Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine
- PMID: 33386332
- DOI: 10.1542/peds.2019-4035
Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine
Abstract
Background and objectives: Human papillomavirus (HPV) antibody responses to the 9-valent human papillomavirus (9vHPV) vaccine among girls and boys (aged 9-14 years) receiving 2-dose regimens (months 0, 6 or 0, 12) were noninferior to a 3-dose regimen (months 0, 2, 6) in young women (aged 16-26 years) 4 weeks after last vaccination in an international, randomized, open-label trial (NCT01984697). We assessed response durability through month 36.
Methods: Girls received 2 (months 0 and 6 [0, 6]: n = 301; months 0 and 12 [0, 12]: n = 151) or 3 doses (months 0,2, and 6 [0, 2, 6]: n = 301); boys received 2 doses ([0, 6]: n = 301; [0, 12]: n = 150); and young women received 3 doses ([0, 2, 6]: n = 314) of 9vHPV vaccine. Anti-HPV geometric mean titers (GMTs) were assessed by competitive Luminex immunoassay (cLIA) and immunoglobulin G-Luminex immunoassay (IgG-LIA) through month 36.
Results: Anti-HPV GMTs were highest 1 month after the last 9vHPV vaccine regimen dose, decreased sharply during the subsequent 12 months, and then decreased more slowly. GMTs 2 to 2.5 years after the last regimen dose in girls and boys given 2 doses were generally similar to or greater than GMTs in young women given 3 doses. Across HPV types, most boys and girls who received 2 doses (cLIA: 81%-100%; IgG-LIA: 91%-100%) and young women who received 3 doses (cLIA: 78%-98%; IgG-LIA: 91%-100%) remained seropositive 2 to 2.5 years after the last regimen dose.
Conclusions: Antibody responses persisted through 2 to 2.5 years after the last dose of a 2-dose 9vHPV vaccine regimen in girls and boys. In girls and boys, antibody responses generated by 2 doses administered 6 to 12 months apart may be sufficient to induce high-level protective efficacy through at least 2 years after the second dose.
Copyright © 2021 by the American Academy of Pediatrics.
Conflict of interest statement
POTENTIAL CONFLICT OF INTEREST: Dr Bornstein reports grants from Merck Sharp & Dohme Corp (MSD), a subsidiary of Merck & Co, Inc (Kenilworth, NJ), during the conduct of the study; Dr Petersen reports study fees for engaged study personnel from the University Hospital Aarhus, Denmark; Dr Dobson reports grants from MSD to conduct this clinical trial; Dr Diez-Domingo reports grants from MSD (clinical trial fees to his institution) during the conduct of the study and personal fees from MSD for lectures on human papillomavirus vaccines outside the submitted work; Dr Schilling reports personal fees from MSD as the principal investigator of a site for this study protocol during the conduct of the study, personal fees from MSD and MSD Chile outside the submitted work, and has written chapters about human papillomavirus vaccines in a pediatric and adolescent gynecology book, a book for parents of adolescents, and an infectious disease journal; Dr Ferris reports institutional funding from MSD for conducting the research study; Dr Y-J Kim reports receiving grant support through her institution from MSD; Drs Bautista, Nolan, Sankaranarayanan, Saah, and Luxembourg are current or former employees of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc (Kenilworth, NJ), and may own stock or stock options in Merck & Co, Inc (Kenilworth, NJ); the other authors have indicated they have no potential conflicts of interest to disclose.
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