From: SCAL Regional Immunization Practice Committee (RIPC)                   Date:  March 26, 2007    

 

To:     Chiefs, Physicians, and Dept. Administrators of Family Medicine, Internal Medicine, OB-GYN, and Employee Health Services

Re:     Recommendation for Usage of Human Papillomavirus Vaccine (HPV)

Background:

Human papillomavirus vaccine (HPV) strains 16 and 18 together cause about 70% of cervical cancer cases. HPV strains 6 and 11 cause about 90% of genital wart cases. The FDA has approved a quadrivalent HPV vaccine (strains 6, 11, 16, 18) that protects against cervical, vaginal and vulvar cancers as well as genital warts caused by those strains. The vaccine is safe and effective for girls and women ages 9 to 26. Recommendations have been made to routinely administer the vaccine to females 11-12 years of age to ensure protection prior to the initiation of any sexual activity. Females 9-26 years of age who are sexually active may benefit from the vaccine, if they have not already been exposed to HPV.  The vaccine may be less effective in females who are sexually active and have, thus, already been exposed to HPV. It appears that as the number of sexual partners increases, the risk of exposure to HPV increases, and the effectiveness of the vaccine decreases. 

There is no reliable test to determine whether a sexually active woman now has or has had type 6, 11, 16, or 18 HPV.  If her high-risk HPV test obtained from the endocervix is positive, she may have a high-risk HPV type other than 16, or 18 (and hence still benefit from the HPV vaccine).  If her endocervical high-risk HPV test is negative, she may have already been exposed to HPV type 16 or 18 and have cleared the virus (and hence will derive no benefit from the HPV vaccine) or she may never have been exposed (in which case the HPV vaccine will be effective).

CDC's Advisory Committee on Immunization Practices (ACIP) has recommended that all girls ages 11 and 12 receive human papillomavirus (HPV) Vaccine. The ACIP recommendation also allows for girls as young as nine to receive the vaccine and recommends that girls and women ages 13 to 26 receive HPV vaccine. Although the vaccination should be given before a girl begins sexual activity, sexually active girls and women still should receive HPV Vaccine.

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm?s_cid=rr5602a1_e

RIPC Recommendations:

1.  Vaccination of female adolescents

a) Routine vaccination of all 11-12 years of age with three doses of quadrivalent HPV vaccine. Earlier vaccination (age 9-10) is an option, if clinically appropriate.

b) Catch up vaccination of all females age 13 up to age 18 who have not been previously vaccinated. Discussion of contraception and sexually transmitted disease (STDs) and the potential benefit of the vaccine are also recommended at this visit.

2.  Vaccination of females aged 18--26 years                                                                                     Vaccination also is recommended for females aged 18--26 years who have not been previously vaccinated or who have not completed the full series. Ideally, vaccine should be administered before potential exposure to HPV through sexual contact; however, females who might have already been exposed to HPV should be vaccinated. Sexually active females who have not been infected with any of the HPV vaccine types would receive full benefit from vaccination. Vaccination would provide less benefit to females if they have already been infected with one or more of the four vaccine HPV types. However, it is not possible for a clinician to assess the extent to which sexually active persons would benefit from vaccination, and the risk for HPV infection might continue as long as persons are sexually active. Pap testing and screening for HPV DNA or HPV antibody are not needed before vaccination at any age.

3.   HPV vaccine is not licensed for use in males and is not recommended at this time.

4.   Despite the advent of this vaccine, continued screening is recommended as per current KP cervical cancer  

screening guidelines.

 

Schedule:

Dosing schedule of first dose, 2nd dose 2 month later, 3rd dose 6 months after first dose.

Management of persons off recommended dosing schedule

 

 

Between doses 1 and 2

Between doses 2 and 3

Minimum interval

 4 weeks

12 weeks

 

Interrupted schedule

Do not restart schedule

Dose 2 is DELAYED

Dose 3 is DELAYED

Give 2nd dose as soon as possible. Give third dose a minimum of 12 weeks after 2nd dose.

Give 3rd dose as soon as possible

 

 

 

Special Situations:

ˇ         Quadrivalent HPV vaccine can be given to females who have an equivocal or abnormal Pap test, a    positive Hybrid Capture IIŽ high risk test, or genital warts. Vaccine recipients should be advised that data from clinical trials do not indicate the vaccine will have any therapeutic effect on existing Pap test abnormalities, HPV infection or genital warts. Vaccination of these females would provide protection against infection with vaccine HPV types not already acquired.

ˇ         Lactating women can receive quadrivalent HPV vaccine.

ˇ         Females who are immunocompromised either from disease or medication can receive quadrivalent HPV vaccine. However the immune response to vaccination and vaccine effectiveness might be less than in females who are immunocompetent.

Pregnancy:

Quadrivalent HPV vaccine is not recommended for use in pregnancy. The vaccine has not been causally associated with adverse outcomes of pregnancy or adverse events in the developing fetus. However, data on vaccination during pregnancy are limited. Until additional information is available, initiation of the vaccine series should be delayed until after completion of the pregnancy. If a woman is found to be pregnant after initiating the vaccination series, the remainder of the 3-dose regimen should be delayed until after completion of the pregnancy. If a vaccine dose has been administered during pregnancy, no intervention is needed. A vaccine in pregnancy registry has been established; patients and health-care providers should report any exposure to quadrivalent HPV vaccine during pregnancy (telephone: 800-986-8999).

Contraindications to use of vaccine:

ˇ         Quadrivalent HPV vaccine is contraindicated for people with a history of immediate hypersensitivity to yeast or to any vaccine component.