Evidence map›Paper›PMID 28984053›Full record

ArticleCancer medicine2017

Ten-year immune persistence and safety of the HPV-16/18 AS04-adjuvanted vaccine in females vaccinated at 15-55 years of age.

Tino F Schwarz, Andrzej Galaj, Marek Spaczynski, Jacek Wysocki, Andreas M Kaufmann, Sylviane Poncelet, Pemmaraju V Suryakiran, Nicolas Folschweiller, Florence Thomas, Lan Lin and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Cancer medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00196937 (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), which is not on this map. Cited by 41 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  12. Cost-effectiveness analysis of 9-valent human papillomavirus vaccine combined with screening for cervical cancer in Japan.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
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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.

Tino F SchwarzCentral Laboratory and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Würzburg, Germany.ORCID http://orcid.org/0000-0003-1505-1823
Andrzej GalajNZOZ Vitamed, Bydgoszcz, Poland.
Marek SpaczynskiFaculty of Medicine and Health Sciences, University of Zielona Gora, Zielona Gora, Poland.
Jacek WysockiDepartment of Preventive Medicine, Poznan University of Medical Sciences, Poznan, Poland.
Andreas M KaufmannDepartment of Gynecology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Sylviane PonceletGSK, Rixensart, Belgium.
Pemmaraju V SuryakiranGSK, Bangalore, India.
Nicolas FolschweillerGSK, Wavre, Belgium.
Florence ThomasGSK, Wavre, Belgium.
Lan LinGSK, Wavre, Belgium.
Frank StruyfGSK, Wavre, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Women remain at risk of human papillomavirus (HPV) infection for most of their lives. The duration of protection against HPV-16/18 from prophylactic vaccination remains unknown. We investigated the 10-year immune response and long-term safety profile of the HPV-16/18 AS04-adjuvanted vaccine (AS04-HPV-16/18 vaccine) in females aged between 15 and 55 years at first vaccination. Females who received primary vaccination with three doses of AS04-HPV-16/18 vaccine in the primary phase-III study (NCT00196937) were invited to attend annual evaluations for long-term immunogenicity and safety. Anti-HPV-16/18 antibodies in serum and cervico-vaginal secretions (CVS) were measured using enzyme-linked immunosorbent assay (ELISA). Serious adverse events (SAEs) were recorded throughout the follow-up period. Seropositivity rates for anti-HPV-16 remained high (≥96.3%) in all age groups 10 years after first vaccination. It was found that 99.2% of 15-25-year olds remained seropositive for anti-HPV-18 compared to 93.7% and 83.8% of 26-45-year olds and 45-55-year olds, respectively. Geometric mean titers (GMT) remained above natural infection levels in all age groups. Anti-HPV-16 and anti-HPV-18 titers were at least 5.3-fold and 3.1-fold higher than titers observed after natural infection, respectively, and were predicted to persist above natural infection levels for ≥30 years in all age groups. At Year 10, anti-HPV-16/18 antibody titers in subjects aged 15-25 years remained above plateau levels observed in previous studies. Correlation coefficients for antibody titers in serum and CVS were 0.64 (anti-HPV-16) and 0.38 (anti-HPV-18). This study concluded that vaccinated females aged 15-55 years elicited sustained immunogenicity with an acceptable safety profile up to 10 years after primary vaccination, suggesting long-term protection against HPV.

Indexed as

VaccinationAdolescentAdultAntibodies, ViralBodily SecretionsCervix UteriFemaleFollow-Up StudiesHuman papillomavirus 16Human papillomavirus 18HumansMiddle AgedPapillomavirus InfectionsPapillomavirus VaccinesUterine Cervical NeoplasmsVaginaAntibodies, ViralPapillomavirus VaccinesAS04-HPV-16/18 vaccineolder womenpersistencesafety

Identifiers

PMID28984053
PMCPMC5673947

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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.