Evidence map›Paper›PMID 25483701›Full record

Trial reportHuman vaccines & immunotherapeutics2014

Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: end-of-study analysis of a Phase III randomized trial.

Mark H Einstein, Peter Takacs, Archana Chatterjee, Rhoda S Sperling, Nahida Chakhtoura, Mark M Blatter, Jacob Lalezari, Marie-Pierre David, Lan Lin, Frank Struyf and 2 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2014. 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 68 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 5 pooled it
9.0field-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.

NCT00423046 phase3completednot on this map

Phase IIIb, Observer-blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus (HPV-6,11,16,18 L1 VLP) Recombinant Vaccine Merck & Co., Inc.]

TypeinterventionalSponsorGlaxoSmithKlineRan2007 to 2012Enrolled1,106ConditionsInfections, Papillomavirus, Papillomavirus VaccinesArmsGSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM), Gardasil ® (Merck & Co. Inc), Placebo
NCT03350698 phase4unknown statusnot on this mapstarted 2018, after this paper: background citation

Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination (Version IV Dated 24Oct2017)

TypeinterventionalSponsorEastern Virginia Medical SchoolRan2018 to 2023Enrolled100ConditionsPapillomavirus VaccinesArmsGardasil-9
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 5 syntheses or guidelines pooled it, 126 citations in OpenAlex.

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  18. Immunogenicity comparison of anThe Lancet regional health. Western Pacific · 2025
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8 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

12 authors at 9 institutions in 5 countries.

Mark H Einsteina Montefiore Medical Center and Albert Einstein College of Medicine; Obstetrics & Gynecology and Women's Health ; Bronx , NY USA.
Peter Takacs
Archana Chatterjee
Rhoda S Sperling
Nahida Chakhtoura
Mark M Blatter
Jacob Lalezari
Marie-Pierre David
Lan Lin
Frank Struyf
Gary Dubin
HPV-010 Study Group
GlaxoSmithKline (Belgium) · BEAlbert Einstein College of Medicine · USBeijing Obstetrics and Gynecology Hospital · CNDigital Research Alliance of CanadaGlaxoSmithKline (United States) · USNew York Proton Center · USQuest Clinical Research (United States) · USUniversity of Miami · USUniversity of Sioux Falls · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The observer-blind, randomized, age-stratified, head-to-head study (NCT00423046) comparing immunogenicity and safety of HPV-16/18 and HPV-6/11/16/18 vaccines in healthy women aged 18-45 y was completed. Five y after vaccination, in subjects from the Month 60 according-to-protocol cohort (seronegative and DNA negative for HPV type analyzed at baseline), serum neutralizing antibody (nAb) responses induced by HPV-16/18 vaccine remained 7.8-fold (18-26-y stratum), 5.6-fold (27-35-y stratum) and 2.3-fold (36-45-y stratum) higher than those induced by HPV-6/11/16/18 vaccine for HPV-16. For HPV-18, the fold differences were 12.1, 13.0 and 7.8, respectively. At Month 60, all (100%) subjects in HPV-16/18 vaccine group and the majority (95.7%-97.5%) in HPV-6/11/16/18 vaccine group were seropositive for HPV-16. For HPV-18, the majority (98.1%-100%) of subjects in HPV-16/18 vaccine group were seropositive; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably (61.1%-76.9%) across the 3 age strata. In the total vaccinated cohort (received ≥1 dose regardless of baseline HPV serostatus and DNA status), geometric mean titers for anti-HPV-16 and anti-HPV-18 nAb were higher in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. Based on the 5-y data, piece-wise and modified power-law models predicted a longer durability of nAb response for HPV-16/18 vaccine compared to HPV-6/11/16/18 vaccine. Beyond the differences apparent between the vaccines in terms of immunogenicity and modeled persistence of antibody responses, comparative studies including clinical endpoints would be needed to determine whether differences exist in duration of vaccine-induced protection.

Indexed as

Adjuvants, ImmunologicAdolescentAdultAntibodies, ViralFemaleHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansMiddle AgedPapillomaviridaePapillomavirus VaccinesYoung AdultAdjuvants, ImmunologicAntibodies, ViralHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18human papillomavirus vaccine, L1 type 16, 18Papillomavirus Vaccines50 μg) adsorbed on aluminum salt (500 μg Al3+)AAHS, amorphous aluminum hydroxyphosphate sulfateANOVA, analysis of varianceantibodiesAS04, Adjuvant System containing 3-O-desacyl-4’-monophosphoryl lipid A (MPLATP, according-to-protocolCervarix®CI, confidence intervalED50, effective dose producing 50% responseELISA, enzyme-linked immunosorbent assayGardasil®GMT, geometric mean titerHPV, human papillomavirushuman papillomavirusimmunogenicitymodelsMSC, medically significant conditionnAb, neutralizing antibodiesneutralizingNOAD, new onset autoimmune diseaseNOCD, new onset chronic diseasePBNA, pseudovirion-based neutralization assaySAE, serious adverse eventsafetySP, seropositivitystatisticalTVC, total vaccinated cohort

Identifiers

PMID25483701
PMCPMC4514070
OpenAlexW2127058706

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.