CERVICAL cancer, which kills 300,000 women a year around the world, could be largely prevented by a vaccine, researchers have found.

The first big study of a cervical cancer vaccine has proved 100 per cent successful — a “stunning result”, according to one specialist. The results offer hope that women may be spared the indignity of under-going regular smear tests to detect early signs of the disease.

“We’re breaking out the champagne”, said Eliav Barr, head of clinical development for the drug, which is manufactured by Merck under the name Gardasil. “To have 100 per cent efficacy is something that you have very rarely.”

None of the 5,300 women given a full course of the vaccine developed cervical cancer or evidence of pre-cancerous damage over two years, researchers will report today at a meeting of the Infectious Diseases Society of America in San Francisco. Cervical cancer is the second commonest cancer in younger women. Each year more than 3,000 cases are diagnosed in the UK, and there are 1,100 deaths. The vaccine protects against human papilloma virus (HPV), the cause of the cancer. HPV is transmitted sexually, with the greatest risk of infection occurring in the late teens and twenties.

“These are stunning results,” said Professor Margaret Stanley, of Cambridge University, a specialist in HPV and cervical cancer who was not involved in the trial. “For a vaccine to show 100 per cent efficiency, even over a short time like two years, is a really good result.”

Gardasil will be competing for a market potentially worth £2.2 billion a year with a rival product, Cervarix, from Glaxo SmithKline which has also shown excellent results in trials.

The results come from a Phase III multinational trial, one of the final pieces of evidence needed to apply for a licence. More than 12,000 sexually active women aged between 16 and 26 who were free of HPV were divided into two groups and given either three doses of Gardasil over six months, or three dummy doses. Neither doctors nor patients knew which they were getting.

After two years, said Sven-Eric Olsson, of Danderyds Hospital in Stockholm, one of the trial leaders, twenty-one cases of cervical cancer had been detected.

When the trial was unblinded, “amazingly, we found that all the cases occurred in the placebo group”, he said. Among women who did not get the full course of vaccinations, but only had a single jab, the results were nearly as good. There was a single case of cervical cancer, which represented 97 per cent efficacy with a single jab.

“We’re very pleased,” said Dr Olsson. “This is a huge study, and we hope these results will help prepare the way for the vaccine to be licensed.”

Gardasil, a genetically engineered vaccine, blocks infection by two of the hundred-plus types of human papilloma virus, HPV 16 and 18. Between them these two sexually transmitted viruses cause about 65 per cent of cervical cancers around the world, Professor Stanley said.

It is not clear yet if the vaccine offers any “cross-protection” against other HPVs. But if it does not, its range could be extended by adding extra components. Eventually the vaccine might be extended to block the viruses responsible for 87 per cent of cervical cancer.

Gloria Bachmann, the director of the Women’s Health Institute at Robert Wood Johnson Medical School in New Brunswick, New Jersey, said: “I see this as a phenomenal breakthrough.

“You have to get students in grammar school, middle school, high school vaccinated before they become sexually active,” she said.

Merck plans to submit the trial evidence to the regulatory authorities in the US by the end of this year, and hopes for clearance some time in 2006.

Glaxo’s vaccine has also shown impressive results, also proving 100 per cent effective in blocking infections with human papillomavirus types 16 and 18.

Professor Peter Rigby, chief executive of the Institute of Cancer Research, said: “These results are extremely encouraging. Nearly 3,000 people in the UK are diagnosed with cervical cancer each year, so it is very exciting to hear it may be possible to drastically reduce this number.”

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