NCT01150747

Chlamydia Trachomatis Immunology and Vaccinology Study

Chlamydia Trachomatis Immunology and Vaccinology Study: Determination of Protective T Cell Responses to Chlamydia Trachomatis Infection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 347 (actual)
• Sponsor: Harold Wiesenfeld · Academic / Other
• Sex: Female
• Age: 15 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chlamydia

Interventions

Type	Name	Description
DRUG	ceftriaxone	250mg IM once
DRUG	Azithromycin	1 gm once

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2010-06-28
• Last updated: 2015-12-03

Locations

4 sites across 1 country: United States