Bureau of Immunization

Use of Vaccines in Persons With Altered Immunocompetence: Recommendations of the ACIP

Summary of Principles for Vaccinating Immunocompromised Persons

The degree to which an individual patient is immunocompromised should be determined by a physician. Severe immunosuppression can be due to a variety of conditions, including congenital immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, generalized malignancy or therapy with alkylating agents, antimetabolites, radiation, or large amounts of corticosteroids. For some of these conditions, all affected persons will be severely immunocompromised: for others, such as HIV infection, the spectrum of disease severity due to disease or treatment stage will determine the degree to which the immune system is compromised. The responsibility for determining whether a patient is severely immunocomprimised ultimately lies with the physician.

Killed or inactivated vaccines do not represent a danger to immunocompromised persons and generally should be administered as recommended for healthy persons. For specific immunocompromised conditions (e.g. asplenia) such patients may be at higher risk for certain diseases, and additional vaccines, particularly bacterial polysaccharide vaccines (Haemophilus influenza type b [Hib], pneumococcal and meningococcal) are recommended for them. Frequently, the immune response of immunocompromised persons to these vaccine antigens is not as good as that of immunocompetent persons; higher doses or more frequent boosters may be required, although even with these modifications, the immune response may be suboptimal.

Steroid therapy usually does not contraindicate administration of live-virus vaccines when such therapy is short-term (< 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal or tendon injection. The exact amount of systemic corticosteroids and the duration of their administration needed to suppress the immune system of an otherwise healthy child are not well defined. The immunosuppressive effects of steroid treatment vary, but many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live-virus vaccines. Corticosteroids used in greater than physiologic doses also may reduce the immune response to vaccines. Physicians should wait at least 3 months after discontinuation of therapy before administering a live-virus vaccine to patients who have received high-dose, systemic steroid for >2 weeks.

Specific Immunocompromising Conditions

Persons with immunocompromising conditions may be divided into three groups:

1. Persons who are severely immunocompromised not as a result of HIV infection;
2. Persons with HIV infection; and
3. Persons with conditions that cause limited immune deficits (e.g., asplenia, renal failure) that may require use of special vaccines or higher doses of vaccines but that do not contraindicate use of any particular vaccine.

These groups differ primarily in the recommendations for use of live virus vaccines, which are contraindicated for all persons in group A, for some vaccines and some persons in group B, and are not contraindicated in group C.

A. Severely Immunocompromised Non-HIV Infected Persons

Severe immunosuppression not associated with HIV can be the result of congenital immunodeficiency, leukemia, lymphoma, generalized malignancy or therapy with alkylating agents, antimetabolites, radiation, or large amounts of corticosteroids. Virus replication after administration of live, attenuated-virus vaccines can be enhanced in severely immunocompromised persons. In general, these patients should not be administered live vaccines, with the exception below. In addition, OPV should not be administered to any household contact of a severely immunocompromised person. Measles-mumps-rubella (MMR) vaccine is not contraindicated for the close contacts (including health care providers) of immunocompromised persons.

Persons with leukemia in remission who have not received chemotherapy for a least three months are not considered severely immunosuppressive for the purpose of receiving live-virus vaccines. When cancer chemotherapy or immunosuppressive therapy is being considered (e.g., for patients with Hodgkin's disease or organ transplantation), vaccination ideally should precede the initiation of chemotherapy or immunosuppression by > 2 weeks. Vaccination during chemotherapy or radiation therapy should be avoided because antibody responses are suboptimal. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks before starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.

Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of or in addition to vaccination. When exposed to a vaccine preventable disease such as measles, severely immunocompromised children should be considered susceptible regardless of their history of vaccination.

B. HIV-Infected Persons

In general, persons known to be HIV infected should not receive live-virus or live bacteria vaccines. However, evaluation and testing for HIV infection of asymptomatic persons are not necessary before decisions concerning vaccination and live-virus vaccines are made. Measles disease may be severe in HIV-infected persons. Available data indicate that vaccination with MMR has not been associated with severe or unusual adverse events in HIV-infected persons without evidence of severe immunosuppression, although antibody responses have been variable. MMR vaccine is recommended for all asymptomatic HIV-infected persons, and should be considered for symptomatic persons who are not severely immunosuppressed.

Asymptomatic children do not need to be evaluated and tested for HIV infection before MMR and other measles-containing vaccines are administered. MMR and other measles-containing vaccines are not recommended for HIV-infected persons with evidence of severe immunosuppression (see table below):

Age-specific CD4 + T-lymphocyte count and percent of total lymphocytes as criteria for severe immunosuppression in HIV-infected persons:

Enhanced inactivated polio vaccine (eIPV) is the preferred polio vaccine for persons known to have HIV infection. Pneumococcal vaccine is indicated for all HIV-infected persons >2 years of age. Children < or = 2 years of age with known HIV infection should receive Hib vaccine according to the routine schedule. Clinicians deciding whether to administer Hib vaccine to HIV-infected persons should take into consideration the individual patient's risk of Hib disease and the effectiveness of the vaccine for these persons. In some settings, the incidence of Hib disease may be higher among HIV-infected adults, and the disease can be severe in these patients.

C. Medical Conditions Associated Only With Special Indication Vaccines

Certain medical conditions, such as renal failure, diabetes, alcoholic cirrhosis, or asplenia, may increase the patient's risk for certain diseases. Some antigens, particularly bacterial polysaccharide vaccines, are recommended for such patients. Frequently the immune response of these patients to these antigens is not as good as that of immunocompetent persons, and higher doses or more frequent boosters may be required. Persons with these conditions are generally not considered immunosuppressed for the purposes of vaccination and should receive routine vaccinations with both live and inactivated vaccines according to the usual schedules.

Renal Failure: Patients with renal failure have an increased risk of infection with a variety of pathogens, particularly pneumococcus and hepatitis B. Nephrotic syndrome is the renal disease most clearly associated with an increased risk for pnemococcal infection.

Diabetes: Patients with long-standing diabetes mellitus often have cardiovascular, renal, and other end-organ dysfunction, and one-time pneumococcal vaccination and annual influenza vaccination are recommended. Pneumococcal vaccine is safe and effective for these patients and does not interfere with insulin levels or glucose control. Patients receiving either insulin or oral antidiabetic agents respond normally to influenza vaccination without impairment of diabetic control.

Alcoholic cirrhosis: patients with alcoholism and alcoholic liver disease have an increased incidence of infections, especially pneumonia. Patients with alcoholism or alcoholic liver disease should receive one-time pneumococcal and yearly influenza vaccination.

Asplenia: Persons who have anatomic or functional asplenia have an increased risk for fulminate bacteria, associated with a high mortality rate. Polyvalent pneumococcal vaccine is recommended for all asplenic persons > or = 2 years of age. In some instances, reimmunization with pneumococcal vaccine is indicated. When elective spenectomy is planned, vaccination with pneumococcal vaccine should precede surgery by at least 2 weeks, if possible.

Source: Centers for Disease Control and Prevention, Epidemiology and Prevention of Vaccine-Preventable Diseases, 4th Edition, September 1997.

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