Clinical trial NCT00867464: Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls
Official title: Extended Follow-Up of Young Women in Costa Rica Who Received Vaccination Against Human Papillomavirus Types 16 and 18 and Unvaccinated Controls
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anal Carcinoma
Cervical Carcinoma
Human Papillomavirus Infection
Human Papillomavirus-Related Cervical Carcinoma
Oral Cavity Carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-03-23
Enrollment: 8670
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young women in Costa Rica who received vaccination against human papillomavirus types 16 and 18 and unvaccinated controls.

Brief summary: This research trial studies extended follow up of young women in Costa Rica who received vaccine for human papillomavirus types 16 and 18 and unvaccinated controls. Collecting information from young women in Costa Rica who have received vaccine for human papillomavirus types 16 and 18 and a new group of unvaccinated controls enrolled for the follow-up period, may help doctors learn more about the risks and benefits of prophylactic human papillomavirus vaccine.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the 10-year global impact of human papillomavirus (HPV)-16/18 vaccination of young adult women.

II. To evaluate determinants of the immune response to HPV and the vaccine, and markers of long-term protection.

III. To evaluate the natural history of HPV and cervical disease in vaccinated and unvaccinated populations.

OUTLINE:

Participants undergo long term follow-up comprising risk factor questionnaire, pelvic examination for all sexually experienced women, and specimen collection at years 6, 8, and 10.

Eligibility criteria: Inclusion Criteria:

* Women who participated in the Costa Rica Vaccine Trial (CVT) and lived in the Guanacaste province and a few areas of Puntarenas closest to Guanacaste will be eligible for the long-term follow up LTFU study
* Women who received the HPV-16/18 vaccine at the start of CVT will be invited for up to 6 years of additional follow-up, and women who were originally in the control arm of CVT and were offered the HPV-16/18 vaccine at crossover will be invited for an additional 2 years of follow-up
* A subset of the control arm women who are in the crossover immunogenicity subcohort will be followed the full 6 years
* Some women who received HPV vaccination and were not invited into the LTFU protocol (stopped attending their screening visits during CVT, discontinued their study participation during CVT or lived outside the study area) will be invited to participate in the LTFU protocol, particularly those who received an incomplete vaccination schedule
* UNVACCINATED CONTROL GROUP:
* Born in or between July 1978 and November 1987
* Residents of Guanacaste Province and a few areas of Puntarenas closest to Guanacaste at some point during 2005
* Able to speak/understand Spanish
* Apparently mentally competent
* Written informed consent obtained prior to enrollment

Exclusion Criteria:

* History of cervical cancer
* History of hysterectomy
* Any important medical condition or other criteria that the investigator considers that precludes enrollment
* Vaccination with Gardasil or Cervarix will be an exclusionary criterion, but few women are expected to have received these vaccines at the time of enrollment; use of these vaccines after enrollment is not a criterion for study interruption but we plan to collect information on vaccination history so that the few women who report having been vaccinated with one of the HPV vaccines after enrollment can be evaluated separately at analysis

Primary outcomes:
measure: Cumulative rate of cervical intraepithelial neoplasia 3 (CIN3)
timeFrame: At 10 years
measure: Level of immune response markers as prediction of long-term success of HPV vaccine
timeFrame: Up to 10 years
measure: Increase in the rate of cervical lesions associated with other carcinogenic HPV types that the vaccine does not protect against from prevention of HPV-16/18 associated cervical lesions through vaccination
timeFrame: Up to 10 years
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 Kreimer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shing JZ, Hu S, Herrero R, Hildesheim A, Porras C, Sampson JN, Schussler J, Schiller JT, Lowy DR, Sierra MS, Carvajal L, Kreimer AR; Costa Rica HPV Vaccine Trial Group. Precancerous cervical lesions caused by non-vaccine-preventable HPV types after vaccination with the bivalent AS04-adjuvanted HPV vaccine: an analysis of the long-term follow-up study from the randomised Costa Rica HPV Vaccine Trial. Lancet Oncol. 2022 Jul;23(7):940-949. doi: 10.1016/S1470-2045(22)00291-1. Epub 2022 Jun 13.
citation: Porras C, Tsang SH, Herrero R, Guillen D, Darragh TM, Stoler MH, Hildesheim A, Wagner S, Boland J, Lowy DR, Schiller JT, Schiffman M, Schussler J, Gail MH, Quint W, Ocampo R, Morales J, Rodriguez AC, Hu S, Sampson JN, Kreimer AR; Costa Rica Vaccine Trial Group. Efficacy of the bivalent HPV vaccine against HPV 16/18-associated precancer: long-term follow-up results from the Costa Rica Vaccine Trial. Lancet Oncol. 2020 Dec;21(12):1643-1652. doi: 10.1016/S1470-2045(20)30524-6.