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Dryvax Dilution-Prev Vacc Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00032708
First Posted: March 29, 2002
Last Update Posted: August 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  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 2

Study Type: Interventional
Study Design: 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

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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)
  More Information

ClinicalTrials.gov Identifier: NCT00032708     History of Changes
Other Study ID Numbers: 01-651
First Submitted: March 28, 2002
First Posted: March 29, 2002
Last Update Posted: August 27, 2010
Last Verified: May 2006

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