ChlamydiaNCT00970749
Antigen-Specific Cell Mediated Immune Response to Chlamydia Trachomatis
An observational study of Chlamydia, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydia
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: 20 women with history of endocervical chlamydia and 10 women with no history of endocervical chlamydia
Who may be able to join
- 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).
Who cannot join
- Pregnancy.
- Immunocompromised, by history (including but not limited to known HIV, cancer, autoimmune diseases).
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Antigen-specific Cell Mediated Immune Response to Chlamydia Trachomatis
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.
Read the 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.
- 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.
- Conditions
- Chlamydia
- Keywords
- chlamydia, healthy women, history of endocervical chlamydia, no history of endocervical chlamydia
- Medical subject headings
- Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChlamydiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Thomas L Cherpes, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970749
- Sponsor's protocol ID
- PRO09070184
- Other IDs
- U19AI084024
- Status last verified
- Apr 2017
- First submitted
- 29 Aug 2009
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antigen-specific Cell Mediated Immune Response to Chlamydia Trachomatis
- ClinicalTrials.gov ID
- NCT00970749
- Acronym / sponsor ID
- PRO09070184
- Conditions
- Chlamydia
- Keywords
- chlamydia, healthy women, history of endocervical chlamydia, no history of endocervical chlamydia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 20 women with history of endocervical chlamydia and 10 women with no history of endocervical chlamydia
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Pregnancy.
- Immunocompromised, by history (including but not limited to known HIV, cancer, autoimmune diseases).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas L Cherpes, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chlamydia, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.