A summary
HPV VACCINE OVERVIEW ? Human papillomavirus (HPV) is a virus that causes cervical cancer and genital warts. Persistent infection with certain types of HPV can lead to cancer of the cervix, which affects more than 10,000 American women every year. HPV can also cause cancers of the vulva, vagina, and anus, although these cancers are much less common than cervical cancer.
Two vaccines (Gardasil® and Cervarix®) are available to prevent infection with several types of HPV known to cause cervical cancer. It is hoped that these vaccines will significantly reduce the number of women who develop cervical cancer and pre-cancer.
WHAT IS HPV? ? Human papillomavirus (HPV) is a virus that is spread by skin-to-skin contact, including sexual intercourse, oral sex, anal sex, or any other contact involving the genital area (eg, hand to genital contact). Condoms do not provide complete protection from HPV infection because condoms do not cover all exposed genital skin. People do not become infected with HPV by touching an object, such as a toilet seat.
The risk of HPV exposure increases with the number of sexual partners you have and the number of partners your partner has. It has been estimated that 75 to 80 percent of sexually active adults will acquire HPV infection before the age of 50. A majority of women and men become infected with HPV for the first time between ages 15 and 25 years. Most people who are infected with HPV have no signs or symptoms and clear the infection within two years, often without treatment.
In 10 to 20 percent of people, however, the infection persists. In this situation, there is a greater chance of developing cervical pre-cancer and then cancer. However, it usually takes at least 20 years for HPV infection to cause cervical cancer. Thus, regular testing is important in detecting cervical abnormalities early, before cancer develops.
Over 100 different types of HPV have been identified; 40 of these are known to infect the cervix and 15 are known to cause cervical cancer. Researchers have labeled the HPV types as being high or low risk for causing cervical cancer.
HPV types 6 and 11 can cause about 90 percent of genital warts. These types are low-risk because they do not cause cervical cancer. (See "Patient information: Genital warts in women".)
Types 16 and 18 are the high-risk types that cause most (about 70 percent) cases of cervical cancer. HPV types 45 and 31 are also high-risk types, causing about 5 to 10 percent of cervical cancers.
There are two HPV vaccines available. Talk to your healthcare provider to determine which vaccine is best for you.
One HPV vaccine (Gardasil®) helps to prevent infection with four HPV types (6, 11, 16, and 18)
The other vaccine (Cervarix®) prevents infection with HPV types 16 and 18, and it may offer some protection against HPV types 45 and 31.
HPV VACCINE TIMING AND DOSE ? Gardasil® is given by injection and requires three doses; the first injection is followed by a second and third dose two and six months later, respectively.
Cervarix® is also given by injection and requires three doses, although the schedule is slightly different than with Gardasil; the first injection is followed by a second and third dose one and six months later, respectively.
It is not clear if the vaccine is effective if fewer than three doses are given.
Who should be vaccinated? ? In the United States, HPV vaccination is recommended for all girls and women who are between ages 9 and 26 years.
With both vaccines, you will have the greatest protection from HPV if you are vaccinated BEFORE becoming sexually active. The vaccine does not help to get rid of HPV infection after it has occurred. However, if you are less than 26 years old and you have been sexually active, had genital warts, a positive HPV test, or an abnormal Pap smear, you may still obtain some benefit from the HPV vaccine.
How long will you be protected for? ? Scientists do not know exactly how long the vaccine protects against HPV infection. Clinical trials show that it provides protection for at least five years.
Neither vaccines contain mercury
Efficacy
Efficacy in females
The FUTURE II trial ? In a phase III, multi-national prospective, double-blind, placebo-controlled trial (FUTURE II), more than 12,000 women, aged 15 to 26 years (mean age of 20 years), were randomly assigned to receive a three-dose regimen of vaccine or placebo. The majority of the study participants were from Europe (65 percent) and Latin America (26 percent). Women with greater than four lifetime sexual partners or a history of abnormal cytology were excluded from the study. Evidence of past or current infections with HPV 16 and/or HPV 18 (as measured by serology and DNA detection in cervical specimens) was found in approximately one-fourth of the women in the vaccine and placebo arms (23 and 28 percent, respectively) through one month follow-up after vaccination.
The primary efficacy analysis (According-To-Protocol [ATP] analysis) was performed in those subjects who did not have evidence of either HPV 16 or 18 infection (by HPV DNA or HPV serological testing) through one month after the third dose of vaccine; these patients were referred to as "HPV-naive" as per protocol. The primary composite end point was the development of CIN 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV 16 or HPV 18 among the "HPV-naive" women. After a mean follow-up of three years, the following results were demonstrated:
Vaccine efficacy, for the prevention of the primary composite end point, was 98 percent in study participants who were "HPV-naive".
Vaccine efficacy remained high (95 percent) in those HPV-negative participants who did not receive all doses of vaccine according to protocol, suggesting some flexibility in the timing of the vaccine schedule.
Seroconversion rates at 24 months among 1512 vaccinated women in the immunogenicity sub-study were 96, 97, 99, and 68 percent for HPV types 6, 11, 16, and 18, respectively.
The FUTURE 1 trial ? A similarly designed phase III placebo-controlled trial was conducted in 5455 women aged 16 to 24 years to assess the efficacy of quadrivalent vaccine to prevent HPV-related anogenital disease (FUTURE I) . The majority of the study participants were from Latin America (41 percent) or North America (29 percent). Women with greater than four lifetime sexual partners or a history of any genital warts or abnormal cytology were excluded from the study. Evidence of past or current infection with one or more of the vaccine genotypes (HPV 6, 11, 16 and/or 18) as measured by serology and DNA detection in cervical specimens was found among women in the vaccine and placebo arms (38 and 42 percent, respectively) through one month follow-up after vaccination.
The primary aim of the trial was to determine vaccine efficacy in reducing the combined endpoint of incidence of anogenital warts, vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VAIN) grades 1 to 3 or cancer associated with HPV 6, 11, 16, or 18. A secondary aim was to observe whether the administration of vaccine reduced the combined incidence of CIN grades 1 to 3, adenocarcinoma in situ, or cancer associated with vaccine-type HPV. After a mean follow-up of three years, the following results were demonstrated:
The vaccine was 100 percent effective in preventing anogenital disease in women who were "HPV-naive" (ie, no cases were identified in the vaccine group versus 60 cases in the placebo group).
Vaccine efficacy was 100 percent in preventing CIN grades 1 to 3 or adenocarcinoma in situ caused by the vaccine-type HPVs in those women who were "HPV-naive" (ie, no cases were diagnosed in the vaccine group, whereas 65 cases were diagnosed in placebo group).
refs
FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007; 356:1915.
Garland SM, Hernandez-Avila M, Wheeler CM, et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med 2007; 356:1928.
Brown DR, Kjaer SK, Sigurdsson K, et al. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years. J Infect Dis 2009; 199:926.
Wheeler CM, Kjaer SK, Sigurdsson K, et al. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years. J Infect Dis 2009; 199:936.
most up to date info on safety
further research
a 2011 meta analysis of all 11 published studies on safety and efficacy
conclusion
Prophylactic HPV vaccines are safe, well tolerated, and highly efficacious in preventing persistent infections and cervical diseases associated with vaccine-HPV types among young females. However, long-term efficacy and safety needs to be addressed in future trials
(this is because the longest study is only at 6.4 years follow up and can not give info beyond that.) Be assured the research is continuing
Based on the information already obtained, we are highly unlikely to see the appearance of long term safety issues. Efficacy is predicted to last 15 years
Hope that overview helps you all to make your own informed decision