Evidence map›Paper›PMID 26084514›Full record

Trial reportClinical and vaccine immunology : CVI2015

Evaluation of the Long-Term Anti-Human Papillomavirus 6 (HPV6), 11, 16, and 18 Immune Responses Generated by the Quadrivalent HPV Vaccine.

Mari Nygård, Alfred Saah, Christian Munk, Laufey Tryggvadottir, Espen Enerly, Maria Hortlund, Lara G Sigurdardottir, Scott Vuocolo, Susanne K Kjaer, Joakim Dillner

Registry-linked trialOpen access · diamondAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and vaccine immunology : CVI, 2015. 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 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
8.9field-weighted citation impact, top 2% 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

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 91 citations in OpenAlex.

  1. Pooled it
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  12. Human papillomavirus in Italy: retrospective cohort analysis and preliminary vaccination effect from real-world data.The European journal of health economics : HEPAC : health economics in prevention and care · 2021
    Observational
  13. Review
  14. Prospects for mucosal vaccine: shutting the door on SARS-CoV-2.Human vaccines & immunotherapeutics · 2020
    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

10 authors at 5 institutions in 5 countries.

Mari NygårdDepartment of Research, Cancer Registry of Norway, Oslo, Norway mari.nygard@kreftregisteret.no.
Alfred SaahMerck & Co., Inc., Kenilworth, New Jersey, USA.
Christian MunkUnit of Virus, Lifestyle and Genes, Danish Cancer Society Research Center, Copenhagen, Denmark.
Laufey TryggvadottirIcelandic Cancer Registry, Reykjavik, Iceland Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
Espen EnerlyDepartment of Research, Cancer Registry of Norway, Oslo, Norway.
Maria HortlundDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
Lara G SigurdardottirIcelandic Cancer Registry, Reykjavik, Iceland Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
Scott VuocoloMerck & Co., Inc., Kenilworth, New Jersey, USA.
Susanne K KjaerUnit of Virus, Lifestyle and Genes, Danish Cancer Society Research Center, Copenhagen, Denmark Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Joakim DillnerDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
Cancer Registry of Norway · NODanish Cancer Society · DKIcelandic Cancer Society · ISKarolinska Institutet · SEMerck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This quadrivalent human papillomavirus (qHPV) (HPV6, -11, -16, and -18) vaccine long-term follow-up (LTFU) study is an ongoing extension of a pivotal clinical study (FUTURE II) taking place in the Nordic region. The LTFU study was designed to evaluate the effectiveness, immunogenicity, and safety of the qHPV vaccine (Gardasil) for at least 10 years following completion of the base study. The current report presents immunogenicity data from testing samples of the year 5 LTFU visit (approximately 9 years after vaccination). FUTURE II vaccination arm subjects, who consented to being followed in the LTFU, donated serum at regular intervals and in 2012. Anti-HPV6, -11, -16, and -18 antibodies were detected by the competitive Luminex immunoassay (cLIA), and in addition, serum samples from 2012 were analyzed by the total IgG Luminex immunoassay (LIA) (n = 1,598). cLIA geometric mean titers (GMTs) remained between 70% and 93% of their month 48 value depending on HPV type. For all HPV types, the lower bound of the 95% confidence interval (CI) for the year 9 GMTs remained above the serostatus cutoff value. The proportion of subjects who remained seropositive based on the IgG LIA was higher than the proportion based on cLIA, especially for anti-HPV18. As expected, the anti-HPV serum IgG and cLIA responses were strongly correlated for all HPV types. Anti-HPV GMTs and the proportion of vaccinated individuals who are seropositive remain high for up to 9 years of follow-up after vaccination.

Indexed as

AdolescentAntibodies, ViralDouble-Blind MethodFemaleFollow-Up StudiesHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansImmunoassayImmunoglobulin GPapillomavirus InfectionsSerumTime FactorsYoung AdultAntibodies, ViralHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18Immunoglobulin G

Identifiers

PMID26084514
PMCPMC4519713
OpenAlexW1865606554

What OpenQuestion holds

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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.