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Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination Clinical research trials and Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination. Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination clinical trial. Human subjects often get the best healthcare possible for their Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination  Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination
Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination
For Condition: Smallpox
Status: No longer recruiting
Sponsor(s): Acambis ,
Synopsis: The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.
Details: Specifically, the objectives of this study are to: 1. Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age and previously vaccinated to smallpox. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis. 2. Determine the immunogenicity of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age by comparing: a. the proportion of subjects at each dose level who develop a major cutaneous reaction b. the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30. 3. Determine the minimum dose of ACAM2000 that is calculated to produce a major cutaneous reactionin at least 90% of a population of healthy adults at least 28 years of age, with a history of smallpox vaccination.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 28 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION: - have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar. - females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children. - agree to be available for the entire study and agree to comply with all requirements. EXCLUSION: - children 1 year of age or younger in the household or be in close contact - smallpox vaccination within ten years - known or suspected HIV infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above. - renal disease - current or past history of eczema or a household member or direct contact who has eczema. - known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B - known allergy or past allergic reaction to blood products. - known allergy to cidofovir or sulfa-containing drugs. - history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome. - transfusion of blood or treatment with any blood product. - current or history of drug or alcohol abuse - innoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.
Total Enrollment: 350
Location and Contact Information:
Memorial Hospital of Rhode Island Division of Infectious Diseases
Pawtucket, Rhode Island, 02860
United States
Bio-Kinetic Clinical Applications
Springfield, Missouri, 65802
United States
PRA International
Lenexa, Kansas, 66219
United States
Additional Information:
Study ID Numbers: H-400-003;
Study Start Date: January 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053482
Other Smallpox Studies:
1. Safety and Immunogenicity of Smallpox Vaccine MVA-BN
2. Dressing Preparation Comparison for Smallpox Vaccination Sites
3. A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
4. Vaccinia virus vaccine (APSV) in vaccinia- naive subjects: PILOT
5. Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults without Previous Smallpox Vaccination
Related Studies:
Other Smallpox Clinical Trials
Other Kansas Clinical Trials
Other Lenexa Clinical Trials
Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination
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