Cervical-Cancer Vaccine Demonstrates Long-Term Safety in Large Cohort: Presented at ESPID

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Title: Cervical-Cancer Vaccine Demonstrates Long-Term Safety in Large Cohort: Presented at ESPID
URL: http://www.pslgroup.com/dg/221E1E.htm
Doctor's Guide
May 23, 2008

By Neil Osterweil

GRAZ, Austria -- May 23, 2008 -- Pooled data on nearly 30,000 girls and young women indicate that a human papillomavirus (HPV)-16/18 adjuvanted vaccine for the prevention of cervical cancer has a safety profile similar to that of others on the market after over 5 years of follow-up.

The study was reported here on May 14 at the 26th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID).

Results were examined from 16,142 girls and women age 10 years and up who received at least 1 dose of the vaccine in 11 clinical phase 2 and 3 trials, and from 13,811 control subjects who received vaccines against hepatitis A.

The specific vaccines were chosen according to age group. An analysis was performed by treatment, as well as by age group, examining results from girls aged 10 to 14 years, teens/young women aged 15 to 25 years, and women older than 25 years. The analysis was also categorised by adverse event reporting period: either months 0 to 7 or month 7 and beyond.

Compliance was similar between the HPV-vaccine arm (93.4%) and control groups (88.7% to 98.2%).

For the first 7 months of follow-up, there were no differences in the rates of serious adverse events across age groups (0.9%-1.4% for the HPV vaccine vs 0.9%-1.5% for controls). Medically significant conditions were likewise similar, at 12.4% to 17.6% for the HPV vaccine, compared with 13.6% to 21.6% for controls.

New-onset autoimmune disease rates also did not differ, at 0.1% to 0.2% among those who received the HPV vaccine, compared with 0.1% to 0.3% of controls. New onset of autoimmune disease was examined for up to 5.5 years after vaccination.

"Beyond month 7, no differences were observed between groups in the rates of any adverse event," noted lead author Dominique Descamps, MD, Director, Clinical Development for Cervarix, GlaxoSmithKline Biologicals, Rixensart, Belgium. "Also, no differences were observed in pregnancy outcomes or the proportion of study withdrawals due to adverse events or serious adverse events."

"The size of this cohort allows detection of infrequent or rare adverse events that might otherwise have slipped under the clinical radar," Dr. Descamps added.

Among all groups, the most commonly reported medically significant conditions reported were chlamydial infections and spontaneous abortions.

This study was funded by GlaxoSmithKline.

[Presentation title: Safety of Human Papillomavirus (HPV)-16/18 Adjuvanted Vaccine for Cervical Cancer Prevention: Integrated Summary of 11 Clinical Trials. Abstract 126]

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