Dryvax Dilution-Prev Vacc Adults

This study has been completed.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
First received: March 28, 2002
Last updated: August 26, 2010
Last verified: May 2006
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
Biological: Dryvax
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Double Blind, Randomized Dose Response Study of Dryvax Vaccine Against Smallpox in Previously Vaccinated Adults

Resource links provided by NLM:

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


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

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

ClinicalTrials.gov Identifier: NCT00032708     History of Changes
Other Study ID Numbers: 01-651 
Study First Received: March 28, 2002
Last Updated: August 26, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2016