Immune Responses to Smallpox Vaccination
|First Received Date ICMJE||May 15, 2006|
|Last Updated Date||March 14, 2014|
|Start Date ICMJE||February 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00325975 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Immune Responses to Smallpox Vaccination|
|Official Title ICMJE||Immune Responses to Vaccinia Virus 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 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:
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 Center for blood tests on the day of vaccination, 4 weeks after vaccination, and once again within a year after vaccination. At each visit, 6 teaspoonfuls of blood will be drawn. This group will also include individuals who have been vaccinated within 8 months of entering the study and are not currently receiving the vaccine, but for whom blood samples are not available.
Control Group Vaccinated at Least 6 Months Before Entering the Study
Participants will come to the NIH Clinical Center for blood tests every 2 to 3 days for 2 weeks, then at 1 month after the first blood draw, and again within a year of the first blood draw. About 8 teaspoonfuls of blood will be drawn at each visit.
Vaccinia virus is used to vaccinate persons to prevent disease with smallpox. Limited information is available regarding cellular immune responses to vaccinia virus. We will obtain blood from vaccinated persons and measure immune responses in vitro to the virus and correlate these findings with symptoms from vaccination. Elucidation of these responses might help to predict side effects associated with vaccination, and suggest new therapies to reduce these side effects.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Smallpox Vaccine|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||340|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Both males and females
Patients will be checked on day 0 and those with a hemoglobin of greater than or equal to12 g/dL will have blood drawn as described in the protocol. Patients with a hemoglobin of 11-11.9 will have a 50% reduction in the amount of blood drawn after the first visit from 40 ml per visit to 20 ml per visit. Patients with a hemoglobin less than 11 g/dL will be terminated from the study and referred for medical follow-up.
Able to sign the consent form and be willing to comply with study procedures.
Must be a laboratory worker, health care worker, or emergency response worker who is receiving smallpox vaccination as a routine part of employment. Persons who were previously vaccinated at least 8 months ago are eligible.
Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00325975|
|Other Study ID Numbers ICMJE||030090, 03-I-0090|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP