Vaccination of Solid Organ Transplant Candidates and Recipients

Transplant candidates and recipients are at significant risk for infection and efforts should be optimized to limit these risks. Vaccine-preventable diseases continue to plague solid organ transplant recipients and can be minimized with proper interventions, yet vaccines remain underutilized. The reason behind the poor vaccination compliance is multi-factorial and varies by transplant center, but one common obstacle is the concern that immunizations might trigger allograft rejection (7).  However, most large studies have not shown an increase incidence in rejection after immunizations. Every effort should be made to ensure that transplant candidates (including their household members) have completed the full complement of recommended vaccinations prior to transplantation (Table 1 ).

Timing of Immunization

Timing of vaccination is critical to optimize response (Table 1 and Table 3 ). The response to many vaccines diminish with organ failure, thus transplant candidates should be immunized early in the course of their disease and prior to transplantation when feasible. The first 6 months after transplantation are associated with the poorest vaccine response because the patients are nearly always the most immunosuppressed (62). Administration of immunizations too close to transplantation may also result in ineffective protection (54). When it is not possible to vaccinate prior to transplantation, waiting for 3-6 months when immunosuppressive medications are at their baseline and the activity of induction agents (such as ATG or alemtuzumab) is waning is ideal.

Pre-Transplant Vaccination

The pretransplant evaluation is a perfect time for reassessment of the candidate's vaccine status. Transplant centers must develop systems to screen for prior vaccination, including appropriate responses to select vaccinations, and must intervene when updates are indicated. Studies have revealed that only 62% of lung transplant candidates reported prior pneumococcal vaccination despite anticipated vaccination rates of 100% due to underlying pulmonary disease (25). Not only are there more vaccine options pre-transplant, but they are also more effective at preventing disease.  A study of 704 pediatric renal transplant recipients showed that varicella vaccination was effective in reducing the incidence of disease from 45% in non-vaccinated patients to 12% in those who were vaccinated with no deaths related to varicella-zoster virus in the vaccinated group (8).

In general, live-attenuated vaccines (Table 1, 2, 4) are acceptable when given prior to solid organ transplantation, though each patient should be assessed individually in light of varying pretransplant medications and medical conditions. Some live vaccines, such as BCG (for TB prevention) or smallpox, are not indicated in the USA due to low rates of disease.  They are meant to prevent disease and thus are not routinely recommended even though they would be safe to give prior to transplant. Table 1 provides a list of recommended pre-transplant vaccinations as well as providing details regarding the monitoring of titers to determine if repeat doses are required.

Post-Transplant Vaccination

Clinicians' reluctant to administer vaccines to transplant recipients stems from a variety of factors including fear of precipitating allograft rejection. Despite anecdotal reports, there is minimal substantial evidence to support this association. While enhanced lymphocyte proliferative response to donor-specific aortic endothelial cells following influenza vaccination has been reported (66), most previous studies have shown a lack of association between influenza vaccine and rejection (27,40).   In the study of a two-dose series of influenza vaccine in heart transplant recipients, 4/14 vaccine recipients compared with 1/14 controls had episodes of rejection (not statistically significant) (7).  Several recent studies provide additional evidence of the safety of influenza vaccination after transplant. Studies involving 62 and 51 liver transplant recipients demonstrated the safety of influenza immunization in this population (11,45). Neither excess rejection nor elevation of ALT levels was documented (45). The largest study to date, a multi-institutional study by of 3601 patients, revealed a wide variation of vaccination protocols. Of 28 centers, 5 required patients to be 12 months posttransplant, 1 center 6 months and 1 center 3 months posttransplant before administering influenza vaccine, while 3 centers did not administer influenza vaccine at all (68). There were no differences in overall rejection rates, nor in rejection episodes by month, between centers with different vaccination policies. The authors concluded that influenza vaccine can safely be administered to heart recipients (68). Furthermore, several viral infections have been reported to trigger rejection (4,9,19,37). A rejection epidemic among renal recipients was described in association with influenza A Victoria in 1978. Influenza B and adenovirus infections have also been associated with rejection in these patients (24). This suggest that the infectious agent, more than the vaccine, is a common cause of rejection, and effective immunizations may be protective. Vaccination series should be restarted at approximately 3-6 months after transplantation, when baseline immunosuppression levels are attained. Since the immunogenicity of vaccines is impacted by both organ failure and organ transplantation, efficacy should be documented by serologic assays when indicated (Table 1).

Live versus Inactivated Vaccines

Inactivated vaccines are generally safe after solid organ transplantation while live-attenuated vaccines are not commonly administered after transplantation. It is recommended to administer live vaccines against viruses such as MMR, Zoster and Varicella prior to transplantation (Table 1 and 3). A minimum of four weeks between live-virus vaccine administration and transplantation is suggested.

Varicella can cause a severe infection in immunosuppressed individuals, and vaccination is recommended prior to transplantation in children and adolescents (9,39). Vaccination for varicella has also been recommended for seronegative household contacts of immunocompromised patients by numerous organizations. Varicella vaccine was given to17 pediatric renal patients and resulted in one case of mild varicella at 2 weeks and three additional cases after 2 to 4 years. Antibody response was 76%, but response was delayed (68).  Concerns about the use of the vaccine in immunosuppressed patients have been raised. However, the rate of zoster after vaccination was lower than after natural infection in a population of children with leukemia (10).  In a separate studyIn a different study, the incidence of zoster was 7% in pediatric renal recipients who received the vaccine, compared to 38% of those who developed primary infection after transplant (9). Use of varicella vaccine remains controversial in adult solid-organ recipients and the efficacy in this patient population is unknown suggesting the need for long-term large studies.

MMR is also a live-attenuated vaccine, but its use in adults is rarely required, except in the prevention of rubella in young female patients. Rubella infection does not cause severe infection in solid-organ recipients, but the congenital rubella syndrome is a concern because of the increased number of pregnancies in young women of child-bearing age who survived transplantation. Since the vaccine was proven to be safe and effective in bone marrow recipients (47) and patients with human immunodeficiency virus (23), some authors recommend vaccination of all seronegative female transplant recipients before pregnancy (12).  However, after bone marrow transplant, measles-rubella revaccination is recommended after at least 2 years posttransplant in those patients who are stable and without graft-versus host disease (13).  A small study of measles vaccination in pediatric liver recipients showed that immunity developed in 7 out of 18 vaccinated children (58). No complications directly attributable to the vaccine were reported. As there are no large clinical trials evaluating safety and efficacy in adult solid-organ recipients, caution is recommended.

Some vaccines are absolutely contraindicated in solid-organ transplant recipients (Table 1, 2, 4). These include oral polio vaccine, vaccinia, BCG, and live oral typhoid (2). Although case reports of yellow fever vaccination with human immunodeficiency virus infection have been published (59), no data is available in solid-organ recipients and should be considered contraindicated. Oral polio vaccine is also contraindicated in family members of transplant recipients because of possible contagion by shedding of the virus and close contact with excreta. Inactivated polio vaccine (given IM) is safe and effective in renal transplant recipients (34). For safety concerns, the killed parenteral Vi polysaccharide vaccine for typhoid fever should be used instead of the live attenuated oral Ty21a (57).  No data on the efficacy of this vaccine in organ transplant recipients are available.

Health-Care Workers, Family and Household Contact Vaccination

Healthcare workers (HCWs) and family members (including close contacts) should be fully immunized including yearly influenza vaccination (Table 2). If a family member has received a live vaccine, there is no evidence to suggest that shedding vaccine-related particulate (without clinical infection) poses a significant risk to the transplant recipient. Household contacts of severely immunocompromised patients may be given live-virus vaccines such as yellow fever, MMR, or varicella vaccine but should not be given oral polio. Flumist (for either seasonal influenza or H1N1 can be given to household contacts during vaccination shortages, but the inactivated intramuscular exam is preferred. Immunization rates in health-care workers also remain suboptimal. In one tertiary-care hospital, only 18% of health-care workers were fully immunized according to current guidelines. Only half had received influenza vaccine in the preceding 12 months (53). According to a survey of transplant surgeons for whom vaccination was indicated, 22.5% had received less than the recommended three doses of HBV vaccine. Of the 27.3% of surgeons reporting at least one needlestick while operating on an HBV-infected patient, 14.9% were inadequately vaccinated.29 Health-care workers should receive, at minimum, yearly influenza vaccination, a full three-dose HBV vaccine series and measles, mumps, rubella and varicella vaccination (unless already immune). In addition, a single dose of TDaP should be given to all health care workders according to current guidelines (42).

Travel Vaccinations

Overall considerations for travel-related vaccines (Table 4), such as destination and risk behavior, are the same as for non-transplant recipients, although the consequences of not administering an indicated vaccine may be more severe. Users are encouraged to visit http://wwwnc.cdc.gov/travel/default.aspx for travel related information on a country-by-country basis. A high risk for acquiring infections should prompt discussion of trip deferral or consideration of an alternate itinerary (including purchasing of travel insurance for emergencies). For safety concerns, the killed parenteral Vi polysaccharide vaccine for typhoid fever should be used instead of the live attenuated oral Ty21a (57):

1. Should not be given live-virus or live bacterial vaccines
2. May require additional vaccines when compared with the healthy traveler
3. May receive decreased protection from some or all vaccines administered.

Vaccine Specific Comments

Table 5 provides a detailed list of available vaccinations and comments regarding them. For a full review of vaccine associated side effects, readers are invited to visit http://www.cdc.gov/vaccines/vac-gen/side-effects.htm for more information.

BCG (Bacillus Calmette-Guerin)

Indications for BCG

• People who live in areas with high rates of TB and test negative for latent TB
• Infants may be vaccinated at birth prior to TB exposure

Vaccine Side Effects

After the vaccination, a small erythematous lesion usually develops within 2-6 weeks. After a few weeks it becomes scaly, crusting and with slight bruising. This will eventually heal to form a round flat scar.

Comments

BCG, a live attenuated form of Mycobacterium bovis, is utilized in some countries to help prevent tuberculosis. Studies have demonstrated 70-80% effectiveness in preventing tuberculosis following a single dose. This vaccine is not routinely utilized in the United States due to the low prevalence of tuberculosis and should never be given to transplant recipients. BCG vaccination may lead to false positive PPD results, though a patient’s BCG vaccination history should not be taken into account when determining whether or not to treat for latent TB. Besides being utilized as a vaccine, BCG is also used as intravesicular therapy for bladder carcinomas. However, its effectiveness in the transplant population is questionable and safety is of concern. BCG exhibits its anti-tumor activity by provoking production of Th1 cytokines, but this immune response is blunted in the transplant recipient due to immunosuppressive medications and therapy may actually increase the potential for rejection. Risks and benefits of treatment with BCG should be weighed against the risk for rejection and suboptimal response to treatment. The infectious risks associated with treatment are not clear.

Hepatitis A Vaccine

Indications for Hepatitis A Vaccine

• Chronic liver disease
• Persons who receive clotting factor concentrates
• Men who have sex with men
• Illegal drug use
• Persons working with hepatitis A virus (such as infected primates or a research laboratory)
• Persons traveling to or working in countries with high or intermediate rates of hepatitis A

Vaccine Side Effects

Mild symptoms include injection site soreness, headache, loss of appetite, or tiredness. Severe problems such as allergic reactions typically occur within a few minutes to hours after the shot and are rare.

Comments

Antibody titers are lower in patients with ESLD and after renal and liver transplantation compared with antibody titers in healthy control subjects and may decrease after solid organ transplant. Serologic response should be assessed 1–3 months after completion of the primary hepatitis A vaccine series and a single Hepatitis A vaccine booster dose should be administered to non-responders.

Hepatitis B Vaccine (HBV)

Indications for Hepatitis B Vaccine

• End-stage renal disease, including hemodialysis
• HIV
• Chronic liver disease
• Health-care and public-safety workers exposed to blood or other infectious body fluids.
• Sexually active persons not in a long-term, mutually monogamous relationship
• Seeking evaluation for STD
• Current or past injection-drug users
• Men who have sex with men
• Household contacts and sex partners of persons with chronic HBV infection
• International travelers to countries with high or intermediate prevalence of HBV

Vaccine Side Effects

Mild problems include injection site soreness and low grade fever. Severe problems are extremely rare. Severe allergic reactions are believed to occur approximately once in 1.1 million doses.

Comments

Liver transplantation performed for hepatitis-B-related cirrhosis is generally accompanied by long-term prophylaxis with hepatitis B immune globulin (HBIg) and/or lamivudine (or other oral agents active against HBV) to prevent recurrence of HBV infection. However, administration of long-term HBIg is expensive and antiviral resistance can develop to medications such a lamivudine. Numerous centers are assessing the possibility of vaccinating posttransplant liver recipients with HBV vaccine with the goal of truncating prophylaxis. While vaccine efficacy in these studies has been suboptimal, recent work involving adjuvants is promising . Current studies are underway to evaluate new adjuvants as well as a higher number of vaccine injections in an effort to stimulate an immune response. Patients with ESRD on hemodialysis have a decreased serologic response to vaccination, thus higher‐dose vaccine formulations (2-4 times the standard dose) have been developed. Patients with ESLD also produce lower antibody titers in response to vaccination and may benefit from the higher-dose hepatitis B vaccine. Hepatitis B surface antibody titers should be assessed 1–3 months after completion of the primary HBV vaccine series.15,26,32 For patients who do not respond to the initial HBV series (i.e., who have antibody titers 10 IU/L), administration of an additional 3, or 4dose series is recommended.  Although antibody titers may decrease after SOT, higher rates of protection are seen when vaccination occurs before SOT compared with rates of protection when vaccination occurs after SOT.  Hepatitis B surface antibody titers should be monitored after SOT and booster doses given once titers decrease below 10 IU/L.

Human Papilloma Virus (HPV) Vaccine

Indications for HPV Vaccine

Prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age preferably prior to transplantation.

Side Effects

Mild problems include injection site pain, itching, redness or swelling, mild-to-moderate fever (100-102 degrees F).

Comments

This vaccine utilizes the L1 major capsid protein of HPV for types 6, 11, 16 and 18, and is an vaccine. The recommendation for the vaccination of males is a recently approved indication.  The vaccine appears to be effective for prevention of persistent infection and cervical cancer due to the vaccine strains. Ideally, vaccine should be administered before potential exposure to HPV through sexual activity; however, males and females who are sexually active should still be vaccinated consistent with age-based recommendations. For optimal response, it is advisable to administer the HPV vaccine to pretransplant nonpregnant female transplant candidates between the ages of 9 and 26. The recommended gender and age may broaden when further data becomes available. History of genital warts, abnormal Papanicolaou test, or positive HPV DNA test is not evidence of prior infection with all vaccine HPV types thus vaccination is still recommended. Transplant recipients with anogenital HPV infection are at a significantly increased risk of cervical intraepithelial neoplasia and other anogenital malignancies (33) as well as warts and skin cancers. There are no currently published studies of immunogenicity of this vaccine in transplant recipients and candidates. Since it is an inactivated vaccine, it can be given after transplantation.

Influenza/FluMist Vaccines

Indications for Influenza Vaccine

• Chronic disorders of the cardiovascular or pulmonary systems
• Chronic metabolic diseases (DM, renal or hepatic dysfunction, hemoglobinopathies)
• Immunocompromising conditions including HIV
• Any condition that compromises respiratory function or the handling of respiratory secretions (e.g., cognitive dysfunction, spinal cord injury, seizure disorder or other neuromuscular disorder)
• Pregnancy during the influenza season
• Long-term care and assisted-living facilities employees -Caregivers of children less than 5 years old -Residents of long-term care and assisted-living facilities
• Persons likely to transmit influenza to persons at high risk -Anyone who would like to decrease their risk of getting influenza

FluMist Indications

• Healthy, nonpregnant adults aged less than 50 years without high-risk medical conditions who are not contacts of severely immunocompromised persons in special care units
• FluMist for H1N1 includes target groups listed above who meet these criteria
• Do NOT administer to transplant recipients

Vaccine Side Effects (Intramuscular)

Mild problems include soreness, redness, tenderness, or swelling at the injection site, fainting (mainly adolescents), headache, muscle aches, fever or nausea. They usually begin soon after the shot and last 1-2 days. Severe problems including life-threatening allergic reactions are very rare. If they do occur, it is usually within a few minutes to a few hours.

Vaccine Side Effects (FluMist)

Mild problems include runny nose, nasal congestion, cough, headache, muscle aches, fever, wheezing, abdominal pain, vomiting or diarrhea. Severe problems include life-threatening allergic reactions are very rare. If they do occur, it is usually within a few minutes to a few hours after the vaccination.

Comments

Seasonal influenza vaccine is approved for infants and children greater than 6 months of age. Pediatric transplant recipients do respond to influenza vaccines although their cellular responses may not be as vigorous as that found in healthy children (19) therefore household and close contacts should also be vaccinated. Pediatric solid organ transplant recipients 6-12 months of age should be a priority group for vaccination, given the lack of data on antiviral agents in infants < 12 months. Studies have revealed both adequate and impaired immune responses to the influenza vaccine in renal, heart, and liver transplant recipients (5, 20, 22, 49). Given that the risks of the trivalent inactivated vaccine are minimal, this vaccine should be administered annually to transplant candidates as well as recipients.

Meningococcal Vaccine

Indications for Meningococcal Vaccine

• Anatomic or functional asplenia, or terminal complement deficiencies
• First-year college students living in dormitories
• Microbiologists exposed to isolates of Neisseria meningitidis
• Military recruits
• Persons who travel to or live in countries in which meningococcal disease is hyperendemic or epidemic (e.g., the “meningitis belt” of sub-Saharan Africa during the dry season [December–June]), particularly if their contact with local populations will be prolonged
• Required by the government of Saudi Arabia for all travelers to Mecca during the annual Hajj -Pretransplant candidate’s ages 11-18-year-old

Vaccine Side Effects

Mild problems include injection site redness or pain may occur in nearly half of those vaccinated, usually lasting for 1 or 2 days. A small percentage of people who receive the vaccine develop a fever. Severe problems include allergic reactions which occur within a few minutes to a few hours of the shot and are very rare. Guillain-Barre Syndrome has been reported among some people who received MCV4. This happens so rarely that it is currently not possible to tell if the vaccine might be a factor.

Comments

The meningococcal conjugate vaccine (MCV 4) confers protection against meningococcal types A, C, Y and W-135, but not type B and is recommended for ages 11-54.14 For high-risk individuals ages 2-10 or >55, MPSV 4 (quadrivalent polysaccharide vaccine) should be administered (14). Immunogenicity of polysaccharide vaccines is limited under the age of 2 years; consequently, conjugated vaccines have been developed. ACIP has recommended that all 11-12-year-olds be immunized with MCV 4 at their preadolescent visit (14). College students who will be living in dormitories are at higher risk and should be offered the vaccine. Revaccination with MCV after 5 years might be indicated for adults previously vaccinated with MPSV 4 who remain at increased risk for infection (e.g., persons residing in areas in which disease is epidemic). As of yet, no comparative data on efficacy of MCV 4 and MPSV 4 in transplant candidates and recipients is available. It is reasonable to follow the guidelines for the general population as neither vaccine is a live vaccine

Measles Mumps and Rubella (MMR)

Indications for Measles Mumps and Rubella

Adults born before 1957 can be considered immune to measles. Adults born in or after 1957 should receive at least one dose of MMR unless they have a medical contraindication, documentation of at least one dose, history of measles based on health-care provider diagnosis, or laboratory evidence of immunity. A second dose of MMR is recommended for adults if:

• Exposed to measles or in an outbreak setting
• Previously vaccinated with killed measles vaccine
• Vaccinated with an unknown type of measles vaccine between 1963 and 1967
• Students in post-secondary educational institutions
• Work in health care facilities
• International travel

Adults born before 1957 can generally be considered immune to mumps. Adults born during or after 1957 should receive 1 dose of MMR unless they have a medical contraindication, a history of mumps based on health-care provider diagnosis, or laboratory evidence of immunity. A second dose of MMR is recommended for the following adults if:

• Age group is affected during a mumps outbreak in their community
• Students in post-secondary educational institutions
• International travel
• Work in health care facilities
• Unvaccinated health-care workers born before 1957 who do not have other evidence of mumps immunity (consider giving 1 dose on a routine basis and strongly consider giving a second dose during an outbreak)

One dose of MMR vaccine is recommended for women whose vaccination history is unreliable or who lack laboratory evidence of immunity against Rubella. For women of childbearing age, regardless of year of birth, rubella immunity should be determined. Women without evidence of immunity should receive MMR vaccine upon completion of pregnancy and before discharge from the health-care facility.

Vaccine Side Effects

Mild Problems include fever, rash, and glandular swelling in the cheeks or neck (rare). If these occur, it is usually within 7-12 days after vaccination. They occur less often after the second dose. Moderate problems include febrile seizures, joint pain and stiffness (mostly in teenage or adult women), temporary thrombocytopenia. Severe problems (rare) include allergic reaction, deafness, long-term seizure disorder, coma, or permanent brain damage. Whether these severe side effects are truly vaccine related is a matter of debate.

Comments

The measles, mumps, rubella vaccine is a live attenuated vaccine and should be administered, when indicated, prior to transplantation. Serologic testing for measles, mumps, and rubella is therefore recommended in all SOT candidates and additional MMR vaccination should be completed before transplantation in those adults who are seronegative. Immunity to rubella is particularly important in female transplant candidates who are of childbearing age because the risks of congenital rubella syndrome in those who may become pregnant outweigh the risks of the vaccine. The MMR vaccine has been proven to be safe in bone marrow transplant recipients and in patients with human immunodeficiency virus (HIV) infection and may eventually be proven safe after solid organ transplantation. However, until further evidence is available, MMR vaccination should not be given after transplant.

Pneumococcal Vaccine

Indications for Pneumococcal Vaccine

• Chronic lung disease (including asthma)
• Chronic cardiovascular diseases
• Diabetes mellitus
• Chronic liver diseases, cirrhosis; chronic alcoholism
• Chronic renal failure or nephrotic syndrome
• Functional or anatomic asplenia -Immunocompromising conditions
• Cochlear implants and cerebrospinal fluid leaks
• Residents of nursing homes or other long-term care facilities and persons who smoke cigarettes.
• One-time revaccination after 5 years is recommended for:
• Chronic renal failure or nephrotic syndrome
• Functional or anatomic asplenia (e.g., sickle cell disease or splenectomy)
• Immunocompromising conditions
• For persons > age 65, one-time revaccination if they were vaccinated 5 or more years previously and were < 65 years at the time of primary vaccination.
• Additional doses should be avoided to prevent the possible development of immune tolerance

Vaccine Side Effects

Approximately half have mild side effects, such as redness or pain. Less than 1 percent develops a fever, muscle aches, or more severe local reactions.

Comments

The traditional pneumococcal vaccine is a 23-valent polysaccharide vaccine (PPV23), which is not immunogenic in children under the age of 2. The 7-valent pneumococcal conjugate vaccine (PCV7) is licensed for infants 2 months and older, with a recommended primary dosing series of 2, 4, 6 and 12-15 months (60). Pretransplant vaccination is preferred given that the antibody response in SOT recipients is lower than that of patients with end-organ disease, whose response is lower than that of control subjects (6, 51, 62, 63) A randomized controlled trial of a single dose of PPV23 versus PCV7 in 60 renal transplant recipients demonstrated an improved response rate for two serotypes and mean titers were higher for two serotypes in the PCV7 group, but functional antibody responses were not significantly different (43). In a follow-up study of the same patients, titers declined significantly after 3 years with both PPV23 and PCV7. The authors concluded that PCV7 does not improve durability of response (44). In another study of transplant recipients between the ages of 2 and 18 years, two doses of PCV7 were followed by one dose of PPV23; age-matched controls received one dose of PCV 7 then PPV23. Although significant rises in serotype-specific pneumococcal antibodies were observed in both groups, transplant recipients had lower antibody responses, and heart transplant recipients had a lower response than liver recipients. These responses to PCV7 serotypes were not boosted by the 2nd PCV7 or the PPV23 vaccine (46). More studies are needed to determine the optimal number of doses and interval between doses in the transplant population.

Tetanus, Diphtheria and Pertussis (DTaP, Td and Tdap) Vaccine

Indications for Tetanus, Diphtheria and Pertussis

• DTaP vaccination is one of the recommended childhood immunizations.
• DTaP vaccine can be safely given to infants
• Five DTaP injections are recommended and are usually given to children at ages 2 months, 4 months, 6 months, 15-18 months, and 4-6 years
• DTaP immunization is generally required before a child can start school
• Tdap vaccine is recommended for children around ages 11 – 12
• Adults ages 19 – 64 should receive one dose of TDaP as a substitute for the Td vaccine
• Td can be used for the 10 year booster once adults have received the TDaP booster

Vaccine Side Effects

Mild problems include fever, redness, swelling or injection site soreness. These problems occur more often after the 4th and 5th doses. Sometimes the 4th or 5th dose of vaccine is followed by swelling of the entire arm or leg in which the shot was given, for 1 to 7 days. Other mild problems include tiredness or poor appetite and vomiting. These problems generally occur 1 to 3 days after the vaccine. Other more significant problems include seizure and high fever.

Comments

There is no data on the incidence or severity of tetanus, diphtheria, or pertussis in transplant recipients. Tetanus, diphtheria and pertussis immunization is part of the routine vaccination series for infants and young children, but until recently adolescents and adults received only booster doses of tetanus-diphtheria (Td) vaccine. However, pertussis immunity wanes 5-10 years after initial immunization (42). In 2005, the Tdap vaccine was licensed in the US for persons 11-64 years of age. Currently, the ACIP recommends a single dose of Tdap as a booster for adults whose last Td was >10 years ago, for health-care workers and for persons who are in close contact with infants <12 months of age. Tdap can be given as little as 2 years (or shorter intervals in special siuations) after Td vaccine in high-risk persons (42). Currently a single booster with Tdap is indicated, with future tetanus vaccinations being the Td vaccine. In accordance with ACIP guidelines for the general public, it would make sense to vaccinate transplant candidates with Tdap during the pretransplant evaluation when the clinician would otherwise administer a Td booster. Tetanus and diphtheria vaccination appears to be safe and immunogenic in pediatric populations with ESRD and/or ESLD and in pediatric SOT recipients (3, 21); however, accelerated loss of diphtheria antibodies has been seen in the early posttransplant period. Tdap is not a live vaccine and therefore could theoretically be given to posttransplant patients, though its efficacy in this population is unknown.

Varicella Zoster Vaccine

Indications for Varicella Zoster Vaccine

• All adults without evidence of immunity to varicella should receive 2 doses if not previously vaccinated or the second dose if they have received only one dose
• Special consideration should be given to those who:

1. Close contact with persons at high risk for severe disease (e.g., health-care personnel and family contacts of persons with immunocompromising conditions)
2. High risk for exposure or transmission (e.g., teachers; child care employees; residents and staff members of institutional settings, college students; military personnel; adolescents and adults living in households with children; nonpregnant women of childbearing age; and international travelers)

Vaccine Side Effects

Mild problems include injection site soreness or swelling, fever, mild rash (up to a month after vaccination). It is possible for these people to infect other members of their household, but this is extremely rare. More significant problems include seizures (often febrile) and pneumonia.

Comments

Greater than 95% of U.S. born adults is immune to VZV. Serologic testing may be performed as a cost-effective way to determine if vaccination is indicated. Evidence of immunity to varicella in adults includes any of the following: -Documentation of 2 doses of varicella vaccine at least 4 weeks apart -US born before 1980 (for health-care workers and pregnant women, birth before 1980 should not be considered evidence of immunity) -A health-care provider diagnosis of varicella or verification of history of varicella (for patient reporting a history of or presenting with an atypical and/or mild case, health-care providers should seek either an epidemiological link with a typical varicella case or evidence of laboratory confirmation, if it was performed at the time of acute disease) -History of herpes zoster based on health-care provider diagnosis or verification of zoster by a health-care provider -Laboratory evidence of immunity or laboratory confirmation of disease

Transplant candidates can be considered to be a high‐risk group for whom VZV vaccination is highly recommended. Varicella vaccine, a live-attenuated vaccine, was traditionally considered contraindicated in posttransplant patients (28). Every effort should be made to vaccinate seronegative patients prior to transplant. Despite these efforts, however, some patients will still be found to be seronegative after transplantation. Varicella vaccination has been studied in pediatric renal‐transplant candidates with good safety and effectiveness (8, 9). Varicella vaccination has also been studied in pediatric SOT recipients and has demonstrated safety and effectiveness (38, 67); however, some studies have demonstrated that a few children will develop mild varicella disease after vaccination. Use of the varicella vaccine in adults after SOT requires further study before it can be recommended.

Zoster Vaccine (Herpes Zoster Vaccine)

Indications

All adults age 60 years and older should receive one dose of herpes zoster vaccine whether or not they report a prior episode of herpes zoster.

Vaccine Side Effects

Mild problems include redness, swelling, or itching at the site of the injection and headache.

Comments

Herpes zoster (shingles) represents the reactivation of varicella-zoster virus (VZV) acquired during primary varicella infection earlier in life. This vaccine contains 19,400 PFU of the Oka/Merck strain of VZV, the same live virus strain used in varicella vaccine for children and adults but with14 time’s higher amount of antigen (56). A randomized trial of over 38,000 adults demonstrated a reduction in herpes zoster of >50% (56). In zoster victims who previously received the herpes zoster vaccine, the risk of post herpetic neuralgia (PHN) is reduced by 39% (overall reduction of PHN is 67% in all vaccine recipients compared with placebo). These benefits are thought to be a result of boosting the immunity to herpes zoster virus, leading to suppression of reactivation of VZV in the dorsal root (sensory) ganglia. The ACIP recommends the zoster vaccine specifically for “persons anticipating immunosuppression”. They suggest that the zoster vaccine be administered 14 days before immunosuppressive agents are initiated with the caveat that some experts advise a period of 1 month between administration of live vaccines and immunosuppression (1, 35). The duration of protection against shingles in unknown but is at least 4 years. Clinical manifestations in transplant recipients vary from a painful, blistering, uni- or multi-dermatomal eruption to a severe, sometimes fatal form with cutaneous and/or visceral dissemination (55). Presentation with abdominal pain and without rash is a particularly challenging diagnostic dilemma. ACIP recommendations call for a single dose of zoster vaccine for individuals ages 60 and above, whether or not they report a prior episode of herpes zoster, unless a contraindication exists (1). According to licensing information, contraindications include immunodeficiency states and immunosuppressive therapy, as well as pregnancy and active tuberculosis (65). As with other live vaccines, the herpes zoster vaccine is currently contraindicated after transplantation; thus, every effort should be made to complete zoster vaccination before transplantation. However, if the zoster vaccine is given to immunocompromised individuals who already have some cellular and humoral immunity to VZV infection as measured by VZV antibodies, vaccination with the live‐virus vaccine might be less dangerous (though further studies are warranted to clarify this issue). Some centers currently recommend that the herpes zoster vaccine be given to all adult SOT candidates with evidence of immunity to varicella, regardless of age, if transplantation is not imminent (within 2 months). There is growing evidence that varicella vaccine may be safe, particularly, in seronegative pediatric transplant recipients who are not in the early posttransplant phase and who are clinically stable, but case reports suggest that the vaccine is not necessarily safe for all posttransplant patients. Larger studies would be helpful to identify the population of transplant recipients in whom varicella vaccine is indicated

CONCLUSION

Despite emerging evidence that vaccination is in general safe and effective among immunosuppressed patients, most vaccines are still underutilized in transplant candidates and recipients (30). The following general principles apply:

(i) Immune response is best when the vaccine is administered prior to the start of immunosuppression

(ii) The efficacy of the vaccination, as measured by antibody response, is usually decreased compared to normal subjects

(iii) Effective protection from the vaccination can be lost at an earlier time

(iv) Live attenuated vaccines are usually contraindicated

Solid-organ recipients will benefit from consistent immunization practices and transplant centers are encourage to be proactive, especially pre-transplant. Most inactivated vaccinations appear safe in solid-organ transplant recipients, and the side effects are minimal and self-limited. Live attenuated vaccinations require further studies to determine safety of routine use after transplant, though pretransplant they are effective and typically indicated. Appropriate timing of vaccination is important so patients may have the best opportunity to mount a robust immune response. Influenza vaccine should be given annually both before and after transplantation, while most other vaccines will not require such long term diligence. Further vaccine related studies are necessary to improve established protocols and help determine efficacy and safety in this most complex patient population.

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Table 1. Adult and Pediatric Immunizations

Vaccine		Adult (A)/ Pediatric (P)/ Both (B)	Inactivated/ Live Attentuated (I/LA)	Recommended Before Transplant	Recommended After Transplant	Monitor Vaccine Titers?
Anthrax		A	I	No*	No	No
BCG		A	LA	No*	No	No
Hepatitis A		B	I	Yes	Yes	Yes
Hepatitis B		B	I	Yes	Yes	Yes
Human papilloma virus (HPV)		B (females only)	I	Yes	Yes	No
Influenza (IM)^		B	I	Yes	Yes	No
Influenza (Nasal)^		B	LA	Yes	No	No
N. meningitides (MCV4)		B	I	Yes	Yes	No
Pertussis (TDaP)		B	I	Yes	Yes	No
Polio (IM)		B	I	Yes	Yes	No
Rabies		B	I	No*	Yes	No
Rotavirus		P	LA	Yes	No	No
Smallpox		A	LA	No*	No	No
S. pneumoniae (conjugate vaccine)		P	I	Yes	Yes	Yes
S. pneumonaie (Pneumovax)		B	I	Yes	Yes	Yes
Tetanus, Diphtheria, Pertussis (DTaP, Td)		B	I	Yes	Yes	No
Varicella (Varivax)		B	LA	Yes	No	Yes
Zoster (Zostavax)		A	LA	Yes	No	No

IM = Intramuscular            
* Not routinely recommended in Usa for most patients
^Includes both seasonal and h1n1

Table 2. Health Care Workers, Close Contacts, Household Members

Vaccine	INactivated/	Recommended before transplanta	Recommended after transplant
	Live attentuated
	(I/LA)
H. influenzae	I	Yes	Yes
Hepatitis A	I	Yes	Yes
Hepatitis B	I	Yes	Yesb
Influenza	I (IM)	Yes	Yes
	LA (FLUMIST)	Yes	No
Measles	LA	Yes	Yes
Mumps	LA	Yes	Yes
Pertussis (Tdap)	I	Yes	Yes
Rubella	LA	Yes	Yes
Varicella	LA	Yes	Yes

 

Table 3.   Vaccinations in Patients with Solid Organ Transplantation (20)

Vaccine	Recommendations
BCG	Contraindicated
Diphtheria, Tetanus, Pertussis	Before and after transplantation
Haemophilus	Before and after transplantation
Hepatitis A	For travelers to endemic areas before and after transplantation
Hepatitis B	Before and after transplantation
Influenza	Patients and family members before and after transplantation
MMR	Before transplantation
Pneumococcal	Before and after transplantation
Polio (oral)	Contraindicated
Vaccinia	Contraindicated in patients, household members, transplant health-care workers
Varicella	Controversial
Yellow Fever	Contraindicated

 

Table 4. Travel Vaccines (See www.cdc.gov/travel for country specific recommendations)

Vaccine	INactivated/	safe before transplant	safe after transplant	MONITOR VACCINE TITERS
	Live attentuated
	(I/LA)
Dukoral (Cholera)	I	Yes	Yes	No
Japanese encephalitis	I	Yes	Yes	No
Salmonella typhi	I (IM)	Yes	Yes	No
	LA (oral)	Yes	No	No
Vibrio cholerae	I	Yes	Yes	No
	LA	Yes	No	No
Yellow fever	LA	Yes	No	No

 

 

 

 

 

 

 

 

 

Table 5. Vaccine Overview

Vaccine	Indications	Ages	Primary Series	Catch-up	Live virus	Comments
Haemophilus influenza B	All children	>6 weeks of age	2m, 4m, 6m, 12-15m	Variable	No	Not routinely given once >5 years old
Hepatitis A	All children, travelers, high risk groups, post-expsure	>1 years old	2 doses 6 months apart	2nd dose can be given anytime after 6 months.  Repeating entire series not indicated	No	Antibody titers recommended to ensure protection
Hepatitis B	All children, travelers, high risk groups	All	3 doses at 0, 1 and 6 months.	Ok to administer 6 month dose at a later interval but need to confirm antibody response	No	Antibody titers recommended to ensure protection, a repeat 3 shot series often needed.  No indication for more than 2 vaccination series
Herpes zoster	Adults  age >60	>60	1 dose	NA	Yes
HPV	Females age 11-26	11-12	0,2, 6 months	Must be at least 24 weeks between doses #2 and #3	No
Influenza Flumist (seasonal)	All children 2-18 years and all high risk patients	>2 years of age and <50	Yearly	If first flu vaccine, 2nd dose required 4 weeks later	Yes
Influenza IM (seasonal)	All children 6mos -18 years and all high risk patients	>6 mos of age	Yearly	If first flu vaccine, 2nd dose required 4 weeks later	No
Influenza Flumist (H1N1)	All children 2-18 years and all high risk patients	>2 years of age and <50	NA	If first flu vaccine, 2nd dose required 4 weeks later	Yes
Influenza IM (H1N1)	All children 6mos -18 years and all high risk patients	>6 mos of age	NA	If first flu vaccine, 2nd dose required 4 weeks later	No
MMR	Everyone	>12 months	#1 12-15mos, #2 4-6 years	Must space 2 doses at least 4 weeks apart.	Yes
Meningococcal (Menactra* or Menomune)	Menactra age 11 or later  and to unvaccinated college students	Menomune if ages 2-10 or >55	1 dose	NA	No
Pneumococcal	All pediatrics but only high risk adults	Conjugate (PCV) vaccine < 5 yo; polysaccharide (PPSV) vaccine >2 yo	PCV 2m, 4m, 6m, 12-15m; PPSV at any age >2, repeat dose 5 years later	PCV catch-up varies, 2nd dose of PPSV can be given at any interval after 5 years	No
DTaP	Everyone	Ages 0-10	5 doses; 2m, 4m, 6m, 15-18m,4-6 yrs		No
Tdap	Used for DTap booster once >11 yo	Age >11	Booster every 10 years	Use Td vaccine at weeks 0, 2, 24 then every 10 years.  1 dose of Tdap during series is acceptable	No
Varicella	Age >12 months and no history of Varicella infection	>12 months	Dose #1 at 12 months, #2 after age of 4.	2nd dose can be given at any interval after first dose	No

 

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