Smallpox Clinical Trial
Official title:
A Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of Various Concentrations of Aventis Pasteur's Smallpox Vaccine, USP (APSV) in Vaccinia-naive Adults
To define the safety of vaccination with APSV as determined by the reactogenicity of the
vaccine and the development of expected and un-expected adverse events associated with
vaccination.
To assess the proportion of individuals who respond to vaccination with a "take" (those who
form a visible lesion at the injection site) 6 to 8 days after the vaccination.
Status | Completed |
Enrollment | 330 |
Est. completion date | August 2002 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 32 Years |
Eligibility |
INCLUSION CRITERIA: - Age: 18-32 (Volunteers over 32 years of age are not included since they usually are not vaccinia-naive.) Children are excluded due to concerns of safety, including autoinoculation. - Acceptable medical history by screening evaluation form and brief assessment. - Negative urine pregnancy test for women. - Negative history of smallpox vaccination. - Negative ELISA for HIV or negative Western blot for volunteers who have a positive ELISA and have participated in an HIV vaccine trial. - Availability for follow-up for planned duration of the study (6 months). Note: Stage 1 - clinic visit at Day 180+/-15 days, Stage 2 - phone call at Day 180 +/- 15 days. - If the volunteer is female, she agrees to use acceptable contraception and not become pregnant for the duration of the study. - Willing to sign informed consent. - Adequate renal functions as defined as a serum creatinine of 1.5 mg/dL, urine protein < 100 mg/dL or negative proteinuria, and a calculated creatinine clearance > 55 mL/min based on the following formulas: For males ((140 minus age in years) x weight in kg)/72 x serum creatinine). For females: 0.85 x ((140 minus age in years) x weight in kg)/72 x serum creatinine). Note: Renal function is measured to ensure subjects could meet criteria for use of cidofovir if needed. EXCLUSION CRITERIA: - History of immunodeficiency. - Serology positive for HIV, hepatitis B, or hepatitis C at the screening visit. - Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease. - Diabetes mellitus. - Moderate to severe kidney impairment. - Malignancy, other than squamous cell or basal cell skin cancer. - Autoimmune disease. - Use of immunosuppressive medication. - Corticosteroid nasal sprays are permissible. - Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol. - History of "illegal" injection drug use. - Live attenuated vaccines within 60 days of study. - Use of experimental agents within 30 days prior to study. - Any history of vaccination with any vaccinia vectored or other pox vectored experimental vaccine. - Typical vaccinia scar without known history of vaccination. - History of smallpox vaccination. - Acute febrile illness on the day of vaccination. - Pregnant or lactating women. - Eczema or any degree or history of eczema. - History of exfoliative skin disorders/conditions. - Any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2x2 cm. - Receipt of blood products or immunoglobulin in the past 6 months. - Household contacts/sexual contacts with, or occupational exposure to (other than minimal contact), people with any of the following: pregnancy, < 12 months of age, eczema or history of eczema, previously listed skin disorders/conditions, immunodeficiency disease or use of immunosuppressive medications. - Allergies to any component of the vaccines (e.g. polymyxin B sulfate, dihydrostreptomycin sulfate, chlortetracycline hydrochloride, neomycin sulfate). - Allergies to any known component of the diluent. - Allergies to any known component of VIG, i.e., thimerosal or previous allergic reaction to immunoglobulins. - Allergies to cidofovir or probenicid. - Blood donation within the past 55 days (stage 1 only). |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
United States | University of Iowa - Iowa City IA | Iowa City | Iowa |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Kaiser Permanente Vaccine Study Center | Oakland | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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