Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions

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Journal Article 1 Mention

The FUTURE II Study Group•2007

Top 5% · 95th percentile

2,059 citations · Epidemiology

Open Access

TLDR

A vaccine given to young women can almost completely prevent serious cervical problems caused by certain types of HPV, but it works best if given before any infection.

Summary

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1 Study Aim

The main goal of this study was to find out if a vaccine that targets four types of human papillomavirus (HPV-6, HPV-11, HPV-16, and HPV-18) can prevent serious cervical changes, such as high-grade cervical intraepithelial neoplasia (CIN 2/3), adenocarcinoma in situ, or cervical cancer, especially those caused by HPV-16 and HPV-18, in young women who have not been previously infected. Simply put: The study wanted to see if a new vaccine could stop serious cervical problems caused by certain HPV types in young women.

2 Study Design

This was a randomized, double-blind, placebo-controlled phase 3 clinical trial. The researchers enrolled 12,167 women aged 15 to 26 from 13 countries. Participants were randomly assigned to receive either the quadrivalent HPV vaccine (protecting against HPV-6, HPV-11, HPV-16, and HPV-18) or a placebo, given in three doses over six months. The main group analyzed included women who had no signs of HPV-16 or HPV-18 infection before or shortly after vaccination. Participants were followed for about three years to monitor for serious cervical changes. Simply put: The researchers gave either the vaccine or a dummy shot to thousands of young women and checked them for cervical problems over three years.

3 Findings

The study reveals that the vaccine was 98% effective in preventing high-grade cervical lesions (serious changes in cervical cells that can lead to cancer) caused by HPV-16 or HPV-18 in women who had never been infected with these types. In the broader group, including women who may have already been infected, the vaccine reduced these lesions by 44%. The vaccine also lowered the risk of all high-grade cervical lesions, regardless of HPV type, by 17%. Side effects were mostly mild, such as pain at the injection site, and serious side effects were rare and similar between groups. The authors argue that vaccinating young women before they are exposed to HPV-16 or HPV-18 can greatly reduce the risk of developing serious cervical disease. Simply put: The vaccine almost completely stopped serious cervical problems from certain HPV types in women who had not been infected before, and it was safe.

Abstract

BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18. METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18. RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31). CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group. (ClinicalTrials.gov number, NCT00092534 [ClinicalTrials.gov].).

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