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Dryvax Dilution-Prev Vacc Adults

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ClinicalTrials.gov Identifier: NCT00032708
Recruitment Status : Completed
First Posted : March 29, 2002
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

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

Condition or disease Intervention/treatment Phase
Smallpox Biological: Dryvax Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Double Blind, Randomized Dose Response Study of Dryvax Vaccine Against Smallpox in Previously Vaccinated Adults
Study Start Date : April 2004
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

ClinicalTrials.gov Identifier: NCT00032708     History of Changes
Other Study ID Numbers: 01-651
First Posted: March 29, 2002    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: May 2006

Additional relevant MeSH terms:
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases