Human Papilloma Virus Vaccine

Aka: Human Papilloma Virus Vaccine, Quadrivalent Human Papillomavirus Vaccine, HPV Vaccine, Gardasil, Gardasil-9, Cervarix

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II. Epidemiology

  1. Under-Vaccination despite high efficacy and potential to prevent anogenital and oropharyngeal cancer
    1. Girls: 57.3% vaccinated (as of 2013 in U.S.)
    2. Boys: 34.6% vaccinated (as of 2013 in U.S.)

III. Indications

  1. General indications
    1. Prevention of Cervical Dysplasia
    2. Prevention of Anal Cancer (receptive anal intercourse)
  2. Girls and women: Part of Primary Series
    1. Females routinely at age 11-12 and catch-up age <26 years
    2. Vaccination may start as early as age 9 years
    3. As of 2018, approved for use in 27-45 year old women at risk (e.g. new partners)
      1. More than half of HPV infections in this age group are new exposures
      2. Prevents 88% of HPV infections if not already exposed (47% overall effectiveness)
      3. (2018) Presc Lett 25(12):68
  3. Boys and men
    1. Part of Primary Series in United States as of 2012
    2. Males routinely at age 11 to 12 years and catch-up age 21 years
    3. Routine use in males ages 22 to 26 years old who have HIV Infection or who have sex with men
    4. Permissive use of Vaccine in males ages 22 to 26 years old
    5. As of 2018, approved for use in 27-45 year old men at risk
    6. Reduces risk of Genital Warts, precancerous lesions and transmission to sexual partners

IV. Preparations: Gardasil-9

  1. Released in 2015 with additional coverage for 5 HPV Antigens in addition to the 4 in the original Gardasil
    1. Replaces original Gardasil Vaccine
    2. Originally approved for males and females 9 to 26 years old
      1. Extended to include 27-45 year olds at risk as of 2018
    3. Improves coverage against Cervical Cancer causing HPV from 70% with Gardasil to 90% with Gardasil-9
    4. Gardasil-9 also reduces the risk of vulvar, vaginal and Anal Cancers when compared with Gardasil
    5. Gardasil-9 causes more local reactions than Gardasil (in which local reactions were already very common)
  2. Two low risk HPV types (but cause 90% of Genital Warts)
    1. HPV 6
    2. HPV 11
  3. Two high risk HPV types (cause 70% of Cervical Cancers)
    1. HPV 16
    2. HPV 18
  4. Additional HPV types responsible for cervical, vulvar, vaginal and Anal Cancers (added to Gardasil-9)
    1. HPV 31
    2. HPV 33
    3. HPV 45
    4. HPV 52
    5. HPV 58

V. Preparations: Gardasil (original version)

  1. No longer available in U.S., was replaced by Gardasil-9 as of 2015
  2. Mixture of primary capsid Proteins of 4 HPV types (Quadrivalent)
  3. Two low risk HPV types (but cause 90% of Genital Warts)
    1. HPV 6
    2. HPV 11
  4. Two high risk HPV types (cause 70% of Cervical Cancers)
    1. HPV 16
    2. HPV 18

VI. Preparations: Cervarix

  1. Human Papillomavirus Bivalent Vaccine
  2. Not available in United States
  3. Approved only for girls and women ages 9 to 25 years old
  4. Covers only two high risk types and none related to Genital Warts (contrast with Gardasil)
    1. HPV 16
    2. HPV 18

VII. Contraindications

  1. Pregnancy
  2. Anaphylaxis to yeast

VIII. Adverse Effects

  1. Local pain at injection site
    1. Gardasil: 84.9%
    2. Gardasil-9: 90.7%
  2. Local redness or swelling: 25%
  3. Fever
    1. Low grade in 10%
    2. Over 102 degrees in 1.4%
  4. Other reactions
    1. Headache (11-14%)
    2. Syncope (rare)

IX. Efficacy

  1. Very High efficacy when administered prior to onset of sexual activity (prior to exposure)
    1. Palmer (2024) J Natl Cancer Inst 116(6): 857-65 [PubMed]
  2. Number Needed to Treat to prevent one HPV related cancer
    1. Age <27 years old: 200
    2. Age 27 to 45 years old: 6500
    3. Meites (2019) MMWR Morb Mortal Wkly Rep 68(32):698-702 +PMID: 31415491 [PubMed]

X. Dosing

  1. Intramuscular Injection
  2. Two dose schedule as of 2017 (indicated if started before age 15 years and immunocompetent)
    1. Indicated for ages 9-14 years old
      1. Age >15 years old should use 3 dose schedules (or if Immunocompromised, e.g. HIV)
    2. Schedule: Two doses at 6-12 months apart (U.S. Primary Series starts series at age 11-12 years old)
      1. Dose 1: Month 0
      2. Dose 2: Month 6-12 (at least 5 months after dose 1)
    3. (2016) Presc Lett 23(12): 67
  3. Three dose schedule (age of first dose >15 years old or Immunocompromised)
    1. If one dose given before age 15 years old, may give a single booster dose age 15-26 years old
    2. Schedule: 0, 2, and 6 months
      1. Dose 1: Month 0
      2. Dose 2: Month 1-2 (at least 1 month after dose 1)
      3. Dose 3: Month 6 (at least 3 months after dose 2, and at least 5 months after dose 1)

XI. Cost

  1. Three doses: >$1000 for Gardasil-9 (covered by most U.S. insurance plans)
    1. Original Gardasil was priced at >$400 for three doses

XII. Resources

  1. CDC Immunization Schedules (last accessed 10/28/2020)
    1. https://www.cdc.gov/vaccines/hcp/imz-schedules/index.html
  2. CDC MMWR
    1. http://www.cdc.gov/mmwr/pdf/rr/rr6002.pdf

XIII. References

  1. Goeser (2007) Am Fam Physician 76:573-4
  2. Joura (2015) N Engl J Med 372:711-23 [PubMed]
  3. Rerucha (2018) Am Fam Physician 97(7): 441-8 [PubMed]
  4. Villa (2005) Lancet Oncol 6:271-8 [PubMed]

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