Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine
Journal
Pediatrics
ISSN
0031-4005
1098-4275
Date Issued
2021
Author(s)
Jacob Bornstein
Surita Roux
Lone Kjeld Petersen
Li-Min Huang
Simon R. Dobson
Punnee Pitisuttithum
Javier Diez-Domingo
Hany Ariffin
Richard Tytus
Richard Rupp
Shelly Senders
Eli Engel
Daron Ferris
Yae-Jean Kim
Young Tae Kim
Zafer Kurugol
Oliver Bautista
Katrina M. Nolan
Sandhya Sankaranarayanan
Alfred Saah
Alain Luxembourg
Type
Resource Types::text::journal::journal article
DOI
URL
Abstract
<jats:sec> <jats:title /> </jats:sec> <jats:sec> <jats:title>BACKGROUND AND OBJECTIVES:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>METHODS:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS:</jats:title> <jats:p>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.</jats:p> </jats:sec>