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1 May 2007

Volume 195, Number 9
The Journal of Infectious Diseases 2007;195:1324–1331
© 2007 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2007/19509-0015$15.00
DOI: 10.1086/513276
MAJOR ARTICLE

Topical Resiquimod 0.01% Gel Decreases Herpes Simplex Virus Type 2 Genital Shedding: A Randomized, Controlled Trial

Karen E. Mark,1

Lawrence Corey,1,2,4

Tze‐Chiang Meng,6

Amalia S. Magaret,2,5

Meei‐Li Huang,2

Stacy Selke,2

Herbert B. Slade,6,a

Stephen K. Tyring,7

Terri Warren,8

Stephen L. Sacks,10,b

Peter Leone,9

Vicki A. Bergland,6 and

Anna Wald1,2,3

Departments of 1Medicine, 2Laboratory Medicine, and 3Epidemiology, University of Washington, and Programs in 4Infectious Diseases and 5Biostatistics, Fred Hutchinson Cancer Research Center, Seattle, Washington; 63M Pharmaceuticals, St. Paul, Minnesota; 7Departments of Dermatology, Microbiology/Molecular Genetics, and Medicine, University of Texas Health Science Center, Houston; 8Westover Heights Clinic, Portland, Oregon; 9Department of Medicine, University of North Carolina, Chapel Hill; 10University of British Columbia, Vancouver, Canada

Background.Resiquimod, an investigational immune response modifier and Toll‐like receptor (TLR) 7 and 8 agonist, stimulates production of cytokines that promote an antigen‐specific T helper type 1 (Th1)–acquired immune response. In animal models, induction of Th1‐specific responses modifies experimental herpes simplex virus (HSV) infection.

Methods.We conducted a randomized, double‐blind, vehicle‐controlled trial to assess the efficacy of resiquimod 0.01% gel for reducing human anogenital HSV‐2 mucosal reactivation. Adults with genital HSV‐2 applied resiquimod or vehicle topically to herpes lesions 2 times weekly for 3 weeks and then collected daily anogenital swabs for 60 days for HSV DNA polymerase chain reaction. Recurrences during the subsequent 7 months were treated with study gel. During the final treatment‐free 60 days, participants again collected daily swabs to assess shedding.

Results.The median lesion and shedding rates were lower for resiquimod compared with vehicle recipients during the initial sampling period (10% vs. 16% [ ] and 10% vs. 17% [ ], respectively) and during the final sampling period (3% vs. 22% [ ] and 10% vs. 26% [ ], respectively). Resiquimod did not influence recurrence length.

Conclusions.These findings suggest that the immunological control of HSV‐2 reactivation and lesion clearance may differ and that TLR7 and TLR8 agonists can reduce the frequency of mucosal HSV‐2 reactivation.

Received 31 August 2006; accepted 1 December 2006; electronically published 16 March 2007.

Reprints or correspondence: Dr. Karen E. Mark, University of Washington/FHCRC HIV Vaccine Trials Unit, 901 Boren Ave. Ste. 1320, Seattle, WA 98104 ().

Cited by

Gregory J. Mertz. (2008) Asymptomatic Shedding of Herpes Simplex Virus 1 and 2: Implications for Prevention of Transmission. The Journal of Infectious Diseases 198:8, 1098-1100
Online publication date: 15-Oct-2008.
Citation-Full Text-PDF Version (48 kB)
Thomas Meyer, Eggert Stockfleth. (2008) Clinical investigations of Toll-like receptor agonists. Expert Opinion on Investigational Drugs 17:7, 1051-1065
Online publication date: 1-Aug-2008.
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Martin A. ‘Mac’ Cheever. (2008) Twelve immunotherapy drugs that could cure cancers. Immunological Reviews 222:1, 357-368
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Richard Rupp, David I Bernstein. (2008) The potential impact of a prophylactic herpes simplex vaccine. Expert Opinion on Emerging Drugs 13:1, 41-52
Online publication date: 1-Apr-2008.
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Valérie Martinez, Eric Caumes, Olivier Chosidow. (2008) Treatment to prevent recurrent genital herpes. Current Opinion in Infectious Diseases 21:1, 42-48
Online publication date: 1-Mar-2008.
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David M. Koelle, Lawrence Corey. (2008) Herpes Simplex: Insights on Pathogenesis and Possible Vaccines. Annual Review of Medicine 59:1, 381-395
Online publication date: 1-Mar-2008.
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Angela Meier, Marcus Altfeld. (2007) Toll-like receptor signaling in HIV-1 infection: a potential target for therapy?. Expert Review of Anti-infective Therapy 5:3, 323-326
Online publication date: 1-Jul-2007.
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  • Potential conflicts of interest: T.‐C. M. and V.A.B. are employees of and own stock in 3M Pharmaceuticals. At the time the study was done, H.B.S. was also an employee of and owned stock in 3M Pharmaceuticals. A.W. has received grant support from 3M Pharmaceuticals. All other authors report no conflicts of interest.

    Presented in part: International Society for Sexually Transmitted Diseases Research, 11 July 2005, Amsterdam, The Netherlands (abstract MO‐603).

    Financial support: 3M Pharmaceuticals; National Institutes of Health/National Institute of Allergy and Infectious Diseases (grants T32 AI07044 and P01 A137031).

  • Present affiliation: DFB Pharmaceuticals, Fort Worth, Texas.

  • Deceased.

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