Antigen-Specific Cell Mediated Immune Response to Chlamydia Trachomatis

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00970749
First received: August 29, 2009
Last updated: July 8, 2010
Last verified: July 2010
  Purpose

This is an exploratory study in which the investigators will develop a way to identify the cell responses most strongly associated with protection against chlamydia infection. This study is not driven by a hypothesis.


Condition
Chlamydia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Antigen-specific Cell Mediated Immune Response to Chlamydia Trachomatis

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • This is an exploratory investigation in which we will develop the methodology needed to identify the antigen-specific cell mediated immune responses most strongly associated with protection against incident C. trachomatis infection. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: December 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
history of endocervial chlamydia
no history of endocervical chlamydia

Detailed Description:

With more than 90 million new cases annually, Chlamydia trachomatis is the most common sexually transmitted bacterial disease. Untreated endocervical C. trachomatis infections can cause pelvic inflammatory disease (PID), a disorder of the endometrium, fallopian tubes, and adjacent structures that occurs after ascension of the bacterium from the lower to upper genital tract. Adverse outcomes secondary to C. trachomatis-induced PID include tubal infertility, ectopic pregnancy, and chronic pelvic pain. Vaccine development has been identified as essential for control of C. trachomatis infections, and current evidence suggests that an effective vaccine will likely be based on several C. trachomatis antigens. Experimental models of infection have identified HSP60, major outer-membrane protein (MOMP), outer membrane protein 2 (OMP2), and polymorphic membrane protein D (PmpD) as promising vaccine candidates. A prospective study of Kenyan commercial sex workers found that production of interferon-gamma (IFN-γ) by peripheral blood cells stimulated with chlamydia heat-shock protein (HSP60) strongly correlated with protection against incident C. trachomatis infection. This proposal details an exploratory identification of the antigen-specific cell mediated immune responses associated with antecedent C. trachomatis infection in women.

C. trachomatis is an obligate, intracellular, gram-negative microorganism recognized as the most common bacterial sexually transmitted disease worldwide. The highest rates of infection with this organism are consistently found among adolescents and young adults. Young women are also the group most adversely impacted by the effects of C. trachomatis infection on reproductive health. While approximately 70% of infections with C. trachomatis in young women are asymptomatic, 20% - 40% of these occult infections will progress from endocervical inflammation to the development of PID. In addition to its strong association with PID, C. trachomatis infection is also thought to enhance HIV transmission and contribute to human papilloma virus induced cervical neoplasia. Although data from both experimental models and clinical studies suggest that antigen specific CD4+ and CD8+ T cells are required for optimal control of genital tract chlamydial infections, the current lack of information regarding the specific C. trachomatis antigens eliciting protective immune responses in humans hinders vaccine development.

This is an exploratory investigation in which we will develop the methodology needed to identify the antigen-specific cell mediated immune responses most strongly associated with protection against incident C. trachomatis infection.

  Eligibility

Ages Eligible for Study:   15 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

20 women with history of endocervical chlamydia and 10 women with no history of endocervical chlamydia

Criteria

Inclusion Criteria:

  • Women between 15-35 years of age at the time of enrollment onto this study. Minors between the ages of 1-17 will require parental consent to participate in the study.
  • History of, in past 5 years, endocervical C. trachomatis infection (total of 20 women) or no history of endocervical C. trachomatis infection (total of 10 women).

Exclusion Criteria:

  • Pregnancy.
  • Immunocompromised, by history (including but not limited to known HIV, cancer, autoimmune diseases).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970749

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Thomas L Cherpes, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Thomas L. Cherpes, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00970749     History of Changes
Other Study ID Numbers: PRO09070184, U19AI084024
Study First Received: August 29, 2009
Last Updated: July 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
chlamydia
healthy women
history of endocervical chlamydia
no history of endocervical chlamydia

Additional relevant MeSH terms:
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 20, 2014