Ignite Creation Date:
2025-12-18 @ 8:42 AM
Ignite Modification Date:
2025-12-23 @ 5:47 PM
Study NCT ID:
NCT02374385
Status:
None
Last Update Posted:
2016-02-09 00:00:00
First Post:
2015-01-06 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase 1 Randomized, Single-Center, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of the BPSC-1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Subjects
Status:
None
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VSVΔG-ZEBOV
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: