Antigen-Specific Cell Mediated Immune Response to Chlamydia Trachomatis

NCT00970749 | Completed

• 2 other identifiers: PRO09070184U19AI084024
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chlamydia

Keywords

chlamydia; healthy women; history of endocervical chlamydia; no history of endocervical chlamydia

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

history of chlamydia infection

Women who self-reported a history of cervical infection with Chlamydia trachomatis

no history of chlamydia infection

Women who self-reported no history of cervical infection with Chlamydia trachomatis

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• Pregnancy.
• Immunocompromised, by history (including but not limited to known HIV, cancer, autoimmune diseases).

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Chlamydia Infections

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Thomas L Cherpes, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2009
• First Posted: September 2, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)