Vaginal Innate Immunity in Normal and HIV-Infected Women

NCT01318304 | Completed

• 1 other identifier: H-29331
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Pregnancy

Keywords

innate immunity; HIV; pregnancy; vaginal immunity

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  up to 2 clinic visits in 10 weeks

Secondary Outcomes (2)

• 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

  up to 2 clinic visits in 10 weeks

• 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.

  up to 2 clinic visits in 10 weeks

Study Arms (4)

Pregnant, HIV- negative

This cohort has completed accrual as of 12/28/11.

Other: Vaginal lavage specimen

Pregnant, HIV-positive

Other: Vaginal lavage specimen

Non-pregnant, HIV-negative

This cohort has completed accrual as of 12/28/11.

Other: Vaginal lavage specimen

Non-pregnant, HIV-positive

This cohort has completed accrual as of 12/28/11.

Other: Vaginal lavage specimen

Interventions

Vaginal lavage specimen OTHER

Collection of 3cc of saline used in the vagina to collect innate immunity markers

Non-pregnant, HIV-negative; Non-pregnant, HIV-positive; Pregnant, HIV- negative; Pregnant, HIV-positive

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal lavage samples

Study Officials

• Jennifer Ballard Dwan, M.D.

  Boston University

  PRINCIPAL INVESTIGATOR

• Deborah Anderson, Ph.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty, OBGYN

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: March 18, 2011
• Study Start: October 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 9, 2016

Record last verified: 2016-05

Locations

US (1)