Long-term Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in 10- to 14-year-old girls open 6-year follow-up of an initial observer-blinded, randomized trial
Journal
Pediatric Infectious Disease Journal
Journal Volume
33
Journal Issue
12
Pages
1255-1261
Date Issued
2014
Author(s)
Schwarz T.F.
Lin T.-Y.
Wittermann C.
Panzer F.
Valencia A.
Suryakiran P.V.
Lin L.
Descamps D.
Abstract
Background: Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine were evaluated up to 6 years postvaccination (month 72) in preteen/adolescent girls. Methods: Participants, who had received 3 HPV-16/18 AS04-adjuvanted vaccine doses at 10-14 years of age in an initial controlled, observerblinded, randomized study (NCT00196924) and participated in the open 3-year follow-up (NCT00316706), were invited to continue the follow-up for up to 10 years postvaccination (NCT00877877). Anti-HPV-16 and -18 antibody titers were measured by enzyme-linked immunosorbent assays at yearly visits and were used to fit the modified power-law and piecewise models, predicting long-term immunogenicity. Serious adverse events (SAEs) and pregnancy information were recorded. Results: In the according-to-protocol immunogenicity cohort, all participants (N = 505) with data available remained seropositive for anti-HPV-16 and -18 antibodies at month 72. In initially seronegative participants, anti-HPV-16 and -18 antibody geometric mean titers were 65.8- and 33.0-fold higher than those associated with natural infection (NCT00122681) and 5.0- and 2.5-fold higher than those measured at month 69-74 in a study demonstrating vaccine efficacy in women aged 15-25 years (NCT00120848). Exploratory antibody modeling, based on the 6-year data, predicted that vaccine-induced population anti-HPV-16 and -18 antibody geometric mean titers would remain above those associated with natural infection for at least 20 years postvaccination. The HPV-16/18 AS04-adjuvanted vaccine safety profile was clinically acceptable. Conclusions: In preteen/adolescent girls, the HPV-16/18 AS04-adjuvanted vaccine induced high anti-HPV-16 and -18 antibody levels up to 6 years postvaccination, which were predicted to remain above those induced by natural infection for at least 20 years. Copyright ? 2014 by Lippincott Williams and Wilkins.
Subjects
Adolescent; HPV-16/18 AS04-adjuvanted vaccine; Human papillomavirus; Immunogenicity; Persistence
SDGs
Other Subjects
Wart virus vaccine; aluminum hydroxide; ASO4 mixture; human papillomavirus vaccine, L1 type 16, 18; immunological adjuvant; lipid A; virus antibody; Wart virus vaccine; abdominal pain; antibody response; antibody titer; aorta rupture; Article; child; controlled study; enzyme linked immunosorbent assay; female; follow up; human; Human papillomavirus type 16; Human papillomavirus type 18; immunogenicity; major clinical study; ovary cyst; papillomavirus infection; pregnancy; priority journal; randomized controlled trial; safety; school child; spontaneous abortion; treatment outcome; vaccination; adolescent; adult; analogs and derivatives; blood; Drug-Related Side Effects and Adverse Reactions; immunology; newborn; Papillomavirus Infections; pathology; single blind procedure; Uterine Cervical Neoplasms; young adult; Adjuvants, Immunologic; Adolescent; Adult; Aluminum Hydroxide; Antibodies, Viral; Child; Drug-Related Side Effects and Adverse Reactions; Enzyme-Linked Immunosorbent Assay; Female; Follow-Up Studies; Humans; Infant, Newborn; Lipid A; Papillomavirus Infections; Papillomavirus Vaccines; Pregnancy; Single-Blind Method; Treatment Outcome; Uterine Cervical Neoplasms; Young Adult
Publisher
Lippincott Williams and Wilkins
Type
journal article