PT - JOURNAL ARTICLE AU - Bornstein, Jacob AU - Roux, Surita AU - Kjeld Petersen, Lone AU - Huang, Li-Min AU - Dobson, Simon R. AU - Pitisuttithum, Punnee AU - Diez-Domingo, Javier AU - Schilling, Andrea AU - Ariffin, Hany AU - Tytus, Richard AU - Rupp, Richard AU - Senders, Shelly AU - Engel, Eli AU - Ferris, Daron AU - Kim, Yae-Jean AU - Tae Kim, Young AU - Kurugol, Zafer AU - Bautista, Oliver AU - Nolan, Katrina M. AU - Sankaranarayanan, Sandhya AU - Saah, Alfred AU - Luxembourg, Alain TI - Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine AID - 10.1542/peds.2019-4035 DP - 2021 Jan 01 TA - Pediatrics PG - e20194035 VI - 147 IP - 1 4099 - http://pediatrics.aappublications.org/content/147/1/e20194035.short 4100 - http://pediatrics.aappublications.org/content/147/1/e20194035.full SO - Pediatrics2021 Jan 01; 147 AB - Video AbstractBACKGROUND 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.