Chlamydia Trachomatis Immunology and Vaccinology Study

December 1, 2015 updated by: Harold Wiesenfeld

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
347

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Risk of positive chlamydia
  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
Drug: ceftriaxone
250mg IM once
Drug: Azithromycin
1 gm once

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Determination of the chlamydia-specific cellular responses that correlates with protection against incident infection
Time Frame: one year per patient
one year per patient

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Identify immunologic correlates associated with containment of the organism to the lower genital tract
Time Frame: one year per patient
one year per patient
Compare chlamydia-specific cellular responses in the PBMCs to endometrial lymphocytes
Time Frame: one year per patient
one year per patient
Evaluate the endocervical T cell phenotypes of women with containment of the organism to the lower genital tract
Time Frame: one year per patient
one year per patient
Characterize transcriptional inflammatory responses of women with Chlamydia
Time Frame: Study participation one year per patient
Study participation one year per patient
Use SNP analysis to identify genetic risk factors for chlamydia infection and disease
Time Frame: Study participation is one year per patient
Study participation is one year per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harold Wiesenfeld

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Toni Darville, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO10010159
  • U19AI084024 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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