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Sustained Immunogenicity of 2-dose Human Papillomavirus 16/18 AS04-adjuvanted Vaccine Schedules in Girls Aged 9-14 Years: A Randomized Trial
- Source :
- The Journal of Infectious Diseases
- Publication Year :
- 2017
-
Abstract
- Summary Human papillomavirus vaccination began using a 3-dose schedule. Compared with the 3-dose schedule in women, the 2-dose schedules are effective options in young girls as of 36 months after first dose. Two-dose schedules could improve compliance and vaccination coverage.<br />Background. We previously reported the noninferiority 1 month after the last dose of 2-dose human papillomavirus 16/18 AS04-adjuvanted (AS04-HPV-16/18) vaccine schedules at months 0 and 6 (2D_M0,6) and months 0 and 12 (2D_M0,12) in girls aged 9–14 years compared with a 3-dose schedule at months 0, 1, and 6 (3D_M0,1,6) in women aged 15–25 years. Here, we report the results at study end (month 36 [M36]). Methods. Girls were randomized 1:1 and received 2 vaccine doses either 6 months (2D_M0,6) or 12 months apart (2D_M0,12); women received 3 doses at months 0, 1, and 6 (3D_M0,1,6). Endpoints included noninferiority of HPV-16/18 antibodies for 2D_M0,6 versus 3D_M0,1,6; 2D_M0,12 versus 3D_M0,1,6; and 2D_M0,12 versus 2D_M0,6; and assessment of neutralizing antibodies, T cells, B cells, and safety. Results. At M36, the 2D_M0,6 and 2D_M0,12 schedules remained noninferior to the 3D_M0,1,6 schedule in terms of seroconversion rates and 3D/2D geometric mean titers for anti-HPV-16 and anti-HPV-18. All schedules elicited sustained immune responses up to M36. Conclusions. Both 2-dose schedules in young girls remained noninferior to the 3-dose schedule in women up to study conclusion at M36. The AS04-HPV-16/18 vaccine administered as a 2-dose schedule was immunogenic and well tolerated in young girls.
- Subjects :
- Pediatrics
medicine.medical_specialty
Adolescent
cervical cancer
Cervarix
Aluminum Hydroxide
Antibodies
law.invention
03 medical and health sciences
2-dose schedule
0302 clinical medicine
Randomized controlled trial
law
medicine
Major Article
Humans
Immunology and Allergy
030212 general & internal medicine
Viral
Papillomavirus Vaccines
Human papillomavirus
Seroconversion
Child
Cervical cancer
Human papillomavirus 16
Human papillomavirus 18
Surrogate endpoint
business.industry
Immunogenicity
medicine.disease
human papillomavirus (HPV)
Antibodies, Viral
Female
Lipid A
Infectious Diseases
Titer
030220 oncology & carcinogenesis
business
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- The Journal of Infectious Diseases
- Accession number :
- edsair.doi.dedup.....dc2960b849eac4dc3654b73a5fe44b36