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A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00026611
First Posted: November 13, 2001
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

The purpose of this study is to see how many people respond to a smallpox vaccine when a sore forms where the shot was given.

The world was declared free of smallpox in 1980. General routine vaccinations for smallpox were stopped in the U.S. in 1971. In 1976, the recommendation for routine vaccination of healthcare workers was also discontinued. The only people who presently receive this vaccine are people who work with vaccinia virus or monkeypox virus. Because the world was considered free of smallpox infections, this vaccine was no longer produced; there is a limited supply available in the United States.

Because of the limited amount of Dryvax vaccine (vaccinia virus) against smallpox, this study will look at the ability to dilute the vaccine making more doses available in the event of a smallpox outbreak. The study seeks to characterize a strategy of vaccination against smallpox with various doses of Dryvax, followed by revaccination with the same dose, if required, in volunteers 18-32 years of age with a negative history of smallpox vaccination.


Condition Intervention Phase
Smallpox Biological: Dryvax vaccine Phase 2

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Prevention
Official Title: A Multicenter, Double-Blind, Randomized Dose-Response Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults

Resource links provided by NLM:


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

Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
  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:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients may be eligible for this study if they:

  • Are between 18 and 32 years of age.
  • Give written informed consent.
  • Are available for follow-up for 2.5 months.
  • Have an acceptable medical history by screening evaluation and brief clinical assessment.
  • Are HIV-negative.
  • Agree to use acceptable contraception and to not get pregnant during the study.

Exclusion Criteria:

Patients may not be eligible for this study if they:

  • Have a suppressed immune system.
  • Have participated in an HIV vaccine trial.
  • Have liver disease, diabetes, or kidney problems.
  • Have malignant skin cancer.
  • Have autoimmune disease.
  • Have used medication that suppresses the immune system.
  • Have had psychiatric or medical problems or have job responsibilites that will keep them from participating in the study.
  • Use illegal intravenous drugs.
  • Have received any live vaccines within 60 days of study start.
  • Have used experimental therapies within 30 days before study start.
  • Have been vaccinated with certain experimental vaccines.
  • Have a vaccination scar but have no record of having a vaccine.
  • Have received a smallpox vaccine.
  • Have taken blood products or immunoglobulin in the past 6 months.
  • Have a fever on the day of vaccination.
  • Have certain skin disorders, including eczema, exfoliative skin, lacerations that require stitches or burns larger than 2 x 2 cm.
  • Live with, have sexual contact with, or work with anyone who is pregnant, less than a year old, has eczema, has certain skin disorders, has a disease or takes medication that suppresses the immune system.
  • Have a condition that, in the opinion of the investigator, might interfere with the study.
  • Are allergic to any parts of the vaccine.
  • Are allergic to thimerosal, immunoglobulins, cidofovir, or probenecid.
  • Are pregnant or breast feeding.
  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): NCT00026611


Locations
United States, Maryland
University of Maryland
Baltimore, Maryland, United States
United States, Missouri
St. Louis University
St. Louis, Missouri, United States
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00026611     History of Changes
Other Study ID Numbers: DMID 01-632
First Submitted: November 12, 2001
First Posted: November 13, 2001
Last Update Posted: August 27, 2010
Last Verified: March 2010

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccine prophylaxis

Additional relevant MeSH terms:
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs