Three-year follow-up of 2-dose versus 3-dose HPV vaccine

• Main Authors: Bornstein, Jacob, Roux, Surita, Petersen, Lone Kjeld, Huang, Li-Min, Dobson, Simon R., Pitisuttithum, Punnee, Diez-Domingo, Javier, Schilling, Andrea, Ariffin, Hany Mohd, Tytus, Richard, Rupp, Richard, Senders, Shelly, Engel, Eli, Ferris, Daron, Kim, Yae-Jean, Kim, Young Tae, Kurugol, Zafer, Bautista, Oliver, Nolan, Katrina M., Sankaranarayanan, Sandhya, Saah, Alfred, Luxembourg, Alain
• Format: Article
• Published: Amer Acad Pediatrics 2021
• Subjects: R Medicine; RJ Pediatrics
• Online Access: http://eprints.um.edu.my/34591/
• Institution: Universiti Malaya

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.