Evidence map›Paper›PMID 29366703›Full record

Trial reportVaccine2018

Evidence for single-dose protection by the bivalent HPV vaccine-Review of the Costa Rica HPV vaccine trial and future research studies.

Aimée R Kreimer, Rolando Herrero, Joshua N Sampson, Carolina Porras, Douglas R Lowy, John T Schiller, Mark Schiffman, Ana Cecilia Rodriguez, Stephen Chanock, Silvia Jimenez and 9 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing 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

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

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

18 more citing papers are in PubMed but not listed here.

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

19 authors.

Aimée R KreimerNational Cancer Institute, NIH, Bethesda, MD, USA. Electronic address: kreimera@mail.nih.gov.
Rolando HerreroPrevention and Implementation Group, International Agency for Research on Cancer, Lyon, France.
Joshua N SampsonNational Cancer Institute, NIH, Bethesda, MD, USA.
Carolina PorrasAgencia Costarricense de Investigaciones Biomédicas (ACIB), formerly Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica.
Douglas R LowyNational Cancer Institute, NIH, Bethesda, MD, USA.
John T SchillerNational Cancer Institute, NIH, Bethesda, MD, USA.
Mark SchiffmanNational Cancer Institute, NIH, Bethesda, MD, USA.
Ana Cecilia RodriguezIndependent Consultant, San José, Costa Rica.
Stephen ChanockNational Cancer Institute, NIH, Bethesda, MD, USA.
Silvia JimenezIndependent Consultant, San José, Costa Rica.
John SchusslerInformation Management Systems, Silver Spring, MD, USA.
Mitchell H GailNational Cancer Institute, NIH, Bethesda, MD, USA.
Mahboobeh SafaeianRoche Molecular Diagnostics, Pleasanton, CA, USA.
Troy J KempHPV Immunology Laboratory, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Bernal CortesPrevention and Implementation Group, International Agency for Research on Cancer, Lyon, France.
Ligia A PintoHPV Immunology Laboratory, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Allan HildesheimNational Cancer Institute, NIH, Bethesda, MD, USA.
Paula GonzalezAgencia Costarricense de Investigaciones Biomédicas (ACIB), formerly Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica.
Costa Rica HPV Vaccine Trial (CVT) Group

Funding

HPV Vaccine TrialZIACP010217 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI KREIMER, AIMEE · 2011 to 2025
$42.3M
Papillomavirus Virion Proteins and VaccinesZIABC010579 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI LOWY, DOUGLAS R. · 2009 to 2025
$15.4M
HPV Vaccine TrialsZIACP010177 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI HILDESHEIM, ALLAN · 2009 to 2009
$3.2M
Intramural NIH HHS Z99 CA999999Intramural NIH HHS ZIA CP010177World Health Organization 001
6 · The paper itself

Abstract

The Costa Rica Vaccine Trial (CVT), a phase III randomized clinical trial, provided the initial data that one dose of the HPV vaccine could provide durable protection against HPV infection. Although the study design was to administer all participants three doses of HPV or control vaccine, 20% of women did not receive the three-dose regimens, mostly due to involuntary reasons unrelated to vaccination. In 2011, we reported that a single dose of the bivalent HPV vaccine could be as efficacious as three doses of the vaccine using the endpoint of persistent HPV infection accumulated over the first four years of the trial; findings independently confirmed in the GSK-sponsored PATRICIA trial. Antibody levels after one dose, although lower than levels elicited by three doses, were 9-times higher than levels elicited by natural infection. Importantly, levels remained essentially constant over at least seven years, suggesting that the observed protection provided by a single dose might be durable. Much work has been done to assure these non-randomized findings are valid. Yet, the group of recipients who received one dose of the bivalent HPV vaccine in the CVT and PATRICIA trials was small and not randomly selected nor blinded to the number of doses received. The next phase of research is to conduct a formal randomized, controlled trial to evaluate the protection afforded by a single dose of HPV vaccine. Complementary studies are in progress to bridge our findings to other populations, and to further document the long-term durability of antibody response following a single dose.

Indexed as

Antibodies, ViralHuman papillomavirus 16Human papillomavirus 18Papillomavirus InfectionsPapillomavirus VaccinesAdolescentAdultClinical Trials as TopicCosta RicaFemaleHumansImmunization ScheduleMass VaccinationSerumTime FactorsUterine Cervical NeoplasmsAntibodies, Viralhuman papillomavirus vaccine, L1 type 16, 18Papillomavirus VaccinesCervical cancerHPVHPV-driven cancersHuman papillomavirusPreventionReduced doseVaccine

Identifiers

PMID29366703
PMCPMC6054558

What OpenQuestion holds

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LicenceCC BY
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.