Evidence map›Paper›PMID 32637895›Full record

ArticleEClinicalMedicine2020

Final analysis of a 14-year long-term follow-up study of the effectiveness and immunogenicity of the quadrivalent human papillomavirus vaccine in women from four nordic countries.

Susanne K Kjaer, Mari Nygård, Karin Sundström, Joakim Dillner, Laufey Tryggvadottir, Christian Munk, Sophie Berger, Espen Enerly, Maria Hortlund, Ágúst Ingi Ágústsson and 12 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00092534 (A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16/18-Related CIN 2/3 or Worse of the Quadrivalent HPV), which is not on this map. Cited by 101 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
101citing papers in PubMed, 5 pooled it
14.8field-weighted citation impact, top 1% 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.

NCT00092534 phase3completednot on this map

A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16/18-Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year Old Women - The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2002 to 2025Enrolled12,167ConditionsCervical Cancer, Genital WartsArmsGardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine, Matching Placebo
3 · Its place in the literature

Who cites it

101 citing papers in PubMed, 5 syntheses or guidelines pooled it, 186 citations in OpenAlex.

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41 more citing papers are in PubMed but not listed here.

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

22 authors at 10 institutions in 5 countries.

Susanne K KjaerUnit of Virus, Lifestyle & Genes, Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Mari NygårdDepartment of Research, Cancer Registry of Norway, Oslo, Norway.
Karin SundströmDepartment of Laboratory Medicine, Karolinska Instituet, Stockholm, Sweden.
Joakim DillnerDepartment of Laboratory Medicine, Karolinska Instituet, Stockholm, Sweden.
Laufey TryggvadottirIcelandic Cancer Registry, Icelandic Cancer Society, Faculty of Medicine, BMC, Laeknagardur, University of Iceland, Reykjavik, Iceland.
Christian MunkUnit of Virus, Lifestyle & Genes, Danish Cancer Society Research Center, Copenhagen, Denmark.
Sophie BergerDepartment of Research, Cancer Registry of Norway, Oslo, Norway.
Espen EnerlyDepartment of Research, Cancer Registry of Norway, Oslo, Norway.
Maria HortlundDepartment of Laboratory Medicine, Karolinska Instituet, Stockholm, Sweden.
Ágúst Ingi ÁgústssonCancer Detection Clinic, Icelandic Cancer Society, Reykjavik, Iceland.
Kaj BjelkenkrantzDepartment of Clinical Pathology and Cytology, Unilabs, Eskilstuna, Sweden.
Katrin FridrichAkershus University Hospital, Norway.
Ingibjorg GuðmundsdóttirIcelandic Cancer Society, Pathology, Reykjavík, Iceland.
Sveinung Wergeland SørbyeDepartment of Clinical Pathology, University Hospital of North Norway, Trømso, Norway.
Oliver BautistaMerck & Co., Inc., Kenilworth, NJ, United States.
Thomas GroupMerck & Co., Inc., Kenilworth, NJ, United States.
Alain LuxembourgMerck & Co., Inc., Kenilworth, NJ, United States.
J Brooke MarshallMerck & Co., Inc., Kenilworth, NJ, United States.
David RadleyMerck & Co., Inc., Kenilworth, NJ, United States.
Yi Shen YangMerck & Co., Inc., Kenilworth, NJ, United States.
Cyrus BadshahMerck & Co., Inc., Kenilworth, NJ, United States.
Alfred SaahMerck & Co., Inc., Kenilworth, NJ, United States.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCancer Registry of Norway · NOKarolinska Institutet · SEIcelandic Cancer Society · ISAkershus University Hospital · NODanish Cancer Society · DKEskilstuna Municipality · SEUniversity Hospital of North Norway · NOUniversity of Copenhagen · DKUniversity of Iceland · IS

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe quadrivalent human papillomavirus (qHPV) vaccine prevented vaccine HPV type-related infection and disease in young women in the 4-year FUTURE II efficacy study (NCT00092534). We report long-term effectiveness and immunogenicity at the end of 14 years of follow-up after enrollment in FUTURE II.

methodsYoung women (16-23 years of age) from Denmark, Iceland, Norway, and Sweden who received three qHPV vaccine doses during the randomized, double-blind, placebo-controlled FUTURE II base study were followed for effectiveness for an additional ≥10 years through national registries. Tissue samples including but not limited to those collected during organized cervical cancer screening programs were obtained from regional biobanks to be adjudicated for histopathology diagnosis and tested for HPV DNA. The observed incidence of HPV16/18-related high-grade cervical dysplasia (primary outcome) was compared with recent historical background incidence rates in an unvaccinated population. Serum was collected at years 9 and 14 to assess antibody responses.

findingsNo cases of HPV16/18-related high-grade cervical dysplasia were observed in the per-protocol effectiveness population (

interpretationVaccination of young women with qHPV vaccine offers durable protection against HPV16/18-related high-grade cervical dysplasia for ≥12 years, with a trend toward continued protection through 14 years post-vaccination, and induces sustained HPV6/11/16/18 antibody responses for up to 14 years post-vaccination. There was no evidence of waning immunity, suggesting no need for a booster dose during that period.

fundingMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Indexed as

Cervical intraepithelial neoplasiaHuman papillomavirusLong-term follow-upQuadrivalent hpv vaccine

Identifiers

PMID32637895
PMCPMC7329692
OpenAlexW3036651224

What OpenQuestion holds

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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.