Transcript Slide 1

Vaccination of
Adolescents
Andrew Kroger
National Center for Immunization and
Respiratory Diseases
National Assembly on Schoolbased Health Care (NASBHC)
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
Adolescent Vaccination
The 11-12 Year Old Visit
•The recommended age
for certain vaccines
•An opportunity to catchup on lapsed
vaccinations
Adolescent Vaccines
Recommended
1.
Tdap or Td
2.
Meningococcal Conjugate
3.
Human Papillomavirus
Catch-up
1.
Hepatitis B
2.
MMR
3.
Varicella
4.
Polio
Risk Groups
1.
Pneumococcal Polysaccharide
2.
Influenza
3.
Hepatitis A
4.
Meningococcal Polysaccharide
Tetanus,reduced-diphtheria,
acellular pertussis vaccine
Tetanus,reduced-diphtheria,
acellular pertussis vaccine
Pertussis
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
Pertussis Clinical
Features
Complications
– Secondary bacterial infection pneumonia
• More often in infants < 6 months
– Seizures, otitis media, anorexia,
dehydration
– Complications from actual coughing:
choking, epistaxis, subdural hematoma,
hernia, rib fractures, rectal prolapse
Adolescent Pertussis
Vaccination Objectives
Primary
– Protect vaccinated adolescents
Secondary
– Reduce B. pertussis reservoir
– Potentially reduce incidence of pertussis in
other age groups
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
General Principles for Use of
Tdap 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
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
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
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
Tdap For Persons Without A
History 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
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
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
Conditions NOT Precautions
for 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
DTaP and Tdap Administration
Errors
Error
DTaP given to person
>7 years
Action
Count dose as valid
Tdap given to child
<7 years as DTaP
#1, 2, or 3
Do not count dose;
give DTaP now
Tdap given to child
<7 years as DTaP #4
or 5
Count dose as valid
Meningococcal Conjugate
Vaccine
Meningococcal Conjugate
Vaccine
Meningococcal Vaccine
Recommended for:
– all persons at the preadolescent visit (ages 1112 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 2005;54(RR-7)
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 2001;286;688-93
Meningococcal Vaccine
Recommended for certain highrisk 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
Meningococcal Belt
Meningococcal Vaccine
Recommended for certain
high-risk persons:
– complement component deficiency
– functional or anatomic asplenia
– HIV infection (“should be considered”)
Conjugate
vaccine - MCV
Meningococcal Vaccines
Menomune – ‘old’
Menactra – new
4 types – A,C,Y,W135
4 types– A,C,Y,W-135
Approved for >2 yrs
of age
1 dose, selective
revaccination
Subcutaneous
injection
Approved for 11-55
years of age
1 dose, (currently) no
revaccination
Intramuscular
injection
Meningococcal Conjugate Vaccine
Contraindications 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
MCV: Extremely High Risk
•Microbiologists routinely
exposed to isolates of
Neisseria meningitidis
Human Papillomavirus
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)
Human Papillomavirus Vaccine
Human Papillomavirus Vaccine
HPV Prevalence: Population Estimates, U.S.
20 million people are infected
6.2 million new infections each year
> 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
Human Papillomavirus
>100 types
Mucosal
(~40 types)
“high-risk”
types
(16,18)
Cutaneous
(~60 types)
“low-risk”
types
(6,11)
“Common”
warts
(hands/feet)
• low grade cervical
• low grade cervical
abnormalities
• high grade abnormalities/
cancer precursors
• anogenital cancers
abnormalities
• genital warts
• respiratory papillomas
Skin Warts and Tags
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
Cervical Cancer Mortality
Rates U.S., 1946-1984
10
8
6
4
2
84
82
80
78
76
74
72
70
68
66
64
62
60
58
56
54
52
50
48
0
46
Mortality Rate (per 100,000)
12
Year
Source: Program for Improving Clinical Pap Smear Programs
and Management, Office of Population Affairs, DHHS, 1987.
Efficacy for Prevention of Clinical
HPV Disease Due to HPV
6/11/16/18*
Vaccine
N Cases
Endpoint
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
Antibody Titers by Age at Enrollment
Serum GMT with 95% CI, mMU/mL
Anti-HPV 6 GMTs (Quadrivalent HPV vaccine)
1600
1500
Immunogenicity Bridge
Efficacy Program
1300
1100
900
700
500
9
10 11 12 13 14 15 16 17 18 19 20 21 22 23
Age at Enrollment (Years)
Merck, unpublished data, ACIP presentation by Eliav Barr, February 2006
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
Pediatricians’ Intention to
Recommend HPV Vaccine for
Female and Male Patients, by
Age
% somewhat or extremely likely
100
90
80
70
female
male
60
50
40
30
20
10
0
11 year olds
14 year olds
Kahn J et al. Journal of Adolescent Health 2005
17 year olds
Quadrivalent HPV Vaccine
Summary
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
Recommendations
Routine vaccination
Catch-up vaccination
Special situations
Precautions and
contraindications
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
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
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
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 >1 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
Special Situations
Equivocal or abnormal
Pap test
Positive HPV test
Genital warts
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
Cervical Cancer Screening
Recommendations
Age to start
USPSTF
2003
ACS
2002
ACOG
2003
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
<30 yr
Conv: at least
every 3 yrs
Conv: 1 yr
LBC: 2 yr
1 yr
2-3 yrs
≥ 30 yr
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
2-3 yrs
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
Vaccination during Pregnancy:Recommendation
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
Questions?