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Vaccine Provides up to 100% Protection Against HPV-Related Precancerous Cervical Lesions and Adenocarcinoma: Presented at ICACT

By Shazia Qureshi

PARIS, FRANCE -- February 8, 2008 -- Four years after administration, the quadrivalent human papilloma virus (HPV) types 6, 11, 16, 18 vaccine was found to offer 97% to 100% efficacy against HPV-related cervical intraepithelial neoplasia (CIN) of grade 2/3 and adenocarcinoma of the cervix, researchers reported here.

Lead investigator Elmar Joura, MD, Associate Professor, Department of Gynaecology and Obstetrics, Medical University of Vienna, Vienna, Austria, presented the combined end-of-study results of four clinical trials in a sponsored symposium during the 19th International Congress on Anti-Cancer Treatment (ICACT).

Enrolment in these randomised, double-blind, phase 2/3, placebo-controlled Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I and II studies was stopped earlier than planned due to the high efficacy results. In addition, patients who had been receiving placebo were offered the vaccine, Dr. Joura said in the presentation on February 5.

The HPV vaccine was administered to 8,493 patients and placebo to 8,464 patients. All patients were healthy women aged 16 to 26 years who had no previous exposure to HPV types 16 and/or 18.

Patients were given three doses of either the vaccine or placebo (day 1, months 2, and month 6) and were followed for 4 years after the first dose. They also underwent Papanikolaou tests every 6 or 12 months and other medical examinations to detect lesions.

According to Dr. Joura, the per-protocol analysis showed that none of the patients receiving the vaccine developed adenocarcinoma of the cervix or grade 2 CIN. Among patients given placebo, 7 patients developed adenocarcinoma of the cervix and 73 developed grade 2 CIN. This meant a 100% efficacy rate for the vaccine for each of these conditions.

Grade 3 CIN occurred in 2 patients given the vaccine and 64 patients on placebo, which translated to an efficacy of 97% for the vaccine (95% confidence interval [CI] 88-100).

After 4 years, 2 vaccine patients developed any of HPV type 16 or 18, CIN grade 2 or 3, or adenocarcinoma of the cervix compared with 112 placebo patients, for an efficacy rate of 98% for the vaccine (95% CI 94-100).

"Vaccination with quadrivalent HPV vaccine is expected to result in protection against both squamous cervical carcinoma and adenocarcinoma related to the vaccine HPV types," Dr. Joura concluded.

The study was funded by Merck & Co. and Sanofi Pasteur Inc.


[Presentation title: Sustained Protection by Quadrivalent HPV (Type 6, 11, 16, 18) Vaccine Through 4 Years Against HPV 6/11/16/18-Related Cervical Intraepithelial Neoplasia Grade 2/3 (CIN2/3) and Adenocarcinoma (AIS) of the Cervix.]

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