Dressing Preparations for Smallpox

Completed · Phase 1/Phase 2

Conditions studied: Smallpox

In brief

The primary purpose of this study is to find out the risk of spreading the vaccine virus, vaccinia, from the smallpox vaccination site when different types of bandages are used to cover the site. The study will also look at how each bandage type affects the healing of the sore. Study participants will include healthy individuals, 18-50 years old, who have not previously received a smallpox vaccine and healthy individuals, 18-50 years old, who have received a previous smallpox vaccine. All participants will receive the smallpox vaccine and be randomly assigned to 1 of 3 different bandage groups to cover the vaccine site: standard gauze dressing attached with paper tape, Opsite gauze-impregnanted occlusive dressing (attached by paper tape and waterproof), and Allevyn hydropolymer dressing (which is self-adhesive and highly absorbent). Volunteers will be involved in study related procedures for up to 252 days.

Key facts

Study ID

NCT00063856

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

102

Starts

2003-07-01

Expected to finish

2004-06-01

Last updated by the study team

2012-02-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A. Vaccinia-naÏve Cohort:
• Age: 18-32 (children are excluded due to concerns of safety, including autoinoculation).
• Willing to sign informed consent.
• Availability for follow-up for planned duration of the study (at least 8 weeks after vaccination).
• Acceptable medical history by screening evaluation and brief clinical assessment.
• Absence of a typical vaccinia scar and negative history of smallpox vaccination.
• Negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to vaccination for woman of childbearing potential. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized.
• If the volunteer is female and of childbearing potential, she agrees to use acceptable contraception, and not become pregnant for 56 days post vaccination. (Acceptable contraception methods are restricted to effective intrauterine devices (IUDs) or licensed hormonal methods (pills, patch, infection, ring or implant) with use of method for a minimum of 30 days prior to vaccination.)
• Negative ELISA for HIV or indeterminate Western blot or other assay confirming that the serostatus does not reflect HIV infection.
• Negative hepatitis B surface antigen and negative antibody to hepatitis C virus.
• Negative urine glucose by dipstick.
• ALT <1.5 times institutional upper limit of normal.
• Adequate renal function defined as a serum creatinine < = 1.5 mg/dl; urine protein < 100 mg/dl or trace or negative proteinuria (by dipstick), and a calculated creatinine clearance >55 mL/min. Formula for calculation is contained within the Manual of Procedures. (Note: Renal function is measured to ensure that subjects could meet criteria for use of cidofovir if needed.)
• Hematocrit > 34% for females, > 38% for males, platelets > 150,000, WBC > 2,500 and < 11, 000/dL.
• B. Vaccinia-experienced Cohort:
• Evidence of previous receipt of smallpox vaccine before 1989 (via immunization records documenting vaccination or the presence of a typical vaccinia scar).
• Age 33 to < 50 years.
• All inclusion criteria used for the vaccinia-naïve cohort, except age and absence of scar or negative history of vaccination.

You may not qualify if…

• A. Vaccinia-naïve Cohort:
• History of immunodeficiency.
• History of myocardial infarction or other ischemic heart disease, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.
• The presence on screening ECG of signs suggestive of prior ischemia disease (e.g. Q-waves).
• The presence of diabetes mellitus.
• History of an immediate family member (father, mother, brother or sister) who has had onset of ischemic heart disease before age 50 years.
• Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool. (a) Volunteers ages 18 to < 20 will not need to have this risk assessed, as the tool is predictive only for those age 20 or older.
• Known or suspectecd impairment of immunologic function including, but not limited to, clinically significant liver disease, moderate to severe kidney impairment.
• History of or current malignancy except squamous cell or basal cell skin cancer.
• Active autoimmune disease.
• Use of immunosuppressive medication (Corticosteroid nasal sprays and inhalers are permissible).
• History of solid organ or bone marrow transplantation.
• Medical or psychiatric condition or occupational responsibilities that might preclude subject compliance with the protocol.
• History of illegal injection drug use.
• Inactivated vaccine 14 days prior to vaccination.
• Live attenuated vaccines within 60 days of study.
• Use of investigational agents under IND within 30 days prior to study.
• Any history of vaccination with any vaccinia vectored or other pox vectored experimental vaccine.
• Typical vaccinia scar or history of vaccination.
• Receipt of blood products or immunoglobulin in the past 6 months.
• Recent donation of the equivalent of a pint of blood within the 30 days prior to enrollment.
• Acute febrile illness ( > = 100.5°F) on the day of vaccination.
• Pregnant or lactating woman.
• Known IgA deficiency (by history)
• Eczema of any degree or history of eczema.

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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