Evidence map›Paper›PMID 26062002›Full record

Trial reportHuman vaccines & immunotherapeutics2015

Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial.

Ting Fan Leung, Anthony Pak-Yin Liu, Fong Seng Lim, Franck Thollot, Helen May Lin Oh, Bee Wah Lee, Lars Rombo, Ngiap Chuan Tan, Roman Rouzier, Damien Friel and 7 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01462357 (Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females), which is not on this map. Cited by 30 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 5 pooled it
6.3field-weighted citation impact, top 3% 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.

NCT01462357 phase3completednot on this map

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females

TypeinterventionalSponsorGlaxoSmithKlineRan2011 to 2015Enrolled1,079ConditionsInfections, PapillomavirusArmsCervarix, Gardasil, Placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 5 syntheses or guidelines pooled it, 49 citations in OpenAlex.

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  17. The situation of vaccines for the prevention of infections in adults: An opinion paper on the situation in Spain.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019
    Article
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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

17 authors at 8 institutions in 6 countries.

Ting Fan Leunga Department of Paediatrics ; The Chinese University of Hong Kong ; Shatin , Hong Kong.
Anthony Pak-Yin Liu
Fong Seng Lim
Franck Thollot
Helen May Lin Oh
Bee Wah Lee
Lars Rombo
Ngiap Chuan Tan
Roman Rouzier
Damien Friel
Benoit De Muynck
Stéphanie De Simoni
Pemmaraju Suryakiran
Marjan Hezareh
Nicolas Folschweiller
Florence Thomas
Frank Struyf
National University of Singapore · SGAssociation Française de Pédiatrie Ambulatoire · FRChangi General Hospital · SGChinese University of Hong Kong · CNInstitut Curie · FRSingHealth Polyclinics · SGUniversity of Hong Kong · HKUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of 2 doses of the HPV-16/18 AS04-adjuvanted vaccine (HPV-16/18(2D)) vs. 2 or 3 doses of the HPV-6/11/16/18 vaccine (HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D)) in healthy girls aged 9-14 y. Girls were randomized (1:1:1) to receive HPV-16/18(2D) at months (M) 0,6 (N = 359), HPV-6/11/16/18(2D) at M0,6 (N = 358) or HPV-6/11/16/18(3D) at M0,2,6 (N = 358). The primary objective was non-inferiority/superiority of HPV-16/18 antibodies by ELISA for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) at M7 in the according-to-protocol immunogenicity cohort (ATP-I) and total vaccinated cohort, respectively. Secondary objectives included non-inferiority/superiority of HPV-16/18(2D) vs. HPV-6/11/16/18(3D) at M7, non-inferiority/superiority at M12, HPV-16/18 neutralizing antibodies, frequencies of T-cells/B-cells, reactogenicity and safety. Antibody responses at M7 for HPV-16/18(2D) were superior to those for HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) (lower limit of 95% confidence interval for geometric mean titer ratio (GMR) was >1): HPV-16/18(2D)/HPV-6/11/16/18(2D) GMRs were 1.69 [1.49-1.91] for anti-HPV-16 and 4.52 [3.97-5.13] for anti-HPV-18; HPV-16/18(2D)/HPV-6/11/16/18(3D) GMRs were 1.72 [1.54-1.93] for anti-HPV-16 and 3.22 [2.82-3.68] for anti-HPV-18; p = 0.0001 for all comparisons. Non-inferiority/superiority was also demonstrated at M12. Among initially seronegative girls in the ATP-I, neutralizing antibody titers were at least 1.8-fold higher for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) at M7 and M12. Frequencies of HPV-16/18-specific T-cells and B-cells were in similar ranges between groups. Reactogenicity and safety were in line with the known profile of each vaccine. In conclusion, superior HPV-16/18 antibody responses were elicited by 2 doses of the HPV-16/18 AS04-adjuvanted vaccine compared with 2 or 3 doses of the HPV-6/11/16/18 vaccine in girls (9-14 years).

Indexed as

Adjuvants, ImmunologicAdolescentAlphapapillomavirusAntibodies, NeutralizingAntibodies, ViralChildFemaleHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansImmunity, CellularImmunity, HumoralImmunization SchedulePapillomavirus InfectionsPapillomavirus VaccinesTime FactorsVaccine PotencyAdjuvants, ImmunologicAntibodies, NeutralizingAntibodies, ViralHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18human papillomavirus vaccine, L1 type 16, 18Papillomavirus Vaccines2D, 2-dose3D, 3-doseAAHS, aluminum hydroxyphosphate sulfateadministration scheduleANOVA, analysis of varianceAS04, Adjuvant System containing 50 µg 3-O-desacyl-4 ′-monophosphoryl lipid A (MPL) adsorbed on aluminum salt (500 µg Al3+)ATP-I, according-to-protocol immunogenicity cohortCI, confidence intervalCMI, cell-mediated immunityED50, effective dose producing 50% responseELISA, enzyme-linked immunosorbent assayELISPOT, enzyme-linked immunosorbent spot assayEU, ELISA unitfemale adolescentsGMR, geometric mean titer ratioGMT, geometric mean antibody titerHPV-16/18(2D), 2-dose schedule of the HPV-16/18 vaccineHPV-6/11/16/18(2D), 2-dose schedule of the HPV-6/11/16/18 vaccineHPV-6/11/16/18(3D), 3-dose schedule of the HPV-6/11/16/18 vaccineHPV, human papillomavirushuman papillomavirus (HPV) vaccinesIFNγ, interferonIgG, immunoglobulin GimmunogenicityM, month(s)PBMC, peripheral blood mononuclear cellsPBNA, pseudovirion-based neutralisation assaypIMD, potential immune-mediated diseaseSAE, serious adverse eventsafetyTVC, total vaccinated cohortVLP, virus-like particley, year(s)

Identifiers

PMID26062002
PMCPMC4514190
OpenAlexW1933192471

What OpenQuestion holds

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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.