# Presentation: 492428

## Human Papillomavirus and HPV Vaccine

**Epidemiology and Prevention of Vaccine-Preventable Diseases**
**National Immunization Program**
**Centers for Disease Control and Prevention**

**Revised January 2007**

## NOTICEContent and order of the slides in this file may differ from those presented on the  broadcast and webcast

## Human Papillomavirus

**More than 100 types**
** ****More than 60 cutaneous types**
**Can lead to skin warts**
**40 mucosal types**
**high risk types (particularly 16 and 18)**
**cervical cell abnormalities**
**certain anogenital cancers**
**Low risk types (particularly 6 and 11)**
**cervical cell abnormalities- usually resolve spontaneously and do not lead to cancer**
**genital warts**
**respiratory papillomatosis**

## Natural History of HPV Infection

**Within 1 Year**

**1-5 Years**

**Up to Decades**

**Initial****HPV Infection**

**Persistent**
**Infection**

**CIN 2/3**

**Cervical Cancer**

**CIN 1**

**Cleared HPV Infection**

**Natural History of HPV Infection**

## Cancer Attributable to HPV - 2002

**Cervical**
**Anal**
**Vulvar/vaginal**
**Penile**
**Oral/pharynx**

**Cancer Attributable to HPV - 2002**

**Estimated**
_**Cases**_
**12,000**
**3,700**
**4,480**
**1,000**
**10,000**

**Attributable**
_**Fraction**_
**100%**
**90%**
**40%**
**40%**
**12%**

## HPV-associated Conditions

_**HPV 16, 18**_
**Cervical cancer**
** ****- High/low grade cervical **
**    ****abnormalities**
**Anal, Vulvar, Vaginal, Penile          **
**Head and neck cancers            **
_**HPV 6, 11**_
**Low grade cervical **
** ****abnormalities**
**Genital warts**
**RRP**

**Estimated %**
**70%**
**30%-50%**
**10%**

**10%**
**90%**
**90%**

## Human Papillomavirus Vaccine

**Contains the L1 protein from four types of HPV (16, 18, 6, 11)**
**Produced using recombinant DNA technology**
**L1 proteins self assemble into non-infectious units called virus-like particles (VLPs)**
**VLPs are highly immunogenic**

## HPV Vaccine Efficacy*

| Endpoint |    Efficacy |
| --- | --- |
| HPV 16/18-related
CIN2/3 or AIS
 |   100 |
| HPV 6/11/16/18
related CIN
 |   95 |
| HPV 6/11/16/18
related genital warts |   99 |

***Among 16-26 year old females. ****CIN – cervical intraepithelial neoplasia; AIS – adenocarcinoma *****in situ***

## Human Papillomavirus Vaccine Efficacy

**No evidence that the vaccine had efficacy against existing disease or infection (i.e., no therapeutic effect)**
**Prior infection with one HPV type did not diminish efficacy of the vaccine against other vaccine HPV types**

## HPV Vaccine 

**HPV vaccine should not be administered to males**
**No safety or efficacy data**
**Off-label use not recommended**
**Studies of vaccine efficacy in males in progress now**
**Long term follow-up studies in progress to examine duration of immunity**

## HPV Vaccine Schedule

**Approved for females 9 through 26 year of age**
**3 doses at 0, 2, and 6 months**
**Minimum intervals:**
**4 weeks between doses 1 and 2**
**12 weeks between doses 2 and 3**

## Correct and consistent condom use may have a protective effect on HPV acquisition, reduce the risk for HPV-associated diseases, and mitigate the adverse consequences of infection with HPV.

**This statement is required by section 317 of the**
**Public Health Service Act, 42 U.S.C., 243 **

## HPV Vaccine –ACIP Recommendations*

**Routine vaccination of females 11 or 12 years of age**
**The vaccination series can be started as young as 9 years of age at the clinician's discretion**
**Vaccination is recommended for females 13 through 26 years of age who have not been previously vaccinated**
**Vaccine should be administered before onset of sexual activity if possible**
**Females who are sexually active should be vaccinated**

***provisional**

## HPV Vaccine – Special Situations*

**Females 26 years of age or younger with an equivocal or abnormal Pap test, positive HPV DNA, or genital warts may be vaccinated**
**Vaccine will have no effect on existing disease or infection**
**Females 26 years of age or younger who are lactating/breastfeeding or are immunocompromised may be vaccinated**
**Not recommended for pregnant women**

***Provisional ACIP recommendation, June 2006**

## HPV VaccineAdverse Reactions

**Local reactions****	****25%-84%**
**   ****(pain, swelling)**
**Temp 100****o****F or ****	**** ****	****10%***
**   ****or higher ****	****	****	**
**No serious adverse reactions reported**

***similar to reports in placebo recipients (9%)**

## HPV VaccineContraindications and Precautions

**Severe allergic reaction to a vaccine component or following a prior dose **
**Moderate or severe acute illnesses (defer until illness  improves)**

## HPV Vaccine and Cervical Cancer Screening

**Cervical cancer screening recommendations have NOT changed for females who receive HPV vaccine**
**Females who are vaccinated could subsequently be infected with a carcinogenic HPV type not in the quadrivalent vaccine **

## HPV Vaccine and Cervical Cancer Screening

**Females who were sexually active prior to vaccination could have been infected with a vaccine type HPV before vaccination**
**Healthcare providers who are administering HPV vaccine should take the opportunity to educate women about the importance of cervical cancer screening **

## HPV Vaccine Storage and Handling

**Store at 36°F-46°F (2°C-8°C)**
**Protect from light**
**Do not expose to freezing temperature**
**Remove from refrigeration immediately before administration**

## National Immunization Program

**Hotline****	****(800) CDC-INFO**
**Email****	****	****nipinfo@cdc.gov**
**Website****	****www.cdc.gov/nip**
**Broadcast Updates and Resources **
**   ****Web Page**
**	****www.cdc.gov/nip/ed/UpdatesandResources.htm**