Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine Academic Article uri icon

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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.

authors

  • Bornstein, Jacob
  • Roux, Surita
  • Kjeld Petersen, Lone
  • Huang, Li-Min
  • Dobson, Simon R
  • Pitisuttithum, Punnee
  • Diez-Domingo, Javier
  • Schilling, Andrea
  • Ariffin, Hany
  • Tytus, Richard
  • Rupp, Richard
  • Senders, Shelly
  • Engel, Eli
  • Ferris, Daron
  • Kim, Yae-Jean
  • Tae Kim, Young
  • Kurugol, Zafer
  • Bautista, Oliver
  • Nolan, Katrina M
  • Sankaranarayanan, Sandhya
  • Saah, Alfred
  • Luxembourg, Alain

publication date

  • January 1, 2021