Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: End-of-study analysis of a Phase III randomized trial

Human Vaccines and Immunotherapeutics

Volumn 10, Issue 12, 2014, Pages 3435-3445

  Einstein, Mark H ^a   Takacs, Peter ^b   Chatterjee, Archana ^c   Sperling, Rhoda S ^d   Chakhtoura, Nahida ^b   Blatter, Mark M ^e   Lalezari, Jacob ^f   David, Marie Pierre ^g   Lin, Lan ^h   Struyf, Frank ^g   Dubin, Gary ⁱ  

^a ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF MIAMI   (United States)

^c UNIVERSITY OF SOUTH DAKOTA   (United States)

^d MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^e Pediatric Alliance   (United States)

^f Quest Clinical Research   (United States)

^g GSK   (Belgium)

^h XPePharma and Science   (Belgium)

ⁱ GLAXOSMITHKLINE   (United States)

Author keywords

Antibodies; Cervarix ; Gardasil ; Human papillomavirus; Immunogenicity; Models; Neutralizing; Safety; Statistical

Indexed keywords

NEUTRALIZING ANTIBODY; WART VIRUS VACCINE; HUMAN PAPILLOMAVIRUS VACCINE, L1 TYPE 16, 18; IMMUNOLOGICAL ADJUVANT; VIRUS ANTIBODY;

ADULT; ANTIBODY BLOOD LEVEL; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; COHORT ANALYSIS; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DRUG SAFETY; FEMALE; HUMAN; HUMAN EXPERIMENT; HUMAN PAPILLOMAVIRUS TYPE 11; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; HUMAN PAPILLOMAVIRUS TYPE 6; IMMUNOGENICITY; MIDDLE AGED; NORMAL HUMAN; PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); UNSPECIFIED SIDE EFFECT; YOUNG ADULT; ADOLESCENT; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; IMMUNOLOGY; PAPILLOMAVIRIDAE; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; ANTIBODIES, VIRAL; FEMALE; HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE QUADRIVALENT, TYPES 6, 11, 16, 18; HUMANS; MIDDLE AGED; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS VACCINES; YOUNG ADULT;

EID: 84922538389     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.36121     Document Type: Article

References (17)

1. Garçon N, Wettendorff M, Van Mechelen M. Role of AS04 in human papillomavirus vaccine: mode of action and clinical profile. Expert Opin Biol Ther 2011; 11:667-77; http://dx.doi.org/10.1517/14712598.2011.573624
2. Einstein MH, Baron M, Levin MJ, Chatterjee A, Edwards RP, Zepp F, Carletti I, Dessy FJ, Trofa AF, Schuind A, et al. Comparison of the immunogenicity and safety of Cervarix and Gardasil human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years. Hum Vaccin 2009; 5:705-19; PMID:19684472; http://dx.doi.org/10.4161/hv.5.10.9518
3. Einstein MH, Baron M, Levin MJ, Chatterjee A, Fox B, Scholar S, Rosen J, Chakhtoura N, Meric D, Dessy FJ, et al. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 vaccine and HPV-6/11/16/18 vaccine: follow-up from months 12-24 in a Phase III randomized study of healthy women aged 18-45 years. Hum Vaccin 2011; 7:1343-58; PMID:22048173; http://dx.doi.org/10.4161/hv.7.12.18281
4. Einstein MH, Levin MJ, Chatterjee A, Chakhtoura N, Takacs P, Catteau G, Dessy FJ, Moris P, Lin L, Struyf F, et al. Comparative humoral and cellular immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: follow-up through Month 48 in a Phase III randomized study. Human Vaccin Immunother (in submission)
5. David MP, Van Herck K, Hardt K, Tibaldi F, Dubin G, Descamps D, Van Damme P. 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. Gynecol Oncol 2009; 115:S1-6; PMID:19217149; http://dx. doi.org/10.1016/j.ygyno.2009.01.011
6. Fraser C, Tomassini JE, Xi L, Golm G, Watson M, Giuliano AR, Barr E, Ault KA. Modeling the long-term antibody response of a human papillomavirus (HPV) virus-like particle (VLP) type 16 prophylactic vaccine. Vaccine 2007; 25:4324-33; PMID:17445955; http://dx.doi.org/10.1016/j.vaccine.2007.02.069
7. Banatvala J, Van Damme P, Oehen S. Lifelong protection against hepatitis B: the role of vaccine immunogenicity in immune memory. Vaccine 2000; 19:877-85; PMID:11115711; http://dx.doi.org/10.1016/S0264-410X(00)00224-3
8. Van Damme P, Banatvala J, Fay O, Iwarson S, McMahon B, Van Herck K, Shouval D, Bonanni P, Connor B, Cooksley G, et al. Hepatitis A booster vaccination: is there a need? Lancet 2003; 362:1065-71; PMID:14522539; http://dx. doi.org/10.1016/S0140-6736(03)14418-2
9. Wilson JN, Nokes DJ, Carman WF. Current status of HBV vaccine escape variants - a mathematical model of their epidemiology. J Viral Hepat 1998; 5 Suppl 2:25-30; PMID:9857357; http://dx.doi.org/10.1046/j.1365-2893.1998.0050s2025.x
10. Paavonen J, Jenkins D, Bosch FX, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter DL, Kitchener HC, Castellsague X, et al. 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. Lancet 2007; 369:2161-70; PMID:17602732; http://dx.doi.org/10.1016/S0140-6736(07)60946-5
11. Draper E, Bissett SL, Howell-Jones R, Waight P, Soldan K, Jit M, Andrews N, Miller E, Beddows S. A randomized, observer-blinded immunogenicity trial of Cervarix® and Gardasil® human papillomavirus vaccines in 12-15 year old girls. PloS One 2013; 8:e61825; PMID:23650505; http://dx.doi.org/10.1371/journal. pone.0061825
12. Squarzon L, Pacenti M, Masiero S, Marcati G, Gottardello L, Gabrielli L, Lazzarotto T, Pascucci MG, Palu G, Barzon L. Evaluation of neutralizing and cross-neutralizing antibodies induced by HPV prophylactic vaccines: an independent study. EUROGIN 2013. Florence, Italy. Abstract OC 6-9 (page 204). Available at http://www.eurogin.com/2013/images/pdf/EUROGIN-2013-Abstracts-Part-2.pdf
13. Villa LL, Costa RL, Petta CA, Andrade RP, Paavonen J, Iversen OE, Olsson SE, Hoye 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 followup. Br J Cancer 2006; 95:1459-66; PMID:17117182; http://dx.doi.org/10.1038/sj.bjc.6603469
14. Krajden M, Cook D, Yu A, Chow R, Su Q, Mei W, McNeil S, Money D, Dionne M, Palefsky J, et al. Assessment of HPV 16 and HPV 18 antibody responses by pseudovirus neutralization, Merck cLIA and Merck total IgG LIA immunoassays in a reduced dosage quadrivalent HPV vaccine trial. Vaccine 2014; 32:624-30; PMID:24055350; http://dx.doi.org/10.1016/j. vaccine.2013.09.007
15. Roteli-Martins CM, Naud P, De Borba P, Teixeira JC, De Carvalho NS, Zahaf T, Sanchez N, Geeraerts B, Descamps D. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: up to 8.4 years of follow-up. Hum Vaccin Immunother 2012; 8:390-7; PMID:22327492; http://dx.doi.org/10.4161/hv.18865
16. Dessy FJ, Giannini SL, Bougelet CA, Kemp TJ, David MP, Poncelet SM, Pinto LA, Wettendorff MA. 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. Hum Vaccin 2008; 4:425-34; PMID:18948732; http://dx.doi.org/10.4161/hv.4.6.6912
17. Harper DM, Franco EL, Wheeler C, Ferris DG, Jenkins D, Schuind A, Zahaf T, Innis B, Naud P, De Carvalho NS, et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 2004; 364:1757-65; PMID:15541448; http://dx.doi.org/10.1016/S0140-6736(04)17398-4