Preventing Cervical Cancer with Gardasil Jana Ogden RN, MSN, MBA-HCA, IHCC Nursing Faculty. Upon Completion of the Lesson the student will be able to:

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1 Preventing Cervical Cancer with Gardasil Jana Ogden RN, MSN, MBA-HCA, IHCC Nursing Faculty Upon Completion of the Lesson the student will be able to: Review statistics related to cervical cancer and HPV infections Review what viruses are and how they infect. Identify how vaccines work to prevent infections Identify risk factors for cervical cancer Review the guidelines for Gardasil administration Review the effectiveness and safety of the Gardasil vaccine The American Cancer Society estimated in 2006, that over 9,700 women were diagnosed with cervical cancer and 3,700 died from cervical cancer in the United States (1). Worldwide, cervical cancer is the second most common cancer in women and it is estimated that there are over 470,000 new cases diagnosed and 233,000 deaths annually (2). Approximately $1.7 billion is spent in the United States each year on the treatment of cervical cancer (3). Risk factors for cervical cancer include Human Papillomavirus (HPV) infections, smoking, human immunodeficiency virus infection, Chlamydia infections, a diet low in fruits and vegetables, long term use of oral contraceptives, multiple pregnancies, being of low socioeconomic status, and a family history of cervical cancer. The most important risk factor by far is HPV infection. Because HPV is a virus it causes infections differently than bacteria and cannot be treated with antibiotics. Bacteria are individual living cells that can cause disease. Because a bacteria is a living cell, antibiotics can destroy it or inhibit the growth of the bacteria, therefore helping to cure the infection. Viruses are either strands of ribonucleic acid (RNA) or deoxyribonucleic acid (DNA) that are enclosed within a protein sheath. Viruses must enter the body to find a living host cell to grow and reproduce. Once inside a living host cell they take over cell production and reproduce their genetic material. Because viruses are not living cells they are much harder to destroy once someone becomes infected. Killing the virus would mean potentially killing the host cell. In cervical cancer the virus infected cell either dies or has functional changes that can lead to precancerous or cancerous cell development. If the case of the HPV virus, if the development of the viral infection can be prevented, the progression of the cervical cells to produce cervical cancer could be stopped. Viruses can be transmitted through direct contact, indirect contact, and airborne transmission. Methods of direct contact include touching, kissing, and sexual intercourse. Indirect contact occurs when one comes into contact with an object contaminated with the virus. Vectorborne transmission (from insect bites) is also considered a type of indirect contact. Airborne transmission can occur with coughing, singing, speaking, and sneezing. HPV is a sexually transmitted virus transferred through genital and skin to skin contact. There are over 100 different HPV types, with types 16 and 18 causing up to 70% of all cervical cancers, and types 6 and 11 causing 90% of genital warts. At least 50% of people who have had intercourse will have HPV at some time during their life time (4). Each year in the United States, about 6.2 million people get HPV (1). There is no cure for HPV and most HPV infections are asymptomatic. About two thirds of all cervical cancers are caused by human papillomavirus (HPV) infections (5). Cancer of the cervix begins in the lining of the cervix, which is the lower part of the uterus. The cervix connects the uterus to the vagina. Normal cervical cells can gradually develop precancerous changes that can progress to cancer. In the precancerous stages, women are asymptomatic. As the cellular changes progress to cancer, abnormal vaginal bleeding and pelvic pain may occur. Cervical cancer is preventable and curable if detected early. The most common prevention and detection measure utilized is the papanicolaou or Pap test. A Pap test is a relatively painless procedure that is performed in the clinic setting. It involves the insertion of a speculum (a metal or plastic device that holds the vagina open for visualization of the cervix) into the vagina by the health care professional. A sample of cervical

2 cells is then obtained by lightly scraping the cervix with a small spatula, small brush, or swab. With a regular Pap test, the sample cells are immediately smeared onto a microscope slide and then sent to a laboratory for analysis. With a liquid based Pap test, the sample cells are placed in a preservative solution that is then sent to the laboratory for analysis. In the laboratory the cells are evaluated microscopically for abnormalities that would suggest precancerous or cancerous conditions. The Pap test therefore can detect precancerous cells and HPV and allows for early treatment of cervical cancer. The American Cancer Society recommends that all women begin screening with Pap tests about three years after they begin having vaginal intercourse but no later than age 21. Testing should be done every year with the regular Pap test until age thirty, when testing can occur every two to three years for women who have had three normal Pap tests and are of low risk based on other criteria. The newest measure to help in prevention of cervical cancer is administration of the Gardasil vaccine. A vaccine stimulates the body to develop natural immunity to disease. Vaccines contain small amounts of antigens or proteins from the virus it is protecting against. When those antigens are introduced into the body, the body s immune system creates antibodies to the disease. When the body is later exposed to that disease, the antibodies generated in response to the vaccine prevent the disease from developing at that time. There are several types of vaccines utilized in disease prevention. Traditional vaccines contain the whole component of an inactivated (killed) microorganism. The rabies vaccine is this type of vaccine. Some vaccines are live, attenuated vaccines. They contain live, weakened microorganisms. The smallpox vaccine is a live, attenuated vaccine. Toxoid vaccines are composed of the inactivated, toxic portion of the microorganism. The Tetanus vaccine is a toxoid vaccine. The newest type of vaccine is the recombinant (subunit) vaccine. It is developed by inserting some of the DNA of the microorganism into another cell where the antigen is produced in massive quantities. The antigen is then utilized as the vaccine. Gardasil is a recombinant vaccine, which means that it contains no live virus. It protects against HPV types 6, 11, 16, and 18. This vaccine can only be used to prevent HPV infection before an abnormal Pap test develops. It can not be used to treat an existing infection. Therefore, the CDC has approved the vaccine for use in females 9-26 years of age. The vaccine is given through a series of three shots over a six month period, with the second and third shots given two and six months respectively, after the first dose. The cost is $120 per injection, or $360 for the full series. Some insurance companies will cover the cost of the vaccine. Gardasil is produced by Merck &Co., Inc. Pharmaceuticals. It is available for administration in single dose vials or prefilled syringes. No dilution or reconstitution is necessary. It must be shaken well prior to administration to maintain the suspension of the vaccine. It is a white, cloudy solution for injection. The dose is 0.5 ml for each injection. It must be given intramuscularly either in the deltoid region of the upper arm or in the higher aspect of the anterolateral area of the thigh. Merck recommends observing the patent for at least 15 minutes after administration of the vaccine, as syncope following any type of vaccination is common in adolescents and young adults. Four studies, one in the United States and three multinational, were conducted in 21,000 women to show how well Gardasil worked in women between the ages of 16 and 26. The results showed that in women who had not previously been infected, Gardasil was 100% effective in preventing precancerous cervical lesions, precancerous vaginal lesions, precancerous vulvular lesions, and genital warts caused by HPV types 6, 11, 16, and 18. Two studies were also performed to evaluate the immune response in females Their immune response was similar to the immune response in the older group, indicating similar effectiveness should be seen. The safety of the vaccine has been evaluated in approximately 11,000 individuals. Most adverse reactions in study participants included mild or moderate local reactions, such as pain or tenderness at the injection site. Safety of the vaccine will continue be monitored. The vaccine is not recommended for pregnant women. Limited studies completed suggest that the vaccine has not caused health problems during pregnancy or problems for the infant, but more research is needed. Pregnant women should complete their pregnancy prior to receiving the vaccine. If a woman finds out she is pregnant after she has started the series, she should complete the pregnancy before finishing the vaccine series. Studies are also being completed to determine the effectiveness of preventing HPV infections in males.

3 Further research indicated that Gardasil protects against 10 additional strains of HPV that are also causes of cervical cancer. The new study, which involved about 11,000 young women aged 15 to 26, showed that the vaccine is also 38% effective against these 10 additional HPV types, which are responsible for an additional 20% of cervical cancers. The vaccine has been the center of some debate since it s release with proponents calling for routine vaccination of young women while critics charge that the vaccine promotes promiscuity and denies parents their rights. Texas is the first and only state to mandate the vaccine although other states are proposing mandatory vaccination. Even if vaccinated, females still need to have regular Pap tests to evaluate for signs of precancerous lesions from the viruses the vaccine does not protect against. The combination of the vaccine and regular Pap tests may help to further decrease the incidence cervical cancer. Resources: 1. CDC: HPV Vaccine Questions & Answers. Retrieved 03/6/2008 from 2. FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in females Caused by Human Papillomavirus. Retrieved 03/6/2008 from 3. National Cancer Institute: A Snapshot of Cervical Cancer. Retrieved 03/6/2008 from 4. U. S. Food and Drug Administration: HPV. Retrieved 03/6/2008 from 5. What Are the Risk Factors for Cervical Cancer? Retrieved 03/6/2008 from 6. Can Cervical Cancer Be Prevented. Retrieved 03/6/2008 from 7. Cervical Cancer Vaccine Exceeds Expectations. Retrieved 03/6/2008 from 8. Gardasil Product Information. Retrieved 03/6/2008 from

4 Preventing Cervical Cancer Post Test Questions Submission deadline January 6, How many women worldwide are stricken with cervical cancer annually? a. 470,000 b. 520,000 c. 9,700 d. 233, HPV infections affect million people in the U. S. annually. a. 47 b. 9.7 c. 233 d The most important risk factor for cervical cancer is a. Smoking b. Long term use of oral contraceptives c. HPV infection d. Low socioeconomic status 4. The Gardasil vaccine is a a. Live virus vaccine b. Recombinant vaccine c. Attenuated vaccine d. Toxoid vaccine 5. The Gardasil vaccine is recommended for females between the ages of a b c. 1-7 d. up to age Gardasil was designed to protect against HPV types a. 2, 4, 16, 18 b. 45, 16, 18 c. 6, 11, 16, 18 d. 16, 18, 44, Gardasil is given by a. Subcutaneous injection b. Intradermal injection c. Intravenous injection d. Intramuscular injection 8. The Gardasil vaccine is a mandated vaccination nationwide. 9. Once you have received the Gardasil vaccination you no longer need routine Pap tests. 10. Recent research has shown that Gardasil is protecting women from additional types of HPV infections.

5 ANSWER SHEET for Preventing Cervical Cancer course # 14/YR REL To receive 1.0 Contact hour for nursing, EMS (OE), social work, physical therapy, occupational therapy circle your answers to the questions above on the answer sheet below, detach and mail to: RHEP, Attn: Sandy Berto, 651Indian Hills Drive, Ottumwa, IA Certificates will be ed to the address provided below. **If not an IHEA member, please enclose the $15 fee. Make checks payable to IHEA. Name Address City State Zip DOB Last 4 digits of SSN address Nursing EMS (Please mark) 1. A B C D 2. A B C D 3. A B C D 4. A B C D 5. A B C D 6. A B C D 7. A B C D 8. A B 9. A B 10. A B You must obtain a score of 80% on the post-test to receive continuing education credit