2011 NORTH CAROLINA IMMUNIZATION CONFERENCE “MAKING A BETTER TOMORROW” 2011 NORTH CAROLINA...

2011 NORTH CAROLINA IMMUNIZATION CONFERENCE2011 NORTH CAROLINA IMMUNIZATION CONFERENCE“MAKING A BETTER TOMORROW”“MAKING A BETTER TOMORROW”

August 12, 2011Greensboro, NC

Cocooning Our Infants

Enhancing Tdap and Flu Vaccinations Among Parents and Contacts of Newborns

COI - Disclaimers

Sponsor Grant support Speaker Advisory Board

GSK √

Medimmune √

Merck* √ √

Novartis* √ √

sanofi pasteur* √ √

Pfizer* √

Definition of Cocoon

• 1 a : an envelope often largely of silk which an insect larva forms about itself and in which it passes the pupa stage

• 1 b : any of various other protective coverings produced by animals

• 2 a : something suggesting a cocoon especially in

providing protection or in producing isolation

http://www.merriam-webster.com/dictionary/cocoon. Accessed July 26, 2011

Cocooning Immunization Strategy

• Aims to protect newborn infants from becoming infected by vaccinating those in closest contact with them. Vaccination protects those who are immunized from getting infection and subsequently passing it on to the young infant– Household Contacts

• Parents• Siblings• Grandparents

– Child Care Contacts– Health Care Contacts

Cocooning

• Potential advantages

– New mothers are easy to access

– High motivation to protect newborns and infants

– Less expensive than universal strategies

– Targets high risk groups

• Potential disadvantages

– Difficulty accessing fathers and other close contacts

– Diffusion of responsibility for vaccination

– Tracking vaccination information

Cocooning: Pertussis and Flu

• Common Themes– Respiratory Pathogens– Readily Spread – Young Children Vulnerable to Infection– High Morbidity In Young Children– Universal Vaccination Strategy Not Fully

Implemented

Pertussis Disease Manifestations

• Incubation period - 7-10 days (range 4 – 21 days)

• Stages Catarrhal: runny nose,

sneezing, low-grade fever, mild cough (1-2 weeks)

Paroxysmal: severe spasms of cough, thick mucus, whoops, cyanosis, vomiting, exhaustion (1-6 weeks)

Convalescent: gradual recovery with less frequent & less severe coughing (weeks to months)

Photograph courtesy of the WHO

Cocooning Rationale: Pertussis

• Recent increases in pertussis incidence• Infants have the highest ages-specific incidence,

hospitalization rates, and mortality• Unvaccinated and under-vaccinated newborns and infants

are most vulnerable • Most young children acquire infection from a parent or

family member

Reported pertussis-related deaths by age-groups, U.S., 1980-2009

Age Group 1980-19891 1990-19991 2000-20092

0-1 month 38 68 152

2-3 month 11 16 23

4-5 month 5 5 2

6-11 month 7 4 1

1-4 years 13 2 2

5-10 years 1 6 3

11-18 years 0 0 3

>18 years 1 2 8

Total 77* 103 194

http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb11/02-2-pertus-surveil.pdf. Accessed July 26, 20111. VitekCR et al. PediatrInfect DisJ 2003; 22(7):628-34. 2 National Notifiable Diseases Surveillance System, CDC, 2009* One case unknown age

Source of Infant Pertussis

Study Location 4 US

States1

International

Hospitals2

International PICU3

Netherlands

Population Based4

Study Years 1999-2002 2003-2004 2001-2004 2006-2008

N 616 95 99 201

Source Identified 43 % 48 % 27 % 60%

Mother 32 %

55%

50 % 38%

Father 15 % 10 % 17%

Sibling 20 % 16 % 17 % 41%

Other 24 % 26 % 23 % 4%

Care Provider 2 % 2 % - -

1. Bisgard et al. Pediatr Infect Dis J. 2004;23:985-989; 2 2004;23:985-989; 2 Wendelboe et al. Pediatr Infect Dis J. 2007;26:293-299; 2007;26:293-299; 3. Kowalzik et al. Pediatr Infect Dis J. 2007;26:238-242 4. de Greff SC. 2007;26:238-242 4. de Greff SC. Clinical Infectious Diseases 2010;50:1339-1345.Clinical Infectious Diseases 2010;50:1339-1345.

Tdap Vaccines

• Adacel (sanofi pasteur)– Approved for persons 11-64 years of age

• Boostrix (GlaxoSmithKline)– Approved for persons 10 years of age and older

• 2006 – Adolescents aged 11-18 years should receive a

single dose of Tdap instead of Td

– Adolescents 11-18 years who received Td, but not Tdap, are encouraged to receive a single dose of Tdap

• Encouraged 5 year interval• Permissive of interval < 5 years

– Adults aged 19-64 years should receive a single dose of Tdap to replace Td if they received their last dose of Td > 10 years earlier and have not previously received Tdap

• Permissive of interval < 10 years

ACIP Tdap Recommendations

MMWR 2006:55(No.RR0-3):1-34, MMWR 2006 55(No. RR-17): 1-44

ACIP Tdap Cocooning Recommendations

• 2006– Adults who expect to have close contact with an infant

aged <12 months (parents , grandparents<65 years, child-care providers, and health care personnel) should receive Tdap

• Permissive of interval as short at 2 years from last Td; shorter intervals can be used

• Women should receive Tdap before becoming pregnant

• Women who have not previously received Tdap should receive a dose of Tdap in the immediate post-partum period

, MMWR 2006 55(No. RR-17): 1-44

ACIP Tdap Cocooning Recommendations

• 2008

–Pregnant women not vaccinated previously with Tdap should be receive Tdap in the immediate postpartum period before discharge from hospital or birthing center

• Permissive of interval as short as 2 years since most recent Td

• If Tdap cannot be administered at or before discharge, the dose should be administered as soon as feasible thereafter.

MMWR 2008:57(No.RR-4):1-51

National Tdap Coverage

http://www.cdc.gov/vaccines/stats-surv/nisteen/figures/09-maps/09-1-tdap.pdf Accessed on 7/28/2011

National Tdap Coverage

TABLE 2. Self-reported tetanus, diphtheria, and acellular pertussis (Tdap) vaccination coverage among adults aged 18--64 years, by selected characteristics --- National Health Interview Survey, United States, 2009

Characteristic No. in sample*† % Tdap coverage§ % Increase08 to 09 % (95% CI)

Total 15,722 100.0 6.6 (6.1-7.2) 0.9

Household infant contact

676 4.3 10.2 (7.7-19.6) 5.2

Health-care personnel

1,168 7.4 17.0 (14.6-19.6) 1.1

http://www.cdc.gov/vaccines/stats-surv/nhis/2009-nhis.htm#08. Accessed July 31, 2011

TIP Study - Tdap Immunization for Parents

• Specific Aims Determine Tdap coverage rates among new mothers and

fathers offered Tdap in pediatric clinic setting (TIP 1) Determine Tdap coverage rates among new mothers

offered Tdap in the postpartum setting (TIP 2) Examine potential determinants of Tdap vaccination

coverage and reasons for vaccine refusal

• Primary Outcome – Tdap coverage

Walter, CDC:3U01-IP000074-02S1

TIP 1 - Methods

• Pediatric providers/nurses introduced Tdap study to parents of 100 consecutive newborns– Location - DCPC Pickett Rd. Clinic – June 11, 2007 – Nov. 5, 2007

• Tdap provided free of charge• Study coordinator

– Reviewed clinic schedules to determine potential study subjects– Reviewed Tdap indications and contraindications with potential subjects– Obtained written informed consent

• Tdap • Survey about reasons for vaccine refusal

– Reviewed medical records to obtain demographic information• Race, ethnicity, insurance status, number of siblings, mother’s age

• Clinic nurse– Administered Tdap vaccine

TIP 1 – Methods (Tdap Exclusions)

• Prior receipt of Tdap• Receipt of Td in previous two years• History of a bleeding disorder• History of Guillain-Barré Syndrome• Ongoing neurologic disorder• Fever in the preceding 24 hours• Any of the following reactions to a diphtheria, tetanus, or

pertussis containing vaccine:– A life threatening allergic reaction– Severe local limb pain or swelling following– A prolonged seizure or coma within 7 days

TIP 1 – Results (Cocooning: Postnatal PeriodPediatric Office – Tdap Vaccine)

.

New Mothers (n=101)

New Fathers(n=99)

Both(n=200)

Tdap Eligibility / Exclusions

Td < 2 years 19 (18.9) 13 (13.1) 32 (16.0)

Tdap previously 2 (2.0) 3 (3.0) 5 (2.5)

Medical precaution 3 (3.0) 0 (0.0) 3 (1.5)

Total Tdap Exclusions 24 (23.8) 16 (16.2) 40 (20.0)

Tdap Eligible 77 (76.2) 83 (83.8) 160 (80.0)

Tdap Coverage if eligible

At first visit 25 (32.5) 23 (27.7) 48 (30.0)

At subsequent visit 20 (26.0) 14 (16.9) 34 (21.2)

Total 45 (58.5) 37 (44.6) 82 (51.2)

Table 1: Tdap Exclusions and Tdap Coverage Among New Parents

Walter EB et al. Acad Pediatr. 2009;9:344-347

TIP 1 – Results: Tdap Coverage ifBoth Parents Eligible n =70

Both parents received vaccine 27 (38.6%)

Neither parent received vaccine 29 (41.4%)

One parent received vaccine 14 (20.0%)

TIP 1 Results: Factors Associated With Higher Tdap Coverage Rates

• For vaccine eligible fathers– Tdap coverage was higher if father present at the

first visit (61.0% vs. 4.2%)– Tdap coverage was higher if newborn was

privately insured versus having Medicaid (52.9% vs. 7.1%)

TIP 1- Results: Reasons for Tdap Refusal n=7

* Concern about Tdap while breast feeding

REASON N

Side effects and safety concerns* 3

Fear of Needles 2

Belief that vaccine is not going to help 2

Not feeling well after C-section delivery 1

TIP 2 - Methods

• Study population: Mothers of newborns • Study location: Durham Regional Hospital, Durham, NC • Study dates: January – April 2009• Intervention: Standing computerized order for staff nurses to offer and administer Tdap to new mothers• Study procedures:

– Mother introduced to study coordinator by nurse– Written informed consent obtained– Brief interview conducted by study coordinator (demographic

information and reasons for refusal of Tdap vaccination) – Verification of Tdap vaccination using computerized medication records and pharmacy charges

TIP 2 - Results

• 615 mothers (622 babies)

• 140 (22.8%) received Tdap

• 348 approached to interview

• 200 (57%) interviewed

• 200 mothers interviewed• 154 (77%) Tdap eligible • 90 (45%) offered Tdap• 69 (34%) eligible and

offered Tdap• 52 (26%) received Tdap• 25 (12%) awareness of

Tdap prior to delivery• 3 (2%) father received

Tdap

TIP 2 - Results

7.0%

13.5%

2.5%

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

14.0%

16.0%

Prior Tdap Vaccination

Td in the past two years

Medical Precaution

Pe

rce

nta

ge o

f W

om

en

Reasons Women Ineligible for Tdap

TIP 2: Cocooning: Immediate Postpartum PeriodBirthing Hospital – Tdap Vaccine

.

TIP 2 - Results

Hospital Based Cocooning Studies for Tdap

Years Location Population N Coverage Publication

2007 New York NICU Parents 598 86.9% of 495 screened

Dylag AM. Pediatrics 2008;122:e550-e555

2008-10 Houston General Postpartum

(Largely Hispanic)

11,174 75%

(86% after removing 2

year requirement and 6% had prior Tdap

Healy AM. Clinical Infectious Diseases 2011;52:157-162.

Cocooning Effectiveness (Tdap)

• Mixed results– One ecological study found no impact of only

maternal postpartum Tdap on infant disease– In a California study, pertussis incidence in

infants born at hospitals with a postpartum Tdap policy was lower compared to hospitals without a postpartum Tdap policy suggesting that vaccination new mothers may reduce transmission of pertussis from mothers to infants

http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-jun11/05-5-pertuss-cocooning.pdf1. CastagniniL, et al. Impact of maternal post-partum Tdap vaccination on pertussis illness in young infants. IDSA , Vancouver Canada. Presented on October 23, 2010 2. Winter K, et al. Effectiveness of postpartum Tdap vaccination in California hospitals. CSTE, Portland Oregon. Presented June 2010.

Pertussis Outbreak – California 2010

• 9,120 cases in 2010 (23.3 cases/100,000)– Most cases since 1947 (9,394)– Highest incidence since 1958 (26.0/100,000)

• 804 hospitalizations – 72% were less than 6 months of age

• 76% of hospitalized infants with known race were Hispanic

• 10 deaths– 9 were Hispanic infants– 9 were < 2 months of age and had not received any

vaccine

http://www.cdph.ca.gov/programs/immunize/Documents/PertussisReport2011-07-12.pdf, Accessed July 26, 2011

ACIP - Expanded Tdap Recommendations

• Can be administered regardless of interval since last tetanus- or diphtheria- toxoid containing vaccine

• Adults age 65 years and Older– Particularly those with close contact to infant < 12 mo.

• Children Aged 7 through 10 years– Those not fully vaccinated against pertussis

– Those never vaccinated against tetanus, diphtheria, or pertussis or who have unknown vaccination status should receive a series of 3 vaccinations containing tetanus and diphtheria toxoids and the first of these should be Tdap

MMWR / Jan 14, 2011 / Vol.60 / No.1 /p13-15

2011 ACIP Tdap Recommendations: Rationale• Suboptimal results have been obtained through providing

Tdap postpartum• Tdap administered during pregnancy will provide

protection to the mother and indirectly to the infant through transplacental passage of antibody

• Pregnancy is not a contraindication for receiving Tdap– Any potential risks from receiving Tdap during pregnancy are

likely to be small

• Tdap during pregnancy would reduce infant cases (hospitalizations and deaths) making it more cost-effective

• May interfere with infant’s immune response DTaP

2011 ACIP Tdap Recommendations

• Women’s health care providers should implement a maternal Tdap vaccination program for women who have not previously received Tdap. Health care providers should administer Tdap preferably during the third or late second trimester (after 20 weeks gestation). Alternatively, administer Tdap immediately postpartum.

• Adolescents and adults who have or anticipate having close contact with an infant aged less than 12 months (e.g., parents, siblings, grandparents, child-care providers and healthcare providers) should receive a single dose of Tdap to protect against pertussis if they have not previously received Tdap. Ideally, these adolescents and adults should receive Tdap at least 2 weeks before beginning close contact with the infant.

http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-jun11/05-6-pertuss-tdap-vac.pdf

Influenza: Clinical Manifestations

• Abrupt onset of fever, chills or rigors, headache, malaise, diffuse myalgia, and a non-productive cough

• Sore throat, nasal congestion, rhinitis, cough • Conjunctival injection, abdominal pain, nausea, and

vomiting• May appear as URI or as febrile illness with few

respiratory tract signs• Young infants – sepsis like picture, croup,

bronchiolitis or pneumonia• Myositis – presents as calf tenderness and refusal

to walk

Cocooning Rationale: Influenza

• Newborns and young children experience increased rates of hospitalizations and outpatient visits.

• Influenza vaccine is not approved for children younger than 6 months of age

• Methods for preventing infection in youngest children– Influenza vaccination of pregnant women– Vaccination of close contacts (cocooning)

• Maternal immunization is effective at preventing infection in young children

Influenza Hospitalizations

http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/flu.pdf

Bhat N. N Engl J Med 2005;353:2559-67.

Influenza-Associated Deaths AmongChildren in the US (2003-2004)

Poehling KA. N Engl J Med 2006;355:31-40

Source of Influenza Infection

• Children are vectors for spread of influenza in households and communities1

• Reduction in influenza related illness in households and communities after influenza immunization of children2-4

• Infection rates in young infants vary significantly by the number of older siblings in the family5

1. Fox JR et al. Am J Epidemiol 1982;116:212-272-4. Hurwitz et al. JAMA 2000;284:1677-1682 , Piedra et al. Vaccine 2005;23:1540-1548, King et al. N Engl J Med 2006;355:2523-32.5. Glezen WP et al. Pediatr Infect Dis J. 1997;16:1065-8.

Influenza immunization

– TIV • Approved for people 6 months of age and older • Clinical trials in children 2 mo. of age

– LAIV• Approved for children 2 years of age and older• Superior efficacy in children 6-59 mo.• Potential for more frequent adverse events in children

6-23 mo.– Medically significant wheezing within 42 days (5.9% vs.

3.8%)– Hospitalization for any cause within 180 days (4.2% vs.

3.2%)Belshe RB.et al. N Engl J Med 2007;356:685-96.

Englund J A. Vaccine 21 (2003): 3460-3464

Influenza – Role of Maternal Antibody

• Infants are protected from symptomatic influenza A infection by transplacentally- acquired antibody

• Transplacentally acquired antibody may interfere with immune response of the infant to TIV

Englund J A. Vaccine.2003; 21:3460-3464, Piedra PA. Vaccine .1993; 11: 718-724

Added Benefits of Influenza Vaccine During Pregnancy

Citation Location Years Study Design Flu Test

Result(First 6 mos of life )

Zaman K. NEJM.2008;359:1555-64

Bangladesh 2004 Prospective Randomized TrialFlu vs. 23-V Pneumo

Antigen Effectiveness at preventing lab confirmed flu 63% [5,85]

Benowitz I.CID 2010;51:1355-61

US – Urban Hospital

2000 - 2009

Case-Control DFA Effectiveness at preventing hospitalization due to lab confirmed flu 91.5% [61.7, 98.1]

Eick A.Arch Ped Adol Med 2011;165:104-111

US – Native American Populations

2002-2005

Prospective cohort enrolled at delivery

Viral Culture

RR for developing lab confirmed flu0.59 [0.37,0.93]RR for developing ILI hospitalization 0.61 [0.41,0.84]

Evolution of Influenza Vaccination RecommendationsYear High

RiskAge Pregnancy Cocooning

1990 √ > 65 yrs. HH contacts of HR

1996 √ > 65 yrs. Consider 3rd trimester

HH contacts of HR

1997 √ > 65 yrs. 2nd - 3rd trimester HH contacts of HR

2000 √ > 50 yrs. 2nd - 3rd trimester HH contacts of HR

2002 √ 6-23 mos. encouraged

2nd - 3rd trimester HH contacts < 2 yrs.*

2004 √ 6-23 months 1st - 3rd trimester HH contacts < 2 yrs.*

2006 √ 6-59 months 1st - 3rd trimester HH contacts < 5 yrs.*

2008 √ 6 mos. – 18 years 1st - 3rd trimester HH contacts < 5 yrs.*

2010 Universal (> 6mos) HH contacts < 5 yrs.*

*Emphasis on children < 6 months of age

Flu Vaccine Coverage in Pregnancy

• Suboptimal rates of vaccine coverage during pregnancy

Year Coverage Data Source

2006-2007 13.4% NHIS

2007-2008 24.2% NHIS

2008-2009 11.3% NHIS

2009 -2010 50.7% PRAMS

2009 H1N1 46.6% PRAMS

http://www.cdc.gov/flu/professionals/acip/coveragelevels.htm Accessed July 31, 2011http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5947a1.htm. Accessed July 31, 2011

Flu Vaccine Coverage in Health Care Workers

• Suboptimal rates of vaccine coverage for HCW

Year Coverage Data Source

2006-2007 44.4% NHIS

2007-2008 49.0% NHIS

2008-2009 NA NHIS

2009 -2010 61.9% Rand Survey

2009 H1N1 37.1% Rand Survey

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5912a1.htm. Accessed July 31 2011http://www.cdc.gov/flu/professionals/acip/coveragelevels.htm Accessed July 31, 2011

Piiitch Study - Prevention of Influenza in Infants by Immunization of Their Contacts in the Household

• OBJECTIVE - To develop and assess a hospital-based program for administering influenza vaccine to newborn household contacts during the immediate postpartum period (October 2007 - February 2008) Assess influenza vaccine coverage among household contacts

of newborns delivered at a hospital with postpartum influenza immunization program

Simultaneously assess influenza vaccine coverage among household contacts of newborns delivered at a hospital without a postpartum influenza immunization program

Walter, CDC:5U01IP00074-02ClinicalTrials.gov:NCT00570037

Durham County, NC

No Immunization Program

Duke University Hospital

Immunization Program

Durham Regional Hospital

Piiitch - SettingPiiitch - Setting

Piiitch - Vaccination Program

• Educational sessions with administrative, medical staff and nursing staff

• Standing orders to administer influenza vaccine To postpartum women by nursing staff To household contacts by part time study nurse

• Educational packets distributed to new mothers by nursing staff Letter introducing the study and immunization

program Coupons for a free influenza vaccine for

household contacts Vaccine information statement for TIV

Piiitch - Vaccination Program

• Mailed vaccine reminders within 4 weeks after delivery

• Promotional materials

Buttons Posters

Piiitch - Vaccine Clinic for Household Contacts

Piiitch - Interviews

• Face-to-face post-partum interview Random selection on day of discharge (M – F) Informed consent Exclusion criteria - fetal demise or stillbirth,

parental rights relinquished, language barrier Demographics, contact information, prenatal

care and delivery history, vaccination status, maternal high-risk conditions, household contact information (age, relationship, vaccination status)

• Follow-up telephone interview (6 to 8 weeks) Vaccination status for household contacts

Cocooning: Immediate Postpartum PeriodBirthing Hospital – Influenza Vaccine

Walter et al. Infection Control and Hospital Epidemiology, 31, 00.1070-73.

Cocooning Studies for Flu vaccine

Years Location Population N Coverage Publication

2005-06 New York NICU Parents 220 95% Shah SI. Pediatrics 2007;120:e617-e621

2008-09 Ohio Parents in hospital-based

pediatric practice

292 85.6% White PC. Clinical Pediatrics 2010;49:1123-

1128.

Cocooning: Whose Job Is It?

• Excellent vaccine coverage can potentially be achieved in the birthing center.

• The immediate postpartum period may not be the optimal time. – New mothers should receive flu vaccine and Tdap during pregnancy. – New fathers should receive Tdap and flu vaccines prior to the birth of

the baby to allow time for development of immune responses.

• In addition to hospitals, office-based practitioners (OB/GYNs, pediatricians, and family practitioners) need to take a more active role administering Tdap and flu vaccines to new parents and close contacts of infants.

Immunizing the Pediatric ParentMaking it Happen?

• Identify an office champion

• Earn staff buy-in

• Sell the idea of vaccinating parents to the parents

• Use best practice immunization tracking tools (EMR/registries)– Screening form (Medical and insurance screening / patient consent / vaccine

administration information)

– VIS

• Payment (cash, credit card, insurance)

• Rider from malpractice carrier

• Monitor vaccine inventory, vaccination costs, reimbursements, immunization rates

Acknowledgements

• Duke Vaccine Unit Investigators– Dennis Clements MD, PhD, MPH– Coleen K Cunningham MD– Joseph St. Geme, MD– Rowena J. Dolor, MD, MHS– Christopher W. Woods, MD, MPH– Vance Fowler, MD, MHS– Kenneth E. Schmader, MD– Geeta K. Swamy, MD– Evan Myers, MD, MPH– Samuel L. Katz, MD

• Vaccine Unit Staff– Beth Patterson RN– Lynn Harrington RN– Lori Hendrickson RN– Kathy Chmielewski– Luis Ballon– Katie Lattimore– Katie Unverferth– Bethany Grim– Liz Hogan– April Feickert– Dee Dee Thompson

• Medical Students− Weiyi Tan− Brian Steiner

2011 NORTH CAROLINA IMMUNIZATION CONFERENCE “MAKING A BETTER TOMORROW” 2011 NORTH CAROLINA...

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