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Dirk Albrecht and Thomas Weitzel

The increased morbidity and mortality of infectious diseases are key features of HIV infection; vaccination and immunoprophylaxis can make an important contribution to their prevention. However, adverse effects and vaccination failure are also increased in HIV patients. Indications and timing of vaccination should therefore be individually tailored.

As vaccination responses decline with decreasing immune status, indications for vaccination should be considered early after HIV diagnosis (see chapter The New HIV Patient). In patients with poor immune status, vaccinations generate little response or are even contraindicated. In these cases, the immunization status of close contact persons should be checked for completeness, routes of exposure to infectious agents should be discussed with the patient and minimized, in some situations passive immunizations should be considered. After a rise in CD4-cells under ART, indications should be reconsidered, some vaccinatinations repeated.

Vaccination recommendations should always take into account the national guidelines, which reflect the strategies for preventing infectious diseases that might differ from country to country. Also, the availability of vaccines may vary. This chapter is, to a certain extent, based on the German standards and the vaccines marketed in Germany.

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Assessing the protective effect of a vaccination § Poor immune status at the time of vaccination decreases the likelihood of developing a protective response. As a general rule, CD4+ T-cell counts < 300/µl may result in a reduced response to immunization; at < 100/µl, significant immunization effects are improbable (Rousseau 1999). ART-mediated immune reconstitution effects require a dynamic approach to vaccination strategies. Consequently, vaccinations should be reconsidered if CD4+ T-cells rise to > 200/µl in patients on ART. Nevertheless, even after immune reconstitution, the CD4+ T-cell nadir might influence the effectiveness of vaccination (Lederman 2003). § In addition, history taking should include individual risk and current status of protection: Sexual behavior? Contacts to people carrying a particular infection? Travel? Frequent contacts with children? Is a prior infection documented or likely? Are prior vaccinations documented? Depending on their immune status, a poorer response to previous vaccines and an accelerated decline of protective immunity over time must be expected in HIV patients. Antibody titer controls should be considered more frequently than in healthy individuals. Assessing the risk of a vaccination Following a vaccination, a rise in viral load is often observed (e.g for tetanus, pneumococcus, influenza, HBV). This effect reflects the stimulation of cellular immunity; viral replication peaks one to three weeks later. Thus, a routine viral load should not be performed within four weeks of vaccination. Numerous studies demonstrated that these viral load elevations are immunologically and clinically irrelevant. However, one study of influenza vaccinees showed 2 out of 34 patients whose HIV strains developed new RT- or protease-gene mutations (Kolber 2002). This risk should be considered in patients with limited therapeutic options. Furthermore, elevations of viral load might lead to an increased risk of materno-fetal transmission during pregnancy. Apart from that, adverse effects of inactivated vaccines are not increased in HIV patients. With live vaccines, however, life-threatening and fatal complications have been reported for smallpox, tuberculosis, measles, and yellow fever. Indications for live vaccines in HIV patients should be carefully examined. Vaccination of contacts Whenever HIV patients are susceptible to vaccine-preventable infections, particular care should be taken to vaccinate close contacts, who, after gaining protective immunity, will not transmit the disease. However, if contacts are vaccinated with certain live vaccines (e.g. oral polio vaccine), the HIV patient is at risk of acquiring vaccine-associated illness. Thus, oral polio vaccination of contact persons is contraindicated and the inactivated vaccine should be used. Secondary transmission of MMR or varicella following vaccination is very unlikely; only if contacts develop vaccine-associated varicella, the HIV patient should receive acyclovir prophylaxis. Vaccinations in HIV-infected children HIV-infected children should be vaccinated according to national children vaccination schedules, with the following exceptions for live vaccines: (1) In children with severe immunodeficiency, as defined by CD4+ T-cell counts < 750/µl (0-12 months old), < 500/µl (1-5 years old), and < 200/µl (> 5 years old), or by relative CD4 counts < 15 %, MMR vaccination is contraindicated. (2) In immunodeficient children, varicella vaccination is contraindicated; in this case, guidelines vary to the extent of immunosuppression: while German guidelines still set the threshold for contraindication at relative CD4+ T-cells < 25 % (STIKO 2005), the US recently adopted a strategy in analogy to MMR supporting the vaccination of children with >15% CD4+ T-cells (Kroger 2006). A possible strategy to avoid unnecessary live vaccines is to predict their probability of success by measuring the response to inactivated vaccines: if there is no measurable response to diphtheria/tetanus booster, a benefit from live vaccines such as MMR or varicella is unlikely, even if CD4+ T-cell counts are higher than the above mentioned limits (Tim Niehues, pers. comm.). In these cases, immunoglobulin prophylaxis might be useful. HIV-infected children should receive a series of the 7-valent pneumococcal conjugate vaccine, starting in the third month of life, and supplemented by the 23-valent-polysaccharide vaccine after the second year of life (Mofenson 2005). Postexposure prophylaxis In susceptible individuals, the risk of infection and/or disease severity can be reduced by postexposure prophylactic measures. These include active and passive immunizations as well as chemoprophylaxes. Usually, the time between exposure and beginning prophylactic measures is crucial and should be minimized. Table 2 provides an overview of reasonable postexposure prophylaxis regimens in HIV patients. Practical approach to vaccinations Informed consent: HIV patients should be circumstantially informed regarding the benefits and risks of vaccines, with particular attention to HIV-related vaccine problems. Some countries might require written information material and/or a written informed consent. Vaccine information statements in different languages are available via the Internet (e.g. www.immunize.org). Timing of a vaccination: Vaccination should be postponed in the presence of a moderate to severe acute infection; a mild infection might be ignored. Live vaccines such as MMR, varicella or yellow fever have to be given either simultaneously or at least four weeks apart from one another. Live vaccines should not be administered within three months after a dose of immunoglobulin. When viral load measurements are crucial for decisions on ART, vaccinations should be postponed. Primary vaccination series or booster: In general, a primary vaccination schedule is only necessary when no prior vaccination is reported or documented; an incomplete primary series should be completed, but not repeated (consider titer controls). Route of application: Vaccination routes are recommended by the manufacturer of each vaccine. High immunogenicity and few complications make intramuscular injections the preferable route of application for the majority of vaccines. The most recommended site is the deltoid muscle, in infants the anterolateral thigh. Many water-soluble vaccines can also be administered subcutaneously. In hemophiliacs, subcutaneous vaccination followed by thorough compression of the injection site for > 2 minutes usually allows vaccination without the coadministration of clotting factors. Only a few vaccines require subcutaneous injection, including meningococcal polysaccharide, Japanese encephalitis, yellow fever, and varicella vaccines. Intradermal rabies vaccination, which is licensed in some countries, should not be performed in HIV patients due to reduced immunogenicity (Tantawichien 2001). Details on individual vaccines Tetanus/Diphtheria/Pertussis: Following a primary series during childhood, lifelong protection should be maintained by boostering at regular intervals. According to a Danish study (Kurtzhals 1992) and our own experiences in Germany, adult HIV patients frequently have insufficient protection against diphtheria. Depending on their CD4+ T-cell count, HIV patients have a reduced booster response and an accelerated antibody waning (Moss 2003). Whenever possible, tetanus-diphtheria combination vaccines should be used, which, in Germany, are also available in combination with polio and/or pertussis. In the context of a rising incidence of pertussis in adolescents and adults, boostering with acellular pertussis vaccine in adolescents has recently been recommended, and is under discussion for adults (Halperin 2005). Since the adult pertussis booster vaccines are exclusively available in the above-mentioned combinations in Germany as well as in other countries, their use should be considered when tetanus/diphtheria vaccines are given. Pneumococcal: Even under ART, HIV patients have an increased risk of invasive pneumococcal infections (Barry 2006), which can be reduced by a vaccination (Breiman 2000, Grau 2005). However, in patients with CD4+ T-cell counts < 500/µl, the response to pneumococcal polysaccharide vaccine was decreased (Weiss 1995), and a double-dose booster did not induce a better response (Rodriguez-Barradas 1996). Similar observations were made with the conjugate vaccine in HIV-infected adults and children (Ahmed 1996, Mahdi 2005). According to current recommendations, HIV patients with CD4+ T-cells > 200/µl should receive pneumococcal vaccination as early as possible after their HIV diagnosis (Benson 2004, Kroger 2006, DH 2006). In patients with CD4+ T-cell counts < 200/µl, the effectivity of the vaccine is uncertain, but vaccination should be considered; after a stable rise to > 200/µl under ART, pneumococcal vaccination should be repeated. Infants from 3 months to 2 years of age should be vaccinated with the 7-valent conjugate vaccine, supplemented by the 23-valent polysaccharide vaccine at age > 2 years. Confusing data arose from a prospective randomized study on 1,392 HIV patients in Uganda, which reported an increased incidence of pneumococcal infections in the vaccine group (French 2000). Long-term follow-up of the initial patient collective, on the other hand, showed reduced mortality in the vaccine group; thus, the effects of pneumococcal vaccination in an African setting on patients without ART is currently unclear (Watera 2004). Influenza: Among HIV patients, an increased incidence of influenza has not been found, but complications and severe courses are more common and increased mortality has been observed (Lin 2001). The vaccine is safe and effective in HIV patients (Yamanaka 2005), should be given annually and is recommended from the 6th month of life (Smith 2006). In children under ten years of age, the first vaccination should include two doses at a 4-week interval. When CD4+ T-cells are < 100/µl, a response is rarely measurable, and it is unclear whether the benefit outweighs the cost (Rose 1993). The intranasal live vaccine is not licenced for HIV patients. Hepatitis B: All HIV patients seronegative to HBV should be vaccinated; as the combination vaccine with hepatitis A is advantageous with regard to price and possibly immunogenicity (Van der Wielen 2006), indication for hepatitis A vaccination should be considered in this context. The vaccination response rate and durability, being generally reduced in HIV patients, correlate with CD4+ T-cell counts; thus, vaccination should be performed early after HIV diagnosis (Laurence 2005). Immuno reconstitution under ART increases vaccination response (Wonk 1996) as does viral load suppression (Overton 2005). The immune response should be monitored by anti-HBs levels 4-8 weeks after the last dose: anti-HBs levels > 100 IE/l indicate protective immunity; a booster should be performed after ten years. With levels < 100 IE/l, the response is inadequate and an immediate booster should be performed followed by another antibody control. Immune response can be increased through repeated immunization, increased vaccine doses and adjuvants (Cooper 2005, Brook 2006). The increased-dose vaccines recommended e.g. for dialysis patients have lower failure rates in HIV patients (Fonseca 2005), and should be considered in non-responders. In patients with isolated anti-HBc, a constellation occasionally observed in HIV patients, an HBV vaccine should be given (Gandhi 2005); if after the first vaccine dose anti-HBs is detectable, a prior hepatitis B infection should be assumed and the vaccination cycle does not need to be completed. Hepatitis A: This infection is common among HIV patients (Fonquernie 2001). The vaccine is indicated in patients with chronic liver disease or increased risk of exposure, in some countries it recently even became part of the general child vaccination schedule. Routine pre-vaccination serology (HAV IgG) is not generally recommended, but can be considered in patients with possible prior exposure (e.g. Germans born before 1950). A combination with HBV is available and reduces costs. Measles: As measles can cause severe disease in HIV patients (Kaplan 1992), susceptible patients should be vaccinated whenever possible. The status of protection should be checked prior to trips in endemic areas (see chapter on Travel). Unless two vaccinations are documented, a serological test should be performed. In the US, persons born before 1957 are considered immune. The vaccine is contraindicated in symptomatic HIV infection and/or with CD4+ T-cell counts < 200/µl or < 14 % (in children: age-specific thresholds, see above). In Germany, usually MMR is used. For susceptible patients, immunoglobulin is indicated post- and in certain high-risk situations even prior to exposure. Yellow fever: Information on the effectivity and safety of yellow fever vaccine in HIV patients is only available from < 50 patients, all with CD4+ T-cell counts > 200/µl (Goujon 1995, Receveur 2000, Tattevin 2004). These limited data indicate good tolerability, but reduced rates of seroconversion. One case report describes fatal encephalitis in a patient with a very low CD4+ T-cell count, who was asymptomatic at the time of vaccination (Kengsakul 2002). International recommendations state that vaccination is possible when HIV patients are asymptomatic, have a good immune status, and exposure can not be avoided (Cetron 2002); in daily practice, CD4+ T-cell counts > 200/µl are often used as cutoff (Schuhwerk 2006). Due to reduced response rates, titer controls might be useful. We recommend the documentation of seroconversion in a paired serum sample (before, and 2-3 weeks after vaccination). If vaccination is contraindicated, a medical waiver should be issued to patients traveling to countries where yellow fever vaccination is mandatory. For the population in endemic areas, the WHO recommends vaccine use even in areas with high HIV prevalence (Moss 2003). Human Papillomavirus (HPV): Recently, an inactivated HPV vaccine was introduced for young women (ACIP 2006). Due to the increased risk for HPV-associated tumors, this vaccine could be relevant for HIV patients; however, so far there are insufficient data. Rotavirus: Since 2006, two live vaccines for infants are available, but not yet generally recommended. In infants with immunodeficiency, severe and chronic rotavirus infections are described; thus, according to US recommendations vaccination can be considered (Parashar 2006). Further studies on the safety in HIV-infected children should be awaited. The following Tables give an overview over current vaccines and recommendations. In Table 1, HIV-specific recommendations can be distinguished as follows: · A: in HIV patients generally recommmended · B: in HIV patients applicable independent of immune status · C: in HIV patients applicaple depending on immune status · D: in HIV patients contraindicated Table 2 lists postexposure vaccinations and prophylaxes. Table 1: Vaccines and their indications in HIV patients Vaccine1 Vaccine type2 Indication3 Recommendation in HIV Comments Cholera I. inactivated + toxoid II. live travelers with high risk of exposure4 I. B II. D I: also limited protection against some forms of travelers' diarrhea Diphtheria toxoid generally recommended B reduced dose after 6th tyear of life Hemophilus influenzae b (HiB) polysaccharide generally recommended in childhood; asplenia B consider in unvaccinated HIV patients (Kroger 2006) Hepatitis A inactivated chronic liver disease increased risk of exposure B Hepatitis B recombinant antigen generally recommended in childhood A Influenza I: inactivated/ fractionated antigen II: live (intranasal) chronic disease, age > 60 years, high transmission risk I. B II. D year-specific antigen combination according to WHO Japanese encephalitis inactivated travelers with high risk of exposure4 B Measles live attenuated generally recommended in childhood susceptible travelers5 to endemic areas C susceptible HIV-patients5 Meningococcal (groups A, C, W135, Y) I. 2-/4-valent polysaccharide II.2-/ 4-valent conjugate generally recommended in childhood immunodeficiency (e.g. complement deficiencies, asplenia); travelers with high risk of exposure5 I + II: B no protection against serotype B (high prevalence in Europe and Brazil) mandatory for pilgrims to Saudi-Arabia Mumps live attenuated generally recommended in childhood susceptible persons5 with frequent contact to children C Pertussis purified acellular antigens generally recommended in childhood in some countries lifelong booster (every 10y) B booster available only in combination vaccines Pneumococcal I. 23-valent polysaccharide II. 7-valent conjugate general recommendation for chronic disease, immunodeficiency, age >60 years I + II: A I: 2 years and older II: 2 months to 5 years protection only against subset of the naturally occurring strains Poliomyelitis I. inactivated (IPV) II. live (OPV) children: generally recommended adults: increased risk of exposure (e.g. health care, travel to endemic areas): boost after 10 y I. B II. D Rabies inactivated occupational risk of animal contact travelers with high risk of exposure4 B often poor response, serological testing recommended, no intradermal vaccination Rubella live attenuated generally recommended in childhood susceptible persons5 with frequent children contact, susceptible women5 of child-bearing age C Smallpox live attenuated controversial D (for prophylaxis) HIV patients should avoid contact with vaccinees for 2 weeks (risk of transmission of vaccine strain) Tetanus toxoid generally recommended B Tick-borne encephalitis (TBE/FSME) inactivated inhabitants of and travelers to endemic regions with risk of tick exposure occupational exposure B consider regional distribution profile European TBE vaccine is probably protective against RSSE (Hayasaka 2001) Tuberculosis live BCG-strain varying strategies D Typhoid fever I. polysaccharide II. live travelers with high risk of exposure4 I. B II. D Varicella live attenuated generally recommended in childhood/adolescence susceptible persons5 with frequent contact to children or immunosuppressed patients susceptible women5 of child-bearing age C Yellow fever live attenuated travelers to endemic areas travel requirements in some countries! C vaccination only in authorized institutions 1. Combination vaccines should be used whenever possible 2. Not all vaccines are licenced or available in all countries 3. Also observe national vaccination guidelines and manufacturer's recommendations 4. If in doubt, seek travel medicine advice 5. Susceptible: No documented history of the disease, no prior vaccination, no specific antibodies in serological test Table 2: Postexposure vaccines and chemoprophylaxes for HIV patients Disease Type of prophylaxis Indication1 Comments Diphtheria I. active immunization II. chemoproph. close / face-to-face contact with a case patient I. if last vaccination > 5 y II. independent of immunization status II: e.g. erythromycin 4x 500 mg/d x 7-10 d Hemophilus influenzae b chemoproph. patients with immunosuppression or persons from their close environment after close contact with a case patient rifampicin 1x 600 mg/d x 4 d Hepatitis A I. active immunization II. simultaneous immunoglobulin I: every exposure of a susceptible person2 II: additionally in patients at risk of severe course (e.g. HBV- or HCV-infection) Hepatitis B I. active immunization/booster II. simultaneous immunoglobulin5 protection status after percutaneous exposure3: insufficient: I+II partial: I complete: not needed Influenza I. active immunization II. chemoproph. I: community outbreak with strain covered by vaccine II: direct exposure of any unvaccinated HIV patient; in patients with severe immunodepression independent of their immunization status II: Influenza A or B: oseltamivir: 1x 75 mg/d x 10d (alternative: zanamivir: 1 x 10 mg/kg/d x 10d; not ubiquitously licenced for prophylactic use) Measles I. active immunization/booster II. (simultaneous) immunoglobulin I: exposure of a susceptible person2 II: exposure of a susceptible person2 with more than mild immunosuppression, when response to active immunization is unlikely or immunization is contraindicated active immunization within 72 hours of exposure consider contraindications for vaccination! Meningococcal I. active immunization II. chemoproph. following an index case: I: according to health authorities II: all household members; persons in contact with oropharyngeal secretions; close contacts in child-care centers, dormitories II: aim <24h after exposure; consider within 14d; (index case was infectious 7d prior to symptoms!) rifampicin 2x 600 mg/d x 2 d or ciprofloxacin 1x 500 mg or ceftriaxone 1x 250 mg i.m. Mumps active immunization exposure of a susceptible person2 active immunization within 3 (-5) days of exposure consider contraindications or vaccination! Pertussis I. active immunization II. chemoproph. I: exposure with incomplete immunization II: close contacts, e.g. household contacts II: within 7 days of exposure macrolides, e.g clarithro-mycin, 2 x 500mg/d x 7 d Polio I. active immunization any exposure independent of immunization status avoid delays! Rabies I. active immunization/booster II. simultaneous immunoglobulin5 according to national or local recommendations HIV: consider double dose of active vaccine on day 0, consider immunoglobulin more liberally in immunosuppressed patients Rubella active immunization exposure of a susceptible person2 within 5 days of exposure consider contraindications for vaccination! Tetanus I. active immunization/booster II. simultaneous immunoglobulin5 I: vaccine status unknown, incomplete primary series or last booster > 5 years ago II: unknown, 0 or 1 dose of primary series or 2 doses of primary series and > 24 hours between injury and booster after minor, clean wounds: booster only if last is > 10 years ago; simultaneous immunoglobulin not needed Tuberculosis chemoproph. HIV patient after contact with open TB case treat in analogy to latent TB (see TB chapter) Varicella I: active immunization II: simultaneous immunoglobulin5 III: chemoproph. I: exposure4 of a susceptible patient1; II/III: exposure4 of a susceptible patient1 with more than mild immunosuppression I: up to 5 days after exposure or 3 days after beginning of exanthema; consider contraindications; not in combination with II/III! II/III: consider < 96h post exposure III: consider >96h post exposure (e.g. acyclovir 4 x 800 mg x 5 d) 1. always also observe national guidelines and licensure status 2. susceptible: No documented history of the disease, no prior vaccination, no specific antibodies on serological testing. 3. hepatitis b protection status: (if available within 48 hrs, test anti-HBs titer) complete: good responder and last dose < 5 years ago; or anti-HBs > 100 IE/ml within the last 12 months partial: good responder and last dose > 5, but < 10 years ago; or current anti-HBs documented > 10 (but < 100) IE/ml insufficient: anything less than partial or complete protection good responder: anti-HBs documented > 100 IE/ml after primary series 4. chickenpox exposure: face-to-face contact, household contact, > 1 hour in the same room; zoster exposure: direct contact with skin lesions or their secretions. 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