Immunogenicity and Safety of the AS04-adjuvanted Human Papillomavirus-16/18 Cervical Cancer Vaccine in Malaysian Women Aged 18-35 years: A Randomized Controlled Trial.
作者： Teoh Yl , Bi D , Bock Hl , Omar Sz , Omar J
DOI:
关键词:
摘要: SUMMARY Introduction: Cervical cancer is the third most common in women worldwide. The HPV-16/18 AS04- adjuvanted vaccine (Cervarix®) has previously been shown to be highly immunogenic with a clinically acceptable safety profile. This phase IIIb, double-blind, randomized (1:1) and placebo controlled trial (NCT00345878) was designed evaluate immunogenicity against HPV-16 HPV-18 as well its reactogenicity Malaysian women. Methods: Healthy aged 18-35 years received intramuscularly three doses of either (HPV group) or aluminium hydroxide (ALU at 0, 1, 6 months. Antibody titers were measured by an enzyme-linked immunosorbent assay (ELISA). Results: A total 271 eligible subjects enrolled 266 completed study. Initially seronegative HPV group showed 100% seroconversion one month post-dose-3 for anti anti-HPV-18 antibodies geometric mean 11107.5 (95% CI: 9727.3-12683.4) EL.U/mL 4273.5 3771.8-4841.9) EL.U/mL, respectively. Over 96% both groups all doses. Solicited local (pain) general symptoms (myalgia, fatigue, arthralgia headache) commonly reported ALU groups. Eight serious adverse events throughout study (five group; group), considered investigators unrelated vaccination. Conclusion: AS04-adjuvanted generally tolerated years.
参考文章(20)
Thomas Verstraeten, Dominique Descamps, Marie-Pierre David, Toufik Zahaf, Karin Hardt, Patricia Izurieta, Gary Dubin, Thomas Breuer, Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. ,vol. 26, pp. 6630- 6638 ,(2008) , 10.1016/J.VACCINE.2008.09.049
Francis J. Dessy, Sandra L. Giannini, Catherine A. Bougelet, Troy J. Kemp, Marie-Pierre M. David, Sylviane M. Poncelet, Ligia A. Pinto, Martine A. Wettendorff, Correlation between direct ELISA, single epitope-based inhibition ELISA and Pseudovirion-based neutralization assay for measuring anti-HPV-16 and anti-HPV-18 antibody response after vaccination with the AS04-adjuvanted HPV-16/18 cervical cancer vaccine Human Vaccines. ,vol. 4, pp. 425- 434 ,(2008) , 10.4161/HV.4.6.6912
S GIANNINI, E HANON, P MORIS, M VANMECHELEN, S MOREL, F DESSY, M FOURNEAU, B COLAU, J SUZICH, G LOSONKSY, Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminium salt combination (AS04) compared to aluminium salt only Vaccine. ,vol. 24, pp. 5937- 5949 ,(2006) , 10.1016/J.VACCINE.2006.06.005
Neerja Bhatla, Vanita Suri, Partha Basu, Surendra Shastri, Sanjoy K. Datta, Dan Bi, Dominique J. Descamps, Hans L. Bock, , Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Indian women Journal of Obstetrics and Gynaecology Research. ,vol. 36, pp. 123- 132 ,(2010) , 10.1111/J.1447-0756.2009.01167.X
John T. Schiller, Douglas R. Lowy, Immunogenicity testing in human papillomavirus virus-like-particle vaccine trials. The Journal of Infectious Diseases. ,vol. 200, pp. 166- 171 ,(2009) , 10.1086/599988
Mark H. Einstein, Mira Baron, Myron J. Levin, Archana Chatterjee, Robert P. Edwards, Fred Zepp, Isabelle Carletti, Francis J. Dessy, Andrew F. Trofa, Anne Schuind, Gary Dubin, Comparison of the immunogenicity and safety of Cervarix™ and Gardasil® human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18–45 years Human Vaccines. ,vol. 5, pp. 705- 719 ,(2009) , 10.4161/HV.5.10.9518
Marie-Pierre David, Koen Van Herck, Karin Hardt, Fabian Tibaldi, Gary Dubin, Dominique Descamps, Pierre Van Damme, Long-term persistence of anti-HPV-16 and -18 antibodies induced by vaccination with the AS04-adjuvanted cervical cancer vaccine: Modeling of sustained antibody responses☆ Gynecologic Oncology. ,vol. 115, pp. S1- S6 ,(2009) , 10.1016/J.YGYNO.2009.01.011
Tino F. Schwarz, Marek Spaczynski, Achim Schneider, Jacek Wysocki, Andrzej Galaj, Pamela Perona, Sylviane Poncelet, Toufik Zahaf, Karin Hardt, Dominique Descamps, Gary Dubin, Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15–55 years Vaccine. ,vol. 27, pp. 581- 587 ,(2009) , 10.1016/J.VACCINE.2008.10.088
D Descamps, F Struyf, M Lehtinen, G Dubin, J Paavonen, P Naud, J Salmerón, CM Wheeler, S-N Chow, D Apter, H Kitchener, X Castellsague, JC Teixeira, SR Skinner, J Hedrick, U Jaisamrarn, G Limson, S Garland, A Szarewski, B Romanowski, FY Aoki, TF Schwarz, WAJ Poppe, FX Bosch, D Jenkins, K Hardt, T Zahaf, Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. The Lancet. ,vol. 374, pp. 301- 314 ,(2009) , 10.1016/S0140-6736(09)61248-4
Jorma Paavonen, David Jenkins, F Xavier Bosch, Paulo Naud, Jorge Salmerón, Cosette M Wheeler, Song-Nan Chow, Dan L Apter, Henry C Kitchener, Xavier Castellsague, Newton S de Carvalho, S Rachel Skinner, Diane M Harper, James A Hedrick, Unnop Jaisamrarn, Genara AM Limson, Marc Dionne, Wim Quint, Bart Spiessens, Pascal Peeters, Frank Struyf, Susan L Wieting, Matti O Lehtinen, Gary Dubin, None, Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial The Lancet. ,vol. 369, pp. 2161- 2170 ,(2007) , 10.1016/S0140-6736(07)60946-5