Four-Year Follow-up of the Immunogenicity and Safety of the HPV-16/18 AS04-Adjuvanted Vaccine When Administered to Adolescent Girls Aged 10-14 Years
Resource
J. Adolesc. Health, 50(2), 187-194
Journal
J. Adolesc. Health
Journal Volume
50
Journal Issue
2
Pages
187-194
Date Issued
2012
Date
2012
Author(s)
Schwarz, Tino F.
Huang, Li-Min
Abstract
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 10-14 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: 2,205.7-2,557.0) EL. U/mL for anti-HPV-16 and 864.8 (796.9-938.4) 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, 15-25 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. (C) 2012 Published by Elsevier Inc. on behalf of Society for Adolescent Health and Medicine.
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