Evidence map›Paper›PMID 24576907›Full record

Trial reportHuman vaccines & immunotherapeutics2014

Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination: results from a randomized study.

Barbara Romanowski, Tino F Schwarz, Linda M Ferguson, Murdo Ferguson, Klaus Peters, Marc Dionne, Karin Schulze, Brian Ramjattan, Peter Hillemanns, Ulrich Behre and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 trial NCT00541970 (Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing), which is not on this map. Cited by 51 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 4 pooled it
14.4field-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.

NCT00541970 phase1completednot on this map

Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing

TypeinterventionalSponsorGlaxoSmithKlineRan2007 to 2013Enrolled961ConditionsInfections, PapillomavirusArmsCervarix, Placebo
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 4 syntheses or guidelines pooled it, 99 citations in OpenAlex.

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  6. Immunogenicity of 2 and 3 Doses of the Quadrivalent Human Papillomavirus Vaccine up to 120 Months Postvaccination: Follow-up of a Randomized Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
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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

13 authors at 11 institutions in 6 countries.

Barbara RomanowskiUniversity of Alberta; Edmonton, AB Canada.
Tino F SchwarzCentral Laboratory and Vaccination Centre; Stiftung Juliusspital; Würzburg, Germany.
Linda M FergusonColchester Research Group; Truro, NS Canada.
Murdo FergusonColchester Research Group; Truro, NS Canada.
Klaus PetersBerner Heerweg 157; Hamburg, Germany.
Marc DionneCentre Hospitalier Universitaire; Québec, QC Canada.
Karin SchulzeWaisenhausstr. 52; Munich, Germany.
Brian RamjattanFirst Line Medical Services Ltd.; St. John's, NL Canada.
Peter HillemannsMedizinische Hochschule Hannover; Hannover, Germany.
Ulrich BehreHauptstrasse 240 Kehl Baden-Württemberg, Germany.
Pemmaraju SuryakiranGlaxoSmithKline; Bangalore, India.
Florence ThomasGlaxoSmithKline Vaccines; Wavre, Belgium.
Frank StruyfGlaxoSmithKline Vaccines; Wavre, Belgium.
Colchester School District · USBavarian State Collection of Zoology · DEGlaxoSmithKline (Belgium) · BEGlaxoSmithKline (Netherlands) · NLGlaxoSmithKline (United States) · USHamburger Fern-Hochschule · DEHealth First · USMedizinische Hochschule Hannover · DERAG Aktiengesellschaft (Germany) · DEStiftung Juliusspital · DEUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This randomized, partially-blind study (ClinicalTrials.gov registration number NCT00541970) evaluated the immunogenicity and safety of 2-dose (2D) schedules of the HPV-16/18 AS04-adjuvanted vaccine. Results to month (M) 24 have been reported previously and we now report data to M48 focusing on the licensed vaccine formulation (20 μg each of HPV-16 and -18 antigens) administered at M0,6 compared with the standard 3-dose (3D) schedule (M0,1,6). Healthy females (age stratified: 9-14, 15-19, 20-25 years) were randomized to receive 2D at M0,6 (n = 240) or 3D at M0,1,6 (n = 239). In the according-to-protocol immunogenicity cohort, all initially seronegative subjects seroconverted for HPV-16 and -18 antibodies and remained seropositive up to M48. For both HPV-16 and -18, geometric mean antibody titer (GMT) ratios (3D schedule in women aged 15-25 years divided by 2D schedule in girls aged 9-14 years) at M36 and M48 were close to 1, as they were at M7 when non-inferiority was demonstrated. The kinetics of HPV-16, -18, -31, and -45 antibody responses were similar for both groups and HPV-16 and -18 GMTs were substantially higher than natural infection titers. The vaccine had a clinically acceptable safety profile in both groups. In summary, antibody responses to a 2D M0,6 schedule of the licensed vaccine formulation in girls aged 9-14 years appeared comparable to the standard 3D schedule in women aged 15-25 years up to 4 years after first vaccination. A 2D schedule could facilitate implementation of HPV vaccination programs and improve vaccine coverage and series completion rates.

Indexed as

Adjuvants, ImmunologicAdolescentAdultChildCohort StudiesDrug Administration ScheduleFemaleHuman papillomavirus 16Human papillomavirus 18HumansImmunity, CellularPapillomavirus VaccinesTime FactorsVaccinationYoung AdultAdjuvants, ImmunologicPapillomavirus Vaccinesadministration schedulefemale adolescentshuman papillomavirus vaccineimmunogenicityrandomized controlled trialsafetywomen

Identifiers

PMID24576907
PMCPMC4896558
OpenAlexW1488317692

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.