In vitro inhibition of human papillomavirus following use of a carrageenan-containing vaginal gel.
OBJECTIVE
To assess in vitro efficacy of Divine 9, a carrageenan-based vaginal lubricant that is being studied as a microbicide to inhibit HPV16 pseudovirus (PsV) infection.


METHODS
Sexually active US women between 19 and 35years without prior HPV vaccination or cervical intraepithelial neoplasia were instructed to use Divine 9 vaginally with an applicator either before sex only or before and after intercourse. Women who applied a single dose of gel returned for cervicovaginal lavage (CVL) collection 1, 4 or 8-12h after intercourse versus those who applied gel before and after intercourse returned 1, 4 or 8-12h after the second gel dose. Carrageenan concentrations were assessed using an ELISA assay and the inhibitory activity was assessed using a PsV-based neutralization assay against HPV16 infection. Carrageenan concentrations and the percentage of PsV16 inhibition were compared using the Wilcoxon rank sum test.


RESULTS
Thirteen women were enrolled and thirty specimens from different time-points were assessed. 87% of CVL samples had detectable carrageenans with levels decreasing over time from intercourse. 93% of CVL samples had detectable PsV16 inhibition with median inhibition of 97.5%. PsV16 inhibition decreased over time, but remained high, with median inhibition of 98.1%, 97.4% and 83.4% at 1, 4 and 8-12h, respectively. Higher carrageenan concentrations were associated with higher levels of PsV16 inhibition (rho=0.69).


CONCLUSIONS
This is the first report of a human study investigating in vitro HPV inhibition of a carrageenan-based vaginal lubricant with CVL collected after sexual intercourse. We demonstrate excellent efficacy in preventing PsV16 infection.
Department of Obstetrics and Gynecology & Women's Health, Montefiore Medical Center and Albert Einstein College of Medicine, 1695 Eastchester Road, Suite 601, Bronx, NY 10461, USA. Electronic address: anovetsk@montefiore.org.
Akiva P
AP
Novetsky
Department of Medicine and Obstetrics & Gynecology and Women's Health, Montefiore Medical Center and Albert Einstein College of Medicine, 1300 Morris Park Avenue, Block, Room 512, Bronx, NY 10461, USA.
Marla J
MJ
Keller
Department of Pediatrics, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Ullmann Building, Room 515, Bronx, NY 10461, USA.
Ana
A
Gradissimo
Department of Pediatrics, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Ullmann Building, Room 515, Bronx, NY 10461, USA.
Zigui
Z
Chen
Department of Obstetrics and Gynecology & Women's Health, Montefiore Medical Center and Albert Einstein College of Medicine, 1695 Eastchester Road, Suite 601, Bronx, NY 10461, USA.
Stephanie L
SL
Morgan
Department of Epidemiology & Population Health, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Belfer Building, Room 1312A, Bronx, NY 10461, USA.
Xiaonan
X
Xue
Department of Epidemiology & Population Health, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Belfer Building, Room 1312A, Bronx, NY 10461, USA.
Howard D
HD
Strickler
Population Council, Center for Biomedical Research, 1230 York Avenue, New York, NY 10065, USA; Science Department, Borough of Manhattan Community College, The City University of New York, New York, NY 10007, USA.
José A
JA
Fernández-Romero
Department of Pediatrics, Microbiology & Immunology, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Ullmann Building, Room 515, Bronx, NY 10461, USA; Department of Epidemiology & Population Health, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Ullmann Building, Room 515, Bronx, NY 10461, USA; Department of Obstetrics, Gynecology & Women's Health, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Ullmann Building, Room 515, Bronx, NY 10461, USA.
Robert
R
Burk
Department of Obstetrics and Gynecology & Women's Health, Montefiore Medical Center and Albert Einstein College of Medicine, 1695 Eastchester Road, Suite 601, Bronx, NY 10461, USA; Department of Obstetrics and Gynecology, Rutgers New Jersey Medical School, USA.
Mark H
MH
Einstein
D000328:Adult; D002351:Carrageenan / Q000008:administration & dosage* / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D027383:Papillomaviridae / Q000187:drug effects*; D014622:Vaginal Creams, Foams, and Jellies
D014622:Vaginal Creams, Foams, and Jellies; D002351:Carrageenan
Carrageenan; Cervical cancer; Divine 9; HPV; Prevention