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## Complete Summary

#### GUIDELINE TITLE

Prevention of secondary disease: immunizations.

#### BIBLIOGRAPHIC SOURCE(S)

New York State Department of Health. Prevention of secondary disease:
immunizations. New York (NY): New York State Department of Health; 2006
Dec. 7 p. \[17 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Human immunodeficiency virus (HIV) infection

-   Tetanus

-   Diphtheria

-   Pertussis

-   Influenza

-   Pneumococcal infection

-   Hepatitis A and B

-   Measles

-   Mumps

-   Rubella

-   Human papillomavirus (HPV) infection

-   Varicella

#### GUIDELINE CATEGORY

Prevention

#### CLINICAL SPECIALTY

Allergy and Immunology\
Family Practice\
Infectious Diseases\
Internal Medicine\
Obstetrics and Gynecology\
Preventive Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Health Care Providers\
Nurses\
Physician Assistants\
Physicians\
Public Health Departments

#### GUIDELINE OBJECTIVE(S)

To provide guidelines for immunization of human immunodeficiency virus
(HIV)-infected patients to prevent secondary diseases

#### TARGET POPULATION

Human immunodeficiency virus (HIV)-infected adults including pregnant
women

#### INTERVENTIONS AND PRACTICES CONSIDERED

Immunization with the following vaccines:

1.  Tetanus, Diphtheria, and Pertussis (Tdap), or Tetanus-Diphtheria
    (Td) vaccine

2.  Influenza vaccine

3.  Pneumococcal polysaccharide vaccine

4.  Hepatitis A and B vaccine

5.  Measles, Mumps, Rubella (MMR) vaccine

6.  Human papillomavirus vaccine

7.  Varicella vaccine

#### MAJOR OUTCOMES CONSIDERED

Risks, benefits, and efficacy of immunizations

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

AIDS Institute clinical guidelines are developed by distinguished
committees of clinicians and others with extensive experience providing
care to people with HIV infection. Committees\* meet regularly to assess
current recommendations and to write and update guidelines in accordance
with newly emerging clinical and research developments.

The Committees\* rely on evidence to the extent possible in formulating
recommendations. When data from randomized clinical trials are not
available, Committees rely on developing guidelines based on consensus,
balancing the use of new information with sound clinical judgment that
results in recommendations that are in the best interest of patients.

\* Current committees include:

-   Medical Care Criteria Committee

-   Committee for the Care of Children and Adolescents with HIV
    Infection

-   Dental Standards of Care Committee

-   Mental Health Committee

-   Women\'s Health Committee

-   Substance Use Committee

-   Physician\'s Prevention Advisory Committee

-   Pharmacy Committee

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

All guidelines developed by the Committee are externally peer reviewed
by at least two experts in that particular area of patient care, which
ensures depth and quality of the guidelines.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Immunizations**

**Recommended Immunizations for Non-Pregnant Human Immunodeficiency
Virus (HIV)-Infected Adults**

**Table 1 Recommended Immunizations for Non-Pregnant HIV-Infected
Adults**

  --------------------------------------------------------------------------
  **Vaccine**          **Indications**                **Schedule**
  -------------------- ------------------------------ ----------------------
  Tetanus, Diphtheria, For patients who have not      Administer 1 dose of
  and Pertussis        received the primary series    Tdap, followed by a
  (Tdap),\* and                                       dose of Td at 1 month
                                                      and a second dose of
                                                      Td 6--12 months later

  Tetanus-Diphtheria   For patients who have already  Administer 1 dose of
  (Td)\*               received the primary series    Tdap booster every 10
                                                      years

  Influenza            For all patients               Administer 1 annual
                                                      dose. Do not use
                                                      FluMist because it
                                                      contains live virus.

  Pneumococcal         For all patients               Administer 1 dose
  polysaccharide                                      followed by one
                                                      revaccination after 5
                                                      to 6 years (or more)
                                                      have elapsed since
                                                      initial vaccination

  Hepatitis A\*        For patients at increased risk Administer 2 doses (0
                       for hepatitis A                and 6--12 months)

  Hepatitis B\*        For patients without serologic Strongly encourage the
                       evidence of prior hepatitis B  vaccine series---3
                       virus (HBV) infection or who   doses (0, 1 to 2, and
                       have not previously received   6 months)
                       the complete series of HBV     
                       vaccination                    

  Measles, Mumps,      For all asymptomatic           Administer 1 dose
  Rubella (MMR)\*      HIV-infected patients who do   
                       not have evidence of severe    
                       immunosuppression and who are  
                       seronegative for antibody to   
                       MMR                            

                       For patients with severe       Do not administer
                       immunosuppression (\<200       vaccine
                       cells/mm^3^)                   

  Human Papillomavirus For women between the ages of  Administer 3 doses (at
  (HPV)                9 and 26 years                 0, 2, and 6 months)

  Varicella\*          For persons who are            Consider administering
                       susceptible                    2 doses (at 0 and 4--8
                                                      weeks)
  --------------------------------------------------------------------------

For other vaccines, see Centers for Disease Control and Prevention (CDC)
recommendations. Available at:
[\>http://www.cdc.gov/vaccines/](http://www.cdc.gov/vaccines/)\
\*Covered by the Vaccine Injury Compensation Program

Refer to the original guideline document for more information on the
recommended vaccines.

**Recommended Immunizations for Pregnant HIV-Infected Adults**

Routine pregnancy testing of women of childbearing age before
administering a live-virus vaccine is not recommended (Centers for
Disease Control and Prevention \[CDC\], 1998).

Clinicians should avoid administering immunizations late in the third
trimester to avoid the theoretical possibility of the vaccines causing
increased viral load levels at the time of delivery.

Because of the importance of protecting women of childbearing age
against rubella, clinicians should adopt the following practices in any
immunization program:

-   Ask women if they are or could be pregnant or intend to become
    pregnant within the next 4 weeks

-   Explain the potential risk of vaccination to the fetus to women who
    state that they are not pregnant

-   Counsel women who are vaccinated to avoid pregnancy during the 4
    weeks after Measles, Mumps, Rubella (MMR) vaccination (CDC, 1998;
    \"Control and prevention of rubella,\" 2001; CDC, \"Revised ACIP
    recommendation,\" 2001).

-   Do not vaccinate women who state that they are pregnant; administer
    rubella vaccine immediately after delivery in rubella-susceptible
    HIV-infected women with CD4 counts \>200 cells/mm^3^

-   Test pregnant women for rubella immunity at the first antepartum
    visit

Clinicians should counsel pregnant women who are inadvertently
vaccinated or who become pregnant within 4 weeks after MMR or varicella
vaccination about the theoretical risk to the fetus; however, exposure
to MMR or varicella vaccines during pregnancy generally is not a reason
to terminate a pregnancy (CDC, 1998; \"Prevention of varicella,\" 1996).

**Table 2 Recommended Immunizations for Pregnant HIV-Infected Adults**

  ------------------------------------------------------------------------
  **Vaccine**      **Indications**           **Recommendations**
  ---------------- ------------------------- -----------------------------
  Tetanus          For women who have not    Administer Td booster
                   received Td vaccination   
                   in last 10 years but have 
                   been previously immunized 

                   For women who have never  Administer the complete
                   been immunized or have    primary series, including
                   only been partially       Tdap (see Table 1 above)
                   immunized                 

                   For women for whom the    Follow up after delivery to
                   vaccine is indicated but  ensure that the series is
                   who do not receive the    completed
                   complete 3-dose series    
                   during pregnancy          

  Influenza        For all pregnant women    Administer vaccine during
                                             influenza season, regardless
                                             of stage of pregnancy

  Hepatitis A      For pregnant women at     Offer hepatitis A vaccine
                   increased risk for        series
                   hepatitis A\*             

  Hepatitis B      For all pregnant women    Administer hepatitis B
                   who are hepatitis B       vaccine
                   surface antigen (HBsAg),  
                   hepatitis B surface       
                   antibody (HBsAb), and     
                   hepatitis B core antibody 
                   (HBcAb) immunoglobulin G  
                   (IgG) negative            

                   For pregnant women who    Ensure that 1) the infant
                   are HBsAg-positive        receives HBIG and that the
                                             hepatitis B vaccine series is
                                             initiated within 12 hours
                                             after birth, and 2) the
                                             recommended hepatitis B
                                             vaccine series is completed
                                             in the infant

  Pneumococcal     For pregnant women who    Administer vaccine
  polysaccharide   have not received the     
                   vaccine within the last 6 
                   years                     

  Measles, Mumps,  For pregnant women or     Do not administer vaccine
  Rubella (MMR)    women intending to become 
                   pregnant in the next 4    
                   weeks                     

                   For pregnant women who    Administer vaccine
                   are rubella-susceptible   immediately after delivery

                   For household contacts of Administer vaccine when
                   pregnant women            indicated

  Varicella        For all pregnant women    Do not administer vaccine

                   For household contacts of Administer vaccine when
                   pregnant women            indicated

                   For women who are exposed Perform antibody testing for
                   to varicella at any point previous varicella exposure.
                   during pregnancy with no  If exposure is negative,
                   history of previous       administer varicella zoster
                   varicella                 immune globulin (VZIG)
  ------------------------------------------------------------------------

(CDC, 1998; CDC, \"Control and prevention of rubella,\" 2001; CDC,
\"Revised ACIP recommendation,\" 2001; CDC, 1996; Shields et al., 2001;
\"Diphtheria, tetanus, and pertussis,\" 1991; Bridges et al., 2001;
Neuzil et al., 1998; \"Hepatitis B virus,\" 1991)

\*Persons with chronic liver disease (e.g. hepatitis B or C); travelers
to countries with high endemicity of infection; persons who live in a
community experiencing an outbreak of hepatitis A virus (HAV) infection;
illicit drug users, particularly injection drug users; persons who have
clotting-factor disorders; persons at occupational risk for infection.

**Notes**\
**Influenza**: It has been shown that women in the second and third
trimesters of pregnancy are at an increased risk for hospitalization
from influenza.\
**Hepatitis A and B**: No known risk exists for the fetus from passive
immunization of pregnant women with immune globulin preparations.\
**MMR**: Persons who receive MMR vaccine do not transmit the vaccine
viruses to contacts (CDC, 1998).\
**Varicella**: Transmission of varicella vaccine virus to contacts is
rare (CDC, 1996).

**Concurrent Administration of Antimicrobial Agents and Vaccines**

Clinicians should discontinue antiviral drugs active against
herpesviruses ≥24 hours before administration of varicella vaccine.

**Vaccines and Allergens**

Before administering the influenza vaccine, clinicians should ask
patients whether they are able to eat eggs without adverse effects.
Clinicians should not administer the influenza vaccine to patients who
have a history of anaphylactic or anaphylactic-like allergy to eggs.

Clinicians should use extreme caution when administering vaccines that
contain gelatin to persons who have a history of anaphylactic reaction
to gelatin or gelatin-containing products.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=10575)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is not specifically stated for each
recommendation.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate immunization of human immunodeficiency virus (HIV)-infected
patients resulting in prevention of secondary disease

#### POTENTIAL HARMS

-   The rare serious allergic reaction after measles or mumps
    vaccination or measles, mumps, and rubella (MMR) is not believed to
    be caused by egg antigens, but by other components of the vaccine
    (e.g., gelatin). Extreme caution should be exercised when
    administering vaccines that contain gelatin to persons who have a
    history of an anaphylactic reaction to gelatin or gelatin-containing
    products. Before administering gelatin-containing vaccines to such
    persons, skin testing for sensitivity to gelatin can be considered.

-   Antiviral drugs active against herpes viruses (e.g., acyclovir or
    valacyclovir) might reduce the efficacy of live attenuated varicella
    vaccine. These drugs should be discontinued ≥24 hours before
    administration of varicella vaccine, if possible.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

-   Pregnancy is a contraindication for measles, mumps, rubella, and
    varicella vaccines.

-   Clinicians should not administer the influenza vaccine to patients
    who have a history of anaphylactic or anaphylactic-like allergy to
    eggs.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

The AIDS Institute\'s Office of the Medical Director directly oversees
the development, publication, dissemination and implementation of
clinical practice guidelines, in collaboration with The Johns Hopkins
University, Division of Infectious Diseases. These guidelines address
the medical management of adults, adolescents and children with HIV
infection; primary and secondary prevention in medical settings; and
include informational brochures for care providers and the public.

The HIV Clinical Guidelines Program works with other programs in the
AIDS Institute to promote adoption of guidelines. Clinicians, for
example, are targeted through the Clinical Education Initiative (CEI)
and the AIDS Education and Training Centers (AETC). The CEI provides
tailored educational programming on site for health care providers on
important topics in HIV care, including those addressed by the HIV
Clinical Guidelines Program. The AETC provides conferences, grand rounds
and other programs that cover topics contained in AIDS Institute
guidelines.

Support service providers are targeted through the HIV Education and
Training initiative which provides training on important HIV topics to
non-physician health and human services providers. Education is carried
out across the State as well as through video conferencing and audio
conferencing.

The HIV Clinical Guidelines Program also works in a coordinated manner
with the HIV Quality of Care Program to promote implementation of HIV
guidelines in New York State. By developing quality indicators based on
the guidelines, the AIDS Institute has created a mechanism for
measurement of performance that allows providers and consumers to know
to what extent specific guidelines have been implemented.

Finally, best practices booklets are developed through the HIV Clinical
Guidelines Program. These contain practical solutions to common problems
related to access, delivery or coordination of care, in an effort to
ensure that HIV guidelines are implemented and that patients receive the
highest level of HIV care possible.

#### IMPLEMENTATION TOOLS

Personal Digital Assistant (PDA) Downloads

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

New York State Department of Health. Prevention of secondary disease:
immunizations. New York (NY): New York State Department of Health; 2006
Dec. 7 p. \[17 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2006 Dec

#### GUIDELINE DEVELOPER(S)

New York State Department of Health - State/Local Government Agency
\[U.S.\]

#### SOURCE(S) OF FUNDING

New York State Department of Health

#### GUIDELINE COMMITTEE

Not stated

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Not stated

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [New York State Department of
Health AIDS Institute Web
site](http://www.hivguidelines.org/GuideLine.aspx?pageID=260&guideLineID=81&vType=txt).

#### AVAILABILITY OF COMPANION DOCUMENTS

This guideline is available as a Personal Digital Assistant (PDA)
download from the [New York State Department of Health AIDS Institute
Web site](http://hivguidelines.org/Content.aspx?pageID=260).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on June 27, 2007.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is
copyrighted by the guideline developer. See the [New York State
Department of Health AIDS Institute Web
site](http://www.hivguidelines.org/Content.aspx?pageID=451) for terms of
use.

### DISCLAIMER

#### NGC DISCLAIMER

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<http://www.guideline.gov/about/inclusion.aspx> .

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Readers with questions regarding guideline content are directed to
contact the guideline developer.

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008