Title: Importance of Vaccination Among Dialysis Patients: Vaccine Recommendations for Patients Receiving Di
1Importance of Vaccination Among Dialysis
PatientsVaccine Recommendations for Patients
Receiving Dialysis
- Matthew J. Arduino, Dr.P.H.
- matthew.arduino_at_cdc.hhs.gov
- Division of Healthcare Quality Promotion
- National Center for Preparedness, Detection, and
Control of Infectious Diseases - Centers for Disease Control and Prevention
Hosted by Paul Webber paul_at_webbertraining.com www.
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2Overview
- Vaccine Preventable Diseases
- Vaccine Preventable Disease in Dialysis Patients
- Hepatitis B Virus
- Pneumococcal Disease
- Influenza
- Vaccine Recommendations as Part of an Overall
Infection Control Program - Vaccination of Healthcare Personnel
- Healthy People 2010 Goals
- The Safe and Timely Vaccine Coalition
3Vaccine Preventable Diseases
- Anthrax
- Chickenpox
- Hepatitis B
- HPV
- Influenza
- Meningococcus
- Pertussis
- Polio
- Rubella
- Smallpox
- Diphtheria
- Hepatitis A
- HiB
- Measles
- Mumps
- Pneumococcus
- Rabies
- Shingles (Zoster)
- Tetanus
- Yellow Fever
4Patients with CKD or ESRD
- Infections account for a large portion of
hospitalizations among patients on dialysis - Infection is the second leading cause of
mortality among patients with ESRD - Infections may contribute to cardiovascular
disease and mortality
5Immunity and Kidney Disease
- CKD and ESRD patients have decreased immune
responses - Uremia contributes to the impaired host response
6Host Defenses are Affected by the Uremic State
- Neutrophil function
- Neutrophils show decreased chemotaxis,
phagocytosis, and intracellular killing.
Ingestion and oxidative metabolism are decreased
markedly and are not improved by hemodialysis - Antigen processing
- Cell-mediated immune responses, T-cell, B-cell,
and monocyte function are impaired, resulting in
faulty presentation of antigens for immune
recognition - Antibody formation
- Alterations in the functional capacity of
lymphocytes result in impaired antibody responses.
7Disease Burden
8Change in Hospital Admissions Since 1993
period prevalent dialysis patients rates
adjusted for age, gender, race, primary
diagnosis. ESRD patients, 2004, used as reference
cohort. Vascular access hospitalizations are
pure inpatient vascular access events, as
described in Appendix A.
USRDS 2006 ADR
9Adjusted Admissions For Principal Diagnoses, By
Modality
period prevalent ESRD patients adjusted for age,
gender, race, primary diagnosis. ESRD patients,
2004, used as reference cohort.
USRDS 2006 ADR
10Hepatitis B Virus
11Risk Factors Associated with Reported Hepatitis
B, 1990-2000, United States
Other Surgery, dental surgery, acupuncture,
tattoo, other percutaneous injury
Source NNDSS/VHSP
12Incidence and Prevalence of Hepatitis B in the
United States, 1976-2002
CDC Infection Control Recommendations (1977)
Vaccine (1982)
13Sources for Bloodborne Virus infections in
Hemodialysis Patients
- External
- Transfusion from unscreened blood
- Non-dialysis related healthcare procedures
- Household/sex with infected contact
- Illegal injection drug use (more common in
western countries) - Internal
- Patient-equipment-patient (HBV HCV
contamination on devices, tubing, supplies,
surfaces) - Patient-equipment-staff-patient (HBV HCV
contaminated surfaces touched by staff transmit
with contaminated gloves or hands) - Patient-staff-patient ( direct contamination of
staff members hands/gloves with blood) - Contamination of multidose vials
14Incidence and Prevalence of HBV Infection Among
US Dialysis Centers, 2002
- Incidence and prevalence has remained stable over
the last decade - 27.3 of centers reported gt 1 patients with
chronic HBV infection - 2.8 of US dialysis facilities reported gt 1
patients with newly acquired HBV infection
15Resurgence of HBV Outbreaks in the mid 1990s
16Outbreaks of HBV in the Hemodialysis
- Simultaneous provision of care to both
HBV-infected and susceptible patients by the same
staff members - Failure to identify and segregate infected
patients from susceptible patients - Failure to vaccinate susceptible patients
- Sharing of supplies and equipment
- Cross-contamination of environmental surfaces,
supplies, or equipment - Multiple dose medication vials
17Preparation of Injectable Medications
- In 2002, 52.8 of centers reported that
medications from multi-dose vials were prepared
for patient administration in a dedicated
medication room or an area separate from the
treatment area - 24.6 reported that medications were prepared on
a medication cart or a medication area within the
treatment area, 3.7 at the dialysis station, and
18.9 in other areas - the incidence of HBV infection was significantly
higher among patients in centers where injectable
medications were prepared on a medication cart or
medication area located in the treatment area
18Patterns Of Hepatitis B Prevalence And
Seroconversion In Hemodialysis Units From Three
Continents The DOPPS
- Protocol for HBV-infected patients was protective
- Hepatitis B virus vaccine not routinely
administered at the unit (depending on the model
2-11 fold higher risk) - In 1977, the CDC in the United States issued a
set of recommendations to control of HBV in
hemodialysis units. The original recommendations
were effective and most are still in place
Burdick RA, et al. Kidney Int 200363(6)2222-9.
19Streptococcus pneumoniae
- Major clinical syndromes
- Pneumonia
- Bacteremia
- Meningitis
- Asymptomatic human carriers (nasopharynx) act as
a reservoir
20Pneumoccoal Pneumonia
- Pneumococcal infections kill more people in the
United States each year than any other
vaccine-preventable disease or the combined
disease burden of other vaccine preventable
diseases - Community-acquired pneumonia is associated with
significant morbidity and mortality and is the
most common cause of death from infectious
diseases in North America
21Pneumococcal Pneumonia
- 36 of adult community acquired cases of
pneumonia - 50 of hospital-acquired pneumonia
- Case fatality rate is 5-7 (higher in the
elderly) - Estimated 175,000 hospitalizations each year
22Burden of Disease
- Vascular access 20.8
- Infections below the knee 19.3
- Pneumonia 13
- Skin and soft tissue 9
Berman SJ. Johnson EW. Nakatsu C. Alkan M. Chen
R. LeDuc J. Burden of infection in patients with
end-stage renal disease requiring long-term
dialysis. Clin Infect Dis 2004 39174753
23Bacterial Pneumonia and Dialysis Patients
- Dialysis Patients have 14-16 times higher
pulmonary infectious (pneumonia) mortality rates
compared with the general population. - The relative risk for death at 6 months in
first-year dialysis patients who experienced an
episode of pneumonia was 5.1 - Relative risk for cardiovascular events in the
first 6 months also was greater at 3.02
Sarnak MJ, Jaber BL. Pulmonary infectious
mortality among patients with end-stage renal
disease. Chest 2001120(6)1883-7. Dinits-Pensy
M, Forrest GN, Cross AS, Hise MK. The use of
vaccines in adult patients with renal disease.
Am J Kidney Dis 2005 46(6) 997-1011
24Data from USRDS
- Hospitalization with pneumonia is common event
(experienced by 33 of dialysis patients by 5
years of follow-up). - A microbiologic diagnosis was not specified in
majority of cases - Older age and comorbid diseases were associated
with a gt risk of pneumonia - Renal transplantation was associated with lower
event rates. - Hospitalization with pneumonia was associated
with lower survival probabilities.
Slinin Y, Foley RN, Collins AJ. Kidney
International 2006 70 (6) 11351141.
25KaplanMeier Estimates of Pneumonia-Free Survival
Probabilities In Non-Waitlisted and Waitlisted
ESRD Patients
Slinin Y, Foley RN, Collins AJ. Kidney
International 2006 70 (6) 11351141.
26KaplanMeier Estimates of Survival Probabilities
After Pneumonia in Non-waitlisted and Waitlisted
ESRD Patients
Solid Line Non-waitlisted Dashed line Waitlisted
Slinin Y, Foley RN, Collins AJ. Kidney
International 2006 70 (6) 11351141.
27Pneumococcal Vaccination Rates
- Relatively low vaccination rates
- Vaccination rate among dialysis patients 13.5
28Influenza
- TEM micrograph of the 1918 influenza virus
29Seasonal Influenza, United States
- Influenza epidemics have been responsible for an
average of 36,000 deaths/year in the United
States between 1990 and 1999 - gt 200,000 people are hospitalized with influenza
complications - Seasonal influenza rates vary from 5-20 a year
- Recent studies indicate Influenza epidemics are
associated with a rise in autopsy-confirmed
coronary deaths
30Influenza Vaccination
- Influenza vaccination rates in the general
population have been increasing - Vaccination rates in the ESRD population have
remained well below the target of Healthy People
2010
31Vaccination is an important tool for preventing
many infectious diseases
32Available from http//www.cdc.gov/ncidod/dhqp/dp
ac_dialysis_pc.html
33Vaccination of Renal Dialysis Patients and
Patients with Chronic Renal Disease
34Vaccine Preventable Diseases and Chronic Renal
Disease
- Patients with Renal failure have an increased
risk of infection to a variety of pathogens - Primary pathogens include Staphylococcus
aureus, hepatitis B virus, Streptococcus
pneumoniae
35The Use of Vaccines in Patients with Kidney
Disease
- Hepatitis B Virus
- Pneumococcal (Streptococcus pneumoniae)
- Influenza
- Tetanus Toxoid (either alone or in combination
with Diphtheria) - Varicella
- Hepatitis A Virus (In patients with existing
liver disease)
Varicella vaccine is not recommended
post-transplant
36Routine Vaccinations in Children with Chronic
Renal Failure
- Children with CRF generally produce protective
serum antibodies to primary vaccinations with
killed or component vaccines and live virus
vaccines - Some children on dialysis and after transplant
may not respond optimally, requiring repeated
vaccination. - Proof of vaccine efficacy is absence of disease,
which can only be confirmed in large cohort
studies. - A few observational studies provide evidence that
vaccination has contributed significantly, at
least in the western hemisphere.
Neuhaus TJ. Immunization in children with
chronic renal failure a practical approach.
Pediatr Nephrol 200419(12)1334-9.
37National Surveillance of Dialysis Associated
Diseases, 1995-2002
Despite the high mortality and increased
cardiovascular event rates associated with
pneumonia, immunization rates with pneumococcal
vaccine remain low
38Hepatitis B Vaccine
- Hepatitis B vaccination is recommended for all
susceptible chronic hemodialysis patients - Vaccination is recommended for pre-ESRD patients
before they become dialysis dependent - Higher seroconversion rates and antibody titers
occur in uremic patients prior to becoming
dialysis dependent
39Hepatitis B Vaccine-General Population ( For
Staff members)
- Licensed in 1982 currently recombinant (in US)
- 3 dose series, typical schedule 0, 1-2, 4-6
months - no maximum time between doses (no need
to repeat missed doses or restart) - 2 dose series (adult dose) licensed by FDA for
11-15 year olds (Merck) - Protection 30-50 dose 1 75 - 2 96 - 3
lower in older, immunosuppressive illnesses
(e.g., HIV, chronic liver diseases, diabetes),
obese, smokers
40Immunogenicity HBV Vaccine
- Primary series produces a protective anti-HBs
response in 90-95 of adults with normal immune
status - Proportion of patients with ESRD who develop a
protective antibody response is lower - For those receiving a 3-dose schedule the median
is 64 (range 34-88) - For those receiving a 4-dose schedule the median
is 86 (range from 48-98)
41Immunogenicity and CKD/ESRD
- Studies indicate that it is better to begin
vaccinating patients before they become dialysis
dependent - Adults with serum creatinine levels lt 4 mg/dl
(mean 2 mg/dl) responded significantly (86)
better than patients with serum creatinine levels
gt 4 mg/dl (mean 9.5 mg/dl) (37).
Fraser GM, Ochana N, Fenyves D, et al.
Increasing serum creatinine and age reduce the
response to hepatitis B vaccine in renal failure
patients. J Hepatol 1994214504. Seaworth B,
Drucker J, Starling J, Drucker R, Stevens C,
Hamilton J. Hepatitis B vaccine in patients with
chronic renal failure before dialysis. J Infect
Dis 19881573327. Dukes CS, Street AC,
Starling JF, Hamilton JD. Hepatitis B vaccination
and booster in pre-dialysis patients a 4-year
analysis. Vaccine 199311122932.
42HBV Vaccine Effectiveness
- Limited data are available on the duration of
immune memory after hepatitis B vaccination in
dialysis patients - No clinically important HBV infections have been
documented among immunocompromised persons who
maintain protective levels of anti-HBs (gt10
mIU/mL). - Infections have occurred in individuals who have
not maintained their anti-HBs (gt10 mIU/mL)
43Doses and Schedules of Licensed HBV Vaccines for
Hemodialysis Patients
Dose recommended by FDA higher doses maybe more
immunogenic for hemodialysis patients
44New Immunogenic Vaccine?
- Single doses of HB-AS04 (Fendrix, GlaxoSmithKline
Biologicals) - Engerix administered at 0, 1, 2, and 6 months,
and followed-up for 36 months - Patients with creatinine clearance lt30 mL/min
- HB-AS04 vaccine elicited a more rapid onset of
protection than the currently licensed vaccine
for this particular population, with 74 versus
52 of subjects seroprotected at 3rd month - After the vaccination course, seroprotection
rates increased to 91 versus 84 in the HB-AS04
45Fendrix References
- Tong NK, et al. Immunogenicity and safety of an
adjuvanted hepatitis B vaccine in
pre-hemodialysis and hemodialysis patients.
Kidney Int 2005 68(5)2298-2303. - Nevens F, et al. Immunogenicity and safety of an
experimental adjuvanted hepatitis B candidate
vaccine in liver transplant patients. Liver
Transpl 200612(10)1489-95. - Boland G, e al. Safety and immunogenicity
profile of an experimental hepatitis B vaccine
adjuvanted with AS04. Vaccine 200423(3)316-20.
46Pneumococcal Vaccine
- Two Vaccines are available
- PPV23 (polyvalent containing 23 capsule
serotypes) - PPV7 (polyvalent, containing the 7 serotypes
responsible for pneumococcal disease in children)
47Children and PCV7
- All children 6 months through 23 months of age
should get PCV7 regardless of their health status
as part of the routine childhood immunization
schedule - For children aged 24-59 months with underlying
medical conditions ACIP recommends two doses of
PCV7, administered 2 months apart, followed by
one dose of PPV23 administered gt2 months after
the second dose of PCV7.
48PPV23 Use
- Persons with underlying medical conditions that
place them at risk (includes CKD and ESRD
patients) - for persons aged gt2 years who are at highest risk
- for those at risk for serious pneumococcal
infection and those who are likely to have a
rapid decline in pneumocococcal antibody levels,
a second dose of vaccine should be given at least
5 years after the initial dose. - Revaccination 3 years after the previous dose may
be considered for children at highest risk for
severe pneumococcal infection who would be aged
lt10 years at the time of revaccination.
49Pneumococcal Vaccine and CKD/ESRD
- Review of 26 published studies in this
population, all studies demonstrated a serologic
response by the majority of patients to at least
some pneumococcal serotypes. - Use of steroids did not alter this response.
- In the studies with a gt 6 month follow-up,
declining antibody titers were consistently
reported, and this decline was usually more rapid
than in healthy controls. - Incidence of serious adverse reactions to vaccine
is very low.
Robinson J. Efficacy of pneumococcal
immunization in patients with renal disease--what
is the data? Am J Nephrol 200424(4)402-9.
50Pneumococcal Vaccine Studies in Chronic Renal
Failure Patients
- Fuchshuber A, Kuhnemund O, Keuth B, Lutticken R,
Michalk D, Querfeld U. Pneumococcal vaccine in
children and young adults with chronic renal
disease. Nephrol Dial Transplant
199611(3)468-73. - Furth SL, Neu AM, Case B, Lederman HM, Steinhoff
M, Fivush B. Pneumococcal polysaccharide
vaccine in children with chronic renal disease a
prospective study of antibody response and
duration. J Pediatr 1996 Jan128(1)99-101. - Nikoskelainen J, Koskela M, Forsstrom J, Kasanen
A, Leinonen M. Persistence of antibodies to
pneumococcal vaccine in patients with chronic
renal failure. Kidney Int 1985 Oct28(4)672-7.
51Influenza Vaccine Response Among Dialysis Patients
- Efficacy of influenza vaccination in this
population has been a point of debate - Earlier studies showed an impaired response to
influenza vaccination in patients with renal
disease - Recent literature shows that although the overall
antibody response to influenza vaccination is
diminished in dialysis patients, they can still
mount a protective antibody response
52Influenza Vaccine Delivery and Effectiveness in
ESRD, USRDS 1997-1999
- Influenza vaccination rates were lower in
non-whites, women, younger patients, and
peritoneal dialysis patients - Influenza vaccination was associated with a lower
risk for hospitalization and death
Gilbertson DT, Unruh M, McBean AM, Kausz AT,
Snyder JJ, Collins AJ. Influenza vaccine delivery
and effectiveness in end-stage renal disease.
Kidney Int 200363738743.
53Influenza
- Patients with CKD or ESRD are a priority group
for vaccination with inactivated influenza
vaccine (TIV) - Live, Attenuated Influenza Vaccine (LAIV) is
contraindicated for these patients
54Influenza and Healthcare Workers
- To reduce staff illnesses and absenteeism during
the influenza season and to reduce the spread of
influenza to and from workers and patients, the
following HCWs should be vaccinated in the fall
of each year - Persons who attend patients at high risk for
complications of influenza - Persons aged 65 years
- Persons with certain chronic medical conditions
- Pregnant women who will be in the second or third
trimester of pregnancy during influenza season.
CDC. Immunization of Health-Care Workers,
Recommendations of the Advisory Committee on
Immunization Practices (ACIP) and the Hospital
Infection Control Practices Advisory Committee
(HICPAC). MMWR 1997 46 (RR-18)1-42
55Healthcare Workers
- Dialysis staff members (healthy persons) aged
549 years in these groups who are not contacts
of severely immunocompromised persons can use
Live, Attenuated Influenza Vaccine (LAIV) (see
Live, Attenuated Influenza Vaccine
Recommendations) can receive either or
inactivated influenza vaccine. - All other persons in this group should receive
inactivated influenza vaccine.
56Live, attenuated influenza vaccine (LAIV)
compared with inactivated influenza vaccine
57Hepatitis A Vaccine
- People with any type of chronic liver disease
including patients with chronic HBV or HCV - Injection and non-injection drug users
- Travelers to places with high rates of HAV
infection (Africa, Central/South America, Asia,
Middle East, Russia) - Men who have sex with men
- People with clotting-factor disorders
(hemophilia) - People waiting for or who have had a liver
transplant - Children living in areas of U.S. with
consistently increased rates of hepatitis A
582010 Healthy People Goals
http//www.healthypeople.gov/document/HTML/Volume1
/14Immunization.htm_Toc494510242
59Safe and Timely Immunization Coalition (STIC)
- A national coalition of healthcare professionals
and ESRD patients was formed in 2005 - Coalition includes representatives from dialysis
providers, CDC, patient groups, network staff,
QIOs, and others - A special project funded by the CMS and CDC to
increase the rate of Hepatitis B, influenza, and
Pneumococcal immunizations in patients and staff
in the dialysis setting - Focused on immunization education, data
collection, ESRD-specific guidelines, developing
interventions to increase vaccination rates among
dialysis patients.
60STIC
- Facilities in ESRD Network 6, 11, and 15 are
participating in the data collection phase of
this project
http//www.esrdnetwork6.org/PatientResources/STICB
ook.pdf
61STIC Goals
- Educate patients and staff about the importance
of vaccine preventable diseases - Improve vaccination rates among patients and
staff - Pneumococcal Vaccine- achieve the Healthy People
2010 goals (90 of patients in high risk groups) - Influenza (90 of patients in high risk groups)
- HBV (90 of patients in high risk groups)
- Vaccinate all susceptible patients
- Vaccinate all staff who have exposures to
bloodborne pathogens
62DHQP Web Resourceshttp//www.cdc.gov/ncidod/dhqp/
dsn.html
63National Immunization Program Resourceshttp//www
.cdc.gov/nip/
64Additional References
- CDC. Prevention and Control of Influenza,
recommendations of the Advisory Committeee on
Immunization Practices. MMWR 200655
(RR-10)1-42. - http//www.cdc.gov/mmwr/PDF/rr/rr5510.pdf
- ACIP Recommendations
- http//www.cdc.gov/nip/publications/acip-list.htm
- Safe and Timely Vaccine Coalition
- http//www.esrdnetwork6.org/PatientResources/STIC
Book.pdf -
65Protect patients,Protect healthcare
personnel,Protect quality healthcare
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