Skip Navigation LinksHome > March 2011 - Volume 30 - Issue 3 > Immunogenicity and Safety of Human Papillomavirus-16/18 AS04...
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Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e318206c26e
Online-Only: Original Studies

Immunogenicity and Safety of Human Papillomavirus-16/18 AS04-Adjuvanted Vaccine Administered According to an Alternative Dosing Schedule Compared With the Standard Dosing Schedule in Healthy Women Aged 15 to 25 Years: Results From a Randomized Study

Esposito, Susanna MD*; Birlutiu, Victoria MD†; Jarcuska, Pavol PhD‡; Perino, Antonio MD§; Man, Sorin Claudiu PhD¶; Vladareanu, Radu PhD∥; Meric, Dorothée MSc**; Dobbelaere, Kurt MD**; Thomas, Florence DTM**; Descamps, Dominique MD**

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Abstract

Background: The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine is immunogenic, has a clinically acceptable safety profile, and prevents incident and persistent HPV-16/18 infection and cervical precancerous lesions. This study (NCT00552279) evaluated the vaccine when administered according to an alternative dosing schedule (0–1–12 months) compared with the standard dosing schedule (0–1–6 months).

Methods: The study was of randomized open design and was conducted at multiple centers in Europe. Healthy women aged 15 to 25 years were randomized (1:1) to receive HPV-16/18 vaccine according to the standard schedule at months 0, 1, and 6 (n = 401) or an alternative schedule at months 0, 1, and 12 (n = 403). HPV-16 and -18 antibodies were measured by enzyme-linked immunosorbent assay at months 0, 2, and 7 or 13 (depending on group); noninferiority evaluation was performed sequentially for seroconversion rates and geometric mean antibody titers. Primary analysis of immunogenicity was based on the according-to-protocol cohort. Vaccine safety and reactogenicity were assessed on the total vaccinated cohort.

Results: Predefined noninferiority criteria were met 1 month after the third vaccine dose when the HPV-16/18 vaccine was administered according to the 0–1–12 month schedule compared with the 0–1–6 month schedule in terms of seroconversion rates for HPV-16 (100% and 100%) and HPV-18 (99.7% and 100%) and geometric mean antibody titers for HPV-16 (11884.7 and 10311.9 ELISA units/mL) and HPV-18 (4501.3 and 3963.6 ELISA units/mL), respectively. The HPV-16/18 vaccine had a clinically acceptable safety profile when administered according to either schedule.

Conclusions: The third dose of the HPV-16/18 vaccine can be administered any time between 6 and 12 months after the first dose, with adequate immunogenicity and a clinically acceptable safety profile.

© 2011 Lippincott Williams & Wilkins, Inc.

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