Extended Follow-Up of Young Women in Costa Rica Who Received Vaccination Against Human Papillomavirus Types 16 and 18 and Unvaccinated Controls

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Brief Title

Extended Follow Up of Young Women in Costa Rica Who Received Vaccine Therapy 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

Brief Summary

      This research trial studies extended follow up of young women in Costa Rica who received
      vaccine therapy for human papillomavirus types 16 and 18 and unvaccinated controls.
      Collecting information from young women in Costa Rica who have received vaccine therapy 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.
    


Study Type

Observational


Primary Outcome

Cumulative rate of cervical intraepithelial neoplasia 3 (CIN3)


Condition

Anal Carcinoma

Intervention

Cytology Specimen Collection Procedure

Study Arms / Comparison Groups

 Observational (long term follow-up)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

8670

Start Date

March 30, 2009

Completion Date

July 5, 2022

Primary Completion Date

July 5, 2022

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
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Aimee Kreimer, , 

Location Countries

Costa Rica

Location Countries

Costa Rica

Administrative Informations


NCT ID

NCT00867464

Organization ID

NCI-2016-00231

Secondary IDs

NCI-2016-00231

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Aimee Kreimer, Principal Investigator, National Cancer Institute (NCI)


Verification Date

February 2020