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Dryvax vaccine immunogenicity in previously vaccinated Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Dryvax vaccine immunogenicity in previously vaccinated conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Dryvax vaccine immunogenicity in previously vaccinated Clinical research trials and Dryvax vaccine immunogenicity in previously vaccinated health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Dryvax vaccine immunogenicity in previously vaccinated. Dryvax vaccine immunogenicity in previously vaccinated Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Dryvax vaccine immunogenicity in previously vaccinated clinical trial. Subjects frequently get the best healthcare possible for their Dryvax vaccine immunogenicity in previously vaccinated condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Dryvax vaccine immunogenicity in previously vaccinated  Dryvax vaccine immunogenicity in previously vaccinated
Dryvax vaccine immunogenicity in previously vaccinated
For Condition: Smallpox
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The study seeks to further 1) evaluate safety in previously vaccinated adults between the ages of 32-70 who are vaccinated with undiluted Dryvax, and 1:5 and 1:10 dilutions; 2) define with very high precision the proportion of individuals who respond with a "take" 6-11 days after vaccination with undiluted Dryvax and Dryvax diluted 1:5; 3) define with good precision the proportion of individuals who respond with a "take" with a 1:10 dilution of Dryvax and; 4) explore correlations between "takes/no takes" and immune responses in all vaccine dilution groups.
Details: This study will evaluate the safety and immunogenicity of Dryvax vaccine against smallpox and its dilutions (1:5 and 1:10) in previously, but remotely, vaccinated adults. Both serologic and cell-mediated immune responses will be evaluated (the latter on a small subgroup of volunteers). The study will be conducted at five clinics in the U.S., commencing at the University of Rochester in New York. Approximately 927 volunteers between the ages of 32 and 70 years who were previously vaccinated against smallpox (but not since 1989) will be randomized to receive Dryvax vaccine undiluted, diluted 1:5 or diluted 1:10. Subjects will be involved in the trial for 8 to 16 weeks.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Dose Comparison, Parallel Assignment
Minimum Age/Maximum Age: 32 Years/70 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Age 32 to 70 years. - Typical vaccinia scar or validated documentation (e.g., military record, international travel certificate) of a smallpox vaccination, but not since 1989. - Willing to sign informed consent. - Availability for follow-up for the planned duration of the study at least 8 weeks after vaccination. - Acceptable medical history by screening evaluation and brief clinical assessment. - Negative urine or serum pregnancy test for women of childbearing potential. - If the subject is female and of childbearing potential, she must use an acceptable contraception and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner). - Negative ELISA for HIV or indeterminant Western blot or other assay confirming that the serostatus does not reflect HIV infection. - ALT < 1.5 times institutional upper limit of normal. - Negative hepatitis B surface antigen and negative antibody to hepatitis C virus. - Negative urine glucose by dipstick. - Adequate renal function defined as a serum creatinine less than or equal to 1.5 mg/dL, urine protein < 100 mg/dL or trace or negative proteinuria by dipstick, and a calculated creatinine clearance > 55 ml/min based on the formulas in the manual of procedures. - Hematocrit > 34% for females, >38% for males, platelets > 150,000/mm3, WBC > 2500/mm3 and < 11000/mm3. EXCLUSION CRITERIA: - Smallpox vaccination in 1990 or more recently. - History of immunodeficiency. - 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. - Active Autoimmune disease. - Use of immunosuppressive medication. - Medical or psychiatric condition or occupational responsibilites that 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 within 30 days prior to study. - Receipt of blood products or immunoglobulin in the past 6 months. - Acute febrile illness on the day of vaccination. - Pregnant or lactating women. - Eczema of any degree or history of eczema. - History of chronic exfoliative skin disorders/conditions. - Any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2x2 cm. - Household contacts/sexual contacts with, or frequent and/or prolonged exposure to, any of the following: Pregnant women, children < 12 months of age, people with or history of eczema, people with chronic exfoliative skin disorders/conditions or any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2x2 cm or people with immunodeficiency disease or use of immunosuppressive medications. - Any condition that, in the opinion of the investigator, might interfere with study objectives. - Known allergies to any component of the vaccine (e.g., polymyxin B sulfate, dihydrostreptomycin sulfate, chlortetracycline hydrochloride, neomycin sulfate). - Known allergies to any known component of the diluent (i.e., glycerin and phenol). - Known allergies to any known component of VIG, i.e., thimerosal or previous allergic reaction to immunoglobulins. - Known allergies to cidofovir or probenecid.
Total Enrollment: 927
Location and Contact Information:
St. Louis University - St. Louis MO (VTEU)
St. Louis, Missouri, 63104
United States
Stanford University Schoool of Medicine
Stanford, California, 94305-5208
United States
University of Maryland School of Medcn - Balt MD
Baltimore, Maryland, 21201
United States
Harbor-UCLA Medical Center - Torrance CA
Torrance, California, 90502
United States
Kaiser Permanente Research Institute
Oakland, California, 94612
United States
Duke University Medical Center - Durham NC
Durham, North Carolina, 27710
United States
University of Rochester
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: 02-007;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050505
Other Smallpox Studies:
1. Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination
2. Safety and Immunogenicity of Smallpox Vaccine MVA-BN
3. APSV in vaccinia naive adults
4. Dryvax vaccine immunogenicity in previously vaccinated
5. A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
Related Studies:
Other Smallpox Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
Dryvax vaccine immunogenicity in previously vaccinated
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