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J Infect Dis. 2009 Mar 15;199(6):805-14. doi: 10.1086/597071.

Natural history of genital warts: analysis of the placebo arm of 2 randomized phase III trials of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine.

Author information

1
Microbiology and Infectious Diseases Department, Royal Women's Hospital, 132 Grattan Street, Carlton, Victoria 3053, Australia. suzanne.garland@thewomens.org.au

Abstract

BACKGROUND:

The placebo arm of human papillomavirus (HPV) vaccine trials helps define the natural history of genital warts (GW).

METHODS:

Women enrolled in the placebo arm (n = 8800) of 2 randomized trials of a quadrivalent vaccine were examined for the presence of GW for up to 9 visits over approximately 4 years. A comprehensive examination of the perianal area, vulva, and vagina prompted biopsy. Biopsy samples were analyzed by a blinded panel of up to 4 histopathologists and tested for 14 HPV genotypes (6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) by use of a polymerase chain reaction-based assay. Risk factors for the development of GW were assessed.

RESULTS:

Women were followed up for an average of 3.6 years (range, 0-4.9 years). Overall, 298 (3.4%) of 8800 participants developed GW related to HPV-6 or HPV-11 (incidence rate, 0.87 cases per 100 person-years-at-risk). In total, 520 distinct lesions were diagnosed as GW. HPV DNA was detected in 472 (90.8%) lesions, with HPV-6 and HPV-11 detected in 447 (86.0%) of these lesions (94.7% of 472 HPV DNA-positive lesions). We found high-risk HPV types in 161 (31.0%) of 520 lesions. Risk factors for HPV-6- and HPV-11-related GW included infection at baseline, acquisition of new sex partners, a higher number of sex partners, and DNA positivity at baseline for a high-risk HPV type.

CONCLUSIONS:

We confirm the major role played by HPV-6 and HPV-11 in GW, as well as associated risk factors. A vaccine that includes these types of HPV could substantially reduce the overall burden of HPV disease.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00092521 NCT00092534.

PMID:
19199546
DOI:
10.1086/597071
[Indexed for MEDLINE]

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