Evidence map›Paper›PMID 25483700›Full record

Trial reportHuman vaccines & immunotherapeutics2014

Comparative humoral and cellular 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: follow-up through Month 48 in a Phase III randomized study.

Mark H Einstein, Myron J Levin, Archana Chatterjee, Nahida Chakhtoura, Peter Takacs, Grégory Catteau, Francis J Dessy, Philippe Moris, 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 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 7% 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
NCT04920526 unknown statusnot on this mapstarted 2021, after this paper: background citation

Effectiveness of the QHPV Among Kenyan HIV Infected Girls and Boys 9 Years Post Vaccination

TypeobservationalSponsorKenya Medical Research InstituteRan2021 to 2022Enrolled135ConditionsHPV-Related CarcinomaArmsQuadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

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  19. Successful Vaccines.Current topics in microbiology and immunology · 2020
    Review
  20. HPV vaccination in HIV infection.Papillomavirus research (Amsterdam, Netherlands) · 2019
    Review
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 6 institutions in 4 countries.

Mark H Einsteina Montefiore Medical Center; Albert Einstein College of Medicine; Department of Obstetrics & Gynecology and Women's Health ; Bronx , NY USA.
Myron J Levin
Archana Chatterjee
Nahida Chakhtoura
Peter Takacs
Grégory Catteau
Francis J Dessy
Philippe Moris
Lan Lin
Frank Struyf
Gary Dubin
HPV-010 Study Group
GlaxoSmithKline (Netherlands) · NLGlaxoSmithKline (Belgium) · BEUniversity of Miami · USAlbert Einstein College of Medicine · USUniversity of Colorado Denver · USUniversity of South Dakota · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We previously reported higher anti-HPV-16 and -18 immune responses induced by HPV-16/18 vaccine compared with HPV-6/11/16/18 vaccine at Month 7 (one month after completion of full vaccination series) in women aged 18-45 y in an observer-blind study NCT00423046; the differences of immune response magnitudes were maintained up to Month 24. Here we report follow-up data through Month 48. At Month 48, in according-to-protocol cohort for immunogenicity (seronegative and DNA-negative for HPV type analyzed at baseline), geometric mean titers of serum neutralizing antibodies were 2.0- to 5.2-fold higher (HPV-16) and 8.6- to 12.8-fold higher (HPV-18) in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. The majority of women in both vaccine groups remained seropositive for HPV-16. The same trend was observed for HPV-18 in HPV-16/18 vaccine group; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably, particularly in the older age groups. In the total vaccinated cohort (regardless of baseline serological and HPV-DNA status), anti-HPV-16 and -18 neutralizing antibody levels induced by HPV-16/18 vaccine were higher than those induced by HPV-6/11/16/18 vaccine. CD4+ T-cell response for HPV-16 and HPV-18 was higher in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. Memory B-cell responses appeared similar between vaccine groups. Both vaccines were generally well tolerated. Overall, the higher immune response observed with the HPV-16/18 vaccine was maintained up to Month 48. A head-to-head study incorporating clinical endpoints would be required to confirm whether the observed differences in immune response between the vaccines influence the duration of protection they provided.

Indexed as

AdolescentAdultAntibodies, ViralB-LymphocytesCD4-Positive T-LymphocytesFemaleFollow-Up StudiesHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansImmunologic MemoryMiddle AgedPapillomavirus VaccinesYoung AdultAntibodies, ViralHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18human papillomavirus vaccine, L1 type 16, 18Papillomavirus Vaccines50 μg) adsorbed on aluminum salt (500 μg Al(OH)3)ANOVA, analysis of varianceAS04, Adjuvant System containing 3-O-desacyl-4’-monophosphoryl lipid A (MPLATP, according-to-protocolCervarix®CI, confidence intervalCMI, cell-mediated immuneCVS, cervicovaginal secretionED50, effective dose producing 50% responseELISA, enzyme-linked immunosorbent assayGardasil®GM, geometric meanGMR, geometric mean (titer) ratioGMT, geometric mean titerHPA, Health Protection AgencyHPV, human papillomavirushuman papillomavirusIgG, immunoglobulin GimmunogenicityMSC, medically significant conditionnAb(s), neutralizing antibody(ies)NOAD, new onset autoimmune diseaseNOCD, new onset chronic diseasePBMC, peripheral blood mononuclear cellsPBNA, pseudovirion-based neutralization assaySAE, serious adverse eventsafetyTVC, total vaccinated cohortVLP, virus-like particle

Identifiers

PMID25483700
PMCPMC4514093
OpenAlexW2119984240

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.