Pertussis and Pertussis Vaccines

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• Pertussis and Pertussis Vaccines

Epidemiology and Prevention of Vaccine-Preventable
Diseases National Immunization Program Centers
for Disease Control and Prevention
Revised January 2007
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Pertussis

• Highly contagious respiratory infection caused by
  Bordetella pertussis
• Outbreaks first described in 16th century
• Bordetella pertussis isolated in 1906
• Estimated 294,000 deaths worldwide in 2002

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Bordetella pertussis

• Fastidious gram-negative bacteria
• Antigenic and biologically active components
• pertussis toxin (PT)
• filamentous hemagglutinin (FHA)
• agglutinogens
• adenylate cyclase
• pertactin
• tracheal cytotoxin

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Pertussis Pathogenesis

• Primarily a toxin-mediated disease
• Bacteria attach to cilia of respiratory
  epithelial cells
• Inflammation occurs which interferes with
  clearance of pulmonary secretions
• Pertussis antigens allow evasion of host defenses
  (lymphocytosis promoted but impaired chemotaxis)

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Pertussis Clinical Features

• Incubation period 5-10 days (range
  4-21 days)
• Insidious onset, similar to minor upper
  respiratory infection with nonspecific cough
• Fever usually minimal throughout course of
  illness

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Pertussis Clinical Features

• Catarrhal stage 1-2 weeks
• Paroxysmalcough stage 1-6 weeks
• Convalescence Weeks to months

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Pertussis Among Adolescents and Adults

• Disease often milder than in infants and children
• Infection may be asymptomatic, or may present as
  classic pertussis
• Persons with mild disease may transmit the
  infection
• Older persons often source of infection for
  children

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Pertussis Complications
Condition Pneumonia SeizuresEncephalopathy Hospit
alization Death
Percent reported 4.9 0.7 0.1 16 0.2
Cases reported to CDC 2001-2003 (N28,998)
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Pertussis Deaths in the United States, 2004-2005
Age at onset
lt3 mos 24 32 56 (85)
gt3 mos 3 7 10 (15)
Total 27 39 66

• 2004
• 2005
• Total

CDC, unpublished data, 2006
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Pertussis Complications by Age
Cases reported to CDC 1997-2000 (N28,187)
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Pertussis Epidemiology

• Reservoir Human Adolescents and adults
• Transmission Respiratory droplets
• Communicability Maximum in catarrhal
  stage Secondary attack rate up to 80

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• PertussisUnited States, 1940-2005

Year
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• PertussisUnited States, 1980-2005

Year
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Reported Pertussis by Age Group, 1990-2005
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Pertussis Incidence, 2004
N25,172. MMWR 200453(53)30.
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Whole-Cell Pertussis Vaccine

• Developed in mid-1930s and combined as DTP in
  mid-1940s
• 70-90 efficacy after 3 doses
• Protection for 5-10 years
• Local adverse reactions common

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Pertussis-containing Vaccines

• DTaP (pediatric)
• approved for children 6 weeks through 6 years (to
  age 7 years)
• contains same amount of diphtheria and tetanus
  toxoid as pediatric DT
• Tdap (adolescent and adult)
• approved for persons 10-18 years (Boostrix) and
  11-64 years (Adacel)
• contains lesser amount of diphtheria toxoid
  and acellular pertussis antigen than DTaP

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Composition of Acellular Pertussis Vaccines
PT 23 25 10 8 2.5
PERT -- 8 3 2.5 3
FHA 23 25 5 8 5
FIM -- -- 5 -- 5
ProductTripedia Infanrix Daptacel Boostrix Adacel
mcg per dose
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DTaP Clinical Trials
Product Daptacel Tripedia Infanrix
Location Sweden Germany Italy
VE (95 CI) 85 (80-89) 80 (59-90) 84 (76-89)
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• Routine DTaP Primary Vaccination Schedule

Minimum Interval --- 4 wks 4 wks 6 mos
Dose Primary 1 Primary 2 Primary 3 Primary 4
Age 2 months 4 months 6 months 15-18 months
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DTaP Fourth Dose

• Recommended at 15-18 months
• May be given at 12 months of age if
• child is 12 months of age, and
• 6 months since DTaP3, and
• unlikely to return at 15-18 months

15-20 months for Daptacel
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School Entry (Fifth) Dose

• Fifth dose recommended when 4th dose given before
  age 4 years
• Infanrix and Tripedia licensed for 5th dose after
  DTaP series

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Interchangeability of Different Brands of DTaP
Vaccine

• Whenever feasible, the same DTaP vaccine should
  be used for all doses of the series
• Limited data suggest that mix and match DTaP
  schedules do not adversely affect safety and
  immunogenicity
• If vaccine used for earlier doses is not known or
  not available, any brand may be used to complete
  the series

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Pediatric DT Schedule

• First dose of DT or DTaP at younger than one year
  of age
• Total of 4 doses
• First dose of DT or DTaP at one year of age or
  older
• Total of 3 doses
• Fourth or fifth dose at school entry not needed
  if pertussis vaccine is not being administered

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The 6 before 7 Rule

• General guidance, not an absolute requirement
• Intended to reduce the frequency of local
  reactions
• Parents should be aware of an increased risk of
  local reactions and agree that the benefit
  outweighs the risk (local reaction)

MMWR 199140(No. RR-10)1-28
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TriHIBit

• DTaP-Hib combination
• Licensed only for 4th dose of DTaP and Hib
  series
• Do not use for primary immunization at 2, 4, or 6
  months of age
• May be used as the final (booster) dose of the
  Hib series at gt12 months of age following any Hib
  vaccine

booster dose should follow prior dose by gt2
months
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Pediarix

• DTaP Hep B IPV combination
• Minimum age 6 weeks
• Approved for 3 doses at 2, 4 and 6 months
• Not approved for booster doses
• Licensed for children 6 weeks to 7 years of age

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Pediarix

• May be used interchangeably with other
  pertussis-containing vaccines if necessary
• Can be given at 2, 4, and 6 months in infants who
  received a birth dose of hepatitis B vaccine
  (total of 4 doses)
• May be used in infants whose mothers are HBsAg
  positive or status unknown

off-label recommendation
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Pertussis Vaccine Use in Children with Underlying
Neurologic Disorders
Underlying Condition Prior seizure Suspected
neurologic disorder Neurologic event between
doses Stable/resolved neurologic condition
Recommendation Delay and assess Delay and
assess Delay and assess Vaccinate
vaccinate after treatment initiated and
condition stabilized
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Pertussis Vaccination of Children Who Have
Recovered From Pertussis

• If documented disease, do not need additional
  doses of pediatric pertussis vaccine
• Satisfactory documentation of disease
• recovery of B. pertussis on culture, or
• typical symptoms and clinical course when
  epidemiologically linked to a culture-proven case

Tdap is recommended when the child is age
eligible.
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DTaP Adverse Reactions

• Local reactions 20-40
• (pain, redness, swelling)
• Temp of 101oF 3-5
• or higher
• More severe adverse reactions not common
• Local reactions more common following 4th and 5th
  doses

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Adverse Reactions Following the 4th and 5th DTaP
Dose

• Local adverse reactions and fever increased with
  4th and 5th doses of DTaP
• Reports of swelling of entire limb
• Extensive swelling after 4th dose NOT a
  contraindication to 5th dose

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Adverse Reactions Reported Following 1st and 4th
Doses of Infanrix
Source Infanrix package insert, 2003
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DTaP Contraindications

• Severe allergic reaction to vaccine component or
  following a prior dose
• Encephalopathy not due to another identifiable
  cause occurring within 7 days after vaccination

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DTaP Precautions

• Moderate or severe acute illness
• Temperature gt105F (40.5C) or higher within 48
  hours with no other identifiable cause
• Collapse or shock-like state (hypotonic
  hyporesponsive episode) within 48 hours
• Persistent, inconsolable crying lasting gt3 hours,
  occurring within 48 hours
• Convulsions with or without fever occurring
  within 3 days

may consider use in outbreaks
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Pertussis Among Adolescentsand Adults

• Prolonged cough (3 months or longer)
• Post-tussive vomiting
• Multiple medical visits and extensive medical
  evaluations
• Complications
• Hospitalization
• Medical costs
• Missed school and work
• Impact on public health system

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Adolescent and Adult Pertussis Vaccination

• Primary objective
• protect the vaccinated adolescent or adult
• Secondary objective
• reduce reservoir of B. pertussis
• potentially reduce incidence of pertussis in
  other age groups and settings

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Tdap Vaccines

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

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General Principles for Useof Tdap and Td

• No brand preference
• Tdap preferred to Td to provide protection
  against pertussis
• Approved only for a single booster dose in
  persons who have received a full series of
  pediatric DTaP or DTP

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Recommendations for Tdap Vaccination of
Adolescents

• 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/DTP vaccination series, and has
not yet received a Td booster
MMWR 200655(RR-3)1-43.
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Recommendations for Tdap Vaccination of Adults

• Single dose of Adacel to replace a single dose of
  Td
• May be given at an interval less than 10 years
  since receipt of last tetanus toxoid-containing
  vaccine
• Special emphasis on adults with close contact
  with infants (e.g., childcare and healthcare
  personnel, and parents)

MMWR 200655(RR-17)1-37.
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Tdap For Persons Without AHistory of DTP or DTaP

• All adolescents and adults 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. MMWR
200655(RR-3)1-43.
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Tdap Use in Older Children

• Tdap minimum ages
• 10 years for Boostrix
• 11 years for Adacel
• Tdap not approved for children 7-9 years of age
• Off-label use of Tdap in this age group NOT
  recommended

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Minimum Interval Between Td and Tdap

• ACIP did not define an absolute minimum interval
  between Td and Tdap
• Interval between Td and Tdap may be shorter if
  protection from pertussis needed
• Decision to administer Tdap based on whether the
  benefit of pertussis immunity outweighs the risk
  of a local adverse reaction

MMWR 200655(RR-3)1-43.
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Tdap and MCV

• MCV is recommended for all children at the
  11-12-year visit
• Administer Tdap and MCV during the same visit,
  if both vaccines are indicated and available
• If simultaneous administration of Tdap and MCV is
  not possible, these vaccines can be administered
  at any time before or after each other

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Use of Tdap Among Pregnant Women

• Td is generally preferred during pregnancy
• Women who have not received Tdap should receive a
  dose in the immediate post-partum period
• Any woman who might become pregnant is encouraged
  to receive a single dose of Tdap
• Clinician may choose to administer Tdap to a
  pregnant woman in certain circumstances (such as
  during a community pertussis outbreak)
• Pregnancy is not a contraindication for Tdap

Provisional recommendations approved by ACIP
June 28, 2006
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Tdap Vaccine and Healthcare Personnel

• Healthcare personnel who work in hospitals or
  ambulatory care settings and have direct patient
  contact should receive a single dose of Tdap
  (Adacel only) as soon as feasible
• Priority should be given to vaccination of
  healthcare personnel who have direct contact with
  infants 12 months of age and younger
• An interval as short as 2 years (or less) from
  the last dose of Td is recommended for the Tdap
  dose

if they have not previously received Tdap.
MMWR 200655(RR-17)1-37.
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Tdap Adverse Reactions

• Local reactions 21-75
• (pain, redness, swelling)
• Temp of 100.4oF 3-5
• or higher
• Adverse reactions occur at approximately the same
  rate as Td alone (without acellular pertussis
  vaccine)

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Tdap Contraindications

• Severe allergic reaction to vaccine component or
  following a prior dose
• Encephalopathy not due to another identifiable
  cause occurring within 7 days after vaccination
  with a pertussis-containing vaccine

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Tdap Precautions

• History of a severe local reaction (Arthus
  reaction) following a prior dose of a tetanus
  and/or diphtheria toxoid-containing vaccine
• Progressive neurologic disorder until the
  condition has stabilized
• History of Guillain-Barré syndrome within 6 weeks
  after a prior dose of tetanus toxoid-containing
  vaccine
• Moderate or severe acute illness

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Conditions NOT Precautions for Tdap

• Following a dose of DTaP/DTP
• temperature 105oF (40.5oC) 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
• Stable neurologic disorder
• Pregnancy
• Breastfeeding
• Immunosuppression including
• HIV infection
• Concurrent minor illness
• Antimicrobial use

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Resource to Help Reduce DTaP/Tdap Administration
Errors
Check Your Vials poster showing images of
DTaP/Tdap/Td vials and packaging Developed by
the California Immunization Branch Free download
from www.dhs.ca.gov/ps/dcdc/izgroup/pdf/IMM-508.pd
f
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Pertussis-Containing VaccinesStorage and Handling

• Stored at 3546F (28C) at all times
• Must never be frozen
• Vaccine exposed to freezing temperature must not
  be administered and should be discarded
• Do not be used after the expiration date printed
  on the box or label

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National Immunization ProgramContact Information

• Telephone 800.CDC.INFO
• Email nipinfo_at_cdc.gov
• Website www.cdc.gov/nip