Vaginal Innate Immunity in Normal and HIV-Infected Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Boston Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jennifer Ballard Dwan, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01318304
First received: October 29, 2010
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

The innate immunity of the vaginal tract provides first-line defense from abnormal microorganisms or overgrowth of common organisms, such as Candida species or Gardnerella vaginalis. It is unclear from the current available literature whether the rate of vaginal infection increases or decreases in frequency during pregnancy when compared to the non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. Vaginal infections are important players in HIV disease, potentially increasing the risk of viral transmission. In addition, these infections may activate inflammatory markers in the reproductive tract and increase the risk of premature delivery or other negative pregnancy outcomes. The vaginal innate immune system has not been well characterized in pregnant women, or in women with HIV infection. The study of how this system changes in pregnancy and HIV infection will provide essential knowledge for further study of vaginal mucosal protection.

The investigators study is an observational study designed to compare levels of vaginal innate immunity markers in women based on a) pregnancy status and b) HIV infection status. Comparisons will be made between pregnant and non- pregnant women and between HIV positive and HIV negative women. The investigators hypothesize that there will be significant differences in levels of innate immunity between the groups.


Condition Intervention
HIV
Pregnancy
Other: Vaginal lavage specimen

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vaginal Innate Immunity in Normal and HIV-Infected Women

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • To compare the vaginal concentrations innate immunity markers (alpha / beta interferons, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI) in pregnant and non-pregnant women who are HIV-negative. [ Time Frame: up to 2 clinic visits in 10 weeks ] [ Designated as safety issue: No ]
    Investigators will quantify the major vaginal innate immunity markers, including type 1 (alpha and beta) interferons, defensins, cathelicidins, lysozyme and lactoferrin, and secretory leukocyte protease inhibitor (SLPI). These antimicrobial host defense peptides are produced by genital tract mucosal epithelial cells and associated immune cells, and have a wide range of antiviral, antibacterial, antifungal and antiparasitic activities and modes of action. We hypothesize that changes in innate immunity markers take place during pregnancy, thereby changing native vaginal immunity.


Secondary Outcome Measures:
  • To compare the vaginal concentrations of innate immunity markers (alpha and beta) interferon, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI)) in HIV-positive pregnant and non-pregnant women [ Time Frame: up to 2 clinic visits in 10 weeks ] [ Designated as safety issue: No ]
    Investigators will quantify the major vaginal innate immunity markers, including type 1 (alpha and beta) interferons, defensins, cathelicidins, lysozyme and lactoferrin, and secretory leukocyte protease inhibitor (SLPI). Women who have HIV may express different innate immunity marker profiles in vaginal secretions when pregnant as compared to non-pregnant HIV positive women. Timing of specimen collection: In pregnancy: Weeks 13 - 30. Non-pregnant: 3 weeks between menstrual bleeding cycles

  • To compare the vaginal concentrations innate immunity markers (alpha / beta interferons, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI) in pregnant women who are HIV-negative to pregnant women who are HIV-positive. [ Time Frame: up to 2 clinic visits in 10 weeks ] [ Designated as safety issue: No ]
    Investigators will quantify the major vaginal innate immunity markers, including type 1 (alpha and beta) interferons, defensins, cathelicidins, lysozyme and lactoferrin, and secretory leukocyte protease inhibitor (SLPI). Women with HIV may express different innate immunity marker profiles in vaginal secretions when pregnant as compared to pregnant, HIV-negative women. This may provide some explanation for differences in vaginal infection rates between the groups. Timing of specimen collection: In pregnancy: Weeks 13 - 30.


Biospecimen Retention:   Samples Without DNA

Vaginal lavage samples


Estimated Enrollment: 96
Study Start Date: October 2010
Groups/Cohorts Assigned Interventions
Pregnant, HIV- negative
This cohort has completed accrual as of 12/28/11.
Other: Vaginal lavage specimen
Collection of 3cc of saline used in the vagina to collect innate immunity markers
Pregnant, HIV-positive Other: Vaginal lavage specimen
Collection of 3cc of saline used in the vagina to collect innate immunity markers
Non-pregnant, HIV-negative
This cohort has completed accrual as of 12/28/11.
Other: Vaginal lavage specimen
Collection of 3cc of saline used in the vagina to collect innate immunity markers
Non-pregnant, HIV-positive
This cohort has completed accrual as of 12/28/11.
Other: Vaginal lavage specimen
Collection of 3cc of saline used in the vagina to collect innate immunity markers

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy women, 18 to 40 years old, with spontaneous menstrual cycles or with normal ongoing pregnancy with gestational age between weeks 13 - 30 and able to provide informed consent

Criteria

Inclusion Criteria:

  • Female
  • Age 18 - 40 years
  • Able to provide informed consent

Exclusion Criteria:

  • Women with the following conditions will be excluded:
  • Currently active Syphilis or Herpes simplex infection
  • Other (non-HIV) comorbid conditions causing acute or chronic inflammatory states or immunosuppression (i.e., transplant recipients, active systemic lupus)
  • Current use of hormonal birth control or with IUD in place
  • History of Hysterectomy or bilateral oophorectomy

Women with the following conditions will require rescheduling of the study visit:

  • Use of hot tub or pool, vaginal creams, douches, vaginal medications, or vaginal intercourse within 48 hours
  • Current vaginal bleeding
  • Recent treatment for vaginal infection will require 4 - 6 week delay in enrollment

Pregnant women with the following conditions at the time of examination will be excluded:

  • Active labor or other conditions of duress
  • Signs or symptoms of preterm labor
  • Vaginal bleeding
  • Placenta previa
  • History of prior preterm birth
  • Ruptured amniotic membranes
  • Multifetal gestation
  • Stillbirth or intrauterine fetal demise (IUFD)
  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: NCT01318304

Contacts
Contact: Jennifer Ballard Dwan, M.D. 617-414-3745 jennifer.dwan@bmc.org
Contact: Deborah Anderson, Ph.D. deborah.anderson@bmc.org

Locations
United States, Massachusetts
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact    617-414-2000      
Principal Investigator: Jennifer Ballard Dwan, M.D.         
Principal Investigator: Deborah Anderson, Ph.D.         
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Jennifer Ballard Dwan, M.D. Boston University
Principal Investigator: Deborah Anderson, Ph.D. Boston University
  More Information

No publications provided

Responsible Party: Jennifer Ballard Dwan, M.D., Assistant Professor, OB/GYN, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01318304     History of Changes
Other Study ID Numbers: H-29331
Study First Received: October 29, 2010
Last Updated: December 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
innate immunity
HIV
pregnancy
vaginal immunity

ClinicalTrials.gov processed this record on July 23, 2014