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Title: Importance of Vaccination Among Dialysis Patients: Vaccine Recommendations for Patients Receiving Di


1
Importance 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.
webbertraining.com
2
Overview
  • 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

3
Vaccine 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

4
Patients 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

5
Immunity and Kidney Disease
  • CKD and ESRD patients have decreased immune
    responses
  • Uremia contributes to the impaired host response

6
Host 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.

7
Disease Burden
8
Change 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
9
Adjusted 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
10
Hepatitis B Virus
11
Risk Factors Associated with Reported Hepatitis
B, 1990-2000, United States
Other Surgery, dental surgery, acupuncture,
tattoo, other percutaneous injury
Source NNDSS/VHSP
12
Incidence and Prevalence of Hepatitis B in the
United States, 1976-2002
CDC Infection Control Recommendations (1977)
Vaccine (1982)
13
Sources 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

14
Incidence 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

15
Resurgence of HBV Outbreaks in the mid 1990s
16
Outbreaks 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

17
Preparation 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

18
Patterns 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.

19
Streptococcus pneumoniae
  • Major clinical syndromes
  • Pneumonia
  • Bacteremia
  • Meningitis
  • Asymptomatic human carriers (nasopharynx) act as
    a reservoir

20
Pneumoccoal 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

21
Pneumococcal 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

22
Burden 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
23
Bacterial 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
24
Data 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.
25
KaplanMeier 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.
26
KaplanMeier 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.
27
Pneumococcal Vaccination Rates
  • Relatively low vaccination rates
  • Vaccination rate among dialysis patients 13.5

28
Influenza
  • TEM micrograph of the 1918 influenza virus

29
Seasonal 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

30
Influenza 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

31
Vaccination is an important tool for preventing
many infectious diseases
32
Available from http//www.cdc.gov/ncidod/dhqp/dp
ac_dialysis_pc.html
33
Vaccination of Renal Dialysis Patients and
Patients with Chronic Renal Disease
34
Vaccine 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

35
The 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
36
Routine 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.
37
National 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
38
Hepatitis 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

39
Hepatitis 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

40
Immunogenicity 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)

41
Immunogenicity 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.
42
HBV 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)

43
Doses and Schedules of Licensed HBV Vaccines for
Hemodialysis Patients
Dose recommended by FDA higher doses maybe more
immunogenic for hemodialysis patients
44
New 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

45
Fendrix 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.

46
Pneumococcal Vaccine
  • Two Vaccines are available
  • PPV23 (polyvalent containing 23 capsule
    serotypes)
  • PPV7 (polyvalent, containing the 7 serotypes
    responsible for pneumococcal disease in children)

47
Children 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.

48
PPV23 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.

49
Pneumococcal 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.
50
Pneumococcal 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.

51
Influenza 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

52
Influenza 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.
53
Influenza
  • 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

54
Influenza 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
55
Healthcare 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.

56
Live, attenuated influenza vaccine (LAIV)
compared with inactivated influenza vaccine
57
Hepatitis 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

58
2010 Healthy People Goals
http//www.healthypeople.gov/document/HTML/Volume1
/14Immunization.htm_Toc494510242
59
Safe 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.

60
STIC
  • 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
61
STIC 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

62
DHQP Web Resourceshttp//www.cdc.gov/ncidod/dhqp/
dsn.html
63
National Immunization Program Resourceshttp//www
.cdc.gov/nip/
64
Additional 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
  •     

65
Protect patients,Protect healthcare
personnel,Protect quality healthcare
Prevention Is Primary!
66
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