Dryvax Seropositives #2 (Expanded Trial)
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.
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.
Allocation: Randomized, Control: Dose Comparison, Intervention Model: Parallel Assignment, Primary Purpose: Prevention
National Institute of Allergy and Infectious Diseases (NIAID)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00050505
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A live VACCINIA VIRUS vaccine of calf lymph or chick embryo origin, used for immunization against smallpox. It is now recommended only for laboratory workers exposed to smallpox virus. Certain countries continue to vaccinate those in the military service. Complications that result from smallpox vaccination include vaccinia, secondary bacterial infections, and encephalomyelitis. (Dorland, 28th ed)
An acute, highly contagious, often fatal infectious disease caused by an orthopoxvirus characterized by a biphasic febrile course and distinctive progressive skin eruptions. Vaccination has succeeded in eradicating smallpox worldwide. (Dorland, 28th ed)
A viral disease infecting PRIMATES and RODENTS. Its clinical presentation in humans is similar to SMALLPOX including FEVER; HEADACHE; COUGH; and a painful RASH. It is caused by MONKEYPOX VIRUS and is usually transmitted to humans through BITES or via contact with an animal's BLOOD. Interhuman transmission is relatively low (significantly less than smallpox).
The cutaneous and occasional systemic reactions associated with vaccination using smallpox (variola) vaccine.
The type species of ORTHOPOXVIRUS, related to COWPOX VIRUS, but whose true origin is unknown. It has been used as a live vaccine against SMALLPOX. It is also used as a vector for inserting foreign DNA into animals. Rabbitpox virus is a subspecies of VACCINIA VIRUS.
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