The Pharmaceutical Journal
Vol 274 No 7349 p577
14 May 2005

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Vaccines prevent persistent infection with HPV

A vaccine targeting the human papillomavirus (HPV) types that are associated with 70 per cent of cervical cancers and 90 per cent of genital warts is effective in preventing persistent infection and clinical disease, according to data presented at the International Papillomavirus Conference held in Vancouver last week. Results from the study were published online last month by Lancet Oncology (7 April).

Luisa Villa, Ludwig Institute for Cancer Research, Brazil, and colleagues conducted a randomised controlled trial involving 552 women aged 16 to 23 years in Brazil, Europe and the US. The women received a quadrivalent (types 6, 11, 16, 18) HPV vaccine or placebo at day 1, month 2 and month 6. Follow up was for 36 months.

The primary endpoint was combined incidence of infection with HPV types 6, 11, 16 or 18, or cervical or external genital disease. Study results showed that the incidence of persistent infection or associated disease fell by 90 per cent in the vaccine group compared with the placebo group (four events versus 36 events; P<0.0001).

The vaccine, called Gardasil and produced by Merck & Co, was generally well tolerated and induced high titres of serum antibodies to HPV types. Large scale studies are currently under way with over 25,000 participants enrolled worldwide.

GlaxoSmithKline is also conducting trials on its HPV vaccine, Cervarix. Results from a randomised controlled trial involving 1,113 women were reported last year (Lancet 2004;364:1731) and showed that the vaccine is 100 per cent effective against persistent HPV-16/HPV-18 infection.

At last week’s conference GSK presented further data, which provided preliminary evidence to show that the vaccine induces cross protection against HPV infection associated with HPV-16 and HPV-18.

Phase III trials in over 30,000 women are currently under way and GSK expects to file for a product licence in 2006.