Safety and Immunogenicity of the HPV-16/18 AS04-Adjuvanted Vaccine: A Randomized, Controlled Trial in Adolescent Girls
Journal
Journal of Adolescent Health
Journal Volume
46
Journal Issue
5
Pages
414-421
Date Issued
2010
Author(s)
Rivera Medina D.M.
Valencia A.
de Velasquez A.
Prymula R.
Garc?a-Sicilia J.
Rombo L.
David M.P.P.
Descamps D.
Hardt K.
Dubin G.
Abstract
Purpose: Immunization of girls against oncogenic human papillomavirus (HPV) types before sexual debut is important for cervical cancer prevention. This phase III blinded, randomized, controlled trial in adolescent girls assessed safety of the HPV-16/18 AS04-adjuvanted vaccine. Methods: Girls (mean age 12 years) in 12 countries received the HPV-16/18 L1 virus-like particle AS04-adjuvanted vaccine (N = 1,035) or hepatitis A virus vaccine as control (N = 1,032) at 0, 1, and 6 months. The primary objective was to compare the occurrence of serious adverse events (SAEs) between groups. HPV-16 and HPV-18 antibody titers were assessed by enzyme-linked immunosorbent assay post-vaccination. Results: Up to study month 7, 11 girls in the HPV-16/18 vaccine group reported 14?SAEs and 13 girls in the control group reported 15 SAEs. The difference in SAE incidence between groups was .20% (95% CI, -.78, 1.20). No SAE in the HPV-16/18 vaccine group was considered related to vaccination or led to withdrawal. The incidence of solicited local and general symptoms up to 7 days post-vaccination was moderately higher with the HPV-16/18 vaccine than with control. The incidence of unsolicited symptoms, new onset of chronic diseases, and medically significant conditions was similar between groups. All girls seroconverted for both antigens after three doses?of the HPV-16/18 vaccine; geometric mean titers were 19,882.0 and 8,262.0 EU/mL for anti-HPV-16 and -18 antibodies, respectively, in initially seronegative girls. Conclusions: The HPV-16/18 AS04-adjuvanted vaccine was generally well tolerated and immunogenic when administered to young adolescent females, the primary target of organized vaccination programs. ? 2010 Society for Adolescent Medicine.
Subjects
Adolescent; Cervical cancer; Girls; Human papillomavirus; Immunogenicity; Safety; Vaccine
SDGs
Other Subjects
aluminum hydroxide; antigen; hepatitis A vaccine; HPV 16/18 AS04 adjuvanted vaccine; unclassified drug; virus antibody; Wart virus vaccine; abdominal pain; adjuvant therapy; adolescent; alanine aminotransferase blood level; anorexia nervosa; antibody titer; appendicitis; article; aspartate aminotransferase blood level; autoimmune thyroiditis; automutilation; bronchitis; child; chronic disease; clinical assessment; clinical trial; concussion; constipation; controlled clinical trial; controlled study; convulsion; Coxsackie virus infection; dehydration; double blind procedure; drug efficacy; drug eruption; drug induced headache; drug safety; drug tolerability; dysmenorrhea; dyspnea; eardrum perforation; enterobiasis; enzyme linked immunosorbent assay; fatigue; female; fever; gastritis; gastroenteritis; geometry; gunshot injury; hepatitis A; human; Human papillomavirus type 16; Human papillomavirus type 18; immunization; immunogenicity; incidence; Ludwig angina; lymphadenitis; major clinical study; mastoiditis; migraine with aura; multicenter study; myalgia; ovary cyst; phase 3 clinical trial; pneumonia; priority journal; pseudocroup; randomized controlled trial; school child; seroconversion; serology; side effect; suicide attempt; symptom; syncope; treatment duration; ulna fracture; upper respiratory tract infection; urinary tract infection; urticaria; uterine cervix cancer; viral gastroenteritis; virus like agent; Adjuvants, Immunologic; Adolescent; Adult; Europe; Female; Human papillomavirus 16; Human papillomavirus 18; Humans; Papillomavirus Infections; Papillomavirus Vaccines; Uterine Cervical Neoplasms; Young Adult
Type
journal article