Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068198
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2003-09-09
Brief Title:
Human Immune Responses Smallpox
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Human Immune Response to Smallpox Vaccine Vaccinia Virus
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to attempt to identify the immune response of healthy adults to an investigational dilution of the Dryvax smallpox vaccine In addition we will try to determine whether certain genetic characteristics influence the size of the sore around the vaccination site and use blood samples from subjects in the study to make a new form of antibody that could be given to people with vaccine side effects
Detailed Description:
Smallpox is a very serious disease that is fatal in about 1 in 3 patients Smallpox does not exist naturally in the world and there have been no cases of smallpox in the world since 1980 Smallpox can be prevented through the use of a very effective vaccine called vaccinia virus Dryvax After the world was considered free of smallpox the production of smallpox vaccine was discontinued but due to the recent concern that the smallpox virus may be used as a means of bioterrorism the production of the smallpox vaccine may be restarted Although Dryvax is known to be an effective vaccine for the prevention of smallpox very little is known about the ability of the body to develop defenses to prevent disease immune responses with this vaccine As new vaccines for preventing smallpox are developed it will be important to compare the immune responses they cause to the responses that occur with the standard vaccine Dryvax
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?:
None