Strength of Recommendation and Quality of Evidence
|SR – Strong||Clear desirable or undesirable effects|
|WR – Weak||Desirable and undesirable effects closely balanced or uncertain|
|Quality of Evidence|
|H – High||Consistent evidence from well-performed RCTs or exceptionally strong evidence from unbiased observational studies|
|M – Moderate||Evidence from RCTs with important limitations or moderately strong evidence from unbiased observational studies|
|L – Low||Evidence for ≥1 critical outcome from observational studies, from RCTs with serious flaws or from indirect evidence|
|VL – Very low||Evidence for ≥1 critical outcome from unsystematic clinical observations or very indirect evidence|
|SR-H||Applies to most patients in most circumstances||Further research is unlikely to change estimate|
|SR-M||Further research may change estimate|
|SR-VL||Estimate of effect for at least one critical outcome is very uncertain|
|WR-H||The best action may differ depending on circumstances or patients or societal values||Further research is unlikely to change estimate|
|WR-M||Alternative approaches likely to be better for some patients under some circumstances||Further research may change estimate|
|WR-L||Other alternatives may be equally reasonable|
|WR-VL||Any estimate of effect, for at least one critical outcome, is very uncertain|
|RCTs, randomized controlled trials.|
For the complete Grading of Recommendations Assessment, Development and Evaluation (GRADE) Strength of Recommendations and Quality of the Evidence Table, visit the IDSA website: http://www.idsociety.org/Guidelines_Other/.
Some recommendations in this guideline have not been addressed by the Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC), or deviate from their recommendations, and are marked by an asterisk (*).
- Impaired host defenses predispose patients to an increased rate or severity of vaccine-preventable infection.
- Such patients may also have greater exposure to pathogens due to frequent contact with medical environments.
- Data on safety, immunogenicity, and efficacy/effectiveness of vaccines for immunocompromised populations are limited.
- Immune system defects vary among and within categories of patients with immunodeficiency (eg, degree of immunodeficiency, nutritional status, immunosuppressive regimen), which may limit the generalizability of study findings.
- Inactivated vaccines can be administered to most immunocompromised patients, and live vaccines are contraindicated for most immunocompromised patients, with some important exceptions.
Responsibility for Vaccination
- Specialists caring for immunocompromised patients share responsibility with the primary care provider for ensuring that appropriate vaccinations are administered to immunocompromised patients (SR-L).*
- Specialists caring for immunocompromised patients share responsibility with the primary care provider for recommending appropriate vaccinations for household members of immunocompromised patients (SR-VL).*
Timing of Vaccination
- Vaccines should be administered prior to planned immunosuppression if feasible (SR-M).
- Live vaccines should be administered ≥4 weeks prior to immunosuppression (SR-L) and should be avoided within 2 weeks of initiation of immunosuppression (SR-L).*
- Inactivated vaccines should be administered ≥2 weeks prior to immunosuppression (SR-M).
Household Members (See Table 1)
6. Immunocompetent household members of immunocompromised patients can safely receive inactivated vaccines based on the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP)’s annually updated recommended vaccination schedules for children and adults (hereafter referred to as the CDC annual schedule) (SR-H) or for travel (SR-M).
7. Household members of immunocompromised patients 6 months and older should receive influenza vaccine annually (SR-H). They should receive either:
a. Inactivated influenza vaccine (IIV) (SR-H) or
b. Live attenuated influenza vaccine (LAIV) provided they are healthy, not pregnant, and age 2-49 years (SR-L). Exceptions include household members of an immunocompromised patient who is a hematopoietic stem cell transplant (HSCT) recipient within 2 months after transplant or with graft-vs-host disease (GVHD), or a patient with severe combined immunodeficiency (SCID).* In these exceptions, LAIV should not be administered (WR-VL) or, if administered, contact between the immunocompromised patient and household member should be avoided for 7 days (WR-VL).
8. Healthy immunocompetent household members of immunocompromised patients should receive the following live vaccines based on the CDC annual schedule: combined measles, mumps, and rubella vaccines (MMR) (SR-M), rotavirus vaccine in infants ages 2-7 months (SR-L), varicella vaccine (VAR) (SR-M), and zoster vaccine (ZOS) (SR-M). They can safely receive vaccines for travel: yellow fever vaccine (SR-M), and oral typhoid vaccine (SR-L).
9. Oral poliovirus vaccine (OPV) should not be administered to household members of immunocompromised patients (SR-M).
10. Highly immunocompromised patients should avoid handling diapers of infants vaccinated with rotavirus vaccine for 4 weeks after vaccination (SR-VL).
11. Immunocompromised patients should avoid contact with persons who develop skin lesions after receiving VAR or ZOS until the lesions have cleared (SR-L).
- Clinicians may administer inactivated vaccines indicated for travel based on the CDC annual schedule for immunocompetent adults and children (SR-L).
- Yellow fever vaccine generally should NOT be administered to immunocompromised persons (SR-M). If travel to an endemic area cannot be avoided, vaccination can be considered in certain adults with human immunodeficiency virus (HIV) infection who are minimally immunocompromised:
- a. Asymptomatic HIV-infected adults with CD4 T-cell lymphocyte counts of ≥200 cells/mm3 (WR-L)
- b. Asymptomatic HIV-infected children age 9 months through 5 years with CD4 T-cell lymphocyte percentages of ≥15% (WR-VL)
- With certain exceptions (eg, yellow fever vaccine and MMR in certain HIV-infected patients [see recommendation 13 and HIV section] and MMR in certain HSCT patients [see HSCT section]), live vaccines should NOT be given to immunocompromised persons (SR-L).
Table 1. Safety of Administration of Live Vaccines to Contacts of Immunocompromised Persons
|Live Vaccine||Shedding of Agent? (Site)||Transmissibility From Vaccinated Immunocompetent Person?||Recommendation for Administering Vaccines (When Indicated) to Healthy Immunocompetent Contacts of Immunocompromised Patients|
|Influenza, live, attenuated nasal||Yes (nasal secretions)||Rare (from 1 vaccinated toddler)||Administer (SR-L); vaccinated persons to avoid close contact with persons with HSCT or SCID for 7 d (WR-VL)|
(nasopharynx, in low titer; breast milk)
|No, except mother-to-infant transmission of rubella vaccine virus via breast milk||Administer (SR-M)|
|Poliovirus, oral||Yes (stool)||Yes, with rare cases of vaccine-associated paralytic poliomyelitis||Do NOT administer (SR-H)|
|Rotavirus, oral||Yes (stool)||Yes, but no reported cases of symptomatic infection in contacts||Administer (SR-L)|
|Typhoid, oral||No||No||Administer (SR-L)|
|Varicella||Yes (skin lesions)||Rare, limited to vaccinees with skin lesions||Administer (SR-M); if skin lesions develop, avoid close contact with immunocompromised persons|
|Yellow fever||No, except possibly shed in breast milk||Yes (at least 3 cases of encephalitis in infants exposed to the vaccine via nursing)||Administer (SR-M) except to women who are nursing|
|Zoster||Yes (rarely recovered from injection-site vesicles)||Not reported||Administer to age ≥60 y (SR-M); if skin lesions develop, avoid close contact with immunocompromised persons|
Varicella and Zoster Vaccines
- VAR should be given to immunocompetent patients without evidence of varicella immunity (ie, either age-appropriate varicella vaccination, serologic evidence of immunity, clinician-diagnosed or verified history of varicella or zoster, or laboratory-proven varicella or zoster) (SR-M) if it can be administered ≥4 weeks before initiating immunosuppressive therapy (SR-L).
- A 2-dose schedule of VAR, separated by >4 weeks for patients ≥13 years and by ≥3 months for patients 1-12 years of age, is recommended if there is sufficient time prior to initiating immunosuppressive therapy (SR-L).
- NOT be administered to highly immunocompromised patients, but certain categories of patients (eg, patients with HIV infection without severe immunosuppression, or a primary immunodeficiency disorder without defective T cell-mediated immunity, such as primary complement component deficiency disorder, or chronic granulomatous disease [CGD]) should receive VAR, adhering to a 2-dose schedule separated by a 3-month interval (SR-M).
- VAR can be considered for patients without evidence of varicella immunity (defined in recommendation 16) who are receiving long-term, low-level immunosuppression (WR-VL).*
- VAR should be administered to eligible immunocompromised patients as the single antigen product, not varicella vaccine combined with measles, mumps, and rubella vaccines (MMRV) (SR-L).
- ZOS should be given to patients ≥60 years of age if it can be administered ≥4 weeks before beginning highly immunosuppressive therapy (SR-L).
- ZOS should be considered for varicella-positive patients (ie, persons with a history of varicella or zoster infection or who are VZV seropositive with no previous doses of VAR) 50-59 years of age if it can be administered ≥4 weeks before beginning immunosuppressive therapy (WR-L).*
- ZOS should be administered to patients ≥60 years of age receiving therapy considered to induce a low level of immunosuppression (SR-L).
- ZOS should NOT be administered to highly immunocompromised patients (SR-VL).
- Annual influenza vaccination with IIV is recommended for immunocompromised patients ≥6 months of age (SR-M) except for patients who are very unlikely to respond (although unlikely to be harmed by IIV), such as those receiving intensive chemotherapy* (SR-L) or those who have received anti-B cell antibodies within 6 months* (SR-M).
- LAIV should NOT be administered to immunocompromised persons (WR-VL).