Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026611
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2001-11-12
Brief Title:
A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Dose-Response Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
Status:
COMPLETED
Status Verified Date:
2010-03
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:
None
Brief Summary:
The purpose of this study is to see how many people respond to a smallpox vaccine when a sore forms where the shot was given
The world was declared free of smallpox in 1980 General routine vaccinations for smallpox were stopped in the US in 1971 In 1976 the recommendation for routine vaccination of healthcare workers was also discontinued The only people who presently receive this vaccine are people who work with vaccinia virus or monkeypox virus Because the world was considered free of smallpox infections this vaccine was no longer produced there is a limited supply available in the United States
Because of the limited amount of Dryvax vaccine vaccinia virus against smallpox this study will look at the ability to dilute the vaccine making more doses available in the event of a smallpox outbreak The study seeks to characterize a strategy of vaccination against smallpox with various doses of Dryvax followed by revaccination with the same dose if required in volunteers 18-32 years of age with a negative history of smallpox vaccination
The world was declared free of smallpox in 1980 General routine vaccinations for smallpox were stopped in the US in 1971 In 1976 the recommendation for routine vaccination of healthcare workers was also discontinued The only people who presently receive this vaccine are people who work with vaccinia virus or monkeypox virus Because the world was considered free of smallpox infections this vaccine was no longer produced there is a limited supply available in the United States
Because of the limited amount of Dryvax vaccine vaccinia virus against smallpox this study will look at the ability to dilute the vaccine making more doses available in the event of a smallpox outbreak The study seeks to characterize a strategy of vaccination against smallpox with various doses of Dryvax followed by revaccination with the same dose if required in volunteers 18-32 years of age with a negative history of smallpox vaccination
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: