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

October 29, 2010
December 28, 2011
October 2010
Not Provided
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.
Same as current
Complete list of historical versions of study NCT01318304 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Vaginal Innate Immunity in Normal and HIV-Infected Women
Vaginal Innate Immunity in Normal and HIV-Infected Women

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Vaginal lavage samples

Non-Probability Sample

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

  • HIV
  • Pregnancy
Other: Vaginal lavage specimen
Collection of 3cc of saline used in the vagina to collect innate immunity markers
  • Pregnant, HIV- negative
    This cohort has completed accrual as of 12/28/11.
    Intervention: Other: Vaginal lavage specimen
  • Pregnant, HIV-positive
    Intervention: Other: Vaginal lavage specimen
  • Non-pregnant, HIV-negative
    This cohort has completed accrual as of 12/28/11.
    Intervention: Other: Vaginal lavage specimen
  • Non-pregnant, HIV-positive
    This cohort has completed accrual as of 12/28/11.
    Intervention: Other: Vaginal lavage specimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
Not Provided
Not Provided

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)
Female
18 Years to 40 Years
Yes
Contact: Jennifer Ballard Dwan, M.D. 617-414-3745 jennifer.dwan@bmc.org
Contact: Deborah Anderson, Ph.D. deborah.anderson@bmc.org
United States
 
NCT01318304
H-29331
No
Jennifer Ballard Dwan, Boston Medical Center
Boston Medical Center
Not Provided
Principal Investigator: Jennifer Ballard Dwan, M.D. Boston University
Principal Investigator: Deborah Anderson, Ph.D. Boston University
Boston Medical Center
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP