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Udvidet opfølgning af kvinder, der modtog en, to og tre doser af HPV-vaccinen i CVT-forsøget, ESCUDDO-CVT-studiet

25. september 2026 opdateret af: National Cancer Institute (NCI)

Femten års immunologisk opfølgning af kvinder, der modtog en, to og tre doser af den bivalente HPV-vaccine i Costa Rica HPV-16/18-vaccineforsøg (CVT): Generering af holdbarhedsdata: ESCUDDO-CVT-undersøgelsen

This study is extending follow up of women who participated in the Costa Rica Vaccine Trial (CVT) and received one dose or two doses of the human papillomavirus (HPV) vaccine, along with a group of women who received three doses. It also studies the stability of HPV defenses in these groups of women for up to 20 years after initial vaccination. Studying samples of blood in the laboratory may provide information on how long one, two, and three doses of the vaccine provide protection against HPV. The results of this study may also help researchers learn whether one dose of HPV vaccine is enough to protect against HPV.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. Estimate the change in antibody levels between years 11 and 20. II. Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 11 and 20.

SECONDARY OBJECTIVES:

I. Assess the prevalence and distribution of type-specific HPV infections at least 18 years after HPV vaccination.

II. Assess the number and type of premalignant lesions present at least 18 years after vaccination.

III. For each dose regimen, characterize HPV-specific memory B cells and long-lived plasma cells present at least 18 years after HPV vaccination, and compare these characteristics with results from earlier time points.

OUTLINE: This is an observational study.

Patients complete a short questionnaire regarding risk factors for HPV infection and undergo collection of blood samples for testing HPV16 and HPV18 levels on study.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

946

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Costa Rica
    • Guanacaste Province
      • Liberia, Guanacaste Province, Costa Rica, 50101
        • Agencia Costarricense de Investigaciones Biomédicas (ACIB)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Women who participated in the Costa Rica Vaccine Trial and received the HPV vaccine

Beskrivelse

Inclusion Criteria:

  • Participation in the CVT Long Term Follow-Up (LTFU) study

Exclusion Criteria:

  • A random subset of the three-dose women

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Observational (questionnaire, biospecimen collection)

Patients complete a short questionnaire regarding risk factors for HPV infection and undergo collection of blood samples for testing HPV16 and HPV18 levels on study.
Procedure: Biospecimen Collection

Undergo collection of blood samples

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Andet: Questionnaire Administration

Complete questionnaire

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Seropositivity
Tidsramme: Up to 20 years after initial vaccination

Negative/positive status will be assessed using the standard predefined cutoffs established at the testing laboratory.
Up to 20 years after initial vaccination
Change in antibody levels
Tidsramme: Between years 11 and 20 after initial vaccination

Will report the geometric mean titer levels and their 95% confidence intervals at years 1, 2, 3, 4, 7, 9, 11, 14, 16, 18, and 20 for the 1-dose, 2-dose and 3-dose groups and for both human papillomavirus (HPV)-16 and HPV-18 antibodies. Will estimate these quantities using a weighted linear mixed models with log-titer level as the dependent variable and year as the independent variable, adjusting for laboratory batch and including a random-effects for participant and, when needed, participant: study year. For the three-dose analysis, will also include a covariate for study group. Moreover, will model the 19-year trend (e.g. excluding peak titers at year 1) by including time as a single continuous variable (i.e. linear effect) and then model time flexibly using a natural spline to assess a potentially non-linear relationship.
Between years 11 and 20 after initial vaccination
Proportion of individuals who serorevert
Tidsramme: Between years 11 and 20 after initial vaccination

For each dose regimen and for HPV 16, HPV 18, and a composite endpoint of either HPV type, will estimate the proportion of individuals who serorevert (i.e., become antibody negative by the assay cutoff) in years 1, 2, 3, 4, 7, 9, 11, 14, 16, 18, and 20. Will also report 95% confidence intervals for these estimates. Again, will follow the approach described in our previous work. Note, will consider both standard and updated cutoffs and will use batch-adjusted levels. Can obtain the relative risk for seroreversion and its 95% confidence interval using score tests. Will then use generalized linear mixed models with seroreversion as the outcome and all other parameters similar to above to assess trends over time.
Between years 11 and 20 after initial vaccination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Aimee R Kreimer, National Cancer Institute (NCI)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. juli 2018

Primær færdiggørelse (Faktiske)

5. marts 2026

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

12. oktober 2017

Først indsendt, der opfyldte QC-kriterier

12. oktober 2017

Først opslået (Faktiske)

13. oktober 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCI-2020-07430
  • NCI-2020-07430 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 999917173
  • 20G012-07
  • CEC-ICIC-E095-2017 (Anden identifikator: National Cancer Institute)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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