Dryvax Seropositives #2 (Expanded Trial)
Summary
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.
Description
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.
Study Design
Allocation: Randomized, Control: Dose Comparison, Intervention Model: Parallel Assignment, Primary Purpose: Prevention
Conditions
Smallpox
Intervention
Dryvax
Status
Completed
Source
National Institute of Allergy and Infectious Diseases (NIAID)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00050505
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Smallpox Vaccine
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)
Smallpox
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)
Monkeypox
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).
Vaccinia
The cutaneous and occasional systemic reactions associated with vaccination using smallpox (variola) vaccine.
Vaccinia Virus
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.
Clinical Trials
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The purpose of this study is to see how many people respond to a smallpox vaccine when a sore forms where the shot was given. The world was declared free of smallpox in 1980. General rou...
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
Dryvax Dilution-Prev Vacc Adults
A double-blind, randomized, dose-response study of four dilutions of Dryvax in previously vaccinated adults in order to assess the clinical success rates, humoral responses, and virus-spec...
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MVA Post-Event: Administration Timing and Boost Study
The purpose of this study is to evaluate an investigational smallpox vaccine, called IMVAMUNE®, with respect to safety and immune (body's defense system) response. Participants will inclu...
PubMed Articles
Smallpox vaccine safety is dependent on T cells and not B cells.
(See the editorial commentary by Bray, on pages 1037-9.) The licensed smallpox vaccine, ACAM2000, is a cell culture derivative of Dryvax. Both ACAM2000 and Dryvax are administered by skin scarificatio...
Insights into human CD8(+) T-cell memory using the yellow fever and smallpox vaccines.
Live virus vaccines provide a unique opportunity to study human CD8(+) T-cell memory in the context of a controlled, primary acute viral infection. Yellow fever virus-17D and Dryvax are two such live-...
Modified Vaccinia virus Ankara (MVA) is an attenuated strain of vaccinia virus that is being considered as a safer alternative to replicating vaccinia vaccine strains such as Dryvax(®) and ACAM2000....
On June 24, 2012, CDC notified Public Health Services, County of San Diego Health and Human Services Agency, of a suspected case of vaccinia virus infection transmitted by sexual contact. The case had...
Despite the eradication of smallpox, there is heightened concern that it could be reintroduced as a result of intentional release of Variola major virus through an act of bioterrorism. The live vaccin...
