Implementation of Cocooning Against Pertussis in a High-Risk Population C. Mary Healy, Betsy H. Mayes, Marcia A. Rench Center for Vaccine Awareness and Research, Texas Children’s Hospital Ben Taub General Hospital Baylor College of Medicine, Houston, Texas C Mary Healy MD, 11/30/09. St. David's Medical Center

Disclosures Sanofi Pasteur donated vaccine for the Tdap Cocoon Program Dr Healy has served on an Advisory Board for Novartis Vaccines

Background The incidence of pertussis is up to 20-fold higher in infants too young to have completed the primary immunization series (≤ 6 months of age) Pertussis-related complications and deaths occur almost exclusively in young infants Infants of Hispanic ethnicity are over-represented in pertussis incidence (74% higher) and deaths (70% in 2007) Over 75% of pertussis-infected infants acquire the infection from a household contact, 33% from their mother

Background In 2006, ACIP recommended Tdap* booster immunization of infant caregivers or “cocooning”. Three groups are targeted: Postpartum women before hospital discharge Contacts of infants age < 1 yr Healthcare providers (HCPs) of infants age < 1 yr this group targeted by Occupational Health Programs Cocooning is challenging to implement New immunization platform Pertussis awareness Two populations – postpartum women, families New immunization providers Reimbursement issues * Tetanus, diphtheria, acellular pertussis

Objectives To raise pertussis awareness by educating HCPs and families of newborn infants about the potential for life-threatening pertussis in young infants The phased implementation of cocooning in a high risk, predominantly Hispanic, medically underserved and uninsured population in Houston, Texas Phase 1: postpartum immunization Phase 2: immunization of household contacts To identify potential barriers in implementing this targeted immunization strategy

Methods – Raising Awareness Healthcare Providers (HCP) educated by Grand Rounds and small group in-services Obstetricians, Family Practitioners Midwives and Nursing personnel Translators Posters and literature in antenatal and postnatal areas Pertussis information packets for families Information on other means to access low or no-cost vaccines Available to answer questions

Methods Phase 1: Starting January 2008, standing order for postpartum Tdap unless maternal contraindication is present* Tdap administered on hospital discharge concurrent with rubella vaccine (if needed) Maternal demographics recorded Reasons for Tdap refusal recorded if available * 2 year minimum interval since prior tetanus-containing vaccine observed Jan 2008-May 2009; no minimum interval required June 2009-Jan 2010

Methods Phase 2 Starting June 2009, contacts of newborn infants offered Tdap Where possible, postpartum women were interviewed to ascertain the number of additional contacts eligible and recommended to receive Tdap Pertussis education was provided Consenting eligible contacts were immunized Demographics of vaccinees and likely degree of infant contact was recorded

Results: Mothers since Jan 2008 150 HCPs completed pertussis in-service From Jan 7th, 2008 through Jan 31st, 2010, 8,138 of 11,174 (73%) postpartum women received Tdap prior to discharge* Maternal Age: Median: 27 yrs (11 – 47 yrs) Predominantly Hispanic Ethnicity (92%) Previously reported** 96.2% acceptance rate in women who believed themselves eligible 3-fold higher refusal rate in black women * 2 year minimum interval since prior tetanus-containing vaccine observed through May 2009 ** Vaccine 2009; 27:5599-602

Results: Mothers June 2009 - Jan 2010 2969 of 3455 (86%) mothers got Tdap This accounted for 91% of mothers eligible for Tdap 197 (6%) had received Tdap previously 172 (87%) from this program with a previous baby Maternal Age: Median: 27 yrs (11 – 47 yrs) Ethnicity Hispanic 91.4% White 0.8% Black 5.4% Asian 1.4% Other 1.0%

Results: Maternal Age  High Risk of Infant Infection Percentage of Mothers High Risk of Infant Infection “Adolescent Platform” Required for Entry to Middle School Eligible for Vaccines for Children 

Immunized with Tdap (past or present) Not Immunized (N=279) Age: Median (Range) 27 (14-46) 27 (11-47) Ethnicity * No. (%) Hispanic 2891 (91.3) 228 (81.7) White 27 (0.8) 7 (2.5) Black 167 (5.3) 31 (11) Asian 47 (1.5) 5 (1.8) Other 34 (1.1) 8 (2.8) * P<0.001 Non-medical reasons why Tdap not given included: previous local reactions to vaccines, intercurrent illnesses/underlying medical conditions religious objections

Results: Immunization of Other Infant Contacts 2303 of 3445 (67%) mothers interviewed Median Range Household contacts 4 1-15 External contacts 0 0-7 Contacts Eligible for Tdap * 3 1-11 Contacts given Tdap 2 0-10 1332 families (58%) had ≥ 1 contact immunized 1860 contacts immunized One adverse event unrelated to Tdap 55% did not know date of their last tetanus * Age 11- 64 yrs; no prior Tdap; no medical contraindication

Infant Contacts (N=1860) Timing of immunization Ethnicity 91% before or the day of infant discharge 8% day 1-7 post infant discharge 0.4% day 8-14 post infant discharge 0.6% day 15 or more post infant discharge Ethnicity Hispanic 94.5% Black 2.5% White 1.7% Asian 1.1% Other 0.2%

Contact Age  Median: 30 yrs Range: 11-64 Percentage Median: 30 yrs Range: 11-64 High Risk of Infant Infection “Adolescent Platform” Required for Middle School Entry Eligible for Vaccines for Children 

Contact Relationship to Infant 87% of contacts who were immunized resided in the infant’s household

Degree of Contact with Infant 2% 35% 63%

The Infant Cocoon (N=2303) Mean:58% Median:50% Percentage Mean:58% Median:50% Percentage of Individual Cocoon Completed

Effect of H1N1 Pandemic Pre Post P-value Visiting restrictions One designated visitor for mother/baby for duration of hospitalization Contacts admitted to floor for Tdap but may not visit Effect on Tdap uptake Pre Post P-value Mothers 89% 94% 0.002 Fathers 58% 49% <0.001 ≥ 1 contact 64% 53% <0.001 Complete Cocoon 28% 23% <0.001

Conclusions Postpartum immunization against pertussis was successfully implemented through a standing order protocol. Postpartum Tdap uptake increased 17% after eliminating the requirement for a 2 year interval from previous tetanus-containing vaccine Tdap immunization was well-accepted by this cohort of mothers and their families whose infants were at high risk of acquiring life-threatening pertussis for reasons of ethnicity and underinsured status The H1N1 pandemic negatively impacted the implementation of cocooning

Conclusions Barriers to the full implementation of cocooning include: need for convenient, out of hours service need for accurate, easily accessible immunization records need for targeted education Cocooning requires a multi-faceted, multi-disciplinary approach for successful implementation The necessary infrastructure and education requires investment of finances and time

Acknowledgements Sanofi Pasteur Center for Vaccine All HCPs who care for pregnant women and their newborn infants Center for Vaccine Awareness and Research Carol J. Baker, MD Julie A. Boom, MD Amy B. Middleman, MD Baylor College of Medicine Robin Schroeder Luis A. Castagnini, MD Ben Taub General Hospital Kenneth Mattox, MD Francis Kelly, RN Sara Ruppelt, PharmD Baylor Methodist Community Health Fund Harris County Hospital District Foundation Finally I’d like to acknowledge our associates and funding sources for this study. 22 22