Clinical trial 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
Official title: Long-Term Immunologic Follow-Up of Women Who Received One, Two, and Three Doses of the Bivalent HPV Vaccine in the Costa Rica HPV-16/18 Vaccine Trial (CVT): Generating Durability Data: The ESCUDDO-CVT Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Human Papillomavirus Infection
Human Papillomavirus-Related Malignant Neoplasm
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2017-10-13
Enrollment: 991
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who participated in the Costa Rica Vaccine Trial and received the HPV vaccine

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* A random subset of the three-dose women

Primary outcomes:
measure: Seropositivity
timeFrame: Up to 20 years after initial vaccination
measure: Change in antibody levels
timeFrame: Between years 11 and 20 after initial vaccination
measure: Proportion of individuals who serorevert
timeFrame: Between years 11 and 20 after initial vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Liberia
country: Costa Rica
facility: Agencia Costarricense de Investigaciones Biomédicas (ACIB)
state: Guanacaste
Study officials:
affiliation: National Cancer Institute (NCI)
name: Aimee R Kreimer
role: PRINCIPAL_INVESTIGATOR
References: