HPV Vaccine

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HPV Vaccine

• Emily A. Boohaker, MD
• Associate Professor of Medicine
• Division of General Internal Medicine
• University of Alabama School of Medicine

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Objectives

• HPV and its role in cervical cancer
• Effectiveness of the quadrivalent HPV vaccine
• Recommendations for HPV vaccination
• Common vulvar and cervical lesions

3
HPV

• Highly prevalent
• Tissue specific DNA virus
• Oncogenic types 16, 18, 31, 33, 35, 45, 51, 52,
  56, 58
• Benign types 6, 11, 42, 43, 44

4
HPV-Related Lesions

• Gynecologic Oncology 103 (2006) 21-24
• N Engl J Med 356 19 (2007) 1915-1925

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What are risk factors for HPV?
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HPV Risk Factors

• Young age
• Lifetime number of sexual partners
• Early age of first sexual intercourse
• Male partner sexual behavior
• Smoking
• OCP use
• Uncircumcised male partners

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HPV US Statistics

• By age 50, 80 of women will have acquired
  genital HPV infection
• 40 infected with more than one type
• Risk of high grade precursor lesions with HPV is
  300 fold
• Risk for developing cervical cancer with HPV is
  50-100 fold

Centers for Disease Control and Prevention.
Rockville, Md CDC National Prevention
Information Network 2004
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HPVClearance

• Most HPV infections transient
• Natural desquamation
• Cell mediated immunity
• HPV 16, 18 more likely to persist

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HPV Immunity

• Type-specific immunity
• Remain immunologically naïve to other HPV types
• Vaccine design to incorporate most common
  disease-causing HPV types

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HPVVaccine

• HPV major capsid protein is L1
• L1 is only HPV portion used in vaccine design
• Bivalent HPV 16, 18
• Quadrivalent HPV 6, 11, 16, 18

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Quadrivalent VaccineImmunogenicity

• 100 of naïve subjects receiving vaccine became
  seropositive

Seroconversion ( of subjects)
Villa, L, Ault K, et al. Vaccine 24 (2006)
5571-5583
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FUTURE TRIALVaccine Efficacy
 CI
 Efficacy ()
Placebo
Vaccine
 
Cases
n
Cases
n
 End Point
(86100)
98
42
5,260
1
5,305
HPV 16/18 CIN 2/3 or AIS
100
2,279
0
2,261
(49100)
9
HPV 6/11/16/18 VIN 2/3 or VAIN 2/3
P lt 0.001
N Engl J Med 356 19 (2007) 1915-1925 N Engl J
Med 356 19 (2007) 1928-1942
13
FUTURE TRIALVaccine Efficacy
 CI
 Efficacy ()
Placebo
Vaccine
 
Cases
n
Cases
n
 End Point
(94100)
100
65
2,258
0
2,241
HPV 6/11/16/18 CIN 1







(94-100)
100
57
2,279
0
2,261
HPV 6/11/16/18 Condy, VIN 1, VAIN 1
P lt 0.001
N Engl J Med 356 19 (2007) 1915-1925 N Engl J
Med 356 19 (2007) 1928-1942
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Do Exposed Women Benefit from the Vaccine?
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FUTURE TRIALVaccine Efficacy

• HPV 16 or 18 at baseline
• No alteration of cervical end points
• No alteration of vaginal/vulvar end points
• No influence on rate of viral clearance
• Protection against unexposed HPV types
• JAMA 298 7 (2007) 743-753
• N Engl J Med 356 19 (2007) 1915-1925

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HPVVaccine

• Major public health implications
• Protects against 4 strains of HPV
• Why is it a source of controversy?

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HPV VaccineControversy

• Should it be mandated?
• Undermines abstinence-based prevention messages
• Intrusion on individual and parental rights
• Conflict with religious or personal beliefs

N Engl J Med 355 23 (2007) 2389-2391
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N Engl J Med 356 19 (2007) 1905-1910
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HPV VaccinationRecommendations

• Before onset of sexual activity
• IM injection/Quadrivalent vaccine/GARDASILR
• First dose elected time
• Second dose 2 months
• Third dose 6 months

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HPV VaccinationRecommendations

• ACIP
• Females 11-12 years of age
• Can start as early as 9 up to 26 years of age
• ACOG
• Females 9-26 years of age
• Previous abnormal cervical cytology or genital
  warts
• ACS
• Females 11-12 years of age
• Can start as early as 9 years of age
• Insufficient data to recommend for or against
  universal vaccination for 19-26 years of age

• www.acog.org
• www.cdc.gov
• www.americancancersociety.org

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GARDISILR

• Adverse Reactions
• Fever 10-13
• Injection site
• Pain 84
• Swelling 25
• Erythema 25

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HPV VaccineUnanswered Questions

• Duration of immunity?
• Require booster doses?
• Effectiveness for males/older women?
• Long term safety?
• What will happen to screening?

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Summary

• HPV is highly prevalent
• Certain HPV related lesions can be prevented
• Vaccinate before the onset of sexual activity
• Ongoing studies to address unanswered questions

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Which is an HPV-related lesion?
Cervical Polyp
Strawberry Cervix
Nabothian Cysts
Cervical Condyloma
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Which is an HPV-related lesion?
HPV changes
Gland openings
HSV cervicitis
Cervical Fibroid
27
Condyloma
Images top left and top right Reprinted with
permission from NZ DermNet (www.dermnetnz.org)
28
Which lesions are HPV-related?
Molluscum HSV
VIN 2
Multicentric CIS
Squamous Cell Ca
Chancre
Condyloma lata
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QUESTIONS

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