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Активно (без набиране) NCT03309033

Extended Follow-up of Women Who Received One, Two, and Three Doses of the HPV Vaccine in the Costa Rica Vaccine Trial (CVT), ESCUDDO-CVT Study

Заболявания: Human Papillomavirus Infection Human Papillomavirus-Related Malignant Neoplasm

Спонсор: National Cancer Institute (NCI)

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
Inclusion Criteria: * Participation in the CVT Long Term Follow-Up (LTFU) study Exclusion Criteria: * A random subset of the three-dose women
Интервенции
Biospecimen Collection
PROCEDURE
Questionnaire Administration
OTHER
Места на провеждане 1
Costa Rica (1)
Agencia Costarricense de Investigaciones Biomédicas (ACIB)
Liberia , Guanacaste Province
Технически детайли
Статус
Активно (без набиране)
Вид изследване
OBSERVATIONAL
Пол
Само жени
Здрави доброволци
Не
Начална дата
02.07.2018
Крайна дата
31.12.2028
Регистрационен номер
NCT03309033
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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