Dryvax Dilution-Prev Vacc Adults - Tabular View

Tracking Information
First Received Date ^ICMJE	March 28, 2002
Last Updated Date	May 25, 2006
Start Date ^ICMJE	April 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00032708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Dryvax Dilution-Prev Vacc Adults
Official Title ^ICMJE	A Double Blind, Randomized Dose Response Study of Dryvax Vaccine Against Smallpox in Previously Vaccinated Adults
Brief Summary	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
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Smallpox
Intervention ^ICMJE	Biological: Dryvax
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	90
Completion Date	November 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender
Ages
Accepts Healthy Volunteers
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00032708
Responsible Party
Study ID Numbers ^ICMJE	01-651
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP