TY - JOUR
T1 - Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women
T2 - A randomised double-blind placebo-controlled multicentre phase II efficacy trial
AU - Villa, Luisa L.
AU - Costa, Ronaldo L.R.
AU - Petta, Carlos A.
AU - Andrade, Rosires P.
AU - Ault, Kevin A.
AU - Giuliano, Anna R.
AU - Wheeler, Cosette M.
AU - Koutsky, Laura A.
AU - Malm, Christian
AU - Lehtinen, Matti
AU - Skjeldestad, Finn Egil
AU - Olsson, Sven Eric
AU - Steinwall, Margareta
AU - Brown, Darron R.
AU - Kurman, Robert J.
AU - Ronnett, Brigitte M.
AU - Stoler, Mark H.
AU - Ferenczy, Alex
AU - Harper, Diane M.
AU - Tamms, Gretchen M.
AU - Yu, Jimmy
AU - Lupinacci, Lisa
AU - Railkar, Radha
AU - Taddeo, Frank J.
AU - Jansen, Kathrin U.
AU - Esser, Mark T.
AU - Sings, Heather L.
AU - Saah, Alfred J.
AU - Barr, Eliav
N1 - Funding Information:
E Barr, M T Esser, K U Jansen, F J Taddeo, A J Saah, J Yu, L Lupinacci, R Railkar, H L Sings, and G M Tamms are employees of Merck Research Laboratories, a division of Merck & Co, and potentially own stock and hold stock options in the company, or both. Merck is developing the quadrivalent HPV vaccine and funded this clinical trial. K A Ault, D R Brown, D M Harper, R J Kurman, F E Skjeldestad, and L L Villa have received honoraria from Merck Research Laboratories given for consultation work or membership in the Phase III HPV Vaccine Steering and Registries Oversight Committees, or both, during the past 2 years. A Ferenczy, R J Kurman, B M Ronnett, and M H Stoler are members of the HPV Vaccine Program Pathology Panel. As such, they have been paid for developing the Panel's standard operating procedures and for histopathological readings of biopsy slides. R P Andrade, K A Ault, D R Brown, R L R Costa, A R Giuliano, L A Koutsky, R J Kurman, M Lehtinen, C Malm, C A Petta, F E Skjeldestad, D M Harper, and C M Wheeler led clinical sites that participated in the study and were compensated for all activities related to execution of the study. They are also receiving similar funding for their work on Merck's HPV vaccine phase III programme. L L Villa and A Ferenczy have been given honoraria for lectureships on behalf of Merck's HPV vaccine programme. D R Brown, A R Giuliano, L L Villa, and C M Wheeler have been paid for consultations regarding the HPV vaccine programme in men. K A Ault is a member of Merck's HPV Vaccine Obstetrics and Gynecology Advisory Board and as such receives honoraria for consultative work. D M Harper is a member of Merck's HPV Vaccine Young Adult Primary Care Advisory Board. F E Skjeldestad has received funding from Merck Research Laboratories in support of a natural history study of HPV disease in young Norwegian women.
PY - 2005/5
Y1 - 2005/5
N2 - Background: A randomised double-blind placebo-controlled phase II study was done to assess the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV) types associated with 70% of cervical cancers (types 16 and 18) and with 90% of genital warts (types 6 and 11). Methods: 277 young women (mean age 20·2 years [SD 1·7]) were randomly assigned to quadrivalent HPV (20 μg type 6, 40 μg type 11, 40 μg type 16, and 20 μg type 18) L1 virus-like-particle (VLP) vaccine and 275 (mean age 20·0 years [1·7]) to one of two placebo preparations at day 1, month 2, and month 6. For 36 months, participants underwent regular gynaecological examinations, cervicovaginal sampling for HPV DNA, testing for serum antibodies to HPV, and Pap testing. The primary endpoint was the combined incidence of infection with HPV 6, 11, 16, or 18, or cervical or external genital disease (ie, persistent HPV infection, HPV detection at the last recorded visit, cervical intraepithelial neoplasia, cervical cancer, or external genital lesions caused by the HPV types in the vaccine). Main analyses were done per protocol. Findings: Combined incidence of persistent infection or disease with HPV 6, 11, 16, or 18 fell by 90% (95% CI 71-97, p<0·0001) in those assigned vaccine compared with those assigned placebo. Interpretation: A vaccine targeting HPV types 6, 11, 16, 18 could substantially reduce the acquisition of infection and clinical disease caused by common HPV types.
AB - Background: A randomised double-blind placebo-controlled phase II study was done to assess the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV) types associated with 70% of cervical cancers (types 16 and 18) and with 90% of genital warts (types 6 and 11). Methods: 277 young women (mean age 20·2 years [SD 1·7]) were randomly assigned to quadrivalent HPV (20 μg type 6, 40 μg type 11, 40 μg type 16, and 20 μg type 18) L1 virus-like-particle (VLP) vaccine and 275 (mean age 20·0 years [1·7]) to one of two placebo preparations at day 1, month 2, and month 6. For 36 months, participants underwent regular gynaecological examinations, cervicovaginal sampling for HPV DNA, testing for serum antibodies to HPV, and Pap testing. The primary endpoint was the combined incidence of infection with HPV 6, 11, 16, or 18, or cervical or external genital disease (ie, persistent HPV infection, HPV detection at the last recorded visit, cervical intraepithelial neoplasia, cervical cancer, or external genital lesions caused by the HPV types in the vaccine). Main analyses were done per protocol. Findings: Combined incidence of persistent infection or disease with HPV 6, 11, 16, or 18 fell by 90% (95% CI 71-97, p<0·0001) in those assigned vaccine compared with those assigned placebo. Interpretation: A vaccine targeting HPV types 6, 11, 16, 18 could substantially reduce the acquisition of infection and clinical disease caused by common HPV types.
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U2 - 10.1016/S1470-2045(05)70101-7
DO - 10.1016/S1470-2045(05)70101-7
M3 - Article
C2 - 15863374
AN - SCOPUS:20944448032
SN - 1470-2045
VL - 6
SP - 271
EP - 278
JO - Lancet Oncology
JF - Lancet Oncology
IS - 5
ER -