Evidence map›Paper›PMID 25208608›Full record

ArticleBJOG : an international journal of obstetrics and gynaecology2015

Persistence of immune responses to the HPV-16/18 AS04-adjuvanted vaccine in women aged 15-55 years and first-time modelling of antibody responses in mature women: results from an open-label 6-year follow-up study.

T Schwarz, M Spaczynski, A Kaufmann, J Wysocki, A Gałaj, K Schulze, P Suryakiran, F Thomas, D Descamps

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in BJOG : an international journal of obstetrics and gynaecology, 2015. 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 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 8% 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.

NCT00196937 phase3completednot on this map

Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up

TypeinterventionalSponsorGlaxoSmithKlineRan2004 to 2005Enrolled667ConditionsInfections, PapillomavirusArmsCervarix
NCT00947115 phase3completednot on this map

Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2015Enrolled525ConditionsInfections, PapillomavirusArmsBlood sampling, Cervico-vaginal secretion (CVS) samples
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Prophylactic HPV vaccination in HPV-related gynecologic cancers: European Society of Gynecological Oncology (ESGO) prevention committee opinion.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Guideline
  2. Guideline
  3. Trial
  4. Trial
  5. Trial
  6. [Vaccine prevention of HPV-associated diseases].Dermatologie (Heidelberg, Germany) · 2026
    Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. [Prevention of HPV-induced diseases by prophylactic vaccination].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2021
    Review
  14. Review
  15. Review
  16. Article
  17. Article
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  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 4 countries.

T SchwarzCentral Laboratory and Vaccination Centre, Stiftung Juliusspital, Würzburg, Germany.
M Spaczynski
A Kaufmann
J Wysocki
A Gałaj
K Schulze
P Suryakiran
F Thomas
D Descamps
GlaxoSmithKline (Belgium) · BECharité - Universitätsmedizin Berlin · DEGlaxoSmithKline (India) · INPoznan University of Medical Sciences · PLStiftung Juliusspital · DE

Funding

The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI ROBERT A. PARKER · 2004 to 2026
$94.4M
The Harvard Clinical and Translational Science CenterUL1TR002541 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2018 to 2022
$93.0M
NCATS NIH HHS UL1 TR002541NIAID NIH HHS P30 AI060354
6 · The paper itself

Abstract

objectiveEvaluation of the long-term HPV-16/18 AS04-adjuvanted vaccine immunogenicity persistence in women.

designMulticentre, open-label, long-term follow-up (NCT00947115) of a primary phase-III study (NCT00196937).

settingSix centres in Germany and Poland. POPULATION: 488 healthy women (aged 15-55 years, age-stratified into groups: 15-25, 26-45, and 46-55 years) who received three vaccine doses in the primary study.

methodsImmune responses were evaluated in serum and cervicovaginal secretion (CVS) samples 6 years after dose 1. Anti-HPV-16/18 geometric mean titres (GMTs) were measured by enzyme-linked immunosorbent assay (ELISA), and were used to fit the modified power-law and piecewise models, predicting long-term immunogenicity. Serious adverse events (SAEs) were recorded.

main outcome measuresAnti-HPV-16/18 seropositivity rates and GMTs 6 years after dose 1.

resultsAt 6 years after dose 1, all women were seropositive for anti-HPV-16 and ≥97% were seropositive for anti-HPV-18 antibodies. GMTs ranged from 277.7 to 1344.6 EU/ml, and from 97.6 to 438.2 EU/ml, for anti-HPV-16 and anti-HPV-18, respectively. In all age groups, GMTs were higher (anti-HPV-16, 9.3-45.1-fold; anti-HPV-18, 4.3-19.4-fold) than levels associated with natural infection (29.8 EU/ml). A strong correlation between serum and CVS anti-HPV-16/18 levels was observed, with correlation coefficients of 0.81-0.96 (anti-HPV-16) and 0.69-0.84 (anti-HPV-18). Exploratory modelling based on the 6-year data predicted vaccine-induced anti-HPV-16/18 levels above natural infection levels for at least 20 years, except for anti-HPV-18 in the older age group (piecewise model). One vaccine-related and two fatal SAEs were reported.

conclusionsAt 6 years after vaccination, immune responses induced by the HPV-16/18 AS04-adjuvanted vaccine were sustained in all age groups.

Indexed as

AdolescentAdultAge FactorsAntibodies, ViralEnzyme-Linked Immunosorbent AssayFemaleFollow-Up StudiesHuman papillomavirus 16Human papillomavirus 18HumansMiddle AgedPapillomavirus InfectionsPapillomavirus VaccinesUterine Cervical NeoplasmsYoung AdultAntibodies, Viralhuman papillomavirus vaccine, L1 type 16, 18Papillomavirus VaccinesHPV-16/18 AS04-adjuvanted vaccinehuman papillomaviruspersistence

Identifiers

PMID25208608
PMCPMC4489326
OpenAlexW2070430511

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.