Up to 70% of sexually active women will become infected with human papillomavirus (HPV) during their lifetime. HPV causes around 470 000 cases of cervical cancer each year. Although most cases of cervical cancer occur in the developing world, where organised cervical screening programmes have not been implemented, around 35, 000 women die from the disease every year in Europe and the USA. HPV infections are also responsible for genital warts in 1-2% of young adults. Genital warts can cause sexual dysfunction. Recurrence is common and treatment is painful and expensive.
Luisa Villa (Ludwig Institute for Cancer Research, Brazil) and colleagues undertook a trial to test the effectiveness of a vaccine targeting the HPV types associated with 70% of cervical cancers (types 16 and 18) and 90% of genital warts (types 6 an 11). The investigators recruited 1158 healthy women aged 16-23 onto the study from Brazil, Europe and the USA. The participants were not pregnant, had no previous abnormal cervical smears and reported a history of four or fewer partners. 277 women were randomly assigned to the vaccine and 275 to a placebo. They received given intramuscular injections on day 1, month 2 and month 6. Participants were followed up for 36 months and underwent regular gynaecological examinations, sampling for HPV DNA and cervical smears. The incidence of persistent infection or disease with HPV 6, 11, 16, or 18 fell by 90% in those assigned the vaccine compared with those assigned the placebo. The vaccine was 100% effective against precancerous cervical lesions and genital warts associated with these four HPV types. There were no vaccine related serious adverse events.
The authors suggest that universal HPV vaccination might be most effective if implemented in 10-13 year olds, who are likely to be HPV negative. Large-scale trials of the vaccine are currently underway.
Dr Villa comments: "In the developed world, full implementation of cervical-cancer screening has substantially shifted the burden of HPV infection from cervical cancer mortality to management of precancerous lesions. In these countries, in addition to further reduction in incidence of cervical cancer, universal HPV vaccination might decrease the medical, psychological, and economic costs associated with the management of abnormalities detected by screening. Inclusion of HPV 6 and 11 in a vaccine could also diminish the incidence of genital warts. In developing countries that have not implemented screening programmes for cervical cancer, a universal HPV vaccine could substantially reduce the incidence of the disease."
Contact: Dr Luisa Lina Villa, Ludwig Institute for Cancer Research, 109 - 4o. andar, 01509-010 São Paulo, SP, Brazil.
T) 55-11-3277 6957. llvilla@ludwig.org.br
Notes to editors
The Lancet Oncology is an international monthly specialty journal that was launched in September 2000. It began by publishing informative reviews but from April 7, 2005, it is expanding its scope and will publish its first original research articles online. It is the first of The Lancet's three review publications to begin publishing primary research.
Journal
The Lancet Oncology