Cervical Cancer Virus Study Begins

Monday 22 July 2002

Cervical Cancer Virus Study Begins In Auckland And Christchurch

Three hundred young New Zealand women are being sought for a four year study with a vaccine intended to prevent infection with human papillomavirus (HPV) - the virus that causes most cervical cancer.

Recruitment for the study - being managed in New Zealand by the Family Planning Association - begins this week. Two hundred women aged between 16 and 23 years are being sought in Auckland, with a further 100 sought in Christchurch.

The vaccine - being developed by pharmaceutical company Merck Sharp & Dohme - has already been received by 2,700 women worldwide in Phase I and Phase II clinical studies.

The New Zealand women being recruited will be among 5000 women in 13 countries taking part in this major Phase III study. The aim of the study is to find out if the vaccine is effective at reducing HPV infection by HPV types 6, 11, 16 & 18 – the main types that cause cervical cancer and genital warts.

HPV types 16 and 18 alone are associated with up to 70% of all cervical carcinoma. HPV infection is associated with almost 100% of cervical cancers. HPV 6, 11 are also responsible for about 90% of genital warts. HPV is a very common sexually transmitted disease. It is estimated that over half of all sexually active adults (males and females) will be infected with HPV at some stage in their life. Most infected women are unaware they have HPV and currently there is no known cure.

The rate of cervical cancer is higher in Maori women than non-Maori, and may be higher still in Pacific Island women.

In Christchurch the study is being overseen by Dr Sue Bagshaw with Kate Bridgman-Smith as study coordinator, and in Auckland it will be overseen by Dr Helen Roberts with Melissa Exeter as study coordinator. The study has been approved and will be monitored by New Zealand Research Ethics Committees and the Ministry of Health.

Women taking part in the study will have to make about 11 visits to a Family Planning Clinic - six in the first year, then once every six months for two years. In the final year they will only have to make one visit.

In the first six months they will receive three vaccinations and keep a vaccination diary for two weeks after each visit. They will receive free and regular health checks from qualified professionals - including regular gynecological and physical checks.

If any abnormalities are detected, they may need to undergo further examinations and will be provided with appropriate medical care.

On a random basis, some women will receive what is called a 'placebo' or dummy vaccine, which means it is inactive and does not contain the synthetic HPV product. This will enable results to be compared between the two groups of women to see how effective the HPV vaccine is.

We are seeking healthy young women who we need to stay in the study over the next four years. To meet this challenge we have put together what is possibly the first integrated media campaign for a New Zealand clinical research study. Posters, adverts, emails, a freephone number, study website and campus artists will be used to reach and retain our target group.

The study freephone number is 0800 16 00 00, and information about the study is available on www.hpv.co.nz and by emailing hpvstudy@fpanz.org.nz

The NZ arm of the study will cost about $2 million, funded by Merck Sharp & Dohme (MSD) as part of its clinical research investment programme in this country.

"Major studies like this are extremely thorough and take a considerable amount of time and effort," Dr David Woolner, MSD Medical Director, said. "The HPV study results to date have been promising, and we are cautiously hopeful that this vaccine will be shown to help prevent HPV infection. Every year 470,000 women around the world develop cervical cancer and 225,000 women will die from it yearly.

"Cervical cancer is the second most common cancer among women, and a vaccine that could prevent HPV infection may help reduce the amount of disease many women experience."

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