Smallpox Clinical Trial
Official title:
The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM1000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination A Phase 2, Randomized, Double-Blind, Dose-Response Study
Verified date | January 2014 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
Status | Terminated |
Enrollment | 274 |
Est. completion date | September 2003 |
Est. primary completion date | March 2003 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 29 Years |
Eligibility |
Inclusion criteria: - in good general health. - not pregnant and using effective birth control - agreed to participate in entire study and comply with protocol requirements. Exclusion criteria: - military service prior to 1989. - no previous smallpox vaccination. - no contact with with children 1 year of age or younger - immunodeficiency individuals or close contacts who are immunodeficient - past history or current renal disease - diagnosis or past history of eczema - known allergy or past allergic reactions to latex gloves or to some antibiotics (neomycin, streptomycin, chlortetracycline, and polymyxin B). - known allergy or past allergic to blood products. - known allergy or past allergic reaction to cidofovir or sulfa-containing drugs. - transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit. - serology positive for HIV, hepatitis B or hepatitis C. - current diagnosis or history within six months of drug or alcohol abuse disorders, psychiatric illness. - inoculation with any other live vaccine within 30 days of Day 0 or participation in another drug or vaccine trial within 30 days of Day 0. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Radiant Research | Cincinnati | Ohio |
United States | Orlando Clinical Research Center | Orlando | Florida |
United States | Mayo Vaccine Research Group | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of subjects in each treatment group who develop a major cutaneous reaction on Day 7, Day 10, and/or Day 15. | Day 7, Day 10, and/or Day 15 | No | |
Secondary | 1.The comparison of treatment groups for the proportion of subjects developing a >fourfold rise in neutralizing antibodies. 2. neutralizing antibody response. 3. geometric mean neutralizing titer on day 31 will be compared between treatment groups. | days 0 and 30, day 31 | No |
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