Chlamydia Trachomatis Immunology and Vaccinology Study

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

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.

Study Overview

• Status: Completed
• Conditions: Chlamydia
• Intervention / Treatment: Drug: ceftriaxone; Drug: Azithromycin

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 Type: Observational
• Enrollment (Actual): 347

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital of UPMC
    • Pittsburgh, Pennsylvania, United States, 15213
      • Allegheny County Sexually Transmitted Disease Clinic
    • Pittsburgh, Pennsylvania, United States, 15213
      • Mercy Hospital of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women positive for chlamydia or at high risk of chlamydia infection.

Description

Inclusion Criteria

1. Women 15-35 years of age. Note: Minors must have written informed consent from her parent/legal guardian to participate.

2. At least one of the following:

   1. Current , untreated endocervical C. trachomatis infection.
   2. Mucopurulent cervicitis: defined by the presence of yellow or green endocervical mucopurulent discharge and/ or easily induced endocervical bleeding (bleeding when the first swab is placed in the endocervix).
   3. Sexual contact with a male partner (regardless of condom use) recently diagnosed (within the past 3 months) with C. trachomatis and/or non-gonococcal urethritis.

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Risk of positive chlamydia; current, untreated endocervical C. trachomatis infection; mucopurulent cervicitis on pelvic examination; Sexual contact with a male partner recently diagnosed with C. trachomatis, and/or non-gonococcal urethritis	Drug: ceftriaxone; 250mg IM once; Drug: Azithromycin; 1 gm once

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Harold Wiesenfeld
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Director: Toni Darville, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: June 23, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (ESTIMATE): June 28, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Chlamydia Infections; Anti-Infective Agents; Anti-Bacterial Agents; Ceftriaxone; Azithromycin
• Other Study ID Numbers: PRO10010159; U19AI084024 (NIH)