Hpv Vaccine

From Anvita Health Wiki

Contents 1 Introduction 2 Indications 3 Contraindications 4 Dosage 5 Adverse-effects 6 Mechanism-of-action 7 Notes 8 More General Terms 9 References

Introduction

• Tradename: Gardasil, Cervarix [13]

Indications

• prevention of HPV types 6, 11, 16, 18 (Gardasil); HPV types 16, 18 (Cervarix)
• routine adminstration to all females 9-26 years of age

• start age 11 or 12 [17]
• final dose can be completed after 26 years of age if vaccinated late

• efficacious in women 24-years of age
• may not be cost-effective in women > 30 years of age [11]
• FDA approved for use in males (Gardasil) [12]

• can prevent anal intraepithelial neoplasia in men who have sex with men [20]
• recommended for boys age 11 & 12 years [21,22,23]
• recommended for males age 13-21 years who have not yet been immunized or have not finished the 3-dose series [22,23]
• may be given to males aged 22-26 [17,22,23]

• prevents some if not most cases of cervical cancer
• reduces burden of genital warts (Gardasil) in men & women [14,18]

Contraindications

• does NOT eliminate need for Pap Smears
• not cost effective after age 30

Dosage

• 3 IM injections over 6 months

• 2 doses as good as 3 [19]

• Shelf life of 3 years (refrigerated)

Adverse-effects

• no serious adverse effects reported by manufacturer
• about as safe as any other vaccine [10]
• incidence of adverse effects: 0.054% [10]
• pain

• known as the most painful childhood vaccination
• inability to drive with or sleep on the affected arm for up to a day [8]

• fainting, syncope (0.008%)
• vomiting, dehydration
• venous thromboembolism (0.002%) [10]
• Guillain-Barre syndrome
• no increased risk of miscarriage after HPV vaccine [16]

Mechanism-of-action

• the investigational vaccines contained human papilloma virus type 16-like particles [1] or type 16 & type 18 virus particles [2]
• it is NOT a live virus vaccine
• Cervarix uses a different adjuvant than Gardasil which might give longer immunity; it also seems to offer more cross-protection against some HPV types that are not included in the vaccine
• Gardasil provides protection against HPV 6 & 11, causative agents of genital warts in men & women

Notes

• cost $120/dose ($360 for series)

More General Terms

• vaccine

References

1. Koutsky LA, Ault KA, Wheeler CM, Brown DR, Barr E, Alvarez FB, Chiacchierini LM, Jansen KU; Proof of Principle Study Investigators. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med. 2002 Nov 21;347(21):1645-51. PMID: [1]
2. Harper DM, Franco EL, Wheeler C, Ferris DG, Jenkins D, Schuind A, Zahaf T, Innis B, Naud P, De Carvalho NS, Roteli- Martins CM, Teixeira J, Blatter MM, Korn AP, Quint W, Dubin G; GlaxoSmithKline HPV Vaccine Study Group. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet. 2004 Nov 13;364(9447):1757-65. PMID: [2]
3. Prescriber's Letter 13(5): 2006 Gardasil (Quadrivalent Human Papillomavirus [types 1,11,16,18] Recombinant Vaccine Detail-Document#: [3] (subscription needed) [4]
4. CDC Advisory Committe on Immunization Practices
5. Prescriber's Letter 14(2): 2007 Adult and Pediatric Immunization Update - 2007 Detail-Document#: [5] (subscription needed) [6]
6. Markowitz LE et al, Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Early Release, March 12, 2007, 56:1-24 [7]
7. Prescriber's Letter 14(5): 2007 Safety of Gardasil (Quadrivalent Human Papillomavirus Vaccine) Detail-Document#: [8] (subscription needed) [9]
8. Associated Press, Jan 4, 2008
9. Munoz N et al, Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial. The Lancet, Early Online Publication, 2 June 2009 PMID: [10] doi:10.1016/S0140-6736(09)60691-7
   - Harper DM. Preliminary HPV vaccine results for women older than 25 years. Lancet 2009 Jun 6; 373:1921 PMID: [11]
10. Slade BA et al, Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine JAMA. 2009;302(7):750-757. <PubMed> PMID: [12] <Internet> [13]
    - Haug C The Risks and Benefits of HPV Vaccination JAMA. 2009;302(7):795-796. <PubMed> PMID: [14] <Internet> [15]
11. Kim JJ et al Cost-Effectiveness of Human Papillomavirus Vaccination and Cervical Cancer Screening in Women Older Than 30 Years in the United States Annals of Internal Medicine 2009, 151:538-545 <PubMed> PMID: [16] <Internet> [17]
12. FDA NEWS RELEASE, Oct. 16, 2009 FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys [18]
13. FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine, 16 October 2009 [19]
14. Fairley CK et al Rapid decline in presentations of genital warts after the implementation of a national quadrivalent human papillomavirus vaccination programme for young women. Sex Transm Infect 2009 Oct 16 <PubMed> PMID: [20] <Internet> [21]
15. Prescriber's Letter 16(12): 2009 Human Papillomavirus Vaccine - Cervarix and Gardasil Update Detail-Document#: [22] (subscription needed) [23]
16. Wacholder S et al. Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: Pooled analysis of two randomised controlled trials. BMJ 2010 Mar 2; 340:c712 <PubMed> PMID: [24] <Internet> [25]
17. Centers for Disease Contol and Prevention (CDC) FDA Licensure of Bivalent Human Papillomavirus Vaccine (HPV2, Cervarix) for Use in Females and Updated HPV Vaccination Recommendations from the Advisory Committee on Immunization Practices (ACIP) Morbidity and Mortality Weekly Report (MMWR); May 28, 2010 / 59(20);626-629 <PubMed> PMID: [26] <Internet> [27]
    - Centers for Disease Contol and Prevention (CDC) FDA Licensure of Quadrivalent Human Papillomavirus Vaccine (HPV4, Gardasil) for Use in Males and Guidance from the Advisory Committee on Immunization Practices (ACIP) Morbidity and Mortality Weekly Report (MMWR); May 28, 2010 / 559(20);630-632 <PubMed> PMID: [28] <Internet> [29]
18. Giuliano AR et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. N Engl J Med 2011 Feb 3; 364:401. PMID: [30]
19. Kreimer AR et al Proof-of-Principle Evaluation of the Efficacy of Fewer Than Three Doses of a Bivalent HPV16/18 Vaccine JNCI J Natl Cancer Inst, September 9, 2011 <PubMed> PMID: [31] <Internet> [32]
    - Wheeler CM Less Is More: A Step in the Right Direction for Human Papillomavirus (HPV) Vaccine Implementation JNCI J Natl Cancer Inst, September 9, 2011 <PubMed> PMID: [33] <Internet> [34]
20. Palefsky JM et al HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia N Engl J Med 2011; 365:1576-1585October 27, 2011 <PubMed> PMID: [35] <Internet> [36]
21. The Wahington Post Panel recommends that 11- and 12-year-old boys get the HPV vaccine; now given to girls Associated Press, Published: October 25, 2011 [37]
22. Centers for Disease Control and Prevention Recommendations on the Use of Quadrivalent Human Papillomavirus Vaccine in Males - Advisory Committee on Immunization Practices (ACIP), 2011 MMWR December 23, 2011 / 60(50);1705-1708 [38]
23. HPV Vaccine Recommendations COMMITTEE ON INFECTIOUS DISEASES Pediatrics; published online February 27, 2012 [39]
24. National Guideline Clearinghouse Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). (Centers for Disease Control and Prevention) ngc-guideline: [40]
    - American Cancer Society guideline for human papillomavirus (HPV) vaccine use to prevent cervical cancer and its precursors. ngc-guideline: [41]
    - Cost-benefit analysis of HPV vaccination. In: Canadian consensus guidelines on human papillomavirus. Society of Obstetricians and Gynaecologists of Canada ngc-guideline: [42]

HPV-16/18 vaccine (Gardasil, Cervarix)