Ignite Creation Date:
2024-05-05 @ 10:39 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01150747
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2010-06-23
Brief Title:
Chlamydia Trachomatis Immunology and Vaccinology Study
Sponsor:
Harold Wiesenfeld
Organization:
University of Pittsburgh
Study Overview
Official Title:
Chlamydia Trachomatis Immunology and Vaccinology Study Determination of Protective T Cell Responses to Chlamydia Trachomatis Infection
Status:
COMPLETED
Status Verified Date:
2015-12
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:
The primary objective is to prospectively follow 200 women with or at risk of cervicitis to determine the chlamydia-specific cellular responses that correlate with protection against incident infection The hypothesis is that a positive IFN-y response by peripheral CD4 T cells responding to stimulation with HSP60 will be significantly associated with protection from incident C trachomatis infection
Detailed Description:
A total of 200 women with or at high risk of having cervicitis will be prospectively followed for correlations between chlamydia-specific cellular responses and protection against incident infection
At enrollment participants will undergo a history and physical examination blood draw and pelvic examination including collection of vaginal and cervical samples STD testing and endometrial biopsy
Participants will have follow up visits conducted at 1 4 8 and 12 months following enrollment At the follow-up visits participants will undergo a repeat history and physical blood draw and pelvic examination including collection of vaginal and cervical samples and STD testing
The study design will allow comprehensive identification of the antigen-specific cell mediated immune responses most strongly associated with protection against C trachomatis infection
The primary objective is to prospectively follow 200 women with or at risk for cervicitis to determine the chlamydia-specific cellular responses that correlate with protection against incident infection
At enrollment participants will undergo a history and physical examination blood draw and pelvic examination including collection of vaginal and cervical samples STD testing and endometrial biopsy
Participants will have follow up visits conducted at 1 4 8 and 12 months following enrollment At the follow-up visits participants will undergo a repeat history and physical blood draw and pelvic examination including collection of vaginal and cervical samples and STD testing
The study design will allow comprehensive identification of the antigen-specific cell mediated immune responses most strongly associated with protection against C trachomatis infection
The primary objective is to prospectively follow 200 women with or at risk for cervicitis to determine the chlamydia-specific cellular responses that correlate with protection against incident infection
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 |
|---|---|---|---|
| U19AI084024 | NIH | None | httpsreporternihgovquickSearchU19AI084024 |