NCT02718469

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

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Monovalent Ebola Zaire Vaccine (rVSVN4CT1-EBOVGP1) Delivered by Intramuscular Injection in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Auro Vaccines LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ebola Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	Ebola Vaccine - low dose	2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28
BIOLOGICAL	Ebola Vaccine - mid dose	2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28
BIOLOGICAL	Ebola Vaccine - high dose	2 x 1.0ml vaccine will be given as intramuscular injections on each of day 1 and day 28
BIOLOGICAL	Placebo	2 x 0.5ml or 2 x 1.0ml placebo will be given as intramuscular injections on each of day 1 and day 28 depending on cohort

Timeline

• Start date: 2015-12-22
• Primary completion: 2016-09-15
• Completion: 2016-09-15
• First posted: 2016-03-24
• Last updated: 2017-04-04

Locations

1 site across 1 country: United States