workers).

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-22
• Study Start: 2019-08-01
• Primary Completion: 2021-03-19
• Study Completion: 2021-03-19
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Ad26.ZEBOV/MVA-BN-Filo	Ad26.ZEBOV/ MVA-BN-Filo Vaccines

Primary Outcome Measures

Name	Time	Method
The total IgG against EBOV-GP at day 77 post-vaccination with Ad26.ZEBOV (dose 1) at day 0 and MVA-BN®-Filo (dose 2) at day 56.	21-days post second vaccination	Humoral immune responses as measured by enzyme-linked immunosorbent assay (ELISA) to the Ebola glycoprotein after intramuscular administration of Ad26.ZEBOV/ MVA-BN®-Filo vaccine in all participants on Day 0 and Day 77.
Frequency, incidence and nature of Serious Adverse Events, 6 months following the second vaccination	6 months following second vaccination	The occurrence, incidence and nature of Serious Adverse Events between the time of vaccination with Ad26.ZEBOV and during the ¬ 6 months following vaccination with MVA-BN®-Filo. If a participant does not receive MVA-BN®-Filo for any given reason, the outcome will be the occurrence, incidence and nature of SAE during the 6 months following vaccination with Ad26.ZEBOV

Secondary Outcome Measures

Name	Time	Method
The total IgG against EBOV-GP at 365-days post-vaccination with Ad26.ZEBOV/MVA-BN®-Filo	365-days post-vaccination with Ad26.ZEBOV/MVA-BN®-Filo	Humoral immune responses as measured by enzyme-linked immunosorbent assay (ELISA) against Ebola glycoprotein after intramuscular administration of Ad26.ZEBOV/ MVA-BN®-Filo vaccine in a subset of participants on Day 365.
The total IgG against EBOV-GP at day 56	Day 56 post vaccination with Ad26.ZEBOV	Humoral immune responses as measured by enzyme-linked immunosorbent assay (ELISA) against Ebola glycoprotein after intramuscular administration of Ad26.ZEBOV vaccine in a subset of participants on Day 56
The existing knowledge about Ebola disease and transmission, and the perception and attitudes about the vaccine and protection in a subset of participants.	At baseline (Day 0) and after the second Vaccination	To describe the knowledge about Ebola virus disease and transmission, and the perception and attitudes about the vaccine and protection in a subset of participants in the Ad26.ZEBOV/MVA-BN®-Filo vaccine study.

Trial Locations

Locations (1)

MRC/UVRI & LSHTM Uganda Research Unit; 🇺🇬 Entebbe, Uganda