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Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination: results from a randomized study.
- Source :
-
Human vaccines & immunotherapeutics [Hum Vaccin Immunother] 2014; Vol. 10 (5), pp. 1155-65. Date of Electronic Publication: 2014 Feb 27. - Publication Year :
- 2014
-
Abstract
- This randomized, partially-blind study (ClinicalTrials.gov registration number NCT00541970) evaluated the immunogenicity and safety of 2-dose (2D) schedules of the HPV-16/18 AS04-adjuvanted vaccine. Results to month (M) 24 have been reported previously and we now report data to M48 focusing on the licensed vaccine formulation (20 μg each of HPV-16 and -18 antigens) administered at M0,6 compared with the standard 3-dose (3D) schedule (M0,1,6). Healthy females (age stratified: 9-14, 15-19, 20-25 years) were randomized to receive 2D at M0,6 (n = 240) or 3D at M0,1,6 (n = 239). In the according-to-protocol immunogenicity cohort, all initially seronegative subjects seroconverted for HPV-16 and -18 antibodies and remained seropositive up to M48. For both HPV-16 and -18, geometric mean antibody titer (GMT) ratios (3D schedule in women aged 15-25 years divided by 2D schedule in girls aged 9-14 years) at M36 and M48 were close to 1, as they were at M7 when non-inferiority was demonstrated. The kinetics of HPV-16, -18, -31, and -45 antibody responses were similar for both groups and HPV-16 and -18 GMTs were substantially higher than natural infection titers. The vaccine had a clinically acceptable safety profile in both groups. In summary, antibody responses to a 2D M0,6 schedule of the licensed vaccine formulation in girls aged 9-14 years appeared comparable to the standard 3D schedule in women aged 15-25 years up to 4 years after first vaccination. A 2D schedule could facilitate implementation of HPV vaccination programs and improve vaccine coverage and series completion rates.
- Subjects :
- Adolescent
Adult
Child
Cohort Studies
Drug Administration Schedule
Female
Human papillomavirus 16 drug effects
Human papillomavirus 18 drug effects
Humans
Immunity, Cellular drug effects
Immunity, Cellular immunology
Time Factors
Young Adult
Adjuvants, Immunologic administration & dosage
Human papillomavirus 16 immunology
Human papillomavirus 18 immunology
Papillomavirus Vaccines administration & dosage
Papillomavirus Vaccines immunology
Vaccination trends
Subjects
Details
- Language :
- English
- ISSN :
- 2164-554X
- Volume :
- 10
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Human vaccines & immunotherapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 24576907
- Full Text :
- https://doi.org/10.4161/hv.28022