Immunogenicity and reactogenicity of alternative schedules of HPV vaccine in Vietnam: A cluster randomized noninferiority trial

JAMA

Volumn 305, Issue 14, 2011, Pages 1424-1432

  Neuzil, Kathleen M ^a   Canh, Do Gia ^b   Thiem, Vu Dinh ^b   Janmohamed, Amynah ^a   Huong, Vu Minh ^c   Tang, Yuxiao ^a   Diep, Nguyen Thi Ngoc ^c   Tsu, Vivien ^a   LaMontagne, D Scott ^a  

^a PATH   (United States)

^b MINISTRY OF HEALTH   (Viet Nam)

^c PATH   (Viet Nam)

Author keywords

[No Author keywords available]

Indexed keywords

VIRUS ANTIBODY; WART VIRUS VACCINE;

ADOLESCENT; ANTIBODY BLOOD LEVEL; ANTIBODY TITER; ARTICLE; CHILD; CONTROLLED STUDY; DOSAGE SCHEDULE COMPARISON; DRUG DOSE REGIMEN; DRUG FEVER; FEMALE; HUMAN; IMMUNOGENICITY; IMMUNOLOGICAL TOLERANCE; IMMUNOREACTIVITY; OPEN STUDY; PAPILLOMAVIRUS INFECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SKIN MANIFESTATION; VIET NAM;

EID: 79953869912     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2011.407     Document Type: Article

References (34)

1. Ferlay J, Shin HR, Bray F, et al. GLOBOCAN 2008: Cancer Incidence and Mortality Worldwide. Lyon, France: International Agency for Research on Cancer; 2010.
2. Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005;55 (2):74-108. (Pubitemid 40372904)
3. Pham TH, Nguyen TH, Herrero R, et al. Human papillomavirus infection among women in South and North Vietnam. Int J Cancer. 2003;104(2):213-220. (Pubitemid 36249797)
4. Nguyen QM, Nguyen HC, Parkin DM. Cancer incidence in Ho Chi Minh City, Viet Nam, 1995-1996. Int J Cancer. 1998;76(4):472-479. (Pubitemid 28227987)
5. Hernandez BY, Vu Nguyen T. Cervical human papillomavirus infection among female sex workers in southern Vietnam. Infect Agent Cancer. 2008; 3(7):7.
6. Barr E, Tamms G. Quadrivalent human papillomavirus vaccine. Clin Infect Dis. 2007;45(5):609-7. (Pubitemid 47328643)
7. Muñoz N, Bosch FX, Castellsagué X, et al. Against which human papillomavirus types shall we vaccinate and screen? the international perspective. Int J Cancer. 2004;111(2):278-285. (Pubitemid 38924707)
8. Villa LL, Costa RL, Petta CA, et al. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005; 6(5):271-278. (Pubitemid 40590263)
9. FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007;356(19):1915-1927.
10. FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. J Infect Dis. 2007;196(10):1438-1446.
11. Paavonen J, Naud P, Salmerón J, et al; HPV PATRICIA Study Group. 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. Lancet. 2009; 374(9686):301-314.
12. Goldie SJ, Kohli M, Grima D, et al. Projected clinical benefits and cost-effectiveness of a human papillomavirus 16/18 vaccine. J Natl Cancer Inst. 2004; 96(8):604-615. (Pubitemid 38584984)
13. Goldie SJ, O'Shea M, Diaz M, Kim SY. Benefits, cost requirements and cost-effectiveness of the HPV16,18 vaccine for cervical cancer prevention in developing countries: policy implications. Reprod Health Matters. 2008;16(32):86-96.
14. Kim JJ, Kobus KE, Diaz M, O'Shea M, Van Minh H, Goldie SJ. Exploring the cost-effectiveness of HPV vaccination in Vietnam: insights for evidence-based cervical cancer prevention policy. Vaccine. 2008; 26(32):4015-4024.
15. General Statistics Office. Survey Assessment on Vietnamese Youth Round 2 (SAVY2). Hanoi, Vietnam: Ministry of Health; 2010:5-12.
16. Oliphant NP, Mason JB, Doherty T, et al. The contribution of child health days to improving coverage of periodic interventions in six African countries. Food Nutr Bull. 2010;31(3)(suppl):S248-S263.
17. Biellik R, Levin C, Mugisha E, et al. Health systems and immunization financing for human papillomavirus vaccine introduction in low-resource settings. Vaccine. 2009;27(44):6203-6209.
18. Dias D, Van Doren J, Schlottmann S, et al. Optimization and validation of a multiplexed luminex assay to quantify antibodies to neutralizing epitopes on human papillomaviruses 6, 11, 16, and 18. Clin Diagn Lab Immunol. 2005;12(8): 959-969.
19. Block SL, Nolan T, Sattler C, et al; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006;118(5):2135-2145. (Pubitemid 46393698)
20. Reisinger KS, Block SL, Lazcano-Ponce E, et al. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007;26(3):201-209. (Pubitemid 46340765)
21. Merck&Co Inc. Gardasil quadrivalent human papillomavirus (types 6, 11, 16, 18) vaccine, recombinant [package insert]. Whitehouse Station, NJ: Merck & Co Inc; 2006.
22. Zimmerman RK, Nowalk MP, Lin CJ, et al. Randomized trial of an alternate human papillomavirus vaccine administration schedule in college-aged women. J Womens Health (Larchmt). 2010;19(8):1441-1447.
23. Joura EA, Kjaer SK, Wheeler CM, et al. HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine. Vaccine. 2008;26(52):6844-6851.
24. US Food and Drug Administration. FDA licenses new vaccine for prevention of cervical cancer and other diseases in females caused by human papillomavirus [press release]. Silver Spring, MD: US Food and Drug Administration; June 8, 2006.
25. Giuliano AR, Lazcano-Ponce E, Villa L, et al. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007; 196(8):1153-1162. (Pubitemid 47580270)
26. Villa LL, Ault KA, Giuliano AR, et al. Immunologic responses following administration of a vaccine targeting human papillomavirus types 6, 11, 16, and 18. Vaccine. 2006;24(27-28):5571-5583. (Pubitemid 44172918)
27. Dobson S, Dawar M, Kollmann T, et al. P-690: a two dose HPV vaccine schedule in girls: immunogenicity at 24 months. Presented at: 26th International Papillomavirus Conference; July 3, 2010; Montreal, Quebec, Canada.
28. US Centers for Disease Control and Prevention. Advisory committee on Immunization Practices and Department of Health and Human Services meeting, February 21-22, 2007. http://www.cdc.gov/vaccines/recs/acip/downloads/min- archive/min-feb07.pdf. Accessibility verified March 16, 2011.
29. Schnorr JJ, Cutts FT, Wheeler JG, et al. Immune modulation after measles vaccination of 6-9 months old Bangladeshi infants. Vaccine. 2001;19(11-12): 1503-1510. (Pubitemid 32332736)
30. World Health Organization. Human papillomavirus vaccines: WHO position paper. Wkly Epidemiol Rec. 2009;84(15):118-131.
31. Cost of cervical cancer vaccine reduced. http: //www.iol.co.za/news/ south-africa/cost-of-cervicalcancer-vaccine-reduced-1.427787. Accessed February 28, 2011.
32. Prabhu M. Cervical cancer vaccine, conference offer women hope. http://www.independent.co.ug/index.php/society/society/37-society/ 2563-cervicalcancer-vaccine-conference-offer-women-hope. Accessed on February 28, 2011.
33. Arukesamy K. Government offers cervical cancer vaccine for girls from 2010. http://www.sun2surf.com/article.cfm?id=38371. Accessed on February 28, 2010.
34. Pan American Health Organization. PAHO revolving fund: vaccine and syringe prices, 2010. Immunization Newsletter. 2010;XXXII(1):5-6.