Evaluation of the immunogenicity of the quadrivalent HPV vaccine using 2 versus 3 doses at month 21: An epidemiological surveillance mechanism for alternate vaccination schemes

Human Vaccines and Immunotherapeutics

Volumn 12, Issue 1, 2016, Pages 30-38

  Hernández Ávila, Mauricio ^a   Torres Ibarra, Leticia ^a   Stanley, Margaret ^b   Salmerón, Jorge ^a,c   Cruz Valdez, Aurelio ^a   Muñoz, Nubia ^d   Herrero, Rolando ^e   Villaseñor Ruíz, Ignacio F ^f   Lazcano Ponce, Eduardo ^a  

^a INSTITUTO NACIONAL DE SALUD PÚBLICA   (Mexico)

^b UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^c INSTITUTO MEXICANO DEL SEGURO SOCIAL   (Mexico)

^d Instituto Nacional de Cancerología   (Colombia)

^e INTERNATIONAL AGENCY FOR RESEARCH ON CANCER   (France)

^f Centro Nacional para la Salud de la Infancia y la Adolescencia   (Mexico)

Author keywords

Alternative vaccination scheme; HPV quadrivalent vaccine; Mexico; Non inferiority

Indexed keywords

WART VIRUS VACCINE; VIRUS ANTIBODY;

ADULT; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; BLOOD SAMPLING; CHILD; CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOSAGE SCHEDULE COMPARISON; DRUG SAFETY; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 11; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; HUMAN PAPILLOMAVIRUS TYPE 6; IMMUNE RESPONSE; IMMUNOGENICITY; INJECTION SITE PAIN; SCHOOL CHILD; SKIN REDNESS; VACCINATION; YOUNG ADULT; ADOLESCENT; BLOOD; EPIDEMIOLOGICAL MONITORING; IMMUNIZATION; IMMUNOLOGY; MEXICO; PAPILLOMAVIRUS INFECTIONS; TREATMENT OUTCOME;

ADOLESCENT; ANTIBODIES, VIRAL; CHILD; EPIDEMIOLOGICAL MONITORING; FEMALE; HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE QUADRIVALENT, TYPES 6, 11, 16, 18; HUMANS; IMMUNIZATION SCHEDULE; MEXICO; PAPILLOMAVIRUS INFECTIONS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84961775062     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.1080/21645515.2015.1058458     Document Type: Article

References (45)

1. de Sanjose S, Quint WGV, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, Tous S, Felix A, Bravo LE, Shin HR, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol 2010; 11(11):1048-56; PMID:20952254; http://dx.doi.org/10.1016/S1470-2045(10)70230-8
2. Brisson M, Laprise JF, Drolet M, Van de Velde N, Franco EL, Kliewer EV, Ogilvie G, Deeks SL, Boily MC. Comparative cost-effectiveness of the quadrivalent and bivalent human papillomavirus vaccines: a transmission- dynamic modeling study. Vaccine 2013; 31 (37):3863-71; PMID:23830974; http://dx.doi.org/10.1016/j.vaccine.2013.06.064
3. Stanley M, Pinto LA, Trimble C. Human papillomavirus vaccines–immune responses. Vaccine 2012; 30 Suppl 5:F83-7; PMID:23199968; http://dx.doi.org/10.1016/j.vaccine.2012.04.106
4. Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, Puchalski D, Giacoletti KE, Sings HL, Lukac S, 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):201-9; PMID:17484215; http://dx.doi.org/10.1097/01.inf.0000253970.29190.5a
5. Demarteau N, Van Kriekinge G, Simon P. Incremental cost-effectiveness evaluation of vaccinating girls against cervical cancer pre- and post-sexual debut in Belgium. Vaccine 2013; 31(37):3962-71; PMID:23777952; http://dx.doi.org/10.1016/j.vaccine.2013.06.008
6. Canfell K, Chesson H, Kulasingam SL, Berkhof J, Diaz M, Kim JJ. Modeling preventative strategies against human papillomavirus-related disease in developed countries. Vaccine 2012; 30 Suppl 5:F157-67; PMID:23199959; http://dx.doi.org/10.1016/j.vaccine. 2012.06.091
7. Kane MA, Serrano B, de Sanjose S, Wittet S. Implementation of human papillomavirus immunization in the developing world. Vaccine 2012; 30 Suppl 5:F192-200; PMID:23199963; http://dx.doi.org/10.1016/j.vaccine.2012.06.075
8. Leval A, Herweijer E, Ploner A, Eloranta S, Fridman Simard J, Dillner J, Young C, Netterlid E, Sparén P, Arnheim-Dahlström L. Quadrivalent human papillomavirus vaccine effectiveness: a Swedish national cohort study. J Natl Cancer Inst 2013; 105(7):469-74; PMID:23486550; http://dx.doi.org/10.1093/jnci/djt032
9. Baandrup L, Blomberg M, Dehlendorff C, Sand C, Andersen KK, Kjaer SK. Significant decrease in the incidence of genital warts in young Danish women after implementation of a national human papillomavirus vaccination program. Sex Transm Dis 2013; 40 (2):130-5; PMID:23324976
10. Korostil IA, Peters GW, Law MG, Regan DG. Herd immunity effect of the HPV vaccination program in Australia under different assumptions regarding natural immunity against re-infection. Vaccine 2013; 31 (15):1931-6; PMID:23434388; http://dx.doi.org/10.1016/j.vaccine.2013.02.018
11. Markowitz LE, Hariri S, Lin C, Dunne EF, Steinau M, McQuillan G, Unger ER. Reduction in human papillomavirus (HPV) prevalence among young women following HPV vaccine introduction in the United States, National Health and Nutrition Examination Surveys, 2003-2010. J Infect Dis. 2013; 208(3):385-93; PMID:23785124; http://dx.doi.org/10.1093/infdis/jit192
12. Brotherton JM, Fridman M, May CL, Chappell G, Saville AM, Gertig DM. Early effect of the HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study. Lancet 2011; 377 (9783):2085-92; PMID:21684381; http://dx.doi.org/10.1016/S0140-6736(11)60551-5
13. Baldur-Felskov B, Dehlendorff C, Munk C, Kjaer SK. Early impact of human papillomavirus vaccination on cervical neoplasia–nationwide follow-up of young Danish women. J Natl Cancer Inst 2014; 106(3): djt460; PMID:24552678; http://dx.doi.org/10.1093/jnci/djt460
14. Schwarz TF, Flamaing J, Rumke HC, Penzes J, Juergens C, Wenz A, Jayawardene D, Giardina P, Emini EA, Gruber WC, et al. A randomized, double-blind trial to evaluate immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given concomitantly with trivalent influenza vaccine in adults aged >/=65 years. Vaccine 2011; 29(32):5195-202; PMID:21619909; http://dx.doi.org/10.1016/j.vaccine.2011.05.031
15. Moreira ED, Jr., Palefsky JM, Giuliano AR, Goldstone S, Aranda C, Jessen H, Hillman RJ, Ferris D, Coutlee F, Vardas E, et al. Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. Hum Vaccin 2011; 7(7):768-75; PMID:21712645; http://dx.doi.org/10.4161/hv.7.7.15579
16. Joura EA, Kjaer SK, Wheeler CM, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, et al. HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine. Vaccine 2008; 26 (52):6844-51; PMID:18930097; http://dx.doi.org/10.1016/j.vaccine.2008.09.073
17. Wang JW, Roden RB. Virus-like particles for the prevention of human papillomavirus-associated malignancies. Expert Rev Vaccines 2013; 12(2):129-41; PMID:23414405; http://dx.doi.org/10.1586/erv.12.151
18. Schwarz TF, Leo O. Immune response to human papillomavirus after prophylactic vaccination with AS04- adjuvanted HPV-16/18 vaccine: improving upon nature. Gynecol Oncol 2008; 110(3 Suppl 1):S1-10; PMID:18653222; http://dx.doi.org/10.1016/j.ygyno.2008.05.036
19. Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsagué X, Rusche SA, Lukac S, Bryan JT, et al. 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):2135-45; PMID:17079588; http://dx.doi.org/10.1542/peds.2006-0461
20. Olsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, Iversen OE, Høye J, Steinwall M, Riis-Johannessen G, et al. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine 2007; 25 (26):4931-9; PMID:17499406; http://dx.doi.org/10.1016/j.vaccine.2007.03.049
21. Stanley M. Prospects for new human papillomavirus vaccines. Curr Opin Infect Dis 2010; 23(1):70-5; PMID:19926987; http://dx.doi.org/10.1097/QCO.0b013e328334c0e1
22. Lazcano-Ponce E, Salmeron-Castro J, Garcia-Carranca A, Aranda-Flores C, Madrid-Marina V, Gomez-Altamirano CM, Martínez-Montañez OG. [Recommendations for the definition of a policy on vaccination against papillomavirus in Mexico. Strategic Advisory Group of Experts of the World Health Organization]. Salud Publica Mex 2009; 51(4):336-41; PMID:19668929; http://dx.doi.org/10.1590/S0036-36342009000400011
23. Neuzil KM, Canh do G, Thiem VD, Janmohamed A, Huong VM, Tang Y, Diep NT, Tsu V, LaMontagne DS. Immunogenicity and reactogenicity of alternative schedules of HPV vaccine in Vietnam: a cluster randomized noninferiority trial. JAMA 2011; 305 (14):1424-31; PMID:21486975; http://dx.doi.org/10.1001/jama.2011.407
24. Meeting of the Strategic Advisory Group of Experts on immunization, April 2014 – conclusions and recommendations. Wkly Epidemiol Rec 2014; 89(21):221-36; PMID:24864348
25. Stanley MA, Sudenga SL, Giuliano AR. Alternative dosage schedules with HPV virus-like particle vaccines. Expert Rev Vaccines 2014; 13(8):1027-38; PMID:25001893; http://dx.doi.org/10.1586/14760584. 2014.935767
26. Proyecto de Norma Oficial Mexicana PROY-NOM- 036-SSA2-2014, Prevención y control de enfermades. Aplicación de vacunas, toxoides, faboterápicos (sueros) e inmmunoglobulinas en el humano.
27. Villa LL, Costa RL, Petta CA, Andrade RP, Paavonen J, Iversen OE, Olsson SE, Høye J, Steinwall M, Riis-Johannessen G, et al. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up. Br J Cancer 2006; 95(11):1459-66; PMID:17117182; http://dx.doi.org/10.1038/sj.bjc.6603469
28. Dobson SR, McNeil S, Dionne M, Dawar M, Ogilvie G, Krajden M, Sauvageau C, Scheifele DW, Kollmann TR, Halperin SA, et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA 2013; 309(17):1793-802; PMID:23632723; http://dx.doi.org/10.1001/jama.2013.1625
29. Stokley S, Jeyarajah J, Yankey D, Cano M, Gee J, Roark J, Curtis RC, Markowitz L; Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC; Centers for Disease Control and Prevention (CDC). Human papillomavirus vaccination coverage among adolescents, 2007-2013, and postlicensure vaccine safety monitoring, 2006-2014–United States. MMWR Morb Mortal Weekly Rep 2014; 63(29):620-4; PMID:25055185
30. Ferris D, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Reisinger KS, Mehlsen J, Chatterjee A, Iversen OE, Sings HL, et al. Long-term study of a quadrivalent human papillomavirus vaccine. Pediatrics 2014; 134(3):e657-65; PMID:25136050; http://dx.doi.org/10.1542/peds.2013-4144
31. Bachmann MF, Kalinke U, Althage A, Freer G, Burkhart C, Roost H, Aguet M, Hengartner H, Zinkernagel RM. The role of antibody concentration and avidity in antiviral protection. Science 1997; 276(5321):2024-7; PMID:9197261; http://dx.doi.org/10.1126/science. 276.5321.2024
32. Luna J, Plata M, Gonzalez M, Correa A, Maldonado I, Nossa C, Radley D, Vuocolo S, Haupt RM, Saah A. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil in adult women. PloS One 2013; 8(12):e83431; PMID:24391768; http://dx.doi.org/10.1371/journal. pone.0083431
33. Schiller JT, Lowy DR. Immunogenicity testing in human papillomavirus virus-like-particle vaccine trials. J Infect Dis 2009; 200(2):166-71; PMID:19519255; http://dx.doi.org/10.1086/599988
34. Public Health England DoHaNE. HPV vaccination programme: change from 3 to 2 doses. In: Health Do, editor. England: PHE Publications Gateway; 2014.
35. http://www.msss.gouv.qc.ca/sujets/santepub/vaccination/index.php?aidD136:Gouvernement du Québec; [cited 2015 November 2014]
36. OFSP Ofdlsp. Vaccination contre les HPV: passage du schema a 2 doses chez les adolescentes de moins de 15 ans. Bull OFSP 2012; 6:711-7
37. Available from:http://www.klusemann.at/wir/Schularzt/Mail%20im%20Mai/impfplan2014.pdf.
38. Mapes D. The HPV cancer vaccine: Are two doses as good as three? 2014. Available from: https://www.fred hutch.org/en/news/center-news/2014/08/hpv-cancervaccine-are-two-doses-as-good-as-three.html
39. Human papillomavirus vaccines: WHO position paper, October 2014. Releve epidemiologique hebdomadaire/Section d’hygiene du Secretariat de la Societe des Nations D Weekly epidemiological record/Health Section of the Secretariat of the League of Nations. 2014; 89(43):465-91.
40. Report IAfRoCIWG. Primary End-Points for Prophylactic HPV vaccine trials. IARC, 2014.
41. Lowy DR, Herrero R, Hildesheim A, Participants in the INCIwoPEfPHPVVT. Primary endpoints for future prophylactic human papillomavirus vaccine trials: towards infection and immunobridging. Lancet Oncol 2015; 16(5):e226-e33; PMID:25943067; http://dx.doi.org/10.1016/S1470-2045(15)70075-6
42. Opalka D, Lachman CE, MacMullen SA, Jansen KU, Smith JF, Chirmule N, Esser MT. Simultaneous quantitation of antibodies to neutralizing epitopes on viruslike particles for human papillomavirus types 6, 11, 16, and 18 by a multiplexed luminex assay. Clin Diagno Lab Immunol 2003; 10(1):108-15; PMID:12522048
43. Krajden M, Cook D, Yu A, Chow R, Mei W, McNeil S, Money D, Dionne M, Karunakaran KP, Palefsky JM, et al. Human papillomavirus 16 (HPV 16) and HPV 18 antibody responses measured by pseudovirus neutralization and competitive Luminex assays in a two- versus three-dose HPV vaccine trial. Clin Vaccine Immunol 2011; 18(3):418-23; PMID:21248158; http://dx.doi.org/10.1128/CVI.00489-10
44. Dias D, Van Doren J, Schlottmann S, Kelly S, Puchalski D, Ruiz W, Boerckel P, Kessler J, Antonello JM, Green T, 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):959-69; PMID:16085914
45. Perez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, et al. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer 2008; 122(6):1311-8; PMID:18000825; http://dx.doi.org/10.1002/ijc.23260