Chlamydia Trachomatis Immunology and Vaccinology Study

Completed

• Conditions: Chlamydia
• Interventions: Drug: ceftriaxone; Drug: Azithromycin

• Registration Number: NCT01150747
• Lead Sponsor: Harold Wiesenfeld

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.

Study Timeline

• Study First Submitted: 2010-06-23
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-28
• Study Start: 2011-01
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 347

Inclusion Criteria

Not provided

Exclusion Criteria

1. Pregnant or nursing a baby. Note: a urine pregnancy test will be done at enrollment. Result must be negative to participate in the study.
2. Gynecologic surgery or surgical abortion in preceding 2 months of enrollment.
3. Allergy to any of the study medications and/or derivatives (cephalosporins, azithromycin, erythromycin, any macrolide or ketolide antibiotic) or Type 1 hypersensitivity allergic reaction to penicillin.
4. Systemic or vaginal antibiotic therapy in preceding 7 days of enrollment.
5. Prior hysterectomy.
6. Menopause.
7. Any condition, in the opinion of the investigator that would interfere with the participant's safety or with study outcomes.
8. Participation in any study involving an investigational product in the past 30 days or anticipation of participation in any study using an investigational product in the next 30 days.
9. Previous participation in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Risk of positive chlamydia	Azithromycin	1. current, untreated endocervical C. trachomatis infection 2. mucopurulent cervicitis on pelvic examination 3. Sexual contact with a male partner recently diagnosed with C. trachomatis, and/or non-gonococcal urethritis
Risk of positive chlamydia	ceftriaxone	1. current, untreated endocervical C. trachomatis infection 2. mucopurulent cervicitis on pelvic examination 3. Sexual contact with a male partner recently diagnosed with C. trachomatis, and/or non-gonococcal urethritis

Primary Outcome Measures

Name	Time	Method
Determination of the chlamydia-specific cellular responses that correlates with protection against incident infection	one year per patient

Secondary Outcome Measures

Name	Time	Method
Identify immunologic correlates associated with containment of the organism to the lower genital tract	one year per patient
Compare chlamydia-specific cellular responses in the PBMCs to endometrial lymphocytes	one year per patient
Evaluate the endocervical T cell phenotypes of women with containment of the organism to the lower genital tract	one year per patient
Characterize transcriptional inflammatory responses of women with Chlamydia	Study participation one year per patient
Use SNP analysis to identify genetic risk factors for chlamydia infection and disease	Study participation is one year per patient

Trial Locations

Locations (4)

Mercy Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Magee Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Allegheny County Sexually Transmitted Disease Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States