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A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults

Primary Purpose

Smallpox

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dryvax vaccine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smallpox focused on measuring Vaccine prophylaxis

Eligibility Criteria

18 Years - 32 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Maryland
  • St. Louis University
  • University of Rochester
  • Baylor College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 12, 2001
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00026611
Brief Title
A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
Official Title
A Multicenter, Double-Blind, Randomized Dose-Response Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
December 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox
Keywords
Vaccine prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Dryvax vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
32 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11923490
Citation
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.
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A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults

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