Dryvax Dilution-Prev Vacc Adults

This study has been completed.

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00032708

Purpose

A double-blind, randomized, dose-response study of four dilutions of Dryvax in previously vaccinated adults in order to assess the clinical success rates, humoral responses, and virus-specific actifity of cytotoxi T cells and interferon-y producing T cells

Condition	Intervention	Phase
Smallpox	Biological: Dryvax	Phase II

MedlinePlus related topics: Smallpox

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double Blind, Randomized Dose Response Study of Dryvax Vaccine Against Smallpox in Previously Vaccinated Adults

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	90
Study Start Date:	April 2004
Estimated Study Completion Date:	November 2004

Eligibility

Criteria

Inclusion Criteria:

For cohort E (never vaccinated): Aged 18-31; Never been vaccinated for smallpox.
If female, not pregnant or lactating.
Promise to use an effective method of birth control for 7 months after vaccination.
Negative result on a test for HIV, AIDS, Hepatitis B and C.
Acceptable as blood donors.
For cohorts A, B, C, D (previously vaccinated): Aged 32 to 60 years; known history of smallpox vaccination with a typical vaccinia scar; no smallpox vaccination after 1971.
Healthy adults (aged 18-60).

Exclusion Criteria:

Eczema or history of eczema, or other chronic skin disorder.
Pregnancy or lactation.
History of immunodeficiency, liver disease, severe kidney impairment, malignancy, HIV, Hepatitis B, or Hepatitis C.
Household contact with persons who are under 12 months of age, pregnant or lactating, or have any of the specified diseases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032708

Locations

United States, Missouri
Saint Louis University Health Sciences Center
St. Louis, Missouri, United States, 63110-0250

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Study ID Numbers:	01-651
Study First Received:	March 28, 2002
Last Updated:	May 25, 2006
ClinicalTrials.gov Identifier:	NCT00032708
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Smallpox
Poxviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009