MedTrace Logo

Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine

NCT02374385 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-02-09

No results posted yet for this study

Summary

Background:

Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it.

Objectives:

To study the anti-Ebola vaccine VSV ZEBOV (BPSC1001) to see if it is safe. Also, to see how it affects people's immune system.

Eligibility:

\- Healthy men and women ages 18-65. They must not have a chronic medical condition that requires medicine. They must not be a healthcare worker, an animal care worker, or a childcare worker, and they must not have a household contact that has a compromised immune system, is pregnant, or is under the age of 5 years.

Design:

* Participants will be screened with medical history, physical exam, and blood tests.
* Participants will be randomly assigned to get the vaccine or the placebo.
* At visit 1 (vaccination), vital signs will be taken and blood will be drawn. The vaccine or placebo will be injected into the upper arm muscle.
* Participants will return to the clinic 11 times over the next 6 months. Participants will have blood drawn at every study visit. Their mouth will be swabbed and urine tested at least four times after vaccination.
* For 14 days after vaccination, participants will write down their temperature, any symptoms, and any redness at the injection site. They will bring the booklet to each study visit.

All visits take place at the Canadian Center for Vaccinology, Dalhousie University/IWK Health Centre, Halifax, NS.

Conditions

  • Ebola Viruses

Interventions

BIOLOGICAL

BPSC-1001 (VSVΔG-ZEBOV)

Ebola vaccine candidate

OTHER

Placebo

Normal saline

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • NewLink Genetics Corporation

    collaborator INDUSTRY

  • Dalhousie University

    lead OTHER

Principal Investigators

  • Scott A. Halperin, MD · Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-03-31
Completion
2015-06-30

More Related Trials

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 NCT02374385 on ClinicalTrials.gov