Journal article
Safety Analysis of the Diaphragm in Combination with Lubricant or Acidifying Microbicide Gels: Effects on Markers of Inflammation and Innate Immunity in Cervicovaginal Fluid
American journal of reproductive immunology (1989), Vol.61(2), pp.121-129
02/01/2009
DOI: 10.1111/j.1600-0897.2008.00670.x
PMCID: PMC5619646
PMID: 19143675
Abstract
Diaphragms are being considered for use with vaginal microbicide gels to provide enhanced protection against sexually transmitted pathogens. The purpose of this study was to determine whether use of a diaphragm with microbicide or placebo gel causes cervicovaginal inflammation or perturbations in cervicovaginal immune defense.
Eighty-one non-pregnant women were randomized into three groups and instructed to use Milex((R)) (CooperSurgical, Inc., Trumbull, CT, USA)diaphragms overnight for 14 days in combination with one of the two acid-buffering microbicide gels [ACIDFORM((TM)) (Instead Inc., La Jolla, CA, USA) or BufferGel((TM)) (BG; ReProtect Inc., Baltimore, Maryland)] or placebo gel (K-Y Jelly((R)); Personal Products Inc., Raritan, NJ, USA). Cervicovaginal lavages (CVLs) were performed prior to study entry and on days 8 and 16. Nine soluble mediators of vaginal inflammation or immune defense were measured in CVLs by Bio-Plex or ELISA.
Use of diaphragms with placebo or microbicide gel was not associated with increased levels of inflammation markers. Concentrations of secretory leukocyte protease inhibitor (SLPI) were markedly reduced in the BG group.
Daily use of a diaphragm with placebo or acidifying microbicide gel did not cause cervicovaginal inflammation. However, diaphragm/BG use was associated with markedly reduced levels of SLPI, an important mediator of innate immune defense. Further studies are warranted to establish the safety of diaphragm/microbicide gel combinations.
Details
- Title: Subtitle
- Safety Analysis of the Diaphragm in Combination with Lubricant or Acidifying Microbicide Gels: Effects on Markers of Inflammation and Innate Immunity in Cervicovaginal Fluid
- Creators
- Deborah J. Anderson - Boston UniversityD'Nyce L. Williams - Eastern Virginia Medical SchoolSusan A. Ballagh - Eastern Virginia Medical SchoolKurt Barnhart - University of PennsylvaniaMitchell D. Creinin - Magee-Womens Research InstituteDaniel R. Newman - Centers for Disease Control and PreventionFrederick P. Bowman - Boston UniversityJoseph A. Politch - Boston UniversityAnn C. Duerr - Centers for Disease Control and PreventionDenise J. Jamieson - Centers for Disease Control and Prevention
- Resource Type
- Journal article
- Publication Details
- American journal of reproductive immunology (1989), Vol.61(2), pp.121-129
- Publisher
- Wiley
- DOI
- 10.1111/j.1600-0897.2008.00670.x
- PMID
- 19143675
- PMCID
- PMC5619646
- ISSN
- 1046-7408
- eISSN
- 1600-0897
- Number of pages
- 9
- Grant note
- HRN-A-00-98-00020-00 / United States Agency for International Development (USAID) MO1RR000056 / NIH General Clinic Research Center at the University of Pittsburgh; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA Division of Reproductive Health, Centers for Disease Control and Prevention (CDC); United States Department of Health & Human Services; Centers for Disease Control & Prevention - USA R21AI076966 / NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Allergy & Infectious Diseases (NIAID) M01RR000056 / NATIONAL CENTER FOR RESEARCH RESOURCES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Research Resources (NCRR) MSA-04-385 / CONRAD, Eastern Virginia Medical School
- Language
- English
- Date published
- 02/01/2009
- Academic Unit
- Obstetrics and Gynecology; VPMA - Administration
- Record Identifier
- 9984446062902771
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