Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Indian women

作者: Neerja Bhatla , Vanita Suri , Partha Basu , Surendra Shastri , Sanjoy K. Datta

DOI: 10.1111/J.1447-0756.2009.01167.X

关键词: VaccinationGynecologyPlaceboMulticenter trialMedicineYoung adultCohort studyCervical cancerConfidence intervalInternal medicineAdverse effect

摘要: Aim:  India has the highest number of annual incident cases and mortality rates for cervical cancer worldwide. This study was conducted to assess immunogenicity safety human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in healthy Indian women aged 18–35 years old. Methods:  double-blind, randomized (1:1), controlled multicenter trial with two parallel groups, Vaccine Placebo included 354 subjects four centers across India. Subjects were given GlaxoSmithKline's HPV-16/18 or aluminum hydroxide placebo according a 0, 1 6 month schedule followed up until month 7. Serum samples drawn at pre-vaccination Safety data collected throughout study. Results:  A total 330 completed study. One post-Dose 3, all initially seronegative group had seroconverted HPV-16 HPV-18 antibodies anti-HPV-16 anti-HPV-18 geometric mean titer levels 10226.5 EL.U/ml (95% confidence interval: 8847.1–11821.0) 3953.0 3421.8–4566.8), respectively. Initially seropositive also showed an increase similar levels. Six serious adverse events (two group), unrelated vaccination, reported. Commonly reported solicited local (injection-site pain) general (fatigue, headache fever) symptoms both groups. Compliance three-dose vaccination course >97%. Conclusions:  The highly immunogenic generally well-tolerated making it potential tool prevention control

参考文章(41)
F. Xavier Bosch, Ann N. Burchell, Mark Schiffman, Anna R. Giuliano, Silvia de Sanjose, Laia Bruni, Guillermo Tortolero-Luna, Susanne Kruger Kjaer, Nubia Muñoz, Epidemiology and natural history of human papillomavirus infections and type-specific implications in cervical neoplasia. Vaccine. ,vol. 26, ,(2008) , 10.1016/J.VACCINE.2008.05.064
M Diaz, J J Kim, G Albero, S de Sanjosé, G Clifford, F X Bosch, S J Goldie, Health and economic impact of HPV 16 and 18 vaccination and cervical cancer screening in India. British Journal of Cancer. ,vol. 99, pp. 230- 238 ,(2008) , 10.1038/SJ.BJC.6604462
M Stanley, Prophylactic HPV vaccines: prospects for eliminating ano-genital cancer. British Journal of Cancer. ,vol. 96, pp. 1320- 1323 ,(2007) , 10.1038/SJ.BJC.6603695
Neerja Bhatla, Neena Lal, Yan-Ping Bao, Timothy Ng, You-Lin Qiao, A meta-analysis of human papillomavirus type-distribution in women from South Asia : Implications for vaccination Vaccine. ,vol. 26, pp. 2811- 2817 ,(2008) , 10.1016/J.VACCINE.2008.03.047
Rengaswamy Sankaranarayanan, Neerja Bhatla, Patti E. Gravitt, Partha Basu, Pulikattil O. Esmy, K.S. Ashrafunnessa, Yasantha Ariyaratne, Aarati Shah, Bhagwan M. Nene, Human papillomavirus infection and cervical cancer prevention in India, Bangladesh, Sri Lanka and Nepal. Vaccine. ,vol. 26, ,(2008) , 10.1016/J.VACCINE.2008.05.005
F Xavier Bosch, S de Sanjosé, None, The Epidemiology of Human Papillomavirus Infection and Cervical Cancer Disease Markers. ,vol. 23, pp. 213- 227 ,(2007) , 10.1155/2007/914823
G M Clifford, J S Smith, M Plummer, N Muñoz, S Franceschi, Human papillomavirus types in invasive cervical cancer worldwide: a meta-analysis. British Journal of Cancer. ,vol. 88, pp. 63- 73 ,(2003) , 10.1038/SJ.BJC.6600688
R. Sankaranarayanan, J Ferlay, Worldwide burden of gynaecological cancer: The size of the problem Best Practice & Research Clinical Obstetrics & Gynaecology. ,vol. 20, pp. 207- 225 ,(2006) , 10.1016/J.BPOBGYN.2005.10.007
Bhudev C. Das, Showket Hussain, Vilas Nasare, Mausumi Bharadwaj, Prospects and prejudices of human papillomavirus vaccines in India. Vaccine. ,vol. 26, pp. 2669- 2679 ,(2008) , 10.1016/J.VACCINE.2008.03.056