should i vaccinate my child against cervical cancer mark h stoler md l.
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SHOULD I VACCINATE MY CHILD AGAINST CERVICAL CANCER? Mark H. Stoler, MD. Estimated Annual Burden of HPV-Related Diagnoses in the United States. 9,710 new cases of cervical cancer 1. 3,700 deaths estimated in 2006 1. 330,000 new cases of high-grade cervical dysplasia (CIN 2/3) 2.

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estimated annual burden of hpv related diagnoses in the united states
Estimated Annual Burden of HPV-Related Diagnoses in the United States

9,710 new cases of cervical cancer1

3,700 deaths estimated

in 20061

330,000 new cases of high-grade cervical dysplasia (CIN 2/3)2

CIN = cervical intraepithelial neoplasia.

1.4 million new cases of low-grade cervical dysplasia (CIN 1)2

1 million new cases of genital warts3

CIN = cervical intraepithelial neoplasia.

1. American Cancer Society. Cancer Facts and Figures 2006. Atlanta, Ga: American Cancer Society; 2006:4. 2. Schiffman M, Solomon D. Findings to date from the ASCUS-LSIL Triage Study (ALTS). Arch Pathol Lab Med. 2003;127:946–949. 3. Fleischer AB, Parrish CA, Glenn R, Feldman SR. Condylomata acuminata (genital warts):Patient demographics and treating physicians. Sex Transm Dis. 2001;28:643–647.

hpv and cancer 1
HPV and Cancer1

Cancer

% Associated with Certain HPV Types

Cervical*

≥95%

Vaginal*

50%

Vulvar*

>50%

Penile

50%

Anal

>70%

Oropharyngeal

20%

Nonmelanoma skin/cutaneous squamous cell

90%**

*Includes cancer and intraepithelial neoplasia

**Immunocompromised patients

1. Gonzalez Intxaurraga MA, Stankovic R, Sorli R, Trevisan G. Acta Dermatovenerol. 2002;11:1–8.

natural history of hpv infection
Natural History of HPV Infection

Definitive Efficacy

0 to 1 Year

0 to 3 Years

Up to 20 Years

InitialHPV Infection

CIN 2/3 or AIS

Cervical Cancer

ContinuingInfection

1 Efficacy Objective of Clinical Program for GARDASIL® – Demonstrate Prevention of HPV 16/18-CIN 2/3 and AIS

CIN 1

Cleared HPV Infection

in2 3 is noninvasive cancer
IN2/3 is Noninvasive cancer

Clear precursor relationship

HPV types the same

Invasive cancer develops from IN3

gardasil the first cervical cancer vaccine in the united states
GARDASIL: The First Cervical Cancer Vaccine in the United States
  • Quadrivalent HPV 6/11/16/18 L1 virus-like particle (VLP) vaccine
  • VLPs are produced in Saccharomyces cerevisiae.
    • The L1 proteins self-assemble into VLPs.
    • Purified VLPs are adsorbed on aluminum-containing adjuvant.
    • The adjuvant is amorphous aluminum hydroxyphosphate sulfate (225 μg per dose).
  • Each 0.5-mL dose contains HPV Types 6/11/16/18 (20/40/40/20 μg L1 protein, respectively).
slide10
Prophylactic Efficacy of GARDASIL CIN & AISPer-Protocol Population (Protocols 007, 013, and 015) Mean Follow-Up - 44 months
slide11

Prophylactic Efficacy of GARDASIL®External Genital LesionsPer-Protocol Population (Protocols 007, 013, and 015) Mean Follow-Up - 44 months

* Subjects are counted only once per row, but may be in more than one row

subjects exposed to any vaccine hpv type at enrollment
73% of subjects were naïve to all 4 vaccine HPV types.

Among subjects who were positive to a vaccine HPV type, most were positive to only 1 type.

Exclusion criteria: 6 or more sexual partners

Subjects Exposed to Any Vaccine HPV Type at Enrollment

20%

Efficacy Studies—Combined Population

93% of subjects were naïve to ≥3 vaccine HPV types (6, 11, 16, or 18) at enrollment.

Baseline HPV Status

Naïve to all 4 types

73%

Positive to 1 type

27% of subjects had evidence of prior exposure to or ongoing infection with at least 1 of the

4 vaccine HPV types.

Positive to 2 types

6%

Positive to 3 types

Positive to 4 types

1.2%

0.1%

Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4,

West Point, PA 19486-0004. Please specify information package 20651717(4)-GRD.

efficacy of gardasil in subjects who were positive to 1 vaccine hpv type at day 1
Efficacy of GARDASIL in Subjects Who Were Positive to ≥1 Vaccine HPV Type at Day 1

Individuals with current or past infection with 1 vaccine-related HPV types prior to vaccination were protected from disease caused by the remaining vaccine HPV types for which they were naïve at Day 1.

Case-counting Postdose 1

Ph III–FUTURE I (P013) and FUTURE II (P015)

CIN = cervical intraepithelial neoplasia; VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia

*Among subjects who were positive to ≥ 1 vaccine HPV type, efficacy against HPV types for which they were naïve at Day 1.

n = Number of subjects in the given population with at least 1 follow-up visit following 30 days after Day 1.

Subjects are counted once in each applicable end-point category. A subject may appear in more than 1 category.

Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4,

West Point, PA 19486-0004. Please specify information package 20651717(5)-GRD.

slide14
Impact of GARDASIL Against HPV 6/11/16/18-Related CIN (Any Grade)Based on HPV Status at Day 1; Combined Analysis
  • GARDASILis a prophylactic vaccine.
  • There is no clear evidence of protection from disease caused by HPV types for which subjects were seropositive and/or PCR positive at baseline.

Seropositive and PCR-positive at baseline

AIS = adenocarcinoma in situ.

CIN = cervical intraepithelial neoplasia.

Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4,

West Point, PA 19486-0004. Please specify information package 20651717(6)-GRD.

overall conclusions for gardasil
Overall Conclusions for GARDASIL
  • Highly effective in preventing cervical cancer, CIN 2/3, AIS, and other anogenital diseases including genital warts caused by HPV 6, 11, 16, and 18 in 16- to 26-year-old women naïve to the relevant HPV types
  • Individuals with current or past infection with 1 vaccine-related HPV types prior to vaccination were protected from disease caused by the remaining vaccine HPV types
  • Successful immunogenicity bridge between female adolescents and young adult women
    • Antibody response in 9- to 15-year-old females is higher, compared with response observed in young adult women (16–26 years old)
  • Duration of efficacy is demonstrated between 2 and 4 years
  • Favorable tolerability profile

AIS = adenocarcinoma in situ. CIN = cervical intraepithelial neoplasia.

summary of us vaccine recommendations
Summary of US Vaccine Recommendations

aACIP = Advisory Committee on Immunization Practices. bACOG = American College of Obstetricians and Gynecologists.

cAAFP = American Academy of Family Practitioners. dACP = American College of Physicians.

eAAP = American Academy of Pediatrics.

1.Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 2007;56(RR-2):1-24. 2. American College of Obstetricians and

Gynecologists (ACOG). Obstet Gynecol. 2006;108:699–705. 3. Advisory Committee on Immunization Practices. Ann Intern Med. 2007;147(10):725-729.

4. Committee on Infectious Diseases. Pediatrics. 2007; 120(3);666-668.

important information about gardasil
Important Information About GARDASIL

GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

  • GARDASIL is a vaccine indicated in girls and women 9 to 26 years of age for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by human papillomavirus (HPV) Types 6, 11, 16, and 18.
  • GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.
  • GARDASIL does not substitute for routine cervical cancer screening, and women who receive GARDASIL should continue to undergo screening per standard of care.
important information about gardasil cont
Important Information About GARDASIL (cont)

GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

  • Vaccination with GARDASIL may not result in protection in all vaccine recipients.
  • GARDASIL is not recommended for use in pregnant women.
  • GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN.a
  • GARDASIL has not been shown to protect against diseases due to non-vaccine HPVb types.
  • The vaccine-related adverse experiences that were observed among recipients of GARDASIL at a frequency of at least 1.0% and greater than placebo were pain, swelling, erythema, fever, nausea, pruritus, and dizziness. In addition, common postmarketing reports include vomiting and syncope.

aCIN = cervical intraepithelial neoplasia; VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia.

bHPV = human papillomavirus.