Long-term effectiveness of the nine-valent human papillomavirus vaccine in Scandinavian women: interim analysis after 8 years of follow-up

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

  • Kjær, Susanne Krüger
  • Mari Nygård
  • Karin Sundström
  • Christian Munk
  • Sophie Berger
  • Mensur Dzabic
  • Katrin Elisabeth Fridrich
  • Marianne Waldstrøm
  • Sveinung Wergeland Sørbye
  • Oliver Bautista
  • Thomas Group
  • Alain Luxembourg

A long-term follow-up (LTFU) of the nine-valent human papillomavirus (9vHPV) vaccine efficacy study in young women aged 16–26 years was initiated to evaluate if vaccine effectiveness for up to 14 years post-vaccination will remain above 90%. Vaccine effectiveness is measured as percent reduction in the incidence of HPV16/18/31/33/45/52/58-related high-grade cervical dysplasia in the LTFU cohort relative to expected incidence in a similar unvaccinated cohort. We report an interim analysis 8 years post-vaccination. Overall, 2029 participants from Denmark, Norway, and Sweden who received the 9vHPV vaccine during the clinical efficacy study continued into the LTFU study. National health registries were used to identify screening attendance and cervical pre-cancer/cancer diagnoses. Tissue samples were retrieved for HPV testing by PCR and pathology diagnosis adjudication. A control chart method was used to detect signals indicative of vaccine effectiveness waning below 90%. No new cases of HPV16/18/31/33/45/52/58-related high-grade cervical dysplasia were observed during the LTFU study period over 4084.2 person-years’ follow-up (per-protocol effectiveness population; n = 1448). Thus, there were no signals indicative of vaccine effectiveness waning below 90%. These observations show that the 9vHPV vaccine provides continued statistically significant protection through at least 6 years, with indications of continued effectiveness through 8 years. Trial registration: Clinicaltrials.gov: NCT00543543, NCT02653118.

OriginalsprogEngelsk
TidsskriftHuman Vaccines & Immunotherapeutics
Vol/bind17
Udgave nummer4
Sider (fra-til)943-949
ISSN2164-5515
DOI
StatusUdgivet - 2021

Bibliografisk note

Funding Information:
for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. The authors would like to thank the study participants, investigators, and study-site personnel. Medical writing assistance, under the direction of the authors, was provided by Erin Bekes, PhD, of CMC AFFINITY, McCann Health Medical Communications, in accordance with Good Publication Practice (GPP3) guidelines. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Funding Information:
Medical writing assistance, under the direction of the authors, was provided by Erin Bekes, PhD, of CMC AFFINITY, McCann Health Medical Communications, in accordance with Good Publication Practice (GPP3) guidelines. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Publisher Copyright:
© 2020 Merck & Co. Inc. Published with license by Taylor and Francis Group, LLC.

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