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Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial.
Hum Vaccin Immunother. 2015; 11(7):1689-702.HV

Abstract

This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of 2 doses of the HPV-16/18 AS04-adjuvanted vaccine (HPV-16/18(2D)) vs. 2 or 3 doses of the HPV-6/11/16/18 vaccine (HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D)) in healthy girls aged 9-14 y. Girls were randomized (1:1:1) to receive HPV-16/18(2D) at months (M) 0,6 (N = 359), HPV-6/11/16/18(2D) at M0,6 (N = 358) or HPV-6/11/16/18(3D) at M0,2,6 (N = 358). The primary objective was non-inferiority/superiority of HPV-16/18 antibodies by ELISA for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) at M7 in the according-to-protocol immunogenicity cohort (ATP-I) and total vaccinated cohort, respectively. Secondary objectives included non-inferiority/superiority of HPV-16/18(2D) vs. HPV-6/11/16/18(3D) at M7, non-inferiority/superiority at M12, HPV-16/18 neutralizing antibodies, frequencies of T-cells/B-cells, reactogenicity and safety. Antibody responses at M7 for HPV-16/18(2D) were superior to those for HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) (lower limit of 95% confidence interval for geometric mean titer ratio (GMR) was >1): HPV-16/18(2D)/HPV-6/11/16/18(2D) GMRs were 1.69 [1.49-1.91] for anti-HPV-16 and 4.52 [3.97-5.13] for anti-HPV-18; HPV-16/18(2D)/HPV-6/11/16/18(3D) GMRs were 1.72 [1.54-1.93] for anti-HPV-16 and 3.22 [2.82-3.68] for anti-HPV-18; p = 0.0001 for all comparisons. Non-inferiority/superiority was also demonstrated at M12. Among initially seronegative girls in the ATP-I, neutralizing antibody titers were at least 1.8-fold higher for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) at M7 and M12. Frequencies of HPV-16/18-specific T-cells and B-cells were in similar ranges between groups. Reactogenicity and safety were in line with the known profile of each vaccine. In conclusion, superior HPV-16/18 antibody responses were elicited by 2 doses of the HPV-16/18 AS04-adjuvanted vaccine compared with 2 or 3 doses of the HPV-6/11/16/18 vaccine in girls (9-14 years).

Authors+Show Affiliations

a Department of Paediatrics ; The Chinese University of Hong Kong ; Shatin , Hong Kong.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26062002

Citation

Leung, Ting Fan, et al. "Comparative Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 AS04-adjuvanted Vaccine and HPV-6/11/16/18 Vaccine Administered According to 2- and 3-dose Schedules in Girls Aged 9-14 Years: Results to Month 12 From a Randomized Trial." Human Vaccines & Immunotherapeutics, vol. 11, no. 7, 2015, pp. 1689-702.
Leung TF, Liu AP, Lim FS, et al. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial. Hum Vaccin Immunother. 2015;11(7):1689-702.
Leung, T. F., Liu, A. P., Lim, F. S., Thollot, F., Oh, H. M., Lee, B. W., Rombo, L., Tan, N. C., Rouzier, R., Friel, D., De Muynck, B., De Simoni, S., Suryakiran, P., Hezareh, M., Folschweiller, N., Thomas, F., & Struyf, F. (2015). Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial. Human Vaccines & Immunotherapeutics, 11(7), 1689-702. https://doi.org/10.1080/21645515.2015.1050570
Leung TF, et al. Comparative Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 AS04-adjuvanted Vaccine and HPV-6/11/16/18 Vaccine Administered According to 2- and 3-dose Schedules in Girls Aged 9-14 Years: Results to Month 12 From a Randomized Trial. Hum Vaccin Immunother. 2015;11(7):1689-702. PubMed PMID: 26062002.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial. AU - Leung,Ting Fan, AU - Liu,Anthony Pak-Yin, AU - Lim,Fong Seng, AU - Thollot,Franck, AU - Oh,Helen May Lin, AU - Lee,Bee Wah, AU - Rombo,Lars, AU - Tan,Ngiap Chuan, AU - Rouzier,Roman, AU - Friel,Damien, AU - De Muynck,Benoit, AU - De Simoni,Stéphanie, AU - Suryakiran,Pemmaraju, AU - Hezareh,Marjan, AU - Folschweiller,Nicolas, AU - Thomas,Florence, AU - Struyf,Frank, PY - 2015/6/11/entrez PY - 2015/6/11/pubmed PY - 2016/5/10/medline KW - 2D, 2-dose KW - 3D, 3-dose KW - AAHS, aluminum hydroxyphosphate sulfate KW - ANOVA, analysis of variance KW - AS04, Adjuvant System containing 50 µg 3-O-desacyl-4 ′-monophosphoryl lipid A (MPL) adsorbed on aluminum salt (500 µg Al3+) KW - ATP-I, according-to-protocol immunogenicity cohort KW - CI, confidence interval KW - CMI, cell-mediated immunity KW - ED50, effective dose producing 50% response KW - ELISA, enzyme-linked immunosorbent assay KW - ELISPOT, enzyme-linked immunosorbent spot assay KW - EU, ELISA unit KW - GMR, geometric mean titer ratio KW - GMT, geometric mean antibody titer KW - HPV, human papillomavirus KW - HPV-16/18(2D), 2-dose schedule of the HPV-16/18 vaccine KW - HPV-6/11/16/18(2D), 2-dose schedule of the HPV-6/11/16/18 vaccine KW - HPV-6/11/16/18(3D), 3-dose schedule of the HPV-6/11/16/18 vaccine KW - IFNγ, interferon KW - IgG, immunoglobulin G KW - M, month(s) KW - PBMC, peripheral blood mononuclear cells KW - PBNA, pseudovirion-based neutralisation assay KW - SAE, serious adverse event KW - TVC, total vaccinated cohort KW - VLP, virus-like particle KW - administration schedule KW - female adolescents KW - human papillomavirus (HPV) vaccines KW - immunogenicity KW - pIMD, potential immune-mediated disease KW - safety KW - y, year(s) SP - 1689 EP - 702 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 11 IS - 7 N2 - This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of 2 doses of the HPV-16/18 AS04-adjuvanted vaccine (HPV-16/18(2D)) vs. 2 or 3 doses of the HPV-6/11/16/18 vaccine (HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D)) in healthy girls aged 9-14 y. Girls were randomized (1:1:1) to receive HPV-16/18(2D) at months (M) 0,6 (N = 359), HPV-6/11/16/18(2D) at M0,6 (N = 358) or HPV-6/11/16/18(3D) at M0,2,6 (N = 358). The primary objective was non-inferiority/superiority of HPV-16/18 antibodies by ELISA for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) at M7 in the according-to-protocol immunogenicity cohort (ATP-I) and total vaccinated cohort, respectively. Secondary objectives included non-inferiority/superiority of HPV-16/18(2D) vs. HPV-6/11/16/18(3D) at M7, non-inferiority/superiority at M12, HPV-16/18 neutralizing antibodies, frequencies of T-cells/B-cells, reactogenicity and safety. Antibody responses at M7 for HPV-16/18(2D) were superior to those for HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) (lower limit of 95% confidence interval for geometric mean titer ratio (GMR) was >1): HPV-16/18(2D)/HPV-6/11/16/18(2D) GMRs were 1.69 [1.49-1.91] for anti-HPV-16 and 4.52 [3.97-5.13] for anti-HPV-18; HPV-16/18(2D)/HPV-6/11/16/18(3D) GMRs were 1.72 [1.54-1.93] for anti-HPV-16 and 3.22 [2.82-3.68] for anti-HPV-18; p = 0.0001 for all comparisons. Non-inferiority/superiority was also demonstrated at M12. Among initially seronegative girls in the ATP-I, neutralizing antibody titers were at least 1.8-fold higher for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) at M7 and M12. Frequencies of HPV-16/18-specific T-cells and B-cells were in similar ranges between groups. Reactogenicity and safety were in line with the known profile of each vaccine. In conclusion, superior HPV-16/18 antibody responses were elicited by 2 doses of the HPV-16/18 AS04-adjuvanted vaccine compared with 2 or 3 doses of the HPV-6/11/16/18 vaccine in girls (9-14 years). SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/26062002/Comparative_immunogenicity_and_safety_of_human_papillomavirus__HPV__16/18_AS04_adjuvanted_vaccine_and_HPV_6/11/16/18_vaccine_administered_according_to_2__and_3_dose_schedules_in_girls_aged_9_14_years:_Results_to_month_12_from_a_randomized_trial_ L2 - https://www.tandfonline.com/doi/full/10.1080/21645515.2015.1050570 DB - PRIME DP - Unbound Medicine ER -