A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults

Smallpox Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized Dose-Response Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00026611
• Other study ID #: DMID 01-632
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2001
• Last updated: August 26, 2010
• Est. completion date: December 2001

Study information

• Verified date: March 2010
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 32 Years

Eligibility

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.

Study Design

Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smallpox

Intervention

Biological:
• Dryvax vaccine

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Baylor College of Medicine	Houston	Texas
United States	University of Rochester	Rochester	New York
United States	St. Louis University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Frey SE, Couch RB, Tacket CO, Treanor JJ, Wolff M, Newman FK, Atmar RL, Edelman R, Nolan CM, Belshe RB; National Institute of Allergy and Infectious Diseases Smallpox Vaccine Study Group. Clinical responses to undiluted and diluted smallpox vaccine. N Engl J Med. 2002 Apr 25;346(17):1265-74. Epub 2002 Mar 28. — View Citation