Evidence map›Paper›PMID 33326342›Full record

ArticleHuman vaccines & immunotherapeutics2021

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

Susanne K Kjaer, Mari Nygård, Karin Sundström, Christian Munk, Sophie Berger, Mensur Dzabic, Katrin Elisabeth Fridrich, Marianne Waldstrøm, Sveinung Wergeland Sørbye, Oliver Bautista and 2 more

2 registry-linked trialsOpen access · bronzeAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00543543 phase3completednot on this map

A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26- Year-Old Women

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2007 to 2016Enrolled14,840ConditionsCervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital WartsArmsComparator: GARDASIL, Experimental: V503
NCT02653118 active not recruitingnot on this map

A Registry-Based Extension of Protocol V503-001 in Countries With Centralized Cervical Cancer Screening Infrastructures to Evaluate the Long-Term Effectiveness, Immunogenicity, and Safety of Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine as Administered to 16- to 26- Year-Old Women

TypeobservationalSponsorMerck Sharp & Dohme LLCRan2016 to 2040Enrolled4,453ConditionsCervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital WartsArmsV503, GARDASIL
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. HPV vaccination associates withFrontiers in microbiology · 2026
    Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
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  11. HPV16 Genomes:Current genomics · 2024
    Article
  12. Article
  13. Human Papillomavirus Vaccination.The New England journal of medicine · 2023
    Review
  14. Article
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  16. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 4 countries.

Susanne K KjaerUnit of Virus, Lifestyle & Genes, Danish Cancer Society Research Center, Copenhagen, Denmark.
Mari NygårdUnit of HPV-Related Epidemiological Research, Department of Research, Cancer Registry of Norway, Oslo, Norway.
Karin SundströmDepartment of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.
Christian MunkUnit of Virus, Lifestyle & Genes, Danish Cancer Society Research Center, Copenhagen, Denmark.
Sophie BergerUnit of HPV-Related Epidemiological Research, Department of Research, Cancer Registry of Norway, Oslo, Norway.
Mensur DzabicKarolinska University Laboratory, Clinical Pathology, Stockholm, Sweden.
Katrin Elisabeth FridrichDepartment of Pathology, Akershus University Hospital, Lørenskog, Norway.
Marianne WaldstrømDepartment of Pathology Vejle Hospital, Lillebaelt Hospital, Beriderbakken, Denmark.
Sveinung Wergeland SørbyeDepartment of Clinical Pathology, University Hospital of North Norway, Tromsø, Norway.
Oliver BautistaMerck & Co., Inc., Kenilworth, NJ, USA.
Thomas GroupMerck & Co., Inc., Kenilworth, NJ, USA.
Alain LuxembourgMerck & Co., Inc., Kenilworth, NJ, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCancer Registry of Norway · NOAkershus University Hospital · NODanish Cancer Society · DKKarolinska Institutet · SEKarolinska University Hospital · SEUniversity Hospital of North Norway · NOUniversity of Copenhagen · DKVejle Sygehus · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 registrationClinicaltrials.gov: NCT00543543, NCT02653118.

Indexed as

Papillomavirus InfectionsPapillomavirus VaccinesUterine Cervical NeoplasmsFemaleFollow-Up StudiesHuman papillomavirus 16Human papillomavirus 18HumansNorwayPapillomavirus VaccinesCervical intraepithelial neoplasiaeffectivenesshuman papillomaviruslong-term follow-upnine-valent human papillomavirus vaccinevaccine

Identifiers

PMID33326342
PMCPMC8018381
OpenAlexW3113198324

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.