Chlamydia Trachomatis Immunology and Vaccinology Study

Chlamydia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150747
• Other study ID #: PRO10010159
• Secondary ID: U19AI084024
• Status: Completed
• Phase: N/A
• First received: June 23, 2010
• Last updated: December 1, 2015
• Start date: January 2011
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 35 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chlamydia
• Chlamydia Infections

Intervention

Drug:
• ceftriaxone
250mg IM once
• Azithromycin
1 gm once

Locations

Country	Name	City	State
United States	Allegheny County Sexually Transmitted Disease Clinic	Pittsburgh	Pennsylvania
United States	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Mercy Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Harold Wiesenfeld	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the chlamydia-specific cellular responses that correlates with protection against incident infection		one year per patient	No
Secondary	Identify immunologic correlates associated with containment of the organism to the lower genital tract		one year per patient	No
Secondary	Compare chlamydia-specific cellular responses in the PBMCs to endometrial lymphocytes		one year per patient	No
Secondary	Evaluate the endocervical T cell phenotypes of women with containment of the organism to the lower genital tract		one year per patient	No
Secondary	Characterize transcriptional inflammatory responses of women with Chlamydia		Study participation one year per patient	No
Secondary	Use SNP analysis to identify genetic risk factors for chlamydia infection and disease		Study participation is one year per patient	No