Vaccination of Adolescents

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Vaccination of Adolescents

• Andrew Kroger
• National Center for Immunization and Respiratory
  Diseases

• National Assembly on School-based Health Care
  (NASBHC)

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Disclosure

• The speaker is a U.S. government employee and has
  no conflict or interest with any manufacturer of
  products
• The speaker will discuss the use of Tdap in a
  manner that varies from the package insert

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Adolescent Vaccination
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The 11-12 Year Old Visit

• The recommended age for certain vaccines
• An opportunity to catch-up on lapsed vaccinations

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Adolescent Vaccines

• Recommended
• Tdap or Td
• Meningococcal Conjugate
• Human Papillomavirus
• Catch-up
• Hepatitis B
• MMR
• Varicella
• Polio
• Risk Groups
• Pneumococcal Polysaccharide
• Influenza
• Hepatitis A
• Meningococcal Polysaccharide

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Tetanus,reduced-diphtheria, acellular pertussis
vaccine
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Tetanus,reduced-diphtheria, acellular pertussis
vaccine
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Pertussis
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Pertussis Clinical Features

• Stages
• Incubation period 5-10 days (21 days rare)
• Catarrhal Stage 1-2 weeks
• Paroxysmal Stage 1-6 weeks (10 days rare)
• Convalescent stage 2-3 weeks

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Pertussis Clinical Features

• Complications
• Secondary bacterial infection pneumonia
• More often in infants lt 6 months
• Seizures, otitis media, anorexia, dehydration
• Complications from actual coughing choking,
  epistaxis, subdural hematoma, hernia, rib
  fractures, rectal prolapse

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Adolescent Pertussis Vaccination Objectives

• Primary
• Protect vaccinated adolescents
• Secondary
• Reduce B. pertussis reservoir
• Potentially reduce incidence of pertussis in
  other age groups

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Tdap Vaccines

• AdacelTM (sanofi pasteur)
• Licensed June, 2005
• Approved for persons 11-64 years of age
• Boostrix (GlaxoSmithKline)
• Licensed May, 2005
• Approved for persons 10-18 years of age

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General Principles for Use ofTdap and Td Among
Adolescents

• Tdap products are interchangeable
• Tdap preferred to Td to provide protection
  against pertussis
• Licensed only for a single dose at this time
• Tdap not approved or recommended for children 7-9
  years of age

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ACIP Recommendations for Tdap Vaccines

• Adolescents 11-12 years of age should receive a
  single dose of Tdap instead of Td
• Adolescents 13-18 years who have not received
  Tdap should receive a single dose of Tdap as
  their catch-up booster instead of Td

if the person has completed the recommended
childhood DTaP vaccination series, and has not
yet received a Td booster
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ACIP Recommendations for Tdap Vaccines

• ACIP encourages adolescents who received a Td
  booster to receive a single dose of Tdap to
  provide protection against pertussis
• A 5-year interval between the Td and Tdap is
  encouraged to reduce the chance of a local
  reaction

if the person has completed the recommended
childhood DTaP vaccination series
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Minimum Interval Between Td and Tdap

• ACIP did not define an absolute minimum interval
  between Td and Tdap
• Provider will need to decide based on whether the
  benefit of pertussis immunity outweighs the risk
  of a local adverse reaction

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Tdap For Persons Without AHistory of DTaP

• All adolescents should have documentation of
  having received a series of DTAP, DTP, DT, or Td
• Persons without documentation should receive a
  series of 3 vaccinations
• Preferred schedule
• Single dose of Tdap
• Td at least 4 weeks after the Tdap dose
• Second dose of Td at least 6 months after the
  Td dose

off-label recommendation
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Tdap Contraindications

• Severe allergic reaction to a vaccine component
  or following a prior dose
• Encephalopathy within 7 days of administration of
  a pertussis vaccine that is not attributable to
  another identifiable cause

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Tdap Precautions

• History of an Arthus-type reaction following a
  previous dose of tetanus- or diphtheria-containing
  vaccine
• Progressive neurological disorder, uncontrolled
  epilepsy, or progressive encephalopathy
• History of Guillain-Barré syndrome (GBS) within 6
  weeks after a previous dose of tetanus
  toxoid-containing vaccine
• Moderate or severe acute illness

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Conditions NOT Precautionsfor Tdap

• Following a dose of DTaP/DTP
• Temperature 105o F (40.5o C) or higher
• Collapse or shock-like state
• Persistent crying lasting 3 hours or longer
• Convulsions with or without fever
• History of an extensive limb swelling reaction

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DTaP and Tdap Administration Errors
Error DTaP given to person gt7 years Tdap given
to child lt7 years as DTaP 1, 2, or 3 Tdap given
to child lt7 years as DTaP 4 or 5
Action Count dose as valid Do not count dose
give DTaP now Count dose as valid
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Meningococcal Conjugate Vaccine
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Meningococcal Conjugate Vaccine
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Meningococcal Vaccine

• Recommended for
• all persons at the preadolescent visit (ages
  11-12 years)
• persons about to enter high school (age 15
  years)
• college freshmen living in a dormitory
• other adolescents who wish to reduce their risk
  for meningococcal disease

MMWR 200554(RR-7)
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Meningococcal Disease Among Young Adults, United
States, 1998-1999

• 18-23 years old 1.4 / 100,000
• 18-23 years old not college student 1.4 /
  100,000
• Freshmen 1.9 / 100,000
• Freshmen in dorm 5.1 / 100,000

Bruce et al, JAMA 2001286688-93
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Meningococcal Vaccine

• Recommended for certain high-risk persons
• military recruits
• certain research and laboratory personnel
• travelers to and U.S. citizens residing in
  countries in which N. meningitidis is
  hyperendemic or epidemic

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Meningococcal Belt
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Meningococcal Vaccine

• Recommended for certain high-risk persons
• complement component deficiency
• functional or anatomic asplenia
• HIV infection (should be considered)

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Conjugate vaccine - MCV
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Meningococcal Vaccines

• Menactra new
• 4 types A,C,Y,W-135
• Approved for 11-55 years of age
• 1 dose, (currently) no revaccination
• Intramuscular injection

• Menomune old
• 4 types A,C,Y,W-135
• Approved for gt2 yrs of age
• 1 dose, selective revaccination
• Subcutaneous injection

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Meningococcal Conjugate VaccineContraindications
and Precautions

• Contraindications
• Severe allergic reaction to vaccine component or
  following prior dose
• Precautions
• Moderate or severe acute illness
• Menactra prior history of Guillain-Barré if not
  extremely high risk for meningococcal disease

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MCV Extremely High Risk

• Microbiologists routinely exposed to isolates of
  Neisseria meningitidis

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Human Papillomavirus
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Human Papillomavirus (HPV) Vaccine

• A vaccine to prevent cervical cancer
• Licensed for 9-26 year olds as
• Gardasil Merck- Quadrivalent HPV (Types 6, 11,
  16, 18) L1 VLP Vaccine
• Cervarix- GlaxoSmithKline (GSK) pending
  licensure (Types 16 and 18)

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Human Papillomavirus Vaccine
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Human Papillomavirus Vaccine
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HPV Prevalence Population Estimates, U.S.

• 20 million people are infected
• 6.2 million new infections each year
• gt 50 of sexually active men women acquire
  genital HPV infection
• 74 of new infections occur in persons 15 24
  years of age

W. Cates, STD April 1999, Weinstock, Perspectives
on Sexual and Reproductive Health 2004, Koutsky
Am J Med 1997
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Human Papillomavirus gt100 types
Cutaneous
Mucosal
(40 types)
(60 types)
Common
high-risk
low-risk
warts
types (16,18)
types (6,11)
(hands/feet)

• low grade cervical abnormalities
• high grade abnormalities/
• cancer precursors
• anogenital cancers

• low grade cervical abnormalities
• genital warts
• respiratory papillomas

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Skin Warts and Tags
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Background HPV-associated Conditions
HPV types 16, 18,
6, 11
HPV types 16, 18
Cervical cancer 70
High/low grade cervical abnormalities 40
Anal, vulvar, vaginal, penile 70
Head and neck cancers 10
HPV 6, 11
Low grade cervical abnormalities 10
Genital warts 90
RRP 90

• Clifford GM, BJ Ca 2003, Munoz Int J Cancer 2004
  Brown J Clin Micro 1993 Carter Cancer Res 2001
• Clifford Cancer Epi Biomarkers Prev 2005 Gissman
  Proc Natl Acad Science 1983
• Kreimer Cancer Epidemiol Biomarkers Prev. 2005
• All oncogenic types

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Cervical Cancer Mortality Rates U.S., 1946-1984
Source Program for Improving Clinical Pap Smear
Programs and Management, Office of Population
Affairs, DHHS, 1987.
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Efficacy for Prevention of Clinical HPV Disease
Due to HPV 6/11/16/18
Endpoint Vaccine N Cases Placebo N Cases Efficacy (95 CI)
HPV 16/18 related CIN2/3 or AIS 8487 0 8460 53 100 (93,100)
HPV 6/11/16/18 related CIN 7858 4 7861 83 95 (87, 99)
HPV 6/11/16/18 related Genital warts 7897 1 7899 91 99 (94,100)
Integrated dataset results in the Per-Protocol
Populations
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Antibody Titers by Age at Enrollment Anti-HPV 6
GMTs (Quadrivalent HPV vaccine)
Efficacy Program
Immunogenicity Bridge
1600
1500
1300
1100
900
Serum GMT with 95 CI, mMU/mL
700
500
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10
11
12
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15
16
17
18
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Age at Enrollment (Years)
Merck, unpublished data, ACIP presentation by
Eliav Barr, February 2006
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Potential Unintended Consequences of HPV Vaccine

• Research shows generally low levels of HPV
  knowledge
• Multiple influences on adolescent sexual behavior
• Fear of STD not apparent major motivation for
  abstinence
• Increase in sexual risk unlikely

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Pediatricians Intention to Recommend HPV Vaccine
for Female and Male Patients, by Age
Kahn J et al. Journal of Adolescent Health 2005
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Additional Visits Needed for Females, 1st HPV
Vaccine at Well Visit vs. Any Visit 24 mo window
to vaccinate
Type of visit 1st vaccine
Adapted from Dr. Cynthia Rand, Univ Rochester
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Quadrivalent HPV VaccineSummary

• High efficacy in 16 to 26 year-old females who
  are naïve to the HPV vaccine type
• HPV 16,18 related CIN 2/3
• HPV 6,11,16,18 related CIN
• HPV 6,11,16,18 related external genital lesions
• No evidence of efficacy against disease in
  persons already infected with relevant type
• Efficacy data available through 5 duration of
  protection and need for booster unknown
• Safe side effects mainly local reactions

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Recommendations

• Routine vaccination
• Catch-up vaccination
• Special situations
• Precautions and contraindications

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Routine Vaccination Recommendation

• ACIP recommends routine vaccination of females
  11-12 years of age with three doses of
  quadrivalent HPV vaccine
• The vaccination series can be started as young as
  9 years of age

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Rationale Routine Vaccination Females at 11-12
Years

• Routine
• Prevalent infection, targeting high risk groups
  not possible
• Modeling shows greater impact
• 11-12 years
• Vaccination prior to sexual debut
• Implementation advantages consistent with young
  adolescent health care visit
• High antibody titers after vaccination at this
  age
• Data through 5 years show no evidence of waning
  immunity ongoing studies will monitor duration
  of protection

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Females 13-26 Years Recommendation

• Vaccination is recommended for females 13-26
  years of age who have not been previously
  vaccinated
• Ideally vaccine should be administered before
  onset of sexual activity, but females who are
  sexually active should still be vaccinated

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Rationale Vaccination of Females 13-26 Years

• Females not yet sexually active can be expected
  to have the full benefit of vaccination
• Sexually active females may not have full benefit
  of vaccine because they may have been infected
  with vaccine HPV types, however
• Only a small percentage are likely to have been
  infected with all four vaccine HPV types
• For those already infected with gt1 vaccine HPV
  types, vaccine would provide protection against
  disease caused by the other vaccine HPV types
• Therefore, although overall vaccine effectiveness
  would be lower, most females will still derive
  benefit from
• vaccination

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Special Situations

• Equivocal or abnormal Pap test
• Positive HPV test
• Genital warts

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Cervical Cancer Screening

• Cervical cancer screening no change
• 30 of cervical cancers caused by HPV types not
  in 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
• Decision to vaccinate should not be based on Pap
  testing, HPV DNA testing or HPV serologic testing
• Providers should education women about the
  importance of cervical cancer screening

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Cervical Cancer Screening Recommendations
USPSTF 2003 ACS 2002 ACOG 2003
Age to start Age 21 or within 3 yrs of sexual activity Age 21 or within 3 yrs of sexual activity Age 21 or within 3 yrs of sexual activity
Interval lt30 yr 30 yr Conv at least every 3 yrs Conv 1 yr LBC 2 yr 2-3 yrs 1 yr 2-3 yrs
USPSTF U.S. Preventive Services Task Force ACS
American Cancer Society ACOG American College
of Obstetricians and Gynecologists Conv
Conventional Cervical Cytology LBC Liquid-based
Cytology
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Precautions and Contraindications

• Contraindication History of immediate
  hypersensitivity or severe allergic reaction to
  yeast or to any vaccine component
• Precaution Moderate or severe acute illnesses
  should be deferred until after the illness
  improves

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Vaccination during PregnancyRecommendation

• Initiation of the vaccine series should be
  delayed until after completion of the pregnancy
• If a woman is found to be pregnant after
  initiating the vaccination series, completion
  should be delayed until after the pregnancy  
• If a vaccine dose has been administered during
  pregnancy, there is no indication for
  intervention

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• Questions?