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Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women.
- Source :
-
Science China. Life sciences [Sci China Life Sci] 2020 Apr; Vol. 63 (4), pp. 582-591. Date of Electronic Publication: 2019 Jun 21. - Publication Year :
- 2020
-
Abstract
- A new HPV-16/18 bivalent vaccine expressed by the Escherichia coli has been proven to be efficacious in adult women. A randomized, immunogenicity noninferiority study of this candidate vaccine was conducted in December 2015 in China. Girls aged 9-14 years were randomized to receive 2 doses at months 0 and 6 (n=301) or 3 doses at months 0, 1 and 6 (n=304). Girls aged 15-17 years (n=149) and women aged 18-26 years (n=225) received 3 doses. The objectives included noninferiority analysis of the IgG geometric mean concentration (GMC) ratio (95% CI, lower bound>0.5) to HPV-16 and HPV-18 at month 7 in girls compared with women. In the per-protocol set, the GMC ratio of IgG was noninferior for girls aged 9-17 years receiving 3 doses compared with women (1.76 (95% CI, 1.56, 1.99) for HPV-16 and 1.93 (95% CI, 1.69, 2.21) for HPV-18) and noninferior for girls aged 9-14 years receiving 2 doses compared with women (1.45 (95% CI, 1.25, 1.62) for HPV-16 and 1.17 (95% CI, 1.02, 1.33) for HPV-18). Noninferiority was also demonstrated for neutralizing antibodies. The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.
- Subjects :
- Adolescent
Adult
Antibodies, Neutralizing metabolism
Child
China
Dose-Response Relationship, Radiation
Escherichia coli metabolism
Escherichia coli Vaccines adverse effects
Female
Humans
Immunogenicity, Vaccine
Papillomavirus Vaccines adverse effects
Treatment Outcome
Escherichia coli Vaccines administration & dosage
Human papillomavirus 16 immunology
Human papillomavirus 18 immunology
Papillomavirus Infections prevention & control
Papillomavirus Vaccines administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1869-1889
- Volume :
- 63
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Science China. Life sciences
- Publication Type :
- Academic Journal
- Accession number :
- 31231780
- Full Text :
- https://doi.org/10.1007/s11427-019-9547-7