Providing Additional Information on the Safety and Effectiveness of an Ebola Vaccine

NCT03161366 | Completed Phase 3 DMC

• 1 other identifier: V920-01
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 2

Brief Summary

Interventional, single arm, open-label, non-randomized, phase IIIb study to accumulate additional data on safety and effectiveness of one dose of rVSVΔG-ZEBOV-GP against Ebola virus disease.

Conditions

Ebola Virus Disease

Keywords

Ebola Zaire Outbreak; Safety of rVSVΔG-ZEBOV-GP vaccine; Effectiveness of rVSVΔG-ZEBOV-GP vaccine

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence

  Occurrence of Ebola Zaire cases amongst contacts and contacts of contacts

  84 days after vaccination

Secondary Outcomes (1)

• Assessment of Adverse and Serious Adverse Events

  84 days after vaccination

Study Arms (1)

Single arm

EXPERIMENTAL

Vaccination of contacts and contacts of contacts of a confirmed Ebola Zaire case with one dose of rVSVΔG-ZEBOV-GP (≥ 2x10\^7 PFU)

Biological: rVSVΔG-ZEBOV-GP

Interventions

rVSVΔG-ZEBOV-GP BIOLOGICAL

Ring vaccination with vaccination of contacts and contacts of contacts after laboratory confirmation of one Ebola Zaire case

Single arm

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 6 years or older will be enrolled in the study if they are a contact or contact of contact of a laboratory-confirmed Ebola virus disease case. Children aged between 1 and 6 years may also be enrolled in the study in case there is a confirmed contact with a laboratory-confirmed Ebola patient
• willing to accept weekly visits
• intending to remain in the study area for three months
• providing informed consent, and where applicable, assent

You may not qualify if:

• history of EVD (self-report or laboratory confirmed)
• history of having received other investigational research agents in the previous 28 days
• history of anaphylaxis to a vaccine or vaccine component (self-report)
• severe illness that makes the person bed-bound or requiring hospitalization at the time of the vaccination
• severe immunocompromised status
• history of having received immunosuppressant therapies that would substantially interfere with the mode of action of the Ebola vaccine in the previous 6 months
• unwilling to accept weekly visits
• not intending to remain in the study area for three months
• informed consent or assent not provided
• any other condition in which, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence, or impair the subject or caregiver's ability to give informed consent, and where applicable, assent.
• fever above 38°C
• previous receipt of rVSVΔG-ZEBOV-GP in the last 3 years or at being part of another Ebola vaccine clinical trial.

Sponsors & Collaborators

• Epicentre: lead
• Medecins Sans Frontieres, Netherlands: collaborator

Study Sites (2)

Médecins Sans Frontières

Kinshasa, Democratic Republic of the Congo

Location

Epicentre

Mbarara, 1956, Uganda

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, single arm, open-label, non-randomized

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: May 28, 2018
• Primary Completion: July 14, 2018
• Study Completion: November 30, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

DE (1); UG (1)