Amanda Faulkner, MPH Meningitis and Vaccine Preventable Diseases Branch Centers for Disease Control and Prevention September 25, 2012 Responding to the Rise in Pertussis CT AAP CME Program National Center for Immunization and Respiratory Diseases Division of Bacterial Diseases Kathy Kudish, DVM, MSPH Immunization Program Connecticut Department of Public Health
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Responding to the Rise in Pertussis CT AAP CME Program
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. - PowerPoint PPT Presentation
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Amanda Faulkner, MPHMeningitis and Vaccine Preventable Diseases Branch
Centers for Disease Control and Prevention
September 25, 2012
Responding to the Rise in PertussisCT AAP CME Program
National Center for Immunization and Respiratory DiseasesDivision of Bacterial Diseases
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
• 5 day course azithromycin• 7 day course clarithromycin• 14 day course erythromycin
Alternative agent: • 14 day course trimethoprim-sulfamethoxazole (Bactrim)
8
LABORATORY TESTING
9
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
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
16
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
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
21
Reported Pertussis Cases by Diagnosis±, 1990-2010
1990 1995 2000 2005 20100
5000
10000
15000
20000
25000
30000
UnknownSero+(MA)Epi-linkedDFAPCRCulture
Year
Num
ber o
f Cas
es
±Data collection for PCR and Epi-Link began in 1995Source: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System, 2010
22
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
1922
1930
1940
1950
1960
1970
1980
1990
2000
2011
0
50,000
100,000
150,000
200,000
250,000
300,000
Year
Num
ber o
f cas
esReported NNDSS pertussis cases: 1922-2011
DTP
1990
1995
2000
2005
0
5,000
10,000
15,000
20,000
25,000
30,000
Tdap
DTaP
SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System and 1922-1949, passive reports to the Public Health Service 23
DTaP Coverage among Children Aged 19 through 35 months — 2004-2011
Reported pertussis incidence by age group: 1990-2011
1990
1995
2000
2005
2011
0
20
40
60
80
100
<1 yr1-6 yrs7-10 yrs11-1920+ yrs
Year
Inci
denc
e ra
te
(per
100
,000
)
SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System 25
26
Annual Incidence by State, 2010
Incidence is per 100,000 populationSource : CDC National Notifiable Disease Surveillance System, *2010 data accessed July 22, 2011CDC Wonder Population Estimates (Vintage 2009)
1.1-3.6
3.7-6.5
6.6-10.2
10.3-23.2
Incidence
2010 incidence 9.0(n=27,550)
27
Annual incidence by State, 2011
Incidence is per 100,000 populationSource : CDC National Notifiable Disease Surveillance System, 20112010 Census data used for population estimates
1 Schmitt HJ et al. JAMA 1996;275:37-41; Gustafsson LH et al. NEJM 1996;334:349-3552 Ward JI et al. N Engl J Med. 2005 Oct 13;353(15):1555-63.3 Rank C, et al. Pediatr Infect 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
Series10
10
20
30
40
50
60
70
80
90
100
10.8
30.4
40.8
55.6
68.7
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.
2006 2007 2008
Perc
enta
ge (%
)
2009 2010
30
Incidence of Reported Pertussis — 1990–2010
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
0123456789
10
OverallYear
Case
s/10
0,00
0 Po
pula
tion Tdap
CDC unpublished data
31
Slope = -0.4752, p<.0001
Slope = +0.2225, p<.0001
Accelerated Decline of Pertussis Rate ratios of pertussis incidence among
adolescents 11-18 years, 1990-2009
Skoff et al. Arch Pediatr Adolesc Med. 2012 Jan 11. [ePub ahead of print]
32
Absence of Indirect Effects of Tdap Mean incidence of reported pertussis among infants
1990-2003(pre-peak)
2006-2009(post-peak)
p-value
Mean incidence
(per 100,000)52.1 55.4 0.64
Skoff et al. Arch Pediatr Adolesc Med. 2012 Jan 11. [ePub ahead of print]
33
34
EMERGENCE OF DISEASE AMONG CHILDREN AGED 7 – 10 YEARS
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
0
5
10
15
20
25
Proportion of all Pertussis Cases contributed by Children Aged 7–10 years
Year
Perc
ent
35
36
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 180
200400600800
10001200140016001800
2004
Age (years)
Case
s
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 180
200
400
600
800
1000
1200
1400
1600
2005
Age (years)
Case
s
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 180
50100150200250300350400450
2002
Age (years)
Case
s
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 180
100200300400500600700800
2003
Age (years)
Case
s
Pertussis Cases by Age – 2002-2005
37
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 180
200
400
600
800
1000
1200
2008
Age (years)
Case
s
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 180
200
400
600
800
1000
1200
1400
1600
2009
Age (years)
Case
s
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 180
100200300400500600700800
2006
Age (years)
Case
s
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 180
50100150200250300350400450
2007
Age (years)
Case
s
Pertussis Cases by Age – 2006-2009
38
EVALUATION OF DTaP VACCINE EFFECTIVENESS (VE) AND DURATION OF PROTECTION
39
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
40
Pertussis Disease among Unvaccinated compared to Vaccinated Children
PertussisVaccination Status Case Control OR (95% CI) *Unvaccinated 53 19 8.9 (4.9 – 16.1)5 DTaP doses 629 1,997
* Accounting for clustering by county and provider
41
Overall VE & Duration of Protection Estimates
* Accounting for clustering by county and provider
Model * Case (n)
Control (n)
VE, % 95% CI
Overall VE, All Ages 0 dose 53 19 Ref -- 5 doses 629 1,997 88.7 79.4 – 93.8
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 aP vaccines i.e. a problem of susceptibility despite vaccination
44
2012 U.S. PERTUSSIS ACTIVITY
1922
1930
1940
1950
1960
1970
1980
1990
2000
2012*
0
50,000
100,000
150,000
200,000
250,000
300,000
Year
Num
ber o
f cas
es
* 2012 NNDSS data are provisional and reflect cases reported to NNDSS as of Week 37
Reported NNDSS pertussis cases: 1922-2012*
DTP
1990
1995
2000
2005
2012*
05,000
10,00015,00020,00025,00030,00035,000
Tdap
DTaP
SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System and 1922-1949, passive reports to the Public Health Service 4
5
Changes in Pertussis Reporting by State from 2011 to 2012* †
*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.
35National Incidence without WashingtonNational Incidence
Age (years)
Case
s/10
0,00
0
Acellular Only
3 DTaPs
5th DTaP Tdap
Vaccine Type Re-ceived*
4th DTaP
Transition Period
Whole Cell and Acellular
47
48
PREVENTION AND CONTROL GUIDELINES
49
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
50
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
51
PERTUSSIS SURVEILLANCE—CONNECTICUT, 2006–2012
52
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
Jan Feb MarchApril May June July Aug Sept Oct Nov Dec0
20
40
60
80
100
120
140
2006200720082009201020112012*
Month
Num
ber o
f Cas
es
53
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
Jan Feb March April May June July Aug Sept Oct Nov Dec*0
10
20
30
40
50
60
70
80
2006200720082009201020112012*
Month
Num
ber o
f Cas
es
54
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
Jan Feb March April May June July Aug Sept Oct Nov Dec0
10
20
30
40
50
60
2006200720082009201020112012*
Month
Num
ber o
f Cas
es
55
Percent of Cases by Confirmation Type—Connecticut, 2006–2012
* Through 9/1/2012
2006 2007 2008 2009 2010 2011 20120%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
CulturePCREpi linkProbable (no test)
Year
Perc
ent
of C
ases
58%
10%
Pertussis Incidence by Age Group — Connecticut, 2006–2011
<1 1–6 7–10 11–19 >190
5
10
15
20
25
30
3529.7
2.8
7.75.2
1
Age Group
Incid
ence
per
100
,000
Pop
ulati
on
56
57
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
58
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
59
VACCINATION STRATEGIES TO PROTECT INFANTS
60
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
61
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
CONNECTICUT ACTIVITIES TO COMBAT PERTUSSIS
62
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
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
70
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