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Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule: results from a randomized study.
- Source :
-
Human vaccines [Hum Vaccin] 2011 Dec; Vol. 7 (12), pp. 1374-86. Date of Electronic Publication: 2011 Dec 01. - Publication Year :
- 2011
-
Abstract
- The immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix®, GlaxoSmithKline Biologicals) administered according to its licensed vaccination schedule (3-dose, 3D) and formulation (20 μg of each HPV antigen; 20/20F) has previously been demonstrated. This partially-blind, controlled, randomized trial (NCT00541970) evaluated 2-dose (2D) schedules using the licensed 20/20F or an alternative formulation containing 40 μg of each antigen (40/40F), compared with the licensed 3D schedule. Healthy females stratified by age (9-14, 15-19, 20-25 y) were randomized to receive 2 doses of 20/20F at Months (M) 0,6 (n=240), 40/40F at M0,6 (n=241) or 40/40F at M0,2 (n=240), or 3 doses of 20/20F at M0,1,6 (licensed schedule/formulation, n=239). One month after the last dose, the 3D schedule was not immunologically superior to 2D schedules except in the 40/40F M0,2 group for HPV-16 (lower limit of 95% CI geometric mean antibody titer (GMT) ratio [2D/3D] < 0.5). For both HPV-16 and HPV-18, the 2D schedules in girls 9-14 y were immunologically non-inferior to the 3D schedule in women 15-25 y (the age group in which efficacy has been demonstrated) (upper limit of 95% CI for GMT ratio [3D/2D] < 2) one month after the last dose. At Month 24, non-inferiority was maintained for the 2D M0,6 schedules in girls 9-14 y versus the 3D schedule in women 15-25 y. All formulations had acceptable reactogenicity and safety profiles. These results indicate that the HPV-16/18 vaccine on a 2D M0,6 schedule is immunogenic and generally well tolerated in girls 9-14 y and that the 2D schedule is likely adequate for younger females.
- Subjects :
- Adjuvants, Immunologic administration & dosage
Adolescent
Adult
Aluminum Hydroxide administration & dosage
Child
Dose-Response Relationship, Immunologic
Drug Administration Schedule
Female
Human papillomavirus 16 immunology
Human papillomavirus 18 immunology
Humans
Licensure
Lipid A administration & dosage
Lipid A adverse effects
Lipid A immunology
Papillomavirus Infections immunology
Papillomavirus Infections virology
Papillomavirus Vaccines administration & dosage
Treatment Outcome
Uterine Cervical Neoplasms immunology
Uterine Cervical Neoplasms virology
Young Adult
Adjuvants, Immunologic adverse effects
Aluminum Hydroxide adverse effects
Aluminum Hydroxide immunology
Antibodies, Viral blood
Lipid A analogs & derivatives
Papillomavirus Infections prevention & control
Papillomavirus Vaccines adverse effects
Papillomavirus Vaccines immunology
Uterine Cervical Neoplasms prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1554-8619
- Volume :
- 7
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Human vaccines
- Publication Type :
- Academic Journal
- Accession number :
- 22048171
- Full Text :
- https://doi.org/10.4161/hv.7.12.18322