Chlamydia Trachomatis Immunology and Vaccinology Study

Completed

Conditions studied: Chlamydia

In brief

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.

Key facts

Study ID

NCT01150747

Run by

Harold Wiesenfeld

People needed

347

Starts

2011-01-01

Expected to finish

2015-08-01

Last updated by the study team

2015-12-03

Who can join

Age: 15 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women 15-35 years of age. Note: Minors must have written informed consent from her parent/legal guardian to participate.
• At least one of the following:
• Current , untreated endocervical C. trachomatis infection.
• 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).
• 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.

You may not qualify if…

• Pregnant or nursing a baby. Note: a urine pregnancy test will be done at enrollment. Result must be negative to participate in the study.
• Gynecologic surgery or surgical abortion in preceding 2 months of enrollment.
• 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.
• Systemic or vaginal antibiotic therapy in preceding 7 days of enrollment.
• Prior hysterectomy.
• Menopause.
• Any condition, in the opinion of the investigator that would interfere with the participant's safety or with study outcomes.
• 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.
• Previous participation in this study.

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

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