Trial to Evaluate Safety and Immunogenicity of an Ebola Zaire Vaccine in Healthy Adults

Phase 1

Completed

• Conditions: Ebola Virus Disease
• Interventions: Biological: Placebo; Biological: Ebola Vaccine - low dose; Biological: Ebola Vaccine - high dose; Biological: Ebola Vaccine - mid dose

• Registration Number: NCT02718469
• Lead Sponsor: Auro Vaccines LLC

Brief Summary

The purpose of this study is to assess the safety profile of the Zaire Ebola vaccine and the strength of the immune response.

Detailed Description

Ebola Zaire is a filovirus that has caused devastating epidemics of hemorrhagic fever in South Africa. Research is underway to create a safe and effective vaccine to protect against Ebola disease, especially for the military and health care workers. Promising animal studies with this vaccine indicate safety and immunogenicity, and the vaccine platform used to deliver the Ebola protein antigen has been successful in creating a safe and protective immune response in people. Note that only one Ebola protein is used in this vaccine; since the entire intact Ebola virus is required for infection, it is impossible to get Ebola disease from this vaccine.

The study targets enrollment of 39 healthy adults. These participants are divided into 3 groups that will be administered one of three dose levels of the vaccine (low, medium, high). The study participants will receive two doses of vaccine: one on day 1 and the second on day 28 (1 month). Three participants at each dose level will act as controls and receive a placebo instead of the active vaccine. A total of 13 visits to the clinic are required over a period of 26 weeks. The total study is expected to take 9 months.

Study Timeline

• Study Start: 2015-12-22
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-24
• Primary Completion: 2016-09-15
• Study Completion: 2016-09-15
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Ebola Vaccine - low dose	Ebola Vaccine - low dose	Low Dose Zaire Ebola Vaccine
Ebola Vaccine - high dose	Ebola Vaccine - high dose	High Dose Zaire Ebola Vaccine
Ebola Vaccine - mid dose	Ebola Vaccine - mid dose	Mid Dose Zaire Ebola Vaccine

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)	9 months	To establish the maximum safe and tolerated dose of a monovalent Ebola Zaire vaccine, as determined by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences.

Trial Locations

Locations (1)

Optimal Research; 🇺🇸 Melbourne, Florida, United States