Clinical Trial: Chlamydia Trachomatis Immunology and Vaccinology Study
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Chlamydia Trachomatis Immunology and Vaccinology Study: Determination of Protective T Cell Responses to Chlamydia Trachomatis Infection
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 Summary:
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.
Sponsor: Harold Wiesenfeld
Current Primary Outcome: Determination of the chlamydia-specific cellular responses that correlates with protection against incident infection [ Time Frame: one year per patient ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Identify immunologic correlates associated with containment of the organism to the lower genital tract [ Time Frame: one year per patient ]
- Compare chlamydia-specific cellular responses in the PBMCs to endometrial lymphocytes [ Time Frame: one year per patient ]
- Evaluate the endocervical T cell phenotypes of women with containment of the organism to the lower genital tract [ Time Frame: one year per patient ]
- Characterize transcriptional inflammatory responses of women with Chlamydia [ Time Frame: Study participation one year per patient ]
- Use SNP analysis to identify genetic risk factors for chlamydia infection and disease [ Time Frame: Study participation is one year per patient ]
Original Secondary Outcome:
- Identify immunologic correlates associated with containment of the organism to the lower genital tract [ Time Frame: one year per patient ]
- Compare chlamydia-specific cellular responses in the PBMCs to endometrial lymphocytes [ Time Frame: one year per patient ]
- Evaluate the endocervical T cell phenotypes of women with containment of the organism to the lower genital tract [ Time Frame: one year per patient ]
Information By: University of Pittsburgh
Dates:
Date Received: June 23, 2010
Date Started: January 2011
Date Completion:
Last Updated: December 1, 2015
Last Verified: December 2015
