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W. Michael Brown, MD, FAAP Director of Pediatrics Associate Director Family Medicine Residency Bayfront Medical Center St. Petersburg, Florida Pertussis.

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Presentation on theme: "W. Michael Brown, MD, FAAP Director of Pediatrics Associate Director Family Medicine Residency Bayfront Medical Center St. Petersburg, Florida Pertussis."— Presentation transcript:

1 W. Michael Brown, MD, FAAP Director of Pediatrics Associate Director Family Medicine Residency Bayfront Medical Center St. Petersburg, Florida Pertussis Awareness And Prevention

2 Pertussis Awareness and Prevention: Objectives Increase awareness and prevention of pertussis in the United States Educate health care professionals on epidemiology and diagnosis of pertussis Discuss importance of pertussis immunization Discuss important strategies for improving control of pertussis Increase awareness and prevention of pertussis in the United States Educate health care professionals on epidemiology and diagnosis of pertussis Discuss importance of pertussis immunization Discuss important strategies for improving control of pertussis

3 PERTUSSIS (WHOOPING COUGH) Acute respiratory tract infection by Bordetella pertussis highly communicable 80% secondary attack rates among susceptible persons Significant morbidity and mortality in infants Milder nonspecific upper respiratory tract infection in adolescents and adults Difficult to diagnose Referred to by the Chinese as “the cough of 100 days” Acute respiratory tract infection by Bordetella pertussis highly communicable 80% secondary attack rates among susceptible persons Significant morbidity and mortality in infants Milder nonspecific upper respiratory tract infection in adolescents and adults Difficult to diagnose Referred to by the Chinese as “the cough of 100 days”

4 Prolonged Cough Illness in Adolescents and Adults Due to Bordetella Pertussis SourceLocaleYear(s)% of cough illnesses Jackson et alSeattle % Robertson et alNew S Wales % Mink et alLos Angeles % Schmitt-Grohé et alGermany % Wright et alNashville % Wirsing v Köenig et alGermany % Rosenthal et alChicago % Jansen et alSan Diego % Nennig et alSan Francisco % Strebel et alMinn-St Paul % Birbeback et alDenmark % Vicent et alKorea % Gilberg et alParis199952%

5 Pertussis Disease Manifestations Incubation period days (range ) Stages Catarrhal: runny nose, sneezing, low-grade fever, mild cough Paroxysmal: severe spasms of cough, thick mucus, whoops, vomiting, exhaustion Convalescent: gradual recovery with less frequent & less severe coughing Photograph courtesy of the WHO

6 Why Is Pertussis Increasing? Ascertainment…awareness and better diagnostic tests Incomplete immunization of children Variable vaccine efficacy Waning immunity ~ 15 years after active disease ~ 5-10 years after vaccination Under diagnosis, especially in adolescents and adults Lack of an adolescent/adult booster vaccine UNTIL NOW Ascertainment…awareness and better diagnostic tests Incomplete immunization of children Variable vaccine efficacy Waning immunity ~ 15 years after active disease ~ 5-10 years after vaccination Under diagnosis, especially in adolescents and adults Lack of an adolescent/adult booster vaccine UNTIL NOW

7 DECLINE IN VACCINE-PREVENTABLE DISEASE DiseaseMaximumCases % casesin 2003change _____________________________________________________________________________________ Diphtheria296,939 in % _____________________________________________________________________________________ Tetanus1,560 in % _____________________________________________________________________________________ Pertussis265,269 in % _____________________________________________________________________________________ Measles894,134 in % _____________________________________________________________________________________ Paralytic polio21,269 in % 3,100 died _______________________ _____________________________________________________________ Mumps152,209 in % _____________________________________________________________________________________ Rubella57,686 in % _____________________________________________________________________________________ HIB 20,000 prior to % _____________________________________________________________________________________ From Centers for Disease Control and Prevention. MMWR 2004 DiseaseMaximumCases % casesin 2003change _____________________________________________________________________________________ Diphtheria296,939 in % _____________________________________________________________________________________ Tetanus1,560 in % _____________________________________________________________________________________ Pertussis265,269 in % _____________________________________________________________________________________ Measles894,134 in % _____________________________________________________________________________________ Paralytic polio21,269 in % 3,100 died _______________________ _____________________________________________________________ Mumps152,209 in % _____________________________________________________________________________________ Rubella57,686 in % _____________________________________________________________________________________ HIB 20,000 prior to % _____________________________________________________________________________________ From Centers for Disease Control and Prevention. MMWR 2004

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9 Efficacy of Acellular Pertussis Vaccines Randomized, Blinded Trials* StudyVaccine Efficacy (%) (Confidence Interval) † (WHO) † Stockholm Gustafsson L et al. N Engl J Med. 1996;334: DAPTACEL™85 (81-89) Connaught DTP48 (37-58) Italy Greco D et al. N Engl J Med. 1996;334(6): Infanrix ® 84 (76-89) Connaught DTP36 (14-52) *Shows results for vaccines available in the United States for 3-dose infant immunization series; effects of any booster dose are not included. † The definition closest to the standard WHO case definition (Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999; ). *Shows results for vaccines available in the United States for 3-dose infant immunization series; effects of any booster dose are not included. † The definition closest to the standard WHO case definition (Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999; ).

10 Source: CDC. Pertussis --- United States, MMWR 2002;51: Reported Pertussis Cases by Year United States, 1922 – 2000 Routine pertussis immunization begins Cases (Thousands) Cases (Thousands) Year Year

11 ,000 12,000 14,000 16,000 18,000 20, All Patients 25,827 11,647 9,771 7,867 7,580 7,288 5,137 4,570 1,730 11,647 25,827 73% 5,795 3, % Children  4 yrs. of age 5,795 3,355 The Growing Disease Reservoir Increases Exposure to Pertussis 22,000 24,000 26,000

12 Reports of Pertussis in the U.S. Centers for Disease Control and Prevention. MMWR. 2002;51:73-76; Güriş et al. Clin Infect Dis. 1999;28: National Immunization Program, Bacterial Vaccine Preventable Diseases Branch. Pertussis Surveillance Report, August 6, <1 yr 1-4 yrs 5-9 yrs yrs 20+ yrs Average Number of Cases / Year % 490%

13 …there are between ~800,000 and 3.3 million cases per year in the United States.

14 Estimated Duration of Immunity After Infection or Vaccination Source of Immunity Duration Reference Natural infection 15 years Wirsing Von Konig, 1995 Whole-cell vaccine UK 6 years Jenkinson, 1988 Finland 6 years He, 1994 Germany > 6 years Lugauer, 2002 Acellular vaccine Italy 6 years Salmaso, 2001 Germany > 6 years Lugauer, 2002 Wirsing Von Konig et al. Lancet ID 2002:2:

15 Consequences of Waning Immunity Increased transmission of pertussis disease to unimmunized and underimmunized infants and children 1 Considerable pertussis-related morbidity and economic cost in families 2 Increased incidence of pertussis disease among adolescents and adults 1,3 Increased transmission of pertussis disease to unimmunized and underimmunized infants and children 1 Considerable pertussis-related morbidity and economic cost in families 2 Increased incidence of pertussis disease among adolescents and adults 1,3 1. Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999; Lee LH et al. Arch Fam Med. 2000;9: Centers for Disease Control and Prevention. MMWR. 2002;51:73-76.

16 Reported Pertussis Cases Are the Tip of the Iceberg Not Reported Under- reporting Atypical forms Wide disease variability Inconsistent case definitions Underdiagnosis Low physician awareness Underconsultation Reported Nationwide, an estimated 12% of pertussis cases are actually reportedNationwide, an estimated 12% of pertussis cases are actually reported Underreporting may be greatest among adolescents and adultsUnderreporting may be greatest among adolescents and adults Güriş et al. Clin Infect Dis. 1999;28:

17 Pertussis Cases Reported in 2002 Each Dot Represents One Case The total number of cases and incidence rate for each state represent provisional numbers, which may change as states report more cases for 2002 Source: Bacterial Vaccine Preventable Diseases Branch, National Immunization Program, CDC. Sharp demarcation at state borders illustrates inconsistent reporting.

18 75% Of Suspected Sources For Infant Pertussis Cases Were Family Members 47% Mom or Dad Mom 32% Dad 15% Sibling 20% Grandparent 8% Other 25% 20% Other Adults 33% Other Children Bisgard, K. et al. Ped Infect Dis J. 2004;23:

19 The Cycle of Pertussis Susceptibility Promotes Transmission & Disease Primary vaccination: Protected Booster vaccination: Prolonged protection No additional booster: Immunity wanes Unvaccinated or partially vaccinated infants: Susceptible Susceptible adolescents and adults: Reservoir of B pertussis Break the Pertussis Cycle: Vaccinate Reduce morbidity in all age groups Reduce reservoir of Pertussis disease Prevent transmission of Pertussis disease between adolescents and adults, and from adolescents and adults to infants Supported by multiple publications. See notes

20 Pertussis: Clinical Presentation In Infants

21 Severe vs Mild Pertussis 1. Scott PT et al. Am Fam Physician. 1997;56: Strebel P. Infect Med. 1996;13:S33-S Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999; Scott PT et al. Am Fam Physician. 1997;56: Strebel P. Infect Med. 1996;13:S33-S Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999; Severe * Mild More common in infantsMore common in infants Occurs in nonimmune individualsOccurs in nonimmune individuals Paroxysmal cough (>21 days’ duration) with heavy inspiration (whoops) accompanied by vomiting and gaggingParoxysmal cough (>21 days’ duration) with heavy inspiration (whoops) accompanied by vomiting and gagging Characteristic symptoms (eg, whoop) often absent 1Characteristic symptoms (eg, whoop) often absent 1 An important mechanism of transmission to infantsAn important mechanism of transmission to infants Estimated to represent 21% to 26% of acute cough illness in adults 2,3Estimated to represent 21% to 26% of acute cough illness in adults 2,3 Often unrecognized, underdiagnosedOften unrecognized, underdiagnosed * World Health Organization (WHO) definition.

22 Common Clinical Manifestations of Adolescent-Adult Pertussis Cough 97%  3 weeks, 52%  9 weeks Paroxysms  3 weeks in 73% Whoop in 69% Post-tussive emesis in 65% Teens missed average 5 days of school; Adults missed average 7 days of work Average 14 days of disrupted sleep De Serres et al. J Infect Dis. 2000;182:174–9.

23 PERTUSSIS DEATHS BY AGE, UNITED STATES ( )

24 Pertussis Complications By Age

25 Diagnostic Laboratory Findings In Pertussis Marked lymphocytosis with leukocyte counts often exceeding 50,000 cells/mm 3 Generally afebrile with no elevation of ESR or other acute phase reactions CXR with a “shaggy heart” produced by bilateral perihilar infiltrates, edema, and atelectasis Culture of posterior NP swab may take 2 weeks, but negative cultures are common especially after 4 weeks of illness Direct immunofluorescent assay of NP secretions had variable sensitivity and low specificity Serologic tests to measure immunglobin antibody to pertusis toxin (IgG, IgM, IgA). DNA by PCR of NP secretions is the most sensitive and rapid test but may not always be available *Most cases of Pertussis are diagnosed clinically!

26 Period Of Communicability Of Pertussis Weeks of cough Catarrhal stage Paroxysmal stage Convalescent stage Cough onset Period of communicability Persons with pertussis are most infectious during the catarrhal period starting as early as one day of cough Persons with pertussis are most infectious during the catarrhal period starting as early as one day of cough Some individuals, such as infants who remain culture-positive for several weeks, may be infectious for a longer period Some individuals, such as infants who remain culture-positive for several weeks, may be infectious for a longer period

27 Diagnostic Laboratory Findings in Pertussis Adapted from Mortimer EA. In: Krugman’s Infectious Diseases of Children. 10 th ed. Mosby Year Book, Inc; 1998: Time After Onset of Symptoms (weeks) Catarrhal Paroxysmal Stage Convalescent Lymphocyte Count (thousands) Positive Culture

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29 Diagnosis Diagnosis Culture 1-3 weeks cough PCR 1-4 Serology 3 weeks or longer IFA never Culture 1-3 weeks cough PCR 1-4 Serology 3 weeks or longer IFA never

30 TREAMENT OF PERTUSSIS Infants younger than 6 months generally require hospitalization Antibiotic Therapy: Erythromycin 40 to 50 mg/kg/day given QID x 14 days Azythromycin 10 to 12 mg/kg/day given Qday X 5 days Clarithromycin 15 to 20 mg/kg/day given BID X 7 days Bactrim or Septra 8 mg TMP/ 40 mg SMX per kg per day in two divided doses for 14 days if allergic to macrolides *Treatment with antibiotics does not effect duration or severity of clinical course Cough suppressants MMWR Jan Infants younger than 6 months generally require hospitalization Antibiotic Therapy: Erythromycin 40 to 50 mg/kg/day given QID x 14 days Azythromycin 10 to 12 mg/kg/day given Qday X 5 days Clarithromycin 15 to 20 mg/kg/day given BID X 7 days Bactrim or Septra 8 mg TMP/ 40 mg SMX per kg per day in two divided doses for 14 days if allergic to macrolides *Treatment with antibiotics does not effect duration or severity of clinical course Cough suppressants MMWR Jan. 2005

31 Pertussis toxin (PT), also known as “lymphocytosis-promoting factor” (systemic action) Filamentous hemagglutinin (FHA) Pertactin (PRN) or 69 kD* protein Fimbrial agglutinogens (FIM) (1-4 serotypes) Pertussis toxin (PT), also known as “lymphocytosis-promoting factor” (systemic action) Filamentous hemagglutinin (FHA) Pertactin (PRN) or 69 kD* protein Fimbrial agglutinogens (FIM) (1-4 serotypes) FIM PT PRN FHA Antigenic Components of B pertussis *kD = kilodalton. Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999;

32 Currently licensed in US Tripedia ® Infanrix ® *Daptacel™Boostrix™Adacel ® Indicated Age Group Infants/ Children † Adolescents ‡ (10-18 years) Adults/ Adolescents ‡ (11-64 years) Antigenic Components § PT (µg) FHA (µg) PRN (µg) FIM (µg) D (Lf) T (Lf) — — — — Diphtheria, Tetanus, and Acellular Pertussis Vaccines

33 Comparison of Tdap Vaccines Adacel Boostrix Company Sanofi GSK Age Efficacy 21d 85% 84% 7d 78% 71% Components 4 (fimbrae) 3 Diphtheria LF Adacel Boostrix Company Sanofi GSK Age Efficacy 21d 85% 84% 7d 78% 71% Components 4 (fimbrae) 3 Diphtheria LF 2 2.5

34 The Adacel Program in Newfoundland Replaced Td in 1999 school year Adacel delivered in a Grade 9 (14 year olds) school-based program Approximately 25,000 doses given by June 2004

35 Incidence of Pertussis in Newfoundland, Time Periods Incidence per 100,000 Population Introduction of adolescent dTaP5 CCDR Notifiable Disease Annual Summaries 70 **** **** Pertussis outbreak confined to persons not immunized with dTaP5

36 Pertussis Incidence and Vaccine Use, 1993 – 2004 Canada’s Northwest Territories Kandola, K. Abstract in Can J Infect Dis Med Microbiol. 2004;15:351. Manuscript in preparation. Adacel begun Switch to Pentacel Time Periods Average Yearly Cases / 10,000

37 United States Licensure Trial: Summary of Immunogenicity PrePost Pre DiphtheriaTetanus Data reported for sera collected one month after vaccination. Data on file, Td 506, Aventis Pasteur Limited, Toronto, Canada.

38 FeverHeadache GeneralizedB ody Ache TirednessSore JointsChills United States Licensure Trial: Summary of Solicited Systemic Reactions Data collected from days Data on file, Td 506, Aventis Pasteur Limited, Toronto, Canada.

39 United States Licensure Trial: Summary of Solicited Local Reactions No significant difference was observed between Tdap and Td recipients for any safety parameters measured with the exception of pain in adolescents which was marginally more frequent in Tdap recipients. Data collected from days 0-3. * ≥35 mm; † Severe local pain: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism. Severe Erythema * ErythemaSevere Swelling * SwellingSevere Local Pain † Local Pain Data on file, Td 506, Aventis Pasteur Limited, Toronto, Canada. Adolescents = years. Adults = years.

40 Adequacy, Efficacy, & Safety Data for Tdap Vaccines Age Indications: Adacel years, Boostrix years Both vaccines met all agreed non-inferiority criteria For Diphtheria and Tetanus antigens, at least as immunogenic as US – licensed Td vaccines Pertussis booster response induced an immune response at least as immunogenic as Daptacel and Infanrix Can be used concomitantly with other vaccines Safety profile comparable to US-licensed Td Vaccine Age Indications: Adacel years, Boostrix years Both vaccines met all agreed non-inferiority criteria For Diphtheria and Tetanus antigens, at least as immunogenic as US – licensed Td vaccines Pertussis booster response induced an immune response at least as immunogenic as Daptacel and Infanrix Can be used concomitantly with other vaccines Safety profile comparable to US-licensed Td Vaccine

41 FDA Vaccine Advisory Committee Unanimous vote March 2005 – Adacel safe and effective age years of age – Boostrix safe and effective years of age Licensure… May, June 2005 CDC ACIP July yr Universal Immunization, catch up 5 yrs from last Td Oct 2005 Universal Adult Immunization,10 yrs from Td Unanimous vote March 2005 – Adacel safe and effective age years of age – Boostrix safe and effective years of age Licensure… May, June 2005 CDC ACIP July yr Universal Immunization, catch up 5 yrs from last Td Oct 2005 Universal Adult Immunization,10 yrs from Td

42 Rationale for Vaccinating Adolescents and Adults: Bordetella Pertussis Reservoirs 1. Sheretz et al. Emerg Infect Dis. 2001;7: Izurieta et al. Clin Infect Dis. 1996;22: Postels-Multani et al. Infection. 1995;23: Crowcroft et al. Arch Dis Child. 2003;88: Adolescents and Adults Are Primary Sources for Infant Transmission Health Care Providers Most hospital outbreaks of pertussis disease involve transmission from health care workers to pediatric patients 1 Adults/Parents In Chicago, young mothers with a cough >7 days were shown to be a significant source of pertussis disease transmission to their young infants 2 Grandparents In 15% of families, an adult patient was identified as the source of infection for other household members. Fifteen percent of these adults were grandparents or great- grandparents of an affected child 3 Adolescents/Siblings For 27% of infants hospitalized with pertussis disease in London between 1998 and 2000, an older, fully vaccinated sibling was the source of infection 4

43 Advisory Committee On Immunization Practices (ACIP) Recommendations For Tdap Vaccine In Adolescents Recommendations of the ACIP (CDC) for the use of Tdap vaccines: Adolescents 11 to 12 years of age be given Tdap in place of the Td booster currently being used Tdap vaccine should be given to adolescents 13 to 18 years who missed the 11 to 12 year dose of Td Adolescents 11 to 18 years of age who have already been vaccinated with Td are encouraged to receive a dose of Tdap to further protect against pertussis Adolescents can and should receive Tdap and the meningococcal conjugate vaccine (menactra) at the same visit

44 ACIP Recommendations for Tdap Vaccine Use in Adults Adults who have not received a Td immunization during the last 10 years should receive a single dose of Tdap Vaccine Those not previously given Tdap vaccine may be given Tdap vaccine at shorter intervals (< 10 years) following last Td immunizations in settings of wound management and increased risk (including pertussis outbreaks and contact with infants Adults who anticipate having close contact with infants (ie: parents, healthcare workers and daycare workers) should receive a single dose of Tdap vaccine to protect against pertussis if they have not received Tdap vaccine. Ideally these adults should receive Tdap vaccine at least one month before beginning close contact with infants Adults who have not received a Td immunization during the last 10 years should receive a single dose of Tdap Vaccine Those not previously given Tdap vaccine may be given Tdap vaccine at shorter intervals (< 10 years) following last Td immunizations in settings of wound management and increased risk (including pertussis outbreaks and contact with infants Adults who anticipate having close contact with infants (ie: parents, healthcare workers and daycare workers) should receive a single dose of Tdap vaccine to protect against pertussis if they have not received Tdap vaccine. Ideally these adults should receive Tdap vaccine at least one month before beginning close contact with infants

45 Other ACIP Recommendations for Adult Tdap Use Women should receive Tdap vaccine immediately post partum if not previously immunized Women are encouraged to receive Tdap vaccine before conception Tdap vaccine is encouraged over Td vaccine in the wound care setting for those who have not previously received Tdap vaccine Pregnancy is not a contraindication to Tdap and may be considered in the 2 nd and 3 rd trimester Women should receive Tdap vaccine immediately post partum if not previously immunized Women are encouraged to receive Tdap vaccine before conception Tdap vaccine is encouraged over Td vaccine in the wound care setting for those who have not previously received Tdap vaccine Pregnancy is not a contraindication to Tdap and may be considered in the 2 nd and 3 rd trimester

46 ACIP Recommendations for Tdap Use In Healthcare Workers There are 8-10 million workers employed in hospital and ambulatory settings. The risk of contracting pertussis from healthcare workers is nearly 2 times greater than the general population. For each decade the immunization of healthcare workers could prevent as many as 100, 000 cases of pertussis and save up to $151 million in direct and indirect costs. Therefore it is recommended that all healthcare workers and anyone who works in a healthcare setting receive Tdap. There are 8-10 million workers employed in hospital and ambulatory settings. The risk of contracting pertussis from healthcare workers is nearly 2 times greater than the general population. For each decade the immunization of healthcare workers could prevent as many as 100, 000 cases of pertussis and save up to $151 million in direct and indirect costs. Therefore it is recommended that all healthcare workers and anyone who works in a healthcare setting receive Tdap.

47 Strategies to Control Pertussis… Improve immunization coverage Ensure immunization of all appropriate infants Prevent mild disease Improve surveillance and reporting Implement Tdap vaccines for adolescents and adults Eliminate reservoirs of infection in general population Reduce transmission to vulnerable infants

48 SUMMARY Epidemiology of pertussis disease has changed with the spectrum of illness shifting to a milder form in all age groups B. pertussis infections in the adolescent and adult populations are common and endemic accounting for more of the disease seen today Immunity after natural infection or vaccinations is not life long and wanes rapidly after 5 – 8 years Pertussis acounts for up to 25% of acute cough illnesses in the adolescent and adult populations The adolescent and adult populations serve as a major resevoir of disease transmission to the young infant population Immunizing the infant population on time and implementing a booster vaccine program in the adolescent and adult populations will have the greatest impact on decreasing the amount of disease seen Epidemiology of pertussis disease has changed with the spectrum of illness shifting to a milder form in all age groups B. pertussis infections in the adolescent and adult populations are common and endemic accounting for more of the disease seen today Immunity after natural infection or vaccinations is not life long and wanes rapidly after 5 – 8 years Pertussis acounts for up to 25% of acute cough illnesses in the adolescent and adult populations The adolescent and adult populations serve as a major resevoir of disease transmission to the young infant population Immunizing the infant population on time and implementing a booster vaccine program in the adolescent and adult populations will have the greatest impact on decreasing the amount of disease seen

49 …a universal program of adolescent and adult boosters would decrease the circulation of B pertussis… and possibly could lead to the elimination of the organism…

50 Questions


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