HELP PREVENT CERVICAL CANCER IN WOMEN

Are you a woman 16-23 years old?

Thank you for expressing an interest in the GARDASIL™ study at the Clinical Trials Office at URI. We are currently recruiting women to participate in a program for a preventative vaccine for cervical cancer. Cervical cancer is caused by the Human Papillomavirus (HPV). A vaccine to prevent this virus will prevent cervical cancer. I would like to take this opportunity to give you some information about HPV, why this study is of such importance, and how your participation can benefit the health and well being of millions of women in this country and around the world. Let’s work together to block a female cancer.

HPV is a virus that has many different types. There have been more than 100 types identified. The type that causes warts on the hand is one type. The type that causes external genital warts is yet another type that may be unsightly but is not cancerous. The HPV type that is of concern to the medical community is the type that is a sexually transmitted disease (STD) that currently affects more than 60% of young women and is responsible for 99% of cervical cancer. Since the cancer causing types leave no outward signs, meaning patients have normal looking skin, most women, and their partners, are unaware that they have the virus. In most cases there are no visible signs of infection, making this an insidious virus. Women don’t usually know that there is a problem until they get a report back that they have an abnormal pap smear. The virus causes changes in the cells in and around the cervix. In most cases an abnormal pap smear can be acted upon to prevent the spread of the pre-cancerous condition. However, most health authorities and most patients favor prevention of any disease through vaccination.

For years it was thought that promiscuity played an active role in getting the virus. However, it is now known that your risk of contracting HPV is a staggering 15% per partner. Since HPV is now considered the most common STD, and since most women do not know that they have it is no wonder that the rate of gynecological office visits for cervical disease has increased 500% in the last 20-25 years.

Merck's current vaccine GARDASIL™ protects women against 4 strains of HPV-6, 11, 16 and 18 (so-called quadrivalent). Merck is seeking to expand this coverage to 8 strains of HPV-6, 11, 16, 18, 31, 45, 52, and 58 (so-called octavalent). All participants will receive the current formula of GARDASIL™ (active against HPV types 6, 11, 16, 18). In addition, some will receive one of 3 dose formulations of additional vaccine against HPV types 31, 45, 52, and 58. These 3 dose formulations will be compared to the control group that will receive GARDASIL™ (quadrivalent) only. In summary, the study will determine the correct doses needed to expand protection from quadrivalent to octavalent: and all participants will get the protection against the 4 most-concerning strains. The HPV vaccine is made in a similar manner as the Hepatitis B vaccine, which is given to prevent the Hep B virus, a cause for liver cancer. You cannot get HPV or cancer from this vaccine.

The Clinical Trials Office is located in the lower level of the URI Health Service Building. The office and exam rooms are private and confidential. Our site is one of 5 universities nationwide that will be evaluating this HPV vaccine under the direction of the HPV team of Dr. Insu Kong, a gynecologic specialist, Dr. David Whitaker, June Newman and Cindy Moffitt, Nurse Practitioners.

The program is open to women between the ages of 16-23. Prior to enrolling, you will be asked several questions to assess your eligibility. This is a 7-month study that will involve 5 visits; initially, for a physical exam that includes blood work, a brief exam with a pap smear and subsequently brief visits for vaccine. During this time, June Newman and Cindy Moffitt, Nurse Practitioners, perform all the exams. You will be paid $100 for each visit that is completed. It is not required that the women participants be URI students.

There is much excitement in the medical community about this vaccine research. We are equally as excited to be participating in this program so that a preventative vaccine for this cancer will have a tremendous impact on the prevention of HPV and cervical cancer.

Call June Newman, Nurse Practitioner and Coordinator at South County Consultants in Clinical Trials at URI at 401-782-2570 or contact us

Click here to learn more about HPV and Cervical Cancer from the Kaiser Network

More from Kaiser Network on HPV

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