Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325975
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2006-05-15
Brief Title:
Immune Responses to Smallpox Vaccination
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Immune Responses to Vaccinia Virus Vaccination
Status:
COMPLETED
Status Verified Date:
2016-03-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg 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 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
People 18 years of age and older who are scheduled to receive smallpox vaccination as a routine part of their employment eg 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 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
Detailed Description:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-I-0090 | None | None | None |