Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls

NCT00867464 | Active Not Recruiting DMC

• 3 other identifiers: NCI-2016-0023199990910609-C-N106
• Study Type: observational
• Target: 8,670
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Carcinoma; Cervical Carcinoma; Human Papillomavirus Infection; Human Papillomavirus-Related Cervical Carcinoma; Oral Cavity Carcinoma

Outcome Measures

Primary Outcomes (3)

• Cumulative rate of cervical intraepithelial neoplasia 3 (CIN3)

  Both absolute rate differences and percent reduction in rates will be evaluated.

  At 10 years

• Level of immune response markers as prediction of long-term success of HPV vaccine

  For efficiency, a nested case-control approach is envisioned to evaluate this question. We propose to compare women who become infected against a subset of those who do not (non-failures) with respect to immune response markers of interest.

  Up to 10 years

• 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

  The 10-year cumulative rate of incident CIN2+ associated with HPV types other than HPV-16/18 and closely related HPV types in the alpha-7/9 species for which evidence of vaccine cross-protection is demonstrated will be compared between vaccinated and unvaccinated women.

  Up to 10 years

Study Arms (1)

Observational (long term follow-up)

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.

Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Other: Long-term Follow-up; Other: Questionnaire Administration

Interventions

Cytology Specimen Collection Procedure OTHER

Correlative studies

Also known as: Cytologic Sampling

Observational (long term follow-up)

Laboratory Biomarker Analysis OTHER

Correlative studies

Observational (long term follow-up)

Long-term Follow-up OTHER

Undergo extended follow-up

Also known as: long term follow-up (clinical study), long-term follow-up (research), LTFU

Observational (long term follow-up)

Questionnaire Administration OTHER

Ancillary studies

Observational (long term follow-up)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• History of cervical cancer
• History of hysterectomy
• Any important medical condition or other criteria that the investigator considers that precludes enrollment

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Agencia Costarricense de Investigaciones Biomédicas (ACIB)

Liberia, Guanacaste Province, 50101, Costa Rica

Location

Related Publications (2)

• 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.

  PMID: 35709811 DERIVED

• 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.

  PMID: 33271093 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Anus Neoplasms; Uterine Cervical Neoplasms; Papillomavirus Infections; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Head and Neck Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Aimee Kreimer

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: March 30, 2009
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CO (1)