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NCT00325975 · ClinicalTrials.gov registry record
Immune Responses to Smallpox Vaccination
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 69
- Enrollment target
NCT00325975: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00325975 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 69 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00325975 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 69 participants
- Enrollment target
Study Summary
This study will examine how people s immune systems respond to inoculation with vaccinia virus the standard vaccine used to protect against smallpox and how these responses correlate with symptoms they develop after receiving the vaccine. People 18 years of age and older who are scheduled to receive smallpox vaccination as a routine part of their employment (e.g., laboratory worker, health care worker, or emergency response worker) may be eligible for this study. They may or may not have been vaccinated previously. In addition, individuals who were vaccinated against smallpox at least 6 months before starting the study may participate as control subjects. All candidates will be screened with a brief medical history and physical examination. Participants in the following vaccination categories will undergo the procedures described for their group: Vaccine Recipient Frequent Follow-up Participants will come to the NIH Clinical Center every 2 to 3 days for a total of 7 visits over a 2-week period. At each visit, starting the day of vaccination, they will have the following procedures: * Brief skin examination, possibly with photographs of skin lesions; * Throat and skin swabs for vaccinia virus culture; * Blood draw (about 8 teaspoonfuls). Additional blood samples will be collected 1 month after vaccination and again within a year after vaccination. The blood will be analyzed for the immune response to the vaccine, genetic differences that might influence differences in immune response, and the presence of vaccinia virus. Participants will fill out a diary card every day for 3 weeks after vaccination to record any symptoms. Individuals who develop symptoms lasting more than 2 weeks, such as persistent or new skin lesions, will return to the clinic for additional skin exams and blood tests. Individuals who develop vaccine side effects may have a urine culture for vaccinia virus. Vaccine Recipient Infrequent Follow-up Participants will come to the NIH Clinical C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2003-02-04 |
| Est. Completion | 2016-03-15 |
What the finished NCT00325975 record still lists
NCT00325975 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 69 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00325975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00325975 about?
NCT00325975 is a clinical study titled "Immune Responses to Smallpox Vaccination". This study will examine how people s immune systems respond to inoculation with vaccinia virus the standard vaccine used to protect against smallpox and how these responses correlate with symptoms they develop after receiving the vaccine. People 18 years of age and older who are scheduled to receiv...
What is the current status of trial NCT00325975?
This trial is currently completed. The enrollment target is 69 participants. The study started on 2003-02-04. Estimated completion is 2016-03-15.
Who is sponsoring clinical trial NCT00325975?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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