Evidence map›Paper›PMID 25651922›Full record

Trial reportClinical and vaccine immunology : CVI2015

Efficacy of human papillomavirus 16 and 18 (HPV-16/18) AS04-adjuvanted vaccine against cervical infection and precancer in young women: final event-driven analysis of the randomized, double-blind PATRICIA trial.

Dan Apter, Cosette M Wheeler, Jorma Paavonen, Xavier Castellsagué, Suzanne M Garland, S Rachel Skinner, Paulo Naud, Jorge Salmerón, Song-Nan Chow, Henry C Kitchener and 18 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical and vaccine immunology : CVI, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
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

28 authors.

Dan ApterFamily Federation of Finland, Sexual Health Clinic, Helsinki, Finland dan.apter@vaestoliitto.fi.
Cosette M WheelerDepartments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.
Jorma PaavonenDepartment of Obstetrics and Gynaecology, University of Helsinki, Helsinki, Finland.
Xavier CastellsaguéCancer Epidemiology Research Program, Institut Català d'Oncologia (ICO), IDIBELL, Biomedical Research Centre Network for Epidemiology and Public Health (CIBER-ESP), L'Hospitalet de Llobregat, Catalonia, Spain.
Suzanne M GarlandMicrobiology and Infectious Diseases Department, Royal Women's Hospital and Department of Obstetrics and Gynaecology, University of Melbourne, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.
S Rachel SkinnerVaccine Trials Group, Telethon Institute for Child Health Research, Perth, Western Australia, and Sydney University Discipline of Paediatrics and Child Health, Children's Hospital at Westmead, Sydney, New South Wales, Australia.
Paulo NaudUniversity Federal of Rio Grande do Sul, Hospital de Clínica de Porto Alegre, Porto Alegre, Brazil.
Jorge SalmerónUnidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Morelos, Mexico.
Song-Nan ChowDepartment of Obstetrics and Gynecology, College of Medicine and the Hospital, National Taiwan University, Taipei, Taiwan.
Henry C KitchenerManchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation Trust, St Mary's Hospital, Manchester, United Kingdom.
Julio C TeixeiraUniversity of Campinas, Campinas, Brazil.
Unnop JaisamrarnChulalongkorn University, Department of Obstetrics and Gynaecology, Faculty of Medicine, Bangkok, Thailand.
Genara LimsonUniversity of the Philippines, College of Medicine, Philippine General Hospital, Makati Medical Centre, Makati City, Philippines.
Anne SzarewskiCentre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.
Barbara RomanowskiUniversity of Alberta, Edmonton, Alberta, Canada.
Fred Y AokiUniversity of Manitoba, Winnipeg, Manitoba, Canada.
Tino F SchwarzCentral Laboratory and Vaccination Centre, Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg, Wuerzburg, Germany.
Willy A J PoppeDepartment of Gynaecology, University Hospital KU Leuven Gasthuisberg, Leuven, Belgium.
F Xavier BoschCancer Epidemiology Research Program, Institut Català d'Oncologia (ICO), IDIBELL, Network on Cooperative Cancer Research (RTICC), L'Hospitalet de Llobregat, Catalonia, Spain.
Adrian MindelCentre for AIDS Programme of Research in South Africa, Durban, South Africa.
Philippe de SutterAfdelingshoofd Gynaecologie-Oncologie, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
Karin HardtGSK Vaccines, Wavre, Belgium.
Toufik ZahafGSK Vaccines, Wavre, Belgium.
Dominique DescampsGSK Vaccines, Wavre, Belgium.
Frank StruyfGSK Vaccines, Wavre, Belgium.
Matti LehtinenUniversity of Tampere, School of Public Health, Tampere, Finland.
Gary DubinGSK Vaccines, King of Prussia, Pennsylvania, USA.
HPV PATRICIA Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We report final event-driven analysis data on the immunogenicity and efficacy of the human papillomavirus 16 and 18 ((HPV-16/18) AS04-adjuvanted vaccine in young women aged 15 to 25 years from the PApilloma TRIal against Cancer In young Adults (PATRICIA). The total vaccinated cohort (TVC) included all randomized participants who received at least one vaccine dose (vaccine, n = 9,319; control, n = 9,325) at months 0, 1, and/or 6. The TVC-naive (vaccine, n = 5,822; control, n = 5,819) had no evidence of high-risk HPV infection at baseline, approximating adolescent girls targeted by most HPV vaccination programs. Mean follow-up was approximately 39 months after the first vaccine dose in each cohort. At baseline, 26% of women in the TVC had evidence of past and/or current HPV-16/18 infection. HPV-16 and HPV-18 antibody titers postvaccination tended to be higher among 15- to 17-year-olds than among 18- to 25-year-olds. In the TVC, vaccine efficacy (VE) against cervical intraepithelial neoplasia grade 1 or greater (CIN1+), CIN2+, and CIN3+ associated with HPV-16/18 was 55.5% (96.1% confidence interval [CI], 43.2, 65.3), 52.8% (37.5, 64.7), and 33.6% (-1.1, 56.9). VE against CIN1+, CIN2+, and CIN3+ irrespective of HPV DNA was 21.7% (10.7, 31.4), 30.4% (16.4, 42.1), and 33.4% (9.1, 51.5) and was consistently significant only in 15- to 17-year-old women (27.4% [10.8, 40.9], 41.8% [22.3, 56.7], and 55.8% [19.2, 76.9]). In the TVC-naive, VE against CIN1+, CIN2+, and CIN3+ associated with HPV-16/18 was 96.5% (89.0, 99.4), 98.4% (90.4, 100), and 100% (64.7, 100), and irrespective of HPV DNA it was 50.1% (35.9, 61.4), 70.2% (54.7, 80.9), and 87.0% (54.9, 97.7). VE against 12-month persistent infection with HPV-16/18 was 89.9% (84.0, 94.0), and that against HPV-31/33/45/51 was 49.0% (34.7, 60.3). In conclusion, vaccinating adolescents before sexual debut has a substantial impact on the overall incidence of high-grade cervical abnormalities, and catch-up vaccination up to 18 years of age is most likely effective. (This study has been registered at ClinicalTrials.gov under registration no. NCT001226810.).

Indexed as

Adjuvants, ImmunologicAdolescentAdultAluminum HydroxideAnimalsAntibodies, ViralDNA, ViralDouble-Blind MethodFemaleHuman papillomavirus 16Human papillomavirus 18HumansLipid APapillomavirus InfectionsPapillomavirus VaccinesPrecancerous ConditionsAdjuvants, ImmunologicAluminum HydroxideAntibodies, ViralASO4 mixtureDNA, ViralLipid APapillomavirus Vaccines

Identifiers

PMID25651922
PMCPMC4375348

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.