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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00026611 |
Purpose
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 U.S. 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Smallpox |
Biological: Dryvax vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Multicenter, Double-Blind, Randomized Dose-Response Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults |
Eligibility| Ages Eligible for Study: | 18 Years to 32 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients may be eligible for this study if they:
Exclusion Criteria:
Patients may not be eligible for this study if they:
Contacts and Locations| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States | |
| United States, Missouri | |
| St. Louis University | |
| St. Louis, Missouri, United States | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00026611 History of Changes |
| Other Study ID Numbers: | DMID 01-632 |
| Study First Received: | November 12, 2001 |
| Last Updated: | August 26, 2010 |
| Health Authority: | United States: Federal Government |
|
Vaccine prophylaxis |
|
Smallpox Poxviridae Infections DNA Virus Infections Virus Diseases |