Download Tdap (adolescent/adult) DTaP

Adult Tdap
Rationale and Recommended Use
Katrina Kretsinger M.D., M.A.
Lieutenant Commander, U.S. Public Health Service
National Center for Immunization and Respiratory
Diseases, CDC
National Immunization Conference
March 8, 2007
Pertussis and Adults
Pertussis (whooping cough) – a poorly
controlled vaccine-preventable disease
Incidence increasing
In 2005, 25,616 US cases reported (40 year high)
Adults vulnerable to pertussis
27% reported cases among adults
Pertussis immunity wanes 5 to 10 years after
childhood DTaP* series
First pertussis vaccines (Tdap)† for adolescents
and adults licensed in 2005
*Diphtheria and tetanus toxoids and acellular pertussis vaccine
†Tetanus
toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
Presentation Outline:
Tdap for Adults
Epidemiology and clinical characteristics of
adult pertussis
Tdap product information
Immunogenicity and Efficacy
Safety
Recommendations for adult Tdap use
Burden of Adult Pertussis
Underreported among adults
Often considered a childhood disease and not
recognized by clinicians
Difficult to diagnose
Significant burden of illness
Almost 8,000 cases of adult pertussis reported
in 2005 in United States
Estimate of true disease ~ 600,000 cases /
year among adults aged 19-64 years
Pertussis is costly
Societal cost / adult pertussis case ~$773
Outbreaks burden public health system
(controlled by contact tracing and prophylactic
antimicrobials)
Reported Pertussis Cases –
United States, 1922-2005*
30,000
300,000
25,000
> 18 yrs
20,000
Number of cases
250,000
15,000
DTP
200,000
11-18 yrs
10,000
5,000
< 11 yrs
0
1990
150,000
1995
2000
100,000
DTaP Tdap
50,000
0
1922 1930
1940
1950
1960
1970
1980
1990
2000
Year
*1950-2005, National Notifiable Diseases Surveillance System and 1922-1949,
passive reports to the Public Health Service, courtesy of Kristin Brown
Clinical Pertussis
Upper respiratory illness x 1-2 weeks,
followed by cough illness
Median duration of cough illness >2 months
Antimicrobials do not modify the course of
illness after cough established
Will decrease infectivity of patients if given early
Can result in repeated medical visits and
time lost from work
High risk groups for pertussis not well
defined
Selected Clinical Characteristics and
Complications Among Adults >19 years with
Reported Pertussis
Characteristic
Paroxysmal cough
Cough duration >9 weeks
Difficulty breathing
Post-tussive vomiting
Whoop
Weight Loss
Pneumonia (CXR confirmed)
Rib Fracture
Hospitalization
Frequency (% reported) *
N=1,139
84-86
55
86
45-54
37-41
33
2-5
4
3
*Sources: Lee GM et al. Clin Infect Dis 2004;39:1572-80; National Notifiable Diseases
Surveillance System and Supplemental Reported Pertussis Surveillance System, 19962004.
Pertussis Transmission to Infants
Infants <12 months of age greatest risk for
death and complications from pertussis
From 2000-2004
Accounted for 92 / 100 U.S. pertussis deaths
Risk of death highest among youngest infants
Over 60% infants with pertussis hospitalized
Adults transmit to infants*
Among 264 known source-cases
55% identified as mother, father or grandparent
51% were adults >19 years of age
* Bisgard KM, Pascual FB, Ehresmann KR, Miller CA, Cianfrini C, Jennings CE et al. Infant pertussis: who was the
source? Pediatr Infect Dis J 2004; 23(11):985-989.
Pertussis in Health-Care Settings
Health-care personnel (HCP) at increased
risk of pertussis exposure and infection
HCP can transmit to vulnerable patients,
including infants
Pertussis outbreaks reported in pediatric
and adult inpatient wards, maternity units
and obstetric units
Infection control activities are resourceintensive, disruptive and costly
Tetanus Toxoid, Reduced Diphtheria
Toxoid and Acellular Pertussis Vaccines
(Tdap)
First U.S. pertussis vaccines for adolescents
and adults licensed in 2005
Vaccines combined with tetanus, diphtheria
No pertussis-only vaccines licensed
Licensed for single use only (not for
sequential use as booster)
Two Tdap vaccines
Only one (ADACEL®) licensed for adults
None licensed for adults >65 years
Tdap Products Licensed in the United
States
BOOSTRIX®
ADACEL®
(GlaxoSmithKline (sanofi pasteur)†
Biologicals)*
Date of FDA
licensure
Age Indication
(years)
Usage
May 3, 2005
June 10, 2005
10–18
11–64
Active booster immunization for
prevention of tetanus, diphtheria, and
pertussis as a single dose
*Product label available at http://us.gsk.com/products/assets/us_boostrix.pdf
†Product
label available at http://www.vaccineplace.com/products/
Composition of Tdap Vaccine
Pertussis Antigen and Diphtheria & Tetanus
Toxoid Content
sanofi pasteur
DAPTACEL®
(DTaP)
Tripedia®
(DTaP)
DECAVAC®
(Td)
ADACEL®
(Tdap)
ug/dose
Pertussis toxin (PT)
10
23.4
---
2.5
Filamentous haemagglutinin (FHA)
5
23.4
---
5
Pertactin (PRN)
3
---
---
3
Fimbriae 2&3 (FIM)
5
---
---
5
Lf/dose
Tetanus toxoid
5
5
5
5
Diphtheria toxoid
15
6.7
2
2
Tdap Immunogenicity for Pertussis
No accepted serologic correlate of protection
Efficacy for licensure inferred from immunogenicity
data
Serologic bridge
Immune responses in adults after 1 dose
ADACEL® not inferior to immune responses in
infants after 3 doses DAPTACEL® during
pertussis efficacy trials*
Adult booster responses after Tdap acceptable
*Vaccine efficacy 3 doses DAPTACEL® against pertussis, defined as ≥3 weeks paroxysmal
cough with lab evidence (culture and/or serologic testing results) of pertussis or
epidemiologic link to culture-confirmed household contact 85% (95% CI: 80%, 89%)
(Gustafsson LH et al. NEJM 1996;334:349-355)
Tdap Immunogenicity for
Tetanus and Diphtheria*
Efficacy inferred from immungenicity data for licensure
Accepted serologic correlate of protection (≥0.1 IU/ml)
Adult immune responses after Tdap not inferior to Td
(standard of care)
Seroprotective rate
Tetanus: 100%
Diphtheria: 94%
Booster responses acceptable
*Product label available at http://www.vaccineplace.com/products/
Clinical Efficacy of Adult Acellular
Pertussis Vaccine: US Adult Pertussis
Trial (APERT)*
Persons Aged
15 to 64 years
(N=2781)
Acellular Pertussis
Vaccine† N=1391
Hepatitis A Vaccine
(control) N=1390
Pertussis Case‡
N=1
Pertussis Cases‡
N=9
Vaccine efficacy: 92%
(95% CI 32-99%)
*Ward et al. NEJM 2005; 353(15):1555-63.
†Three
component acellular pertussis vaccine (PT, FHA, PRN) without tetanus and diphtheria
toxoids (manufactured by GlaxoSmithKline biologicals; same pertussis components used in
BOOSTRIX® )
‡Pertussis defined as a cough illness lasting ≥ 5 days with laboratory evidence of pertussis
by culture, PCR, and/or serologic testing results
ADACEL® Safety
Rates of Selected Solicited Adverse Events
In Adults Aged 18─64 Within 15 Days After a
Single Dose of Tdap or Td
Percent of
subjects
100
Tdap (N=1698)
80
65.7
Td (N=561)
62.9
60
40
24.7
21.6
21
20
6.2
1.1
0
Pain, any
0.9
Pain, severe
Erythema,
any
17.3
5.8
4.8
Erythema,
>=3.5 cm
Swelling,
any
5.5
Swelling,
>=3.5 cm
Source: Product label available at http://www.vaccineplace.com/products/
1.4
1.1
Fever
>=100.4
Objectives of Adult Pertussis
Vaccination Policy
Primary objective - Protect vaccinated adult
against pertussis
Secondary objective - Reduce the reservoir of
pertussis in population
Decrease exposure of persons at increased risk
for complicated infection
Reduce the cost and disruption of pertussis in
health-care settings
Recommendations For Tdap Use
Advisory Committee on Immunization Practices (ACIP)
reviewed evidence for use of Tdap in 2005 and 2006
June 2005 – voted to recommend Tdap for routine
adolescent use
October 2005 – voted to recommend Tdap use for
routine adult vaccination and for adults in close
contact with infants
February 2006 – voted to recommend Tdap for healthcare personnel
June 2006 – voted on recommendations to guide use
of Td and Tdap among pregnant women
Routine Adult Tdap Use
Routine recommendations apply to adults
who
Are aged 19-64 years
Have not previously received a dose of Tdap
Licensed for single use only
After receipt of Tdap, subsequent doses of
boosters should be with Td according to
previously published guidance
ADACEL® only Tdap licensed for adults
Routine Adult Tdap Use
General Use
Adults should receive a single dose of Tdap
to replace a single dose of Td if they
received their last dose of Td >10 years
earlier.
If Tdap and another vaccine is indicated,
they should be administered during the
same visit (i.e., simultaneous vaccination).
Interval Between Td and Tdap
Intervals <10 years since the last Td may be used
to protect against pertussis. Particularly in
settings wih increased risk for pertussis, the
benefit of using a single dose of Tdap at an
interval <10 years to protect against pertussis
generally outweighs the risk for local and systemic
reactions after vaccination.
The safety of intervals as short as ~2 years is
supported by data from a Canadian study*;
shorter intervals may be used.
* Canadian study of ~7,000 children/adolescents. Halperin et al. Pediatr Infect
Dis J. 2006;25(3):195-200.
Routine Adult Tdap Use
Adults in Contact With Infants
Adults who have or who anticipate having close
contact with an infant aged <12 months should
receive a single dose of Tdap
An interval as short as 2 years from last Td suggested
Ideally at least 2 weeks before contact with the infant.
Infants should receive DTaP on schedule
When possible, women should receive Tdap before
conception.
Pregnant women should receive Tdap in the
immediate post-partum period.
Routine Adult Tdap Use
Health-care Personnel
Recommendations supported by HICPAC
Health-care personnel (HCP) in hospitals* or
ambulatory care settings who have direct
patient contact should receive Tdap as soon
as feasible at an interval as short as 2 years
from the last Td.
Priority to HCP in contact with infants
Hospitals and ambulatory care facilities
should provide Tdap for HCP and use
approaches that maximize vaccination rates.
*Hospitals, as defined by the Joint Commission on Accreditation of Healthcare Organizations, do not include
long term care facilities such as nursing homes, skilled nursing facilities, rehabilitation and convalescent
facilities. Ambulatory care settings include all outpatient and walk-in facilities.
Routine Adolescent Tdap Use
Adolescents aged 11–18 years should
receive Tdap instead of Td if they have not
received Td or Tdap. The preferred age for
Tdap vaccination is 11–12 years.
Adolescents aged 11–18 years who
received Td, but not Tdap, are encouraged to
receive a single dose of Tdap. A 5 year
interval between Td and Tdap is encouraged
to reduce risk for local and systemic
reactions
Selected Contraindications and
Precautions for Tdap and DTaP
Event
DTaP (infant/child)
Tdap (adolescent/adult)
Serious allergic reaction to
vaccine component
Contraindication
Contraindication
Encephalopathy within 7 days Contraindication
of DTP/DTaP
Contraindication
Neurologic conditions
Progressive
Unstable
Guillain-Barré syndrome ≤6
weeks after tetanus toxoidcontaining vaccine
Certain adverse events after
DTP/DTaP*
Contraindication
Precaution
Precaution (adolescent)
Precaution (adult)
Precaution
Precaution
None
*Temperature ≥105◦F (≥40.5◦C) within 48 hours after DTP/DTaP; collapse or shock-like state
(hypotonic hyporesponsive episode) within 48 hours; persistent crying
lasting ≥3 hours, within 48 hours; convulsions with or without fever, within 3 days
Selected Special Situations
Situation
Pertussis
outbreak
Recommendations for adolescents who
have not received Tdap
Tdap can be used at shorter intervals since
most recent Td
History of
Pertussis
Use Tdap
Wound
management
Tdap preferred to Td if tetanus prophylaxis
indicated; use standard algorithm
Incomplete
schedule
Use Tdap as one of the doses for catch-up;
use Td for other doses
Inadvertent Administration
of Tdap (BOOSTRIX®) or Pediatric DTaP
Source: www.vaccineshoppe.com
If BOOSTRIX® or pediatric DTaP is
administered to an adult aged >19 years,
this dose should count as the Tdap dose and
the patient should not receive an additional
dose of Tdap (ADACEL®).
Vaccination During Pregnancy
Provisional recommendations
Routine post-partum Tdap:
Pregnant women who have not received a dose of Tdap
(including breastfeeding) should receive Tdap after
delivery, before discharge from the hospital.
Tetanus, diphtheria and neonatal tetanus
protection:
Pregnant women for whom 10 years or more have
elapsed since last Td booster may defer Td and use Tdap
post-partum if tetanus protection is likely.
Td recommended if tetanus and diphtheria protection
required during pregnancy
Pregnancy not contraindication for Tdap
Adults Aged >65 Years
Tdap is not licensed for use among adults
aged >65 years.
The safety and immunogenicity of Tdap
among adults aged >65 years were not
studied during U.S. pre-licensure trials.
Adults >65 years of age should receive a
dose of Td every 10 years for protection
against tetanus and diphtheria, and as
indicated for wound management
Where to Find Tdap Recommendations
CDC. Preventing Tetanus, Diphtheria, and Pertussis Among
Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid
and Acellular Pertussis Vaccine: Recommendations of ACIP.
MMWR. 2006 (RR-3):55:1-43.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5503a1.htm
CDC. Preventing Tetanus, Diphtheria, and Pertussis Among
Adults: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and
Acellular Pertussis Vaccine: Recommendations of ACIP and
Recommendation of ADIP, supported bythe Heatlhcare Infection
Control Practices Advisory Committee (HICPAC), for Use of Tdap
among Health-Care Personnel. MMWR. 2006 (RR-17): 55:1-37.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5517a1.htm
CDC. Prevention of Tetanus, Diphtheria and Pertussis Among
Pregnant Women: Provisional ACIP Recommendations for the
Use of Tdap Vaccine.
http://www.cdc.gov/nip/recs/provisional_recs/tdap-preg.pdf
Acknowledgements
Karen Broder
Kristin Brown
Amanda Cohn
Margarete Cortese
John Iskander
Kashif Iqbal
Pat Joyce
Grace Lee
Nancy Rosenstein Messonnier
Christina Mijalski
Stacey Martin
John Moran
Trudy Murphy
Ismael Ortega-Sanchez
Manisha Patel
Larry Pickering
Pam Srivastava
Ben Schwartz
Barbara Slade
Tej Tiwari
Thank you
Backup Slides
Tetanus prophylaxis in routine wound
management
Clean, minor
wound
Tetanus doses
TIG
All other wounds*
Unknown or <3
Tdap
or Td†
Yes
No
Tdap
TIG
or Td†
Yes
Yes
≥3
No§
No
No¶
No
*Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture
wounds; avulsions; and wounds resulting from missiles, crushing, burns and frostbite.
† Tdap is preferred to Td for adults who have never received Tdap. Td is preferred to TT for adults
who received Tdap previously or when Tdap is not available. (If TT and TIG are both used, Tetanus
Toxoid Adsorbed rather than Tetanus Toxoid for Booster Use Only [fluid vaccine] should be used).
§Yes, if >10 years since the last tetanus toxoid-containing vaccine dose.
¶ Yes, if >5 years since the last tetanus toxoid-containing vaccine dose (see text for discussion of
Arthus reactions).