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Responding to the Rise in Pertussis CT AAP CME Program. Kathy Kudish , DVM, MSPH. Immunization Program Connecticut Department of Public Health. Amanda Faulkner, MPH. Meningitis and Vaccine Preventable Diseases Branch Centers for Disease Control and Prevention September 25, 2012.

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responding to the rise in pertussis ct aap cme program
Responding to the Rise in PertussisCT AAP CME Program

Kathy Kudish, DVM, MSPH

Immunization Program

Connecticut Department of Public Health

Amanda Faulkner, MPH

Meningitis and Vaccine Preventable Diseases Branch

Centers for Disease Control and Prevention

September 25, 2012

National Center for Immunization and Respiratory Diseases

Division of Bacterial Diseases

pertussis whooping cough
Pertussis (Whooping Cough)
  • Highly contagious respiratory disease
  • Severe, debilitating cough illness (“100 day cough”) in persons of all ages
  • Highest morbidity and mortality among infants
  • Estimated worldwide deaths > 300,000/yr
  • Vaccine-preventable
  • Poorly controlled, despite high vaccine coverage
  • First U.S. pertussis vaccines for adolescents and adults (Tdap)† licensed in 2005

†Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine

2

clinical course in weeks
Clinical Course (in weeks)

Communicable period

(onset to 3 weeks after start of paroxysmal cough)

Incubation period

(typically 5-10 days;

max 21 days)

Convalescent stage

(weeks to months)

Catarrhal stage

(1-2 weeks)

-3

0

2

8

12

Paroxysmal stage

(1-6 weeks)

Onset

3

clinical stages
Clinical Stages
  • Catarrhal
    • Watery eyes, low-grade fever, malaise, mild eye inflammation, runny nose, late-phase nonproductive cough
  • Paroxysmal
    • Paroxysms (bursts of coughing during a single exhalation) followed by an inspiratory "whooping" sound, post-tussive cyanosis, and vomiting
    • In infants younger than six months (especially those younger than four weeks): apnea, bradycardia, prolonged cough, poor feeding, no paroxysms
  • Convalescent
    • Paroxysms gradually improve but recur with respiratory infections

www.aafp.prg

4

infant pertussis
Young infants at highest risk of disease and complications

Atypical symptoms:

Catarrhal stage and cough may be minimal or absent

Apnea (sometimes with seizures)

Sneezing

Gagging, choking, vomiting

Whoop infrequent

Cough illness among close contacts

Presumptive treatment should begin immediately

Infant Pertussis

Source: Shot of Prevention, Brady passed away at just 2 months from pertussis

5

pertussis among adolescents and adults
Pertussis among Adolescents and Adults
  • Wide spectrum of presentation
    • Disease often milder than in infants and children
    • May be asymptomatic
    • Can be quite severe and with classic presentation
  • Clinically difficult to distinguish from other causes of cough illness
  • Persons with mild disease can transmit infection
pertussis treatment
Pertussis Treatment
  • When to treat
    • Adults, adolescents, children
      • Antimicrobials may modify course if given early (reduce duration and severity of symptoms and lessen communicability)
      • Treatment >3 weeks after cough onset limited benefit
    • Infants and pregnant women near term
      • Treatment up to 6 weeks after cough onset should be considered
  • Recommended treatment
    • Macrolide / azolide antimicrobial
      • 5 day course azithromycin
      • 7 day course clarithromycin
      • 14 day course erythromycin
    • Alternative agent:
      • 14 day course trimethoprim-sulfamethoxazole (Bactrim)
diagnostic challenges
Diagnostic Challenges
  • Stage of disease
  • Quality/timely collection of clinical specimen (s)
  • Antimicrobial administration
  • Vaccination status
  • Transport conditions
  • Contamination of clinical specimen
  • Lack of clinically validated/ standardized tests
diagnostic needs clinical vs public health
Diagnostic NeedsClinical vs. Public Health
  • Clinical setting
    • Optimizes sensitivity
    • Rapid turnover
  • Public health setting
    • Optimizes specificity
    • Confirmation of etiology
    • Prevention and control measures
pertussis diagnostics at cdc
Pertussis Diagnostics at CDC
  • Culture
    • 100% specific
    • Low sensitivity
    • Incubation time 4-10 days
  • Multi-target real-time PCR
    • 4 targets
    • Speciate 3 Bordetella spp.
    • Co-infections
  • IgG anti-PT ELISA
    • Quantitative/qualitative
    • Adolescents and adults
    • Late phase of disease
commercial pertussis serologic assays
Commercial Pertussis Serologic Assays
  • Commercial assays are not standardized and clinical accuracy is unknown
  • CDC is conducting a study to better understand the usefulness of commercially available assays for clinical diagnosis
  • Not included in CDC/CSTE pertussis case definition
  • CDC ELISA is not commercially available
    • Tech transfer is ongoing in collaboration with APHL and state public health laboratories
r pcr assay is481
R-PCR Assay IS481
  • Present in three Bordetella spp.
    • 50 to >200 copies in B. pertussis
    • 8 to 10 copies in B. holmesii
    • 0 to 7 copies in B. bronchiseptica
  • High Ct value could indicate
    • Positive test for B. pertussis
    • False positive
    • Positive for
      • B. holmesii
      • B. bronchiseptica

Real-Time PCR Amplification Plot

slide14

Falsely-positive PCR Results during Outbreak Investigations

  • Hospital: NH, 2006
  • Community: CO, 2009
  • Community: NY, 2010

14

slide15

Falsely-positive PCR Results

  • Use of IS481 as a single target assay
    • High Ct values interpreted as positive results
  • Contamination of clinical specimens during collection
    • B. pertussis DNA present in some vaccines
    • Confirmed by environmental sampling of clinics
    • Key factors likely ungloved hands and use of liquid transport media

+

+

+

+

False Positives

15

cdc best practices guidance for healthcare professionals on the use of pcr for diagnosing pertussis
CDC Best Practices Guidance for Healthcare Professionals on the Use of PCR for Diagnosing Pertussis
  • Target clinicians to optimize the use of PCR
    • Testing patients with signs and symptoms of pertussis
    • Optimal timing and specimen collection for PCR testing
    • Avoiding contamination of clinical specimens with B. pertussis DNA
    • Understanding and interpreting PCR results
  • Available at:

http://www.cdc.gov/pertussis/clinical/diagnostic-testing/diagnosis-pcr-bestpractices.html

specimen collection for pertussis pcr
Specimen Collection for Pertussis PCR
  • Acceptable samples:
    • Nasopharyngeal swabs
    • Nasopharyngeal aspirates
  • Nasal swabs are not acceptable
  • Visit www.cdc.gov/pertussis for instructions on specimen collection
optimal timing in weeks for diagnostic testing
Optimal Timing in Weeks for Diagnostic Testing

Cough Onset

0

2

4

6

8

10

12

Culture

PCR

Serology

pertussis surveillance and reporting
Pertussis Surveillance and Reporting
  • Nationally notifiable
  • Clinical (Probable) case
    • Cough ≥2 weeks AND
    • One among paroxysms, whoop, post-tussive vomiting
  • Confirmed case
    • Culture OR
    • Clinical case and PCR positive OR
    • Clinical case and epi-linked to confirmed case
reported pertussis cases by diagnosis 1990 2010
Reported Pertussis Cases by Diagnosis±, 1990-2010

±Data collection for PCR and Epi-Link began in 1995

Source: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System, 2010

pertussis immunization in the us
Pertussis Immunization in the US
  • Infants/children
    • Widely used since 1940s
    • Transitioned from DTP to DTaP throughout the 1990s
    • DTaP at 2, 4, 6 months; 15-18 months; 4-6 years
    • Children 7 through 10 years not fully immunized against pertussis should receive a single dose of Tdap
  • Adolescents/adults
    • Licensed in 2005, recommended in 2006
    • Single Tdap, preferred at 11-12 years
    • All adolescents/adults who did not receive at 11-12 years should receive a single dose as soon as feasible (includes those 65 yr and older)
      • Tdap can be administered regardless of interval since the previous Td dose
slide23
Reported NNDSS pertussis cases: 1922-2011

DTaP

Tdap

DTP

SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System and 1922-1949, passive reports to the Public Health Service

dtap coverage among children aged 19 through 35 months 2004 2011
DTaPCoverage among Children Aged 19 through 35 months — 2004-2011

24

CDC National Immunization Survey

slide25

Reported pertussis incidence by

age group: 1990-2011

SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System

annual incidence by state 2010
Annual Incidence by State, 2010

2010 incidence 9.0

(n=27,550)

Incidence

1.1-3.6

3.7-6.5

6.6-10.2

10.3-23.2

Incidence is per 100,000 population

Source : CDC National Notifiable Disease Surveillance System, *2010 data accessed July 22, 2011

CDC Wonder Population Estimates (Vintage 2009)

annual incidence by state 2011
Annual incidence by State, 2011

2011 incidence 6.1

(n=18,719)

Incidence

0.7-2.8

2.9-5.1

5.2-9.3

9.4-23.3

Incidence is per 100,000 population

Source : CDC National Notifiable Disease Surveillance System, 2011

2010 Census data used for population estimates

tdap vaccine effectiveness
Tdap Vaccine Effectiveness
  • Bridging studies of ADACEL and BOOSTRIX1
    • 85-89%
  • APERT study2
    • 92% (95% CI: 32.0-99.0)
  • Australia3 – screening method
    • 78.0% (95% CI: 60.7-87.6)
  • St. Croix outbreak4
    • 65.6% (95% CI: -35.8-91.3)
  • MN case-control study
    • 72.3% (95% CI: 38.8-87.4)

1 Schmitt HJ et al. JAMA 1996;275:37-41; Gustafsson LH et al. NEJM 1996;334:349-355

2 Ward JI et al. N Engl J Med. 2005 Oct 13;353(15):1555-63.

3Rank C, et al. PediatrInfect Dis J. 2009 Feb;28(2):152-3.

4 Wei SC, et al. CID 2010; 51(3):315-321.

tdap coverage among adolescents aged 13 17 years 2006 2010
Tdap Coverage among Adolescents Aged 13–17 years — 2006–2010

Percentage(%)

2010

2007

2008

2009

2006

CDC. National, State, and Local Area Vaccination Coverage Among Adolescents Aged 33-17 Years - United States, 2008. MMWR 2008;58(36);997-1001.

CDC. Vaccination Coverage Among Adolescents Aged 13-17 Years – United States, 2007. MMWR 2008;57(40)1100-1103.

CDC. Vaccination Coverage Among Adolescents Aged 13-17 Years– United States, 2006. MMWR 2007;56(34) 885-888.

CDC. National, State, and Local Area Vaccination Coverage among Adolescents Aged 13-17 Years - United States, 2009 MMWR 2010 ;59(32);1018-1023.

30

slide32
Accelerated Decline of PertussisRate ratios of pertussis incidence among adolescents 11-18 years, 1990-2009

Slope = -0.4752, p<.0001

Slope = +0.2225, p<.0001

Skoff et al. Arch PediatrAdolesc Med. 2012 Jan 11. [ePub ahead of print]

32

absence of indirect effects of tdap mean incidence of reported p ertussis a mong infants
Absence of Indirect Effects of TdapMean incidence of reported pertussis among infants

Skoff et al. Arch PediatrAdolesc Med. 2012 Jan 11. [ePub ahead of print]

33

california ve study
California VE Study
  • Cases & controls 4-10 yrs at illness onset or enrollment
  • Reported pertussis cases in 15 CA counties
  • Unmatched controls from case-patient providers (3:1)
  • Vaccine histories collected by in-person visits to providers
  • Logistic regression, accounting for clustering
  • 250 provider offices, 4,000 charts abstracted
pertussis disease among unvaccinated compared to vaccinated children
Pertussis Disease among Unvaccinated compared to Vaccinated Children

* Accounting for clustering by county and provider

overall ve duration of protection estimates
Overall VE & Duration of Protection Estimates

* Accounting for clustering by county and provider

overall ve duration of protection estimates1
Overall VE & Duration of Protection Estimates

* Accounting for clustering by county and provider

tdap and dtap studies summary and conclusions
Tdap and DTaP StudiesSummary and Conclusions
  • Tdap program has reduced the burden of pertussis in adolescents
  • No evidence for “herd immunity”
  • Excellent initial DTaP vaccine effectiveness
  • Modest but immediate waning of immunity from DTaP
  • Pertussis burden in children aged under 10 years appears to be a “cohort effect” from change to all aPvaccines
    • i.e. a problem of susceptibility despite vaccination
slide45
Reported NNDSS pertussis cases: 1922-2012*

DTaP

Tdap

DTP

SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System and 1922-1949, passive reports to the Public Health Service

changes in pertussis reporting by state from 2011 to 2012
Changes in Pertussis Reporting by State from 2011 to 2012*†

Decrease/No change

< 2-fold increase

2 to 3-fold increase

> 3-fold increase

*Data for 2012 are provisional and subject to change.

†Cases reported through Week 37 in 2011 were compared with cases reported through Week 37 in 2012; fold-changes were calculated for each state.

revised cdc guidelines for the prevention and control of pertussis objectives
Revised CDC Guidelines for the Prevention and Control of Pertussis: Objectives
  • Primary: Preventing death and serious complications in individuals at increased risk of severe and/or complicated disease, including infants <12 months
  • Secondary:
    • Limit transmission in outbreak setting
    • Limit further spread and duration of transmission within closed communities
    • Decrease morbidity in affected populations
    • Lower risk of dissemination to unaffected groups within an outbreak
revised cdc pertussis outbreak and control guidelines overview
Revised CDC Pertussis Outbreak and Control Guidelines: Overview
  • Emphasis on those at highest risk
    • Lack of evidence of broad-scale prophylaxis
  • Tiered approach offers flexibility but encourages judicious use of antibiotics
  • Alternatives to prophylaxis
    • Cough exclusion and “watchful waiting”
  • Opportunity to increase pertussis vaccine coverage
cumulative number of cases by month reported connecticut 2006 2012
Cumulative Number of Cases by Month Reported—Connecticut, 2006–2012

* Through 9/19/2012; current state-wide incidence is 5.3 cases/100,000 population

cumulative number of cases by month reported fairfield county connecticut 2006 2012
Cumulative Number of Cases by Month Reported— Fairfield County Connecticut, 2006–2012

* Through 9/19/2012; current incidence in Fairfield County is 8.7 cases/100,000 population

cumulative number of cases by month reported litchfield county connecticut 2006 2012
Cumulative Number of Cases by Month Reported— Litchfield County Connecticut, 2006–2012

* Through 9/19/2012; current incidence in Litchfield County is 26.9 cases/100,000 population

percent of cases by confirmation type connecticut 2006 2012
Percent of Cases by Confirmation Type—Connecticut, 2006–2012

58%

10%

* Through 9/1/2012

culture submissions to the department of public health dph laboratory
Culture Submissions to the Department of Public Health (DPH) Laboratory
  • Culture is still considered to be the gold standard (100% specific)
  • The DPH encourages providers to submit cultures alongside PCR, particularly in situations where a clinical practice is seeing an increase in the number of pertussis diagnoses among patients that share a common setting, such as a school or daycare
  • Availability of culture has contracted over the past decade
  • Culture continues to be available at the DPH Laboratory
  • Successful culture isolation of the organism declines if the patient has received prior antibiotic therapy effective against B. pertussis, if specimen collection has been delayed beyond the first 2 weeks of illness or if the patient has been vaccinated
pertussis culture
Pertussis Culture
  • Samples can be sent to the state either directly by healthcare providers or by a hospital laboratory
  • If specimen collection is to take place in the office:
    • Specimen collection kits which include the transport media for B. pertussis may be obtained by calling the DPH Laboratory at (860) 920-6674 or 6675
    • Kits should be requested ahead of time so they are accessible at the time of specimen collection
    • Instructions for specimen collection are provided with the kits
    • Transport media has a finite shelf life (3-6 months)
  • Once a nasopharyngeal swab has been collected it should be plated directly or placed into transport medium immediately
pregnancy and cocooning acip recommendations
Pregnancy and CocooningACIP Recommendations
  • Pregnant women vaccinated preferably during the third or late second trimester. Alternatively, administer Tdap immediately postpartum
  • Cocooning is the strategy of vaccinating all close contacts of infants with Tdap to reduce the risk of transmission
    • Ideally at least 2 weeks before contact with the infant
    • Parents, siblings, grandparents, child-care providers and health-care personnel
shifting the timing of mother s tdap dose postpartum to pregnancy
Shifting the timing of mother’s Tdap dose:postpartum to pregnancy
  • Provides earlier benefit to mother, thereby protecting infant at birth
  • High levels of transplacental maternal antibodies in infants of mothers vaccinated during pregnancy
    • Likely provides direct immunity to infant

Pregnancy

Postpartum

tdap cocoon program
Tdap Cocoon Program
  • Hospital-based program to vaccinate new mothers and family members of newborns with Tdap upon the birth of their child
  • Of the 28 birth hospitals in Connecticut, 23 are participating in the DPH Tdap Cocoon Program
    • Began fall of 2008
    • Close to 55,000 doses administered through this program, with the number increasing every year
  • List of “referral sites” where family members of infants <12 months can receive Tdap on the DPH Immunization Tdap Cocoon Program web page: http://www.ct.gov/dph/immunizations
tdap cocoon program evaluation
Tdap Cocoon Program Evaluation
  • Surveyed birth hospitals in fall 2011 about use of Tdap
    • 24 (86%) hospitals reported routinely offering Tdap to postpartum patients
    • Mean Tdap immunization rate for postpartum patients where Tdap was offered was 61% (confidence interval 54%–67%; median 63%, range 16%–87%)
    • Manuscript submitted for publication
tdap vaccination effectiveness for preventing infant pertussis
Tdap Vaccination Effectiveness for Preventing Infant Pertussis
  • Case control study in 6 states participating in the Emerging Infections Program (EIP) to evaluate the effectiveness of the Tdap “cocooning” strategy
  • Just getting underway, results probably at least a couple of years away
enhanced pertussis surveillance eps
Enhanced Pertussis Surveillance(EPS)
  • Part of EIP
  • Connecticut funded as an EPS site since 2011
  • One of 6 sites in the U.S.
  • Similar to previous surveillance activities with some additional data collection
  • Collect Bordetella culture isolates where feasible and forward to CDC for molecular characterization
emerging infection program network sites working on pertussis
Emerging Infection Program Network SitesWorking on Pertussis

Areas

CO (5 counties)

CA (state)

CT (state)

MN (state)

NM (state)

NY (15 counties)

OR (3 counties)

enhanced pertussis surveillance eps overview
Enhanced Pertussis Surveillance (EPS)Overview
  • Builds upon existing pertussis surveillance infrastructure at state
    • Improved completeness and quality of data
    • Augmented data collection
  • Objectives
    • 10 - Collect epidemiologic information and isolates, when available, on cases of B. pertussis
    • 20- Collect epidemiologic information and isolates, when available, on other Bordetella species (B. parapertussis, B. bronchiseptica, and B. holmesii)
tdap vaccination strategies evaluation objectives
Tdap Vaccination Strategies Evaluation: Objectives
  • Measure effectiveness of vaccination during pregnancy at preventing pertussis among infants <12 months
    • Age-specific effectiveness for infants <2months, and infants 2 - <6 months
    • Determine if infants 6 - <12 months born to women vaccinated during pregnancy have a higher odds of pertussis compared to infants born to women not vaccinated during pregnancy
  • Measure effectiveness cocooning at preventing pertussis among infants <2 months
    • Effectiveness of maternal vaccination (at any time) at preventing pertussis among infants <2 months
    • Effectiveness of vaccination of the infant cocoon (all household contacts and infant caregivers) at preventing pertussis among infants <2 months
final thoughts
Final Thoughts…
  • Pertussis continues to be a significant public health problem
  • Vaccination is our best prevention tool
  • Goal is no infant deaths
    • Improve Tdap coverage in adults
    • Remove barriers to vaccination of pregnant women
    • Implement cocooning
    • Focus chemoprophylaxis efforts on high risk
  • Maintain high levels of coverage with DTaP
  • Continue to evaluate and refine vaccination policy and prevention and control recommendations
web resources
Web Resources
  • CDC Pertussis Website
    • www.cdc.gov/pertussis
    • Disease overview, podcasts, vaccine recommendations, specimen collection videos, etc.
  • Provider Resources for Vaccine Conversations with Parents
    • www.cdc.gov/vaccines/conversations
    • Materials created by CDC, AAP, and AAFP