A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults

NCT00026611 | Completed Phase 2

• 1 other identifier: DMID 01-632
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Smallpox

Keywords

Vaccine prophylaxis

Interventions

Dryvax vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

University of Maryland

Baltimore, Maryland, United States

Location

St. Louis University

St Louis, Missouri, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related 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. doi: 10.1056/NEJMoa020534. Epub 2002 Mar 28.

  PMID: 11923490 BACKGROUND

MeSH Terms

Conditions

Smallpox

Interventions

DryVax vaccine

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 12, 2001
• First Posted: November 13, 2001
• Primary Completion: December 1, 2001
• Study Completion: December 1, 2001
• Last Updated: August 27, 2010

Record last verified: 2010-03

Locations

US (4)