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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of a Human Papillomavirus 16/18 L1 Virus-Like Particle/AS04 Vaccine Versus a Control for the Prevention of Grade 2 or 3 Cervical Intraepithelial Neoplasia, Adenocarcinoma in Situ of the Cervix, or Invasive Cervical Cancer in Younger Healthy Participants

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Prevention	Closed	18 to 25	NCI	NCI-04-C-N191 NCI-590299/009, GSK-590299/009, NCT00128661

Trial Description

Purpose:

Chemoprevention is the use of certain drugs to keep cancer form forming, growing, or coming back. Vaccines may help the body build an effective immune response against human papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or cervical cancer. It is not yet known whether human papillomavirus vaccine is more effective than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer.

This randomized phase III trial is studying human papillomavirus vaccine to see how well it works compared to hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer in younger healthy participants.

Eligibility:

Eligibility criteria include the following:

• 18-25 years old
• Lives in Guanacaste Province of Costa Rica and surrounding areas
• More than 3 months since immunoglobulins
• More than 1 month since vaccine therapy
• No previous hepatitis A vaccine or human papillomavirus vaccine
• No previous surgery to remove the uterus
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Participants will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Participants in group one will receive an injection of human papillomavirus vaccine once in months 0, 1, and 6.

Participants in group two will receive an injection of hepatitis A vaccine once in months 0, 1, and 6.

Participants will be evaluated at 6 months and at least once a year for 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Rolando Herrero, MD, Protocol chair		Ph: 506-665-0242 Email: rherrero@amnet.co.cr
Allan Hildesheim, PhD, Principal investigator		Ph: 301-496-1691 Email: hildesha@mail.nih.gov

Registry Information
Official Title		A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica
Trial Start Date		2004-06-28
Registered in ClinicalTrials.gov		NCT00128661
Date Submitted to PDQ		2005-07-21
Information Last Verified		2007-02-26