Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine

Bornstein J 1 , Roux S 2 , Kjeld Petersen L 3 , Huang LM 4 , Dobson SR 5 , Pitisuttithum P 6 Show all authors , Diez-Domingo J 7 , Schilling A 8 , Ariffin H 9 , Tytus R 10 , Rupp R 11 , Senders S 12 , Engel E 13 , Ferris D 14 , Kim YJ 15 , Tae Kim Y 16 , Kurugol Z 17 , Bautista O 18 , Nolan KM 18 , Sankaranarayanan S 18 , Saah A 18 , Luxembourg A 19

Affiliations 

  • 1 Department of Obstetrics and Gynecology, Galilee Medical Center and Azrieli Faculty of Medicine, Bar-Ilan University, Nahariya, Israel
  • 2 Synexus Clinical Research SA, Somerset West, Cape Town, South Africa
  • 3 Open Patient Data Explorative Network and Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark
  • 4 Department of Pediatrics, National Taiwan University Children's Hospital, Taipei City, Taiwan
  • 5 Department of Pediatrics, The University of British Columbia, Vancouver, British Columbia, Canada
  • 6 Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Nakhon Pathom, Thailand
  • 7 Vaccine Research Department, Foundation for the Promotion of Health and Biomedical Research of Valencia Region - Public Health, Valencia, Spain
  • 8 Department of Obstetrics and Gynecology, Facultad de Medicina Clinica Alemana, Universidad del Desarrollo, Santiago, Chile
  • 9 University of Malaya Medical Centre, Kuala Lumpur, Malaysia
  • 10 Hamilton Medical Research Group, Hamilton, Ontario, Canada
  • 11 The University of Texas Medical Branch, Galveston, Texas
  • 12 Senders Pediatrics, South Euclid, Ohio
  • 13 Bayview Research Group, Valley Village, California
  • 14 Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta University, Augusta, Georgia
  • 15 Department of Pediatrics, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, Republic of Korea
  • 16 Department of Obstetrics and Gynecology, College of Medicine, Yonsei University, Seoul, Republic of Korea
  • 17 Division of Infectious Disease, Department of Pediatrics, Faculty of Medicine, Ege University, Izmir, Turkey; and
  • 18 Merck & Co, Inc, Kenilworth, New Jersey
  • 19 Merck & Co, Inc, Kenilworth, New Jersey alain_luxembourg@merck.com
Pediatrics, 2021 01;147(1).
PMID: 33386332 DOI: 10.1542/peds.2019-4035

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

MeSH terms
Similar publications