Suivi prolongé des femmes ayant reçu une, deux et trois doses du vaccin contre le VPH dans le cadre de l'essai CVT, étude ESCUDDO-CVT
Quinze ans de suivi immunologique de femmes ayant reçu une, deux et trois doses du vaccin bivalent contre le VPH dans le cadre de l'essai de vaccin contre le VPH-16/18 (CVT) au Costa Rica : générer des données de durabilité : l'étude ESCUDDO-CVT
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Guanacaste Province
-
Liberia, Guanacaste Province, Costa Rica, 50101
- Agencia Costarricense de Investigaciones Biomédicas (ACIB)
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Women who participated in the Costa Rica Vaccine Trial and received the HPV vaccine
La description
Inclusion Criteria:
- Participation in the CVT Long Term Follow-Up (LTFU) study
Exclusion Criteria:
- A random subset of the three-dose women
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
Undergo collection of blood samples
Autres noms:
Complete questionnaire |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Seropositivity
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Aimee R Kreimer, National Cancer Institute (NCI)
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Processus pathologiques
- Attributs de la maladie
- Infections
- Maladies virales
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections par le virus de l'ADN
- Infections virales tumorales
- Conditions pathologiques, signes et symptômes
- Infections à papillomavirus
- Techniques d'investigation
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Manipulation des échantillons
Autres numéros d'identification d'étude
- NCI-2020-07430
- NCI-2020-07430 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- 999917173
- 20G012-07
- CEC-ICIC-E095-2017 (Autre identifiant: National Cancer Institute)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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