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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

Garland, Suzanne M. ; Steben, Marc ; Sings, Heather L. ; James, Margaret ; Lu, Shuang ; Railkar, Radha ; Barr, Eliav ; Haupt, Richard M. ; Joura, Elmar A.

The Journal of infectious diseases, 2009-03, Vol.199 (6), p.805-814 [Peer Reviewed Journal]

Oxford: The University of Chicago Press

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Title:
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: Garland, Suzanne M. ; Steben, Marc ; Sings, Heather L. ; James, Margaret ; Lu, Shuang ; Railkar, Radha ; Barr, Eliav ; Haupt, Richard M. ; Joura, Elmar A.
Subjects: Adolescent ; Adult ; Antibodies ; Applied microbiology ; Biological and medical sciences ; Clinical Trials, Phase III as Topic ; Condylomata acuminata ; Condylomata Acuminata - epidemiology ; Condylomata Acuminata - immunology ; Female ; Follow-Up Studies ; Fundamental and applied biological sciences. Psychology ; Genotype ; Genotypes ; Human papillomavirus ; Human papillomavirus 11 ; Human papillomavirus 16 - genetics ; Human papillomavirus 16 - immunology ; Human papillomavirus 18 - genetics ; Human papillomavirus 18 - immunology ; Human papillomavirus 6 ; Human papillomavirus 6 - genetics ; Human papillomavirus 6 - immunology ; Human viral diseases ; Humans ; Infections ; Infectious diseases ; Lesions ; Medical sciences ; Microbiology ; Miscellaneous ; Papillomavirus Infections - epidemiology ; Papillomavirus Infections - immunology ; Papillomavirus Infections - prevention & control ; Placebos ; Polymerase chain reaction ; Randomized Controlled Trials as Topic ; Risk Factors ; Time Factors ; Vaccination ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Viral diseases ; Viral diseases of the genital and urinary system ; Viral Vaccines - administration & dosage ; Virology ; Viruses ; Young Adult
Is Part Of: The Journal of infectious diseases, 2009-03, Vol.199 (6), p.805-814
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ObjectType-Article-1
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Description: BackgroundThe placebo arm of human papillomavirus (HPV) vaccine trials helps define the natural history of genital warts (GW) MethodsWomen 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 ∼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 ResultsWomen 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 ConclusionsWe 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 registrationClinicalTrials.gov identifiers: NCT00092521 and NCT00092534
Publisher: Oxford: The University of Chicago Press
Language: English

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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

Garland, Suzanne M. ; Steben, Marc ; Sings, Heather L. ; James, Margaret ; Lu, Shuang ; Railkar, Radha ; Barr, Eliav ; Haupt, Richard M. ; Joura, Elmar A.

Oxford: The University of Chicago Press

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