Evidence map›Paper›PMID 22048172›Full record

Trial reportHuman vaccines2011

Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years.

Mark H Einstein, Mira Baron, Myron J Levin, Archana Chatterjee, Bradley Fox, Sofia Scholar, Jeffrey Rosen, Nahida Chakhtoura, Marie Lebacq, Robbert van der Most and 6 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00423046 (Phase IIIb, Observer-blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus), which is not on this map. Cited by 56 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 1 pooled it
10.6field-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.

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
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 1 synthesis or guideline pooled it, 114 citations in OpenAlex.

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  12. Immunogenicity of quadrivalent human papillomavirus vaccine in organ transplant recipients.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2013
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  16. Immune Responses to Human Papillomavirus After Infection and Vaccination.Current topics in microbiology and immunology · 2026
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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

16 authors at 10 institutions in 4 countries.

Mark H EinsteinDepartment of Obstetrics & Gynecology and Women's Health, Division of Gynecologic Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA. meinstei@montefiore.org
Mira Baron
Myron J Levin
Archana Chatterjee
Bradley Fox
Sofia Scholar
Jeffrey Rosen
Nahida Chakhtoura
Marie Lebacq
Robbert van der Most
Philippe Moris
Sandra L Giannini
Anne Schuind
Sanjoy K Datta
Dominique Descamps
HPV-010 Study Group
GlaxoSmithKline (Belgium) · BEGlaxoSmithKline (Switzerland) · CHClinical Research of South Florida · USCreighton University · USErie VA Medical Center · USRapid Medical Research · USThe Bronx Defenders · USUniversity of Colorado Health · USUniversity of Miami · USWalla Walla University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Protection against oncogenic non-vaccine types (cross-protection) offered by human papillomavirus (HPV) vaccines may provide a significant medical benefit. Available clinical efficacy data suggest the two licensed vaccines (HPV-16/18 vaccine, GlaxoSmithKline Biologicals (GSK), and HPV-6/11/16/18 vaccine, Merck & Co., Inc.) differ in terms of protection against oncogenic non-vaccine HPV types -31/45. The immune responses induced by the two vaccines against these two non-vaccine HPV types (cross-reactivity) was compared in an observer-blind study up to Month 24 (18 mo post-vaccination), in women HPV DNA-negative and seronegative prior to vaccination for the HPV type analyzed (HPV-010 [NCT00423046]). Geometric mean antibody titers (GMTs) measured by pseudovirion-based neutralization assay (PBNA) and enzyme-linked immunosorbent assay (ELISA) were similar between vaccines for HPV-31/45. Seropositivity rates for HPV-31 were also similar between vaccines; however, there was a trend for higher seropositivity with the HPV-16/18 vaccine (13.0-16.7%) versus the HPV-6/11/16/18 vaccine (0.0-5.0%) for HPV-45 with PBNA, but not ELISA. HPV-31/45 cross-reactive memory B-cell responses were comparable between vaccines. Circulating antigen-specific CD4+ T-cell frequencies were higher for the HPV-16/18 vaccine than the HPV-6/11/16/18 vaccine (HPV-31 [geometric mean ratio [GMR] =2.0; p=0.0002] and HPV-45 [GMR=2.6; p=0.0092]), as were the proportion of T-cell responders (HPV-31, p=0.0009; HPV-45, p=0.0793). In conclusion, immune response to oncogenic non-vaccine HPV types -31/45 was generally similar for both vaccines with the exception of T-cell response which was higher with the HPV-16/18 vaccine. Considering the differences in cross-protective efficacy between the two vaccines, the results might provide insights into the underlying mechanism(s) of protection.

Indexed as

AdolescentAdultAlphapapillomavirusAntibodies, NeutralizingAntibodies, ViralCD4-Positive T-LymphocytesFemaleHuman papillomavirus 31Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansMiddle AgedPapillomavirus InfectionsPapillomavirus VaccinesTreatment OutcomeVaccinationYoung AdultAntibodies, NeutralizingAntibodies, ViralHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18human papillomavirus vaccine, L1 type 16, 18Papillomavirus Vaccines

Identifiers

PMID22048172
PMCPMC3338933
OpenAlexW1979230907

What OpenQuestion holds

Textmetadata
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.