Pertussis and Pertussis Vaccines

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• Pertussis and Pertussis Vaccines

Epidemiology and Prevention of Vaccine-Preventable
Diseases National Center for Immunization and
Respiratory Diseases Centers for Disease Control
and Prevention
Revised May 2009
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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, 2004-2006
Age at onset
lt3 mos 24 32 13 69 (84)
gt3 mos 3 7 3 13 (16)
Total 27 39 16 82

• 2004
• 2005
• 2006
• Total

CDC, unpublished data, 2007
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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, 1940-2007

Year
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• PertussisUnited States, 1980-2007

Year
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Reported Pertussis by Age Group, 1990-2007
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Pertussis Incidence, 2006
N15,129. MMWR 200756(No. 53)33-34
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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)
• Tdap (adolescent and adult)
• approved for persons 10 through 64 years
  (Boostrix) and 11 through 64 years (Adacel)

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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
• All DTaP vaccines are 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

• ACIP recommends no more than 6 doses of
  DT-containing vaccine before the 7th birthday
• General guidance, not an absolute requirement
• Intended to reduce the frequency of local
  reactions
• If the decision is made to administer more than 6
  doses of DT-containing vaccine 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 12 months of age or older
  following any Hib vaccine

booster dose should follow prior dose by at
least 2 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 ACIP recommendation
www.cdc.gov/vaccines/programs/vfc/downloads/resolu
tions/1003hepb.pdf
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Pentacel Vaccine

• Contains lyophilized Hib (ActHIB) vaccine that is
  reconstituted with a liquid DTaP-IPV solution
• Approved for doses 1 through 4 among children 6
  weeks through 4 years of age
• The DTaP-IPV solution should not be used
  separately (i.e., only use to reconstitute the
  Hib component)

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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)
• Approved for persons 10 through 64 years of age
• Adacel (sanofi pasteur)
• Approved for persons 11 through 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 or 12 years of age should receive
  a single dose of Tdap instead of Td
• Adolescents 13 through 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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Tdap Vaccination of Adults19 Through 64 Years of
Age

• Single dose of Tdap 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

• Tdap minimum ages
• 10 years for Boostrix
• 11 years for Adacel
• Neither brand of Tdap approved for children 7
  trough 9 years of age, or persons 65 years or
  older
• Off-label use of Tdap in these age groups 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 or
  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

MMWR 200857 (No. RR-4)
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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 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.eziz.org/resources/materials_vaccineadmin
.html
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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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CDC Vaccines and ImmunizationContact Information

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