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Dressing Preparation Comparison for Smallpox Vaccination Sites



Dressing Preparation Comparison for Smallpox Vaccination Sites

For Condition: Smallpox
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to find out the risk of spread of the vaccine virus, vaccinia, from the sore when different types of bandages are used to cover the site. This study will also look at how each bandage type affects the healing of the sore. In order to find out if the vaccine virus can be spread through the air, like a cold, the study staff will also look at throat cultures.
Details: The world was declared free of naturally occurring smallpox in 1980. Standard smallpox vaccinations were stopped in the US in 1971. In 1976, the recommendation for vaccination of healthcare workers was also stopped. The only people who have been getting this vaccine since that time are people who work with similar viruses. Because of recent worry about biowarfare and bioterrorism all over the world, the United States government is trying to improve its ability to protect its people in case there is a bioterrorist attack. The need to restart vaccination against smallpox has been widely debated. Large scale vaccination against smallpox of health-care workers has been discussed. Voluntary vaccination of the general public has also been proposed in order to increase the number of immune individuals and deter potential release of smallpox. Recent clinical trials showed that the available vaccine supply still work, even in diluted concentrations. This means that the number of doses can be stretched into millions of doses if needed. In giving vaccinations, the main concern has been the risk of a vaccine virus, called vaccinia, being spread to other individuals. The smallpox vaccine is given in the upper arm. A sore at the site of vaccination 2-5 days later is expected that may last for several weeks. These sores have active vaccinia virus and may spread to other individuals, mainly through direct contact with the lesion. One method used to prevent the spread of vaccinia to other people has been to use a protective dressing over the vaccine site. The exact type of dressing that will be used, however, has not been standardized.
Eligibility:
Study Type:
  Interventional, Prevention, Randomized, Uncontrolled, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Healthy individuals (18 to 32 years old) who have not had the smallpox vaccination before or healthy individuals (32 to 50 years old) who have had the smallpox vaccine before. EXCLUSION CRITERIA: - People who have or have ever had eczema, or who live (or have frequent contact) with someone who has or has had eczema. - People with other skin conditions, such as contact dermatitis, burns, impetigo (red, itchy skin caused by an infection), or varicella zoster (shingles) or those who live (or have frequent daily contact) with people with one of these skin conditions. - People with diseases or conditions which weaken the immune system (such as infection with HIV, a history of organ or bone marrow transplant, or treatment with chemotherapy), or who live (or have frequent daily contact) with someone who has a weakened immune system. - Women who are pregnant, or planning to become pregnant within 2 months following vaccination or those that live (or have frequent daily contact) with a woman who is pregnant or planning to become pregnant within 1 month of vaccination. - People who are less than 18 years old or who live (or have frequent daily contact) with a woman who is pregnant or planning to become pregnant within 1 month of vaccination. - People who are less than 18 years old or who live (or have frequent daily contact) with a child under 1 year old. - People who have a history of myocardial infarction (heart attack), stroke, or other heart condition under the care of a doctor. - People who have diabetes. - People with serious, life-threatening allergies to the vaccine.
Total Enrollment: 84

Location and Contact Information:

Vanderbilt University
Nashville,  Tennessee,  37232-26
United States
 


Additional Information:
Study ID Numbers:
  03-044; 
Study Start Date: June 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063856

Other Smallpox Studies:
1. Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®

2. Safety and Immunogenicity of Smallpox Vaccine MVA-BN

3. Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults without Previous Smallpox Vaccination

4. APSV in vaccinia naive adults

5. Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Adults

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