Research into Cervical Cancer

Vaccine Trial

The HPV Vaccine Trial in Costa Rica is a collaboration between investigators in Costa Rica and the National Cancer Institute. The trial is designed as a blinded, randomized, phase III clinical trial to evaluate the efficacy of a bivalent HPV-16/18 virus-like particle (VLP) vaccine. The vaccine used in the trial was developed by investigators at NCI and other research institutions and is manufactured by GlaxoSmithKline Biologicals. The trial was initiated on June 28, 2004 and enrollment was completed on December 22, 2005; there were 7466 women enrolled.

Trial staff will follow all enrolled women for a period of four years. Women who are eligible, consent, and are randomized into the trial receive three doses of the HPV-16/18 VLP or Havrix (Hepatitis A) vaccine over a period of six months. At entry and throughout follow-up, women are carefully monitored and receive state-of-the-art screening for cervical neoplasia.

This study was designed to evaluate vaccine efficacy, immunological correlates of long-term vaccine success and failure, and other factors of immunological and etiological interest. Active follow-up of participants and the extensive data and biological specimen collection components of the study will permit such evaluations. More information, Allan Hildesheim

ALTS Immunology

The ALTS Immunology Study is a prospective study designed to identify biomarkers associated with a permissive versus protective immune response to low-grade cervical lesions. Approximately 900 women with low-grade cervical disease have been enrolled in this study and are being followed at 6 month intervals for two years. Cellular and humoral immunological responses at entry will be correlated with progression, persistence or regression of low-grade lesions during follow-up. Immunological parameters are also being measured over time in a subgroup of approximately 300 women in our study. Both systemic and local responses are being examined. More information, Allan Hildesheim

Cervical Adenocarcinoma Case-Control Study

A multi-center case-control study of cervical adenocarcinomas and other rare histological forms of cervical cancer was conducted to examine the role of viral and non-viral exogenous and endogenous factors associated with cervical adenocarcinomas and adenosquamous carcinomas. Incident and histologically confirmed cases of in situ and invasive cervical tumors of glandular histology were ascertained. Two control groups were also selected for study. The first comprised a sample of women with squamous cell cervical cancer and the second comprised population controls selected by a modified random digit dialing method. A total of 595 women agreed to participate in the study. Participants responded to a detailed risk factor questionnaire and had blood and cervical specimens collected for HPV testing and other bioassays of interest. More information, Allan Hildesheim