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A Phase I Clinical Trial to Evaluate the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults.

NCT02326194 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-08-28

No results posted yet for this study

Summary

Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14 outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with GP homology of the gene was only 97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry products which could be stored at 4℃.

This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine.

Conditions

  • Ebola Virus Disease

Interventions

BIOLOGICAL

Low dose Ebola Zaire vaccine (Ad5-EBOV)

one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)

BIOLOGICAL

High dose Ebola Zaire vaccine (Ad5-EBOV)

two doses, High dose Ebola Zaire vaccine (Ad5-EBOV), with one dose to each arm at a same time.

BIOLOGICAL

placebo (one dose)

placebo, one doses

BIOLOGICAL

placebo (two doses)

placebo, two doses, with one dose to each arm at a same time.

Sponsors & Collaborators

  • Beijing Institute of Biotechnology

    collaborator OTHER

  • Tianjin Cansino Biotechnology Inc

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-02-28
Completion
2015-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02326194 on ClinicalTrials.gov