Human Papillomavirus

(HPV) and HPV Vaccine

Epidemiology and Prevention of Vaccine-

Preventable Diseases

National Center for Immunization and

Respiratory Diseases
Centers for Disease Control and Prevention
Revised May 2009
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 Human Papillomavirus (HPV)

• Small DNA virus

• More than 100 types identified based
on the genetic sequence of the outer
capsid protein L1
• 40 types infect the mucosal
epithelium

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 Human Papillomavirus Types
and Disease Association
mucosal/genital nonmucosal/cutaneous
(~40 types) (~60 types)

high-risk types
16, 18, 31, 45 low-risk types skin
(and others) 6, 11
(and others) warts
(hands
and feet)

•low grade cervical •low grade cervical

abnormalities abnormalities
•cancer precursors •genital warts
•anogenital cancers •laryngeal papillomas
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 HPV-Associated Disease

Type Women Men

16/18 70% of Cervical Cancer 70% of Anal Cancer
70% of Anal/genital Transmission to women
Cancer
6/11 90% of Genital Warts 90% of Genital Warts
90% of RRP lesions 90% of RRP lesions
Transmission to women

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 Natural History of HPV Infection

Within 1 Year 1-5 Years Up to Decades

Persistent CIN Cervical

Infection 2/3 Cancer
Initial
HPV
Infection
CIN 1

Cleared HPV Infection

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 HPV Clinical Features

• Most HPV infections are asymptomatic

and result in no clinical disease
• Clinical manifestations of HPV infection
include:
– anogenital warts
– recurrent respiratory papillomatosis
– cervical cancer precursors (cervical
intraepithelial neoplasia
– Cancer (cervical, anal, vaginal, vulvar,
penile, and some head and neck cancer)

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 HPV Epidemiology

• Reservoir Human

• Transmission Direct contact,

usually sexual
• Temporal None
pattern

• Communicability Presumed to be
high

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HPV Disease Burden in the United States

• Anogenital HPV is the most common

sexually transmitted infection in the US
– Estimated 20 million currently infected
– 6.2 million new infections/year
• Common among adolescents and young
adults
• Estimated 80% of sexually active women
will have been infected by age 50
• Infection also common in men

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 Cervical Cancer Disease Burden in
the United States

• The American Cancer Society

estimates that in 2008
– 11,070 new cervical cancer cases
– 3,870 cervical cancer deaths
• Almost 100% of these cervical cancer
cases will be caused by one of the 40
HPV types that infect the mucosa

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 Cervical Cancer Screening

• Cervical cancer screening – no change

– 30% of cervical cancers caused by HPV
types not prevented by the quadrivalent
HPV vaccine
– Vaccinated females could subsequently
be infected with non-vaccine HPV types
– Sexually active females could have been
infected prior to vaccination
• Providers should educate women about
the importance of cervical cancer
screening
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 Human Papillomavirus Vaccine
• HPV L1 major capsid protein of the
virus is antigen used for
immunization
• L1 protein expressed in yeast cells
using recombinant technology
• L1 proteins self-assemble into virus-
like particles (VLP)
• VLPs are noninfectious and
nononcogenic

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 HPV Vaccine Efficacy*
Endpoint Efficacy
HPV 16/18-related 100
CIN2/3 or AIS

HPV 6/11/16/18 95
related CIN

HPV 6/11/16/18 99
related genital warts
*Among 16-26 year old females. CIN – cervical intraepithelial neoplasia; AIS –
adenocarcinoma in situ 12
 HPV Vaccine Efficacy

• High efficacy among females without

evidence of infection with vaccine
HPV types
• No evidence of efficacy against
disease caused by vaccine types or
which participants were infected at
the time of vaccination
• Prior infection with one HPV type did
not diminish efficacy of the vaccine
against other vaccine HPV types
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 Routine HPV Vaccination
Recommendations
• ACIP recommends 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
• “Catch-up” vaccination recommended
for females 13 through 26 years of age

MMWR 2007;56(RR-2):1-24 14
 HPV Vaccination Schedule
• Routine schedule is 0, 2, 6 months
• Third dose should follow the first
dose by at least 24 weeks
• An accelerated schedule using
minimum intervals is not
recommended
• Series does not need to be restarted
if the schedule is interrupted

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 Human Papillomavirus Vaccine

• Quadrivalent HPV vaccine is not

currently* approved for males, or for
females younger than 9 years or
older than 26 years
• Off-label use is not recommended
• Studies of safety and efficacy among
males and females older than 26
years are ongoing

*as of May 2009 16

 HPV Vaccine
Special Situations*
• Equivocal or abnormal Pap test
• Positive HPV DNA test
• Genital warts
• Immunosuppression
• Breastfeeding

*Vaccine can be administered

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 HPV Vaccine
Adverse Reactions
• Local reactions 84%
(pain, swelling)
• Fever 10%*
• No serious adverse reactions
reported

*similar to reports in placebo recipients (9%)

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 Syncope Following Vaccination

• An increase in the number of reports of

syncope has been detected by the
Vaccine Adverse Event Reporting System
(VAERS)
• 11-18 year old females have contributed
most of the increase
• Serious injuries have resulted
• Providers should strongly consider
observing patients for 15 minutes after
they are vaccinated

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 HPV Vaccine
Contraindications and Precautions
• Contraindication
– Severe allergic reaction to a
vaccine component or following a
prior dose
• Precaution
– Moderate or severe acute illnesses
(defer until symptoms improve)

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 HPV Vaccination During Pregnancy

• Initiation of the vaccine series should be

delayed until after completion of pregnancy
• If a woman is found to be pregnant after
initiating the vaccination series, remaining
doses should be delayed until after the
pregnancy  
• If a vaccine dose has been administered
during pregnancy, there is no indication for
intervention
• Women vaccinated during pregnancy
should be reported to the Merck registry
(800.986.8999)
MMWR 2007;56(RR-2):1-24 21
 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

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 CDC Vaccines and Immunization
Contact Information

• Telephone 800.CDC.INFO

• Email nipinfo@cdc.gov

• Website www.cdc.gov/vaccines

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