https://scholars.lib.ntu.edu.tw/handle/123456789/566493
標題: | Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 1014 years | 作者: | Schwarz T.F. LI-MIN HUANG Medina D.M.R. Valencia A. Lin T.-Y. Behre U. Catteau G. Thomas F. Descamps D. |
關鍵字: | Adolescent; Cervical cancer; Female; HPV-16/18 AS04-adjuvanted vaccine; Human papillomavirus; Immunogenicity; Long-term; Monophosphoryl lipid A; Safety | 公開日期: | 2012 | 卷: | 50 | 期: | 2 | 起(迄)頁: | 187-194 | 來源出版物: | Journal of Adolescent Health | 摘要: | Purpose: Long-term immunogenicity and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine when administered to adolescent girls was evaluated. Methods: This open-label, follow-up study (NCT00316706) was conducted in 31 centers in Taiwan, Germany, Honduras, Panama, and Colombia. In the initial study (NCT00196924), 1,035 girls aged 1014 years received the HPV-16/18 AS04-adjuvanted vaccine at 0, 1, and 6 months. Here, geometric mean titers (GMTs) of antibodies against HPV-16, HPV-18, and monophosphoryl lipid A (MPL), a component of the AS04 Adjuvant System, were reported up to month 48. Results: In the according-to-protocol immunogenicity cohort (N = 563), GMTs at month 48 in initially seronegative participants were 2,374.9 (95% confidence interval: 2,205.72,557.0) EL.U/mL for anti-HPV-16 and 864.8 (796.9938.4) EL.U/mL for anti-HPV-18, that is, six- and threefold higher than the plateau level in a reference study demonstrating vaccine efficacy in young women (age, 1525 years). All participants remained seropositive for anti-HPV-16 and anti-HPV-18 at month 48. Most participants (81.8%) were seropositive for anti-MPL antibodies before vaccination. Anti-MPL antibody titers in initially seropositive participants increased initially, and then declined. Most initially seronegative participants for anti-MPL seroconverted; 69.6% remained seropositive at month 48, with anti-MPL antibody titers similar to the natural background level. The vaccine was generally well tolerated. No serious adverse events were considered related to vaccination. Conclusions: In adolescent girls, the HPV-16/18 AS04-adjuvanted vaccine produces anti-HPV-16 and anti-HPV-18 antibody titers that are maintained for up to 4 years at higher levels than those in young women in whom vaccine efficacy against cervical lesions was demonstrated. ? 2012 Published by Elsevier Inc. on behalf of Society for Adolescent Health and Medicine. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84856090807&doi=10.1016%2fj.jadohealth.2011.11.004&partnerID=40&md5=5455a66183a28b5ed944283aacf5e97b https://scholars.lib.ntu.edu.tw/handle/123456789/566493 |
ISSN: | 1054-139X | DOI: | 10.1016/j.jadohealth.2011.11.004 | SDG/關鍵字: | phosphoryl lipid A; virus antibody; Wart virus vaccine; abdominal pain; adolescent; adult; allergic rhinitis; antibody titer; appendicitis; article; asthma; bronchitis; child; Colombia; controlled study; drug efficacy; drug safety; drug tolerability; female; follow up; gastritis; Germany; Honduras; human; Human papillomavirus type 16; Human papillomavirus type 18; hypersensitivity; immunogenicity; major clinical study; migraine; ovary cyst; Panama; papillomavirus infection; phase 3 clinical trial; priority journal; randomized controlled trial; school child; Taiwan; treatment outcome; Adjuvants, Immunologic; Adolescent; Child; Female; Follow-Up Studies; Human papillomavirus 16; Human papillomavirus 18; Humans; Immunogenetic Processes; Papillomavirus Infections; Papillomavirus Vaccines; Uterine Cervical Neoplasms |
顯示於: | 醫學系 |
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