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.
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.
Garland
Suzanne M
SM
Microbiology and Infectious Diseases Department, Royal Women's Hospital, 132 Grattan Street, Carlton, Victoria 3053, Australia. suzanne.garland@thewomens.org.au
Steben
Marc
M
Sings
Heather L
HL
James
Margaret
M
Lu
Shuang
S
Railkar
Radha
R
Barr
Eliav
E
Haupt
Richard M
RM
Joura
Elmar A
EA
D000293:Adolescent; D000328:Adult; D017326:Clinical Trials, Phase III as Topic; D003218:Condylomata Acuminata / Q000453:epidemiology / Q000276:immunology*; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D052162:Human papillomavirus 16 / Q000235:genetics / Q000276:immunology*; D052161:Human papillomavirus 18 / Q000235:genetics / Q000276:immunology*; D052163:Human papillomavirus 6 / Q000235:genetics / Q000276:immunology*; D006801:Humans; D030361:Papillomavirus Infections / Q000453:epidemiology / Q000276:immunology* / Q000517:prevention & control; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D013997:Time Factors; D014765:Viral Vaccines / Q000008:administration & dosage*; D055815:Young Adult
D014765:Viral Vaccines