Immunogenicity of HPV prophylactic vaccines: Serology assays and their use in HPV vaccine evaluation and development

Details

• Alternative Title:
  Vaccine
• Personal Author:
  Pinto, Ligia A. ; Dillner, Joakim ; Beddows, Simon ; Unger, Elizabeth R.
• Description:
  When administered as standard three-dose schedules, the licensed HPV prophylactic vaccines have demonstrated extraordinary immunogenicity and efficacy. We summarize the immunogenicity of these licensed vaccines and the most commonly used serology assays, with a focus on key considerations for one-dose vaccine schedules. Although immune correlates of protection against infection are not entirely clear, both preclinical and clinical evidence point to neutralizing antibodies as the principal mechanism of protection. Thus, immunogenicity assessments in vaccine trials have focused on measurements of antibody responses to the vaccine. Non-inferiority of antibody responses after two doses of HPV vaccines separated by 6 months has been demonstrated and this evidence supported the recent WHO recommendations for two-dose vaccination schedules in both boys and girls 9-14 years of age. There is also some evidence suggesting that one dose of HPV vaccines may provide protection similar to the currently recommended two-dose regimens but robust data on efficacy and immunogenicity of one-dose vaccine schedules are lacking. In addition, immunogenicity has been assessed and reported using different methods, precluding direct comparison of results between different studies and vaccines. New head-to-head vaccine trials evaluating one-dose immunogenicity and efficacy have been initiated and an increase in the number of trials relying on immunobridging is anticipated. Therefore, standardized measurement and reporting of immunogenicity for the up to nine HPV types targeted by the current vaccines is now critical. Building on previous HPV serology assay standardization and harmonization efforts initiated by the WHO HPV LabNet in 2006, new secondary standards, critical reference reagents and testing guidelines will be generated as part of a new partnership to facilitate harmonization of the immunogenicity testing in new HPV vaccine trials.
• Subjects:
  Adolescent Antibodies, Neutralizing Antibodies, Viral Child Clinical Trials As Topic Female Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 Humans Immunization Schedule Immunogenicity, Vaccine Male Mass Vaccination Neutralization Tests Papillomavirus Infections Papillomavirus Vaccines Treatment Outcome Uterine Cervical Neoplasms

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• Source:
  Vaccine. 2018; 36(32Part A):4792-4799
• Pubmed ID:
  29361344
• Pubmed Central ID:
  PMC6050153
• Document Type:
  Journal Article
• Funding:
  HHSN261200800001C/RC/CCR NIH HHS/United States ; HHSN261200800001E/CA/NCI NIH HHS/United States ; Z99 CA999999/NULL/International
• Name as Subject:
  World Health Organization
• Volume:
  36
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:be639ebe02fdfa8ba5ff5f69dc2cc28588b929d3284a31540bf3e1e939902017
• Download URL:
  https://stacks.cdc.gov/view/cdc/61569/cdc_61569_DS1.pdf
• File Type:
  [PDF - 738.07 KB ]