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

National Cancer Institute (NCI)

Status: Active, not recruiting

Conditions: Human Papillomavirus Infection; Human Papillomavirus-Related Malignant Neoplasm

Treatments: Other: Questionnaire Administration; Procedure: Biospecimen Collection

Study type: Observational

Funder types: NIH

Identifiers

NCT03309033

20G012-07

CEC-ICIC-E095-2017 (Other Identifier)

999917173

NCI-2020-07430 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 991 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• A random subset of the three-dose women

Trial design

991 participants in 1 patient group

Observational (questionnaire, biospecimen collection)

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Other: Questionnaire Administration