Evidence map›Paper›PMID 26176261›Full record

Trial reportHuman vaccines & immunotherapeutics2016

Sustained immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine administered as a two-dose schedule in adolescent girls: Five-year clinical data and modeling predictions from a randomized study.

Barbara Romanowski, Tino F Schwarz, Linda Ferguson, Klaus Peters, Marc Dionne, Ulrich Behre, Karin Schulze, Peter Hillemanns, Pemmaraju Suryakiran, Florence Thomas and 1 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, 2016. 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 47 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 4 pooled it
9.2field-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.

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

47 citing papers in PubMed, 4 syntheses or guidelines pooled it, 93 citations in OpenAlex.

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  13. The recent advances in vaccine adjuvants.Frontiers in immunology · 2025
    Review
  14. Efficacy, effectiveness and immunogenicity of reduced HPV vaccination schedules: A review of available evidence.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2024
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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

11 authors at 6 institutions in 3 countries.

Barbara Romanowskia University of Alberta ; Edmonton , AB , Canada.
Tino F Schwarzb Central Laboratory and Vaccination Center; Stiftung Juliusspital ; Würzburg , Germany.
Linda Fergusonc Colchester Research Group ; Truro , NS , Canada.
Klaus Petersd Berner Heerweg 157 ; Hamburg , Germany.
Marc Dionnee Centre Hospitalier Universitaire ; Québec , QC , Canada.
Ulrich Behref Hauptstrasse 240; Kehl Baden-Württemberg ; Germany.
Karin Schulzeg Waisenhausstrasse 52 ; Munich , Germany.
Peter Hillemannsh Medizinische Hochschule Hannover ; Hannover , Germany.
Pemmaraju Suryakirani GlaxoSmithKline ; Bangalore , India.
Florence Thomasj GSK Vaccines ; Wavre , Belgium.
Frank Struyfj GSK Vaccines ; Wavre , Belgium.
GlaxoSmithKline (Netherlands) · NLMedizinische Hochschule Hannover · DEQuebec - Clinical Research Organization in Cancer · CAStiftung Juliusspital · DEUniversity of Alberta · CAUniversity of Applied Sciences Kehl · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this randomized, partially-blind study ( clinicaltrials.gov ; NCT00541970), the licensed formulation of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (20 μg each of HPV-16/18 antigens) was found highly immunogenic up to 4 y after first vaccination, whether administered as a 2-dose (2D) schedule in girls 9-14 y or 3-dose (3D) schedule in women 15-25 y. This end-of-study analysis extends immunogenicity and safety data until Month (M) 60, and presents antibody persistence predictions estimated by piecewise and modified power law models. Healthy females (age stratified: 9-14, 15-19, 20-25 y) were randomized to receive 2D at M0,6 (N = 240 ) or 3D at M0,1,6 (N = 239). Here, results are reported for girls 9-14 y (2D) and women 15-25 y (3D). Seropositivity rates, geometric mean titers (by enzyme-linked immunosorbent assay) and geometric mean titer ratios (GMRs; 3D/2D; post-hoc exploratory analysis) were calculated. All subjects seronegative pre-vaccination in the according-to-protocol immunogenicity cohort were seropositive for anti-HPV-16 and -18 at M60. Antibody responses elicited by the 2D and 3D schedules were comparable at M60, with GMRs close to 1 (anti-HPV-16: 1.13 [95% confidence interval: 0.82-1.54]; anti-HPV-18: 1.06 [0.74-1.51]). Statistical modeling predicted that in 95% of subjects, antibodies induced by 2D and 3D schedules could persist above natural infection levels for ≥ 21 y post-vaccination. The vaccine had a clinically acceptable safety profile in both groups. In conclusion, a 2D M0,6 schedule of the HPV-16/18 AS04-adjuvanted vaccine was immunogenic for up to 5 y in 9-14 y-old girls. Statistical modeling predicted that 2D-induced antibodies could persist for longer than 20 y.

Indexed as

Immunization ScheduleAdjuvants, ImmunologicAdolescentAluminum HydroxideAntibodies, ViralChildDrug-Related Side Effects and Adverse ReactionsFemaleHuman papillomavirus 16Human papillomavirus 18HumansLipid APapillomavirus InfectionsPapillomavirus VaccinesTime FactorsTreatment OutcomeAdjuvants, ImmunologicAluminum HydroxideAntibodies, ViralASO4 mixtureLipid APapillomavirus Vaccinesadministration schedulefemale adolescentshuman papillomavirus vaccineimmunogenicityrandomized controlled trialsafetywomen

Identifiers

PMID26176261
PMCPMC4962738
OpenAlexW918099573

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.