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| Vaccinations in Adult Patients
| VACCINES
Haemophilus Influenzae Type B Vaccines
Before 1995, Hib was responsible for thousands of cases of serious illnesses (e.g., meningitis, epiglottitis, pneumonia, sepsis, and septic arthritis). The incidence of Hib disease has declined more than 99% since introduction of the conjugate vaccines based on the organism's capsular substance, polyribosylribitol phosphate (PRP).
The Hib vaccines used are conjugate products consisting of either a polysaccharide or an oligosaccharide of PRP covalently linked to a protein carrier. The protein carrier is important because it provides for T-lymphocyte–dependent immunologic response, whereas earlier Hib vaccines that consisted of only unconjugated PRP elicited a response that was T-cell independent. T-cell involvement in the response provides for (a) a greater antibody response regardless of the age of the patient receiving the vaccine, (b) immunologic response at an earlier age (including infants), and (c) a booster effect on subsequent exposure to the Hib capsule, whether through revaccination or natural exposure. The protein carrier is not considered a vaccine and should not be substituted for immunization against tetanus, diphtheria, or Neisseria meningitidis.
Hib conjugate vaccines are indicated for routine use in all infants and children younger than 5 years. Additionally, these three products differ in their immunogenicity and schedule of administration (Table 133–3). The primary series of Hib vaccination consists of a 0.5-mL IM dose at ages 2, 4, and 6 months if HbOC (HibTITER) or PRP-T (ActHIB) is used. If PRP-OMP is being used, the primary series consists of doses given at ages 2 and 4 months. The series should not be initiated in an infant younger than 6 weeks. Although use of one product for the entire primary series is desirable, adequate protection is achieved even when different products are used during the initial doses. Following the primary series, a booster dose is recommended at age 12 to 15 months. Any of the Hib conjugate vaccines are suitable for the booster dose regardless of which conjugate was used for the primary series of doses.
| | Table 133–2 Tetanus Prophylaxis | | Vaccination History | Clean, Minor | All Other | | | Tda | TIG | Tda | TIG | | Unknown or fewer than three doses | Yes | No | Yes | Yes | | Three or more doses | Noa,b | No | Noa,c | No | | aA single dose of Tdap should be used for the next dose of tetanus-diphtheria toxoid for individuals aged 10 or 11 years to 64 years.
bYes, if more than 10 years since last dose.
cYes, if more than 5 years since last dose.
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| Table 133–3 Haemophilus Influenzae Type B Conjugate Vaccine Products | | Vaccine | Trade Name | Protein Carrier | | PRP-T | ActHIB (Sanofi Pasteur) | Tetanus toxoid | | PRP-OMP | PedvaxHIB (Merck) | Neisseria meningitides serogroup B outer membrane protein | | PRP-T | Hiberix (Glaxo Smith Kline) | Tetanus toxoid (booster only) | | The polysaccharide is polyribosylribitol-phosphate (PRP).
| Schedules are more complex for infants who do not begin Hib immunization at the recommended age or who have fallen behind in the immunization schedule. For infants 7 to 11 months of age who have not been vaccinated, three doses of HbOC, PRP-OMP, or PRP-T should be given: two doses spaced 4 weeks apart and then a booster dose at age 12 to 15 months (but at least 8 weeks since the second dose). For unvaccinated children ages 12 to 14 months, two doses should be given, with an interval of 2 months between doses. In a child older than 15 months, a single dose of any of the four conjugate vaccines is indicated. The American Academy of Pediatrics has made recommendations for children with lapsed immunization. For infants 7 to 11 months who have received one or two doses of Hib vaccine, one dose of vaccine with a booster dose at least 8 weeks later at age 12 to 15 months should be given. For children 12 to 14 months who received two doses, a single dose is indicated. If the child received only one dose before age 12 months, two additional doses separated by 8 weeks should be given. A single dose of vaccine is needed for a child 15 to 59 months old who has received any incomplete schedule.
Vaccines for Hib are recommended for routine use only for patients up to age 59 months; beyond this age, most individuals will have natural immunity to Hib infection. Patients with certain underlying conditions (e.g., HIV infection, IgG2 subclass deficiency, sickle cell disease, splenectomy, and hematopoietic stem cell transplants and those receiving chemotherapy for malignancies) are at higher than normal risk for Hib infection, and use of at least one dose of vaccine in these patients should be considered, although efficacy data in most of these situations are lacking.
Adverse reactions to the Hib vaccine are uncommon. Erythema and induration at the injection site occur in approximately 25% of children and resolve within 24 hours. Fever, diarrhea, and vomiting are reported occasionally. Fever greater than 38°C (100.4°F) is reported in 2.4% of children.
| Hepatitis Vaccines
Information on vaccination for viral hepatitis is given in Chapter 47.
| Human Papillomavirus Vaccine
HPV infections are the most common sexually transmitted infections, with the highest prevalence of infection in sexually active young adults. Although more than 120 different HPV types have been identified, at least 40 different types of HPV infect the anogenital tract. These 40 different viruses are grouped into low-risk and high-risk types. Low-risk types can cause genital warts and mild abnormalities on Papanicolaou (Pap) tests. Ninety percent of all cases of genital warts are caused by types 6 and 11. As many as 18 types are considered high risk. They cause abnormal Pap test results and may lead to cancer of the cervix, vulva, vagina, anus, or penis. Types 16 and 18 cause about 70% of all cervical cancers. High-risk HPV infections are necessary but not sufficient for the development of cervical cancer and for the majority of other anogenital and oral squamous cell cancers.
A bivalent human papillomavirus vaccine (Cervarix, GSK) containing virus-like particles for types 16 and 18 was licensed in late 2009. The quadrivalent vaccine (Gardasil, Merck Vaccines) is directed against cervical cancer-causing types 16 and 18 and types 6 and 11. ACIP recommends either of these HPV vaccine preparations for the prevention of cervical cancer and precancerous lesions. No head-to-head comparison of these vaccines is available, but both vaccines are very efficacious for the prevention of precancerous lesions caused by types 16 and 18. Both vaccines offer some protection against oncogenic nonvaccine strains too. Both vaccines are administered as a three dose series using a harmonized schedule of 0, 1 to 2, and 6 months. The vaccines are recommended for females aged 11 to 12 years and for all females aged 13 to 26 years. Although administration of these vaccines before sexual debut is preferable, the vaccines can be administered without regard to history of sexual activity.
The quadrivalent HPV vaccine is licensed for the prevention of genital warts in males aged 9 to 26 years. Types 6 and 11 cause approximately 90% of genital warts. Although not considered a serious disease, the direct medical cost of genital warts is about $200 million annually, and genital warts have an impact on quality of life. Additionally, approximately one fourth to one third of oropharyngeal cancers are associated with a high risk HPV infection. No data on the usefulness of the vaccine for the prevention of these cancers are available yet. ACIP stated that HPV4 may be given to males aged 9-26 years of age but stopped short of a recommendation for it. The vaccine is effective for the prevention of genital warts, but the cost-effectiveness of the vaccine series for males is a major hurdle.
The vaccines are well tolerated, with injection-site reactions and systemic reactions (e.g., headache and fatigue) occurring as commonly in immunized individuals as in the groups receiving placebo. Although syncope is possible with any immunization, the target population of young women have a higher incidence of syncope, including with administration of the HPV vaccine.
These effective vaccines is an important advance, but the need for a Pap test for cervical cancer screening remains. Surveillance for duration of protection conferred by the vaccine series is ongoing; the need for future booster doses is not yet known.
| Influenza Virus Vaccine
Information on vaccination for influenza is given in Chapter 118.
| Measles Vaccine
Measles (rubeola) is a highly contagious viral illness characterized by rash and high fever. Complications of measles infections include severe diarrhea, otitis media, pneumonia, and encephalitis. Measles results in one to two deaths per 1,000 cases, with a much higher death rate in developing countries. With widespread vaccination, measles is on the verge of elimination from the Western Hemisphere.
The measles vaccine is a live-attenuated viral vaccine that produces a subclinical, noncommunicable infection. Approximately 95% of vaccine recipients seroconvert after a single dose, and most individuals are protected for life. Most persons who do not respond to the initial dose of measles vaccine will seroconvert after receiving a second dose, and this forms the basis for the two-dose vaccine strategy that was implemented in the United States in 1989.
The measles vaccine is administered subcutaneously as a 0.5-mL dose in the arm (or in the thigh if the patient is younger than 15 months). The vaccine is administered routinely for primary immunization to persons 12 to 15 months of age, usually as the MMR vaccine. The measles vaccine is not administered earlier than 12 months (except in certain outbreak circumstances) because persisting maternal antibody that was acquired transplacentally late in gestation can neutralize the vaccine virus before the vaccinated person can mount an immune response. A second dose of MMR or MMRV is recommended when children are 4 to 6 years old. The second dose of vaccine results in seroconversion in 95% of individuals who were first-dose nonresponders.
Measles-containing vaccine should not be given to pregnant women or immunosuppressed patients. The one exception is HIV-infected patients, who are at very high risk for severe complications if they develop measles. Persons with HIV infection who have never had measles or have never been vaccinated against it should be given measles-containing vaccine unless there is evidence of severe immunosuppression. The second dose should be given 1 month later rather than waiting for entry to school.
Recent administration of Ig interferes with measles vaccine response, so the recommended interval between the Ig and vaccine is determined by the dose of Ig. Live vaccines not administered during the same visit must be delayed for at least 30 days following measles or MMR vaccine. Live measles vaccine may suppress a positive tuberculin skin test for up to 6 weeks postadministration. Persons with a history of anaphylactic reaction to egg protein were considered to be at high risk for serious reactions to measles vaccine, a product derived from chick embryo fibroblasts. However, the risk of measles vaccination to egg-allergic patients is exceedingly low. Therefore, individuals requiring the measles vaccine should receive it regardless of a history of egg allergy. A history of serious neomycin hypersensitivity remains a contraindication to measles vaccine use because each 0.5-mL dose contains 25 mcg neomycin. Finally, mild febrile illness and upper respiratory tract infections are not contraindications to vaccination.
Measles vaccination is indicated in all persons born after 1956 or in those who lack documentation of wild virus infection by either history or antibody titers. Persons who received killed measles vaccine alone, who were given live vaccine within 3 months of receiving killed vaccine, or who received a vaccine of unknown type between 1963 and 1967 should be revaccinated. Two doses of a measles-containing vaccine are required for college students and healthcare workers who were born in 1957 or later. If two doses are needed (the person has never been vaccinated), the doses should be given at least 1 month apart.
The measles vaccine has an excellent safety record. The most common side effect following vaccination is fever, which occurs in 5% to 15% of vaccinees. Transient generalized rash may occur in approximately 5% of vaccine recipients. These reactions generally appear 5 to 12 days postvaccination and last 2 to 5 days. Other adverse effects, such as headache, cough, sore throat, eye pain, malaise, and transient thrombocytopenia, occur less frequently. Local reactions at the injection site are rare but may occur in subjects who have been vaccinated previously with killed vaccine. After extensive study, no association between MMR vaccination and the development of autism has been made.
| Meningococcal Polysaccharide and Conjugate Vaccines
N. meningitidis is a leading cause of meningitis and sepsis in children and young adults in the United States. College freshmen, particularly those living in dormitories or residence halls, are at modestly increased risk for invasive meningococcal disease compared with the rest of the population in this age group.
Two meningococcal conjugate vaccines combining the same serotypes are licensed for use in individuals aged 2 to 55 years old (Menaetra®, Sanofi-Pasteur) or 11 to 55 years old (Menveo®, Novartis). A quadrivalent vaccine containing capsular polysaccharides for serotypes A, C, Y, and W-135 has been available since the early 1970s. A conjugate vaccine containing the same serotypes was licensed for use in individuals 2 to 55 years old. Although serogroup B causes approximately one third of all cases, it has not been incorporated into the vaccine because group B polysaccharide is not immunogenic. Either meningococcal conjugate vaccine is recommended for all children 11 to 12 years old and others at high risk for invasive meningococcal infection, including high school students and college freshmen who live in dormitories. The meningococcal polysaccharide vaccine is indicated in high-risk populations, such as those exposed to the disease, those in the midst of uncontrolled outbreaks, travelers to areas with epidemic or hyperendemic meningococcal disease, and individuals who have terminal complement component deficiencies or asplenia. The polysaccharide preparation can be used for the immunization of college students and adults between 20 and 55 years of age, but the conjugate vaccine is preferred.
Meningococcal polysaccharide vaccine is administered subcutaneously as a 0.5-mL dose. Meningococcal conjugate vaccine is administered by IM injection. Reimmunization at 5-year intervals should be considered for individuals who remain at high risk for invasive meningococcal disease.
Injection-site reactions are the most common adverse effects following administration of either the meningococcal conjugate or polysaccharide vaccine.
| Mumps Vaccine
Mumps is a viral illness that classically causes bilateral parotitis 16 to 18 days after exposure. Fever, headache, malaise, myalgia, and anorexia may precede the parotitis. Serious complications are rare but more common in adults.
The mumps vaccine is a lyophilized live-attenuated vaccine prepared from chick embryo cultures. Each 0.5-mL dose of the vaccine also contains neomycin 25 mcg. The vaccine is available alone or in combinations with measles, rubella (as MMR), and varicella (MMRV) vaccines.
The vaccine is administered as a 0.5-mL subcutaneous injection in the upper arm. Dosing recommendations coincide with those for measles vaccine, with the first dose administered at age 12 to 15 months and the second dose prior to the child's entry into elementary school. Two doses of mumps-containing vaccine are recommended for school-aged children, international travelers, students in post-high school educational institutions, and healthcare workers born after 1956. A single dose of vaccine is acceptable documentation of immunity to mumps for other adults considered at lower risk of mumps infection, including adults born after 1956 and those with an uncertain history of wild virus infection.
Mumps vaccine should not be given to pregnant women or immunosuppressed patients. Anaphylactic reactions to mumps-containing vaccines are very rare and generally not associated with hypersensitivity to eggs. Therefore, egg allergy is not a contraindication to vaccination. The effect of Ig preparations on mumps vaccine response is unknown, but the response to measles, rubella, and varicella is compromised if the vaccine is administered after immunoglobulins. The recommended interval between the Ig and vaccine is determined by the dose of Ig. The vaccine should not be given to individuals with anaphylactic reactions to neomycin.
Serious adverse reactions to the vaccine are reported rarely. Parotitis, rash, pruritus, and purpura occur rarely. Local reactions, including soreness, burning, and stinging, may occur at the injection site.
| Pertussis Vaccine
Pertussis is caused by a bacterial infection with Bordetella pertussis. The illness is characterized by paroxysms of coughing to expel thick mucus. At the end of every burst, a long inspiratory effort results in the traditional "whooping" sound. Children will often become cyanotic during the coughing spasm and be exhausted or vomit at the end of the attack. It is during this stage when pertussis is usually diagnosed. Adolescents and adults with pertussis experience similar symptoms, though typically not nearly as severe as infants and young children. Adults are less likely to "whoop" in the paroxysmal stage; in fact their cough can be so minor that it is difficult to distinguish from other common respiratory infections. Prior to the availability of a vaccine, pertussis was a common childhood infection and was a significant cause of childhood mortality. Pertussis is most contagious in the early stage of the disease, can infect people of all ages, but is most serious in infants and young children.
Acellular pertussis vaccines contain components of the B. pertussis organism. All acellular vaccines contain pertussis toxin, and some contain one or more additional bacterial components (e.g., filamentous hemagglutinin, pertactin [a 69-kDa outer membrane protein], and fimbriae types 2 and 3). Acellular pertussis vaccine is recommended for all doses of the pertussis schedule at 2, 4, 6, and 15 to 18 months of age. A fifth dose of pertussis vaccine is given to children 4 to 6 years of age. Pertussis vaccine is administered in combination with diphtheria and tetanus (DTaP). Administration of an acellular pertussis–containing vaccine is also recommended for adolescents once between ages 11 and 18 years. Also, adults up to age 64 years should receive a pertussis-containing vaccine with their next dose of Td toxoids.
Local administration site reactions are relatively common. Systemic reactions, such as moderate fever, occur in 3% to 5% of vaccinees. Very rarely, high fever, febrile seizures, persistent crying spells, and hypotonic hyporesponsive episodes occur following vaccination. Allergy to a vaccine component and encephalopathy without known cause within 7 days of a pertussis vaccine are contraindications to future doses of vaccine.
| Pneumococcal Vaccines
Streptococcus pneumoniae is a common pathogen with a range of manifestations, including asymptomatic upper respiratory tract colonization, sinusitis, acute otitis media, pharyngitis, pneumonia, meningitis, and bacteremia. Rates of invasive infections are highest in children younger than 2 years and in the elderly. Invasive pneumococcal infections cause approximately 40,000 deaths annually. Most of the deaths occur in the elderly or in those with underlying medical conditions. Approximately half the deaths could be preventable by vaccine. Two pneumococcal vaccine preparations, PCV13 and 23-valent pneumococcal polysaccharide vaccine (PPV23) are available. The vaccines have different indications and are not interchangeable.
| Pneumococcal Polysaccharide Vaccine
Pneumococcal polysaccharide vaccine (Pneumovax 23) is a mixture of highly purified capsular polysaccharides from 23 of the most prevalent or invasive types of S. pneumoniae seen in the United States. Serotypes included are 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. These 23 types represent 85% to 90% of all blood isolates and 85% of pneumococcal isolates from other generally sterile sites seen in the United States. The vaccine is administered IM or subcutaneously as a single 0.5-mL dose. Each 0.5-mL dose of vaccine contains 25 mcg of each polysaccharide type dissolved in isotonic saline solution (for a total of 575 mcg polysaccharide) and 0.25% phenol as preservative.
PPSV23 is recommended for the following individuals: - Persons 65 years and older (if an individual received vaccine more than 5 years earlier and was younger than 65 years at the time of administration, revaccination should be given)
- Persons aged 2 to 64 years with a chronic illness (congestive heart failure, cardiomyopathy, chronic pulmonary disease, diabetes, alcoholism, liver disease)
- Persons aged 2 to 64 years with functional or anatomic asplenia (when splenectomy is planned, PPSV23 should be given at least 2 weeks before surgery; a single revaccination is recommended at 5 years in subjects older than 10 years and at 3 years in subjects younger than 10 years)
- Persons aged 2 to 64 years of age living in environments where the risk of invasive pneumococcal disease or its complications is increased (this does not include daycare center employees and children)
- Persons aged 19 to 64 years who smoke cigarettes or have asthma
- Persons with cochlear implants
PPSV23 is recommended for immunocompromised persons 2 years and older with (a) HIV infection, (b) leukemia, (c) lymphoma, (d) Hodgkin disease, (e) multiple myeloma, (f) generalized malignancy, (g) chronic renal failure or nephrotic syndrome, (h) patients receiving immunosuppressive therapy including corticosteroids, and (i) organ and bone marrow transplant recipients. A single revaccination should be given if 5 years or more have passed since the first dose in subjects older than 10 years. In subjects 10 years of age and younger, revaccination should be given 3 years after the previous dose.
PPSV23 induces type-specific antibodies (T-cell–independent mechanisms) with a twofold rise within 2 to 3 weeks in 80% of young healthy adults. No correlation of antibody levels and protection has been determined. Antibody levels to these strains remain elevated for at least 5 years. In certain individuals, these levels decline within 10 years. Children may be protected for only 3 to 5 years. Elderly individuals and patients with chronic disease may have lower antibody levels produced with the vaccine. Children younger than 2 years do not respond adequately to the vaccine.
A number of other groups, including immunocompromised patients (e.g., leukemia, lymphoma, and multiple myeloma), dialysis patients, and patients with acquired immune deficiency syndrome, have reduced antibody production with the vaccine. Asymptomatic HIV-infected patients respond sufficiently to the vaccine. Patients with Hodgkin disease respond to the vaccine better before splenectomy, chemotherapy, or radiation therapy.
PPSV23 vaccine efficacy has been debated in the literature. Although prelicensure trials in young, healthy gold miners in South Africa showed a reduction in nonbacteremic disease rates, randomized clinical trials performed in the postmarketing period on elderly persons with chronic disease did not confirm these findings. A large study of elderly individuals demonstrated a decreased risk of pneumonia caused by S. pneumoniae in vaccinated individuals but showed no change in the risk of community-acquired pneumonia even though most community-acquired pneumonias are caused by S. pneumonia. For invasive disease, reduction rates of 56% to 81% with the vaccine have been shown. Adults hospitalized with community-acquired pneumonia are significantly less likely to die if they have been immunized. In addition, immunized patients were less likely to have respiratory failure and had hospitalization stays that were shorter by 2 days. A meta-analysis of nine randomized controlled trials concluded that the vaccine was efficacious in reducing the frequency of bacteremic pneumococcal disease among adults in low-risk groups and that the vaccine was cost-effective.
PPSV23 safety is well documented. Local reactions occur frequently within the first 48 hours and generally are mild. Local erythema and induration (30%), local discomfort (40%), and local swelling (3%) are the side effects observed most commonly. Revaccination has been associated with self-limited injection-site reactions more commonly than after the first dose. Severe systemic reactions occur rarely and consist of weakness, myalgia, headache, photophobia, chills, and fever.
| Pneumococcal Conjugate Polysaccharide Vaccine
Invasive pneumococcal disease occurs even more frequently in children younger than 2 years than in those older than 65 years. The infection ranges goes from nasopharyngeal carriage to bacteremia and meningitis. Because of the lack of immune responsiveness in children younger than 2 years when exposed to polysaccharide vaccines, a conjugate vaccine was developed to protect young children from certain strains of S. pneumoniae.
A 13 valent vaccine (Prevnar-13) is available for use in children. This vaccine contains the conjugated capsular polysaccharides of serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, which cause the vast majority of pediatric pneumococcal bacteremias in the United States. The vaccine elicits a primary T-cell–dependent antibody response with the first dose and an immunologic memory effect after four doses. In clinical use, the vaccine is associated with a dramatic decline in invasive disease not only in immunized young children but also in individuals in all age groups.
PCV13 is administered as a 0.5-mL IM injection at 2, 4, and 6 months of age and between 12 and 15 months of age. PCV13 also should be used in older children aged 24 to 59 months who are at high risk. Children with sickle cell disease or splenic dysfunction, HIV infection, immunocompromising conditions, or chronic illnesses should be immunized. PPV23 can be used in conjunction with PCV13. PPV23 should be administered after age 2 years and at least 2 months after the last dose of PCV13.
The vaccine series generally is well tolerated. Injection-site reactions and fever are the most commonly reported adverse effects. Widespread use of conjugated pneumococcal vaccines in infants and young children has resulted in a decreased incidence of invasive pneumococcal disease in the entire population.
| Poliovirus Vaccines
Poliomyelitis is a contagious viral infection that usually causes asymptomatic infection; however, in its serious form it causes acute flaccid paralysis. Poliovirus is spread via the fecal–oral route. The virus replicates in the upper respiratory tract, gastrointestinal tract, and local lymphatics. The vast majority of polio infections are subclinical and asymptomatic. Indigenous polio has been absent from the United States since 1979, and the last case in Western Hemisphere was reported in 1991. Global eradication efforts are entering the final stages, and the eradication of polio should be accomplished in the next few years.
An inactivated trivalent vaccine developed by Jonas Salk was licensed for use in 1955. In 1987, an enhanced-potency IPV was introduced and has replaced the original inactivated vaccine. A live-attenuated oral polio vaccine (OPV) was developed by Albert Sabin in 1962. OPV was the primary immunizing agent for poliovirus infection. Widespread OPV use is responsible for eradication of wild-type polio in most of the world. However, with no poliovirus circulation in the United States for years, IPV is the recommended vaccine for the primary series and booster dose for children. OPV will continue to be used in areas of the world that have circulating poliovirus. The CDC maintains a stockpile of OPV to be used only in case of an outbreak.
The IPV series is administered routinely to children at ages 2, 4, and 6 to 18 months, and 4 to 6 years. Protective antibodies to all three serotypes develop in 90% to 100% of children after two doses of vaccine. After three doses, 99% to 100% develop protective immunity, and the fourth dose results in long-term immunity.
Primary poliomyelitis immunization is recommended for all children up to age 18 years. Primary immunization of adults over age 18 years is not recommended routinely because a high level of immunity already exists in this age group and the risk of exposure in developed countries is exceedingly small. However, unimmunized adults who are at increased risk for exposure because of travel, residence, or occupation should receive IPV series. Incompletely immunized adults or children should complete the series of IPV regardless of the interval since initiation of primary immunization. Adults do not need a booster dose routinely unless they are at increased risk of exposure (travel), in which case a single dose of IPV can be given.
Allergies to any component of IPV, including streptomycin, polymyxin B, and neomycin, are contraindications to vaccine use. No serious side effects are attributable to IPV. Pregnant women should be given IPV only if there is a clear need, such as women who will be traveling or living in an area with endemic or epidemic poliovirus. IPV is recommended for immunodeficient individuals and their household contacts. Although the response may be lower, some protection against infection may be conferred.
The routine use of OPV in the United States has been discontinued because OPV is rarely associated with vaccine-associated paralytic poliomyelitis in vaccinees (1 in 6.2 million doses) or contacts (1 in 7.6 million doses). Because individuals with primary immune deficiency are at increased risk for this adverse reaction, OPV is not recommended for persons who are immunodeficient or for normal individuals who reside in a household with an immunocompromised person. The use of OPV is reserved for polio outbreak control.
| Rabies Vaccine
Rabies is a virtually universally fatal infection in humans. Although all mammals are susceptible to rabies, carnivorous mammals are reservoirs of the virus and responsible for persistence of the virus in nature. In the United States, most human cases of rabies are from exposure to rabid bats, but raccoons, foxes, skunks, and coyotes are also associated with possible exposure. Worldwide, canines are the primary vectors. Transmission of rabies can occur via percutaneous, permucosal, or airborne exposure to the rabies virus. Circumstances favoring such transmission include animal bites and attacks and contamination of scratches, cuts, abrasions, and mucous membranes with saliva or other infectious material (brain tissue). Unprovoked attacks and daytime attacks by nocturnal animals are considered highly suspect. A few cases of person-to-person transmission have been reported.
Symptoms of rabies are nonspecific during the prodomal stage—fever, headache, malaise, irritability, nausea, and vomiting. The acute neurologic phase is characterized by hyperexcitability, hyperactivity, hallucinations, salivation, a fear of water and air. A minority of patients present with limp paralysis. Patients die within 5 days of presentation with these neurologic symptoms.
Human diploid cell vaccine (HDCV), and purified chick embryo cell (PCECV) rabies vaccine are killed vaccines used for preexposure and postexposure rabies virus prophylaxis. Preexposure indications for using HDCV, RVA, or PCECV rabies vaccine include persons whose vocation or avocation place them at high risk for rabies exposure, such as veterinarians, animal handlers, laboratory workers in rabies research or diagnostic laboratories, cavers, wildlife officers where animal rabies is common, and anyone who handles bats. Travelers who will be in a country or area of a country where there is a constant threat of rabies, whose stay is likely to extend beyond 1 month, and who may not have readily available medical services (e.g., Peace Corps workers and missionaries) should be considered for preexposure prophylaxis. Rabies immunization of immunocompromised individuals should be postponed until the immunosuppression has resolved, or activities should be modified to minimize the potential exposure to rabies. If the vaccine is used in immunocompromised persons, antibody titers should be checked postimmunization. Pregnancy is not a contraindication if the risk of rabies is great. A rabies immunization series should be completed with the same product because no data exist on interchangeability of products. Both vaccine preparations can be administered for preexposure prophylaxis as a three-dose series of 1 mL IM on days 0 and 7 and once between days 21 and 28.
Individuals with ongoing risk of exposure—either continuous risk (e.g., research laboratory staff or those involved in rabies biologics production) or individuals with frequent exposures (e.g., those involved with rabies diagnosis, spelunkers, veterinarians, animal control workers, and wildlife workers in rabies-enzootic areas)—should undergo serologic testing every 6 months and 2 years, respectively, to monitor rabies antibody concentrations. A booster dose is recommended if the complete virus neutralization is <1:5 serum dilution by the rapid fluorescent focus inhibition test.
Preexposure prophylaxis does not eliminate the need for postexposure therapy. Persons previously immunized with HDCV or PCECV rabies vaccine or those who previously received postexposure prophylaxis should receive two 1-mL IM doses of HDCV or PCECV rabies vaccine on postexposure days 0 and 3. Rabies Ig should not be given to this group.
Postexposure prophylaxis should be given after percutaneous or permucosal exposure to saliva or other infectious material from a high-risk source. Each case must be considered individually. Consideration needs to be given to the geographic area, species of animal, circumstances of the incident, and type of exposure. Local or state health departments should be contacted for assistance. Thorough cleansing of the wound with soap and water followed by irrigation with a virucidal agent such as povidone–iodine solution is an extremely important part of the management of rabies-prone wounds. Individuals who have not been immunized previously should receive the recommended regimen of rabies Ig (see Rabies Immunoglobulin below) and four doses of HDCV or PCECV rabies vaccine 1 mL IM on days 0, 3, 7, and 14 after exposure. However, a fifth dose in a series should be considered if the exposed individual is immunocompromised. Vaccine response for these individuals should be checked. Rabies vaccine must be administered in the deltoid muscle in adults and in the anterolateral thigh in children. The gluteal region should not be used.
Adverse reactions to rabies biologicals are less common and less serious with the currently available vaccines compared with previously used preparations. Local or mild systemic symptoms can typically be managed with antiinflammatory medications or antihistamines. Systemic allergic reactions ranging from hives to anaphylaxis occur in a very small number of subjects. Given the lack of alternative therapy and the fact that rabies infection is almost always fatal, persons exposed to rabies who do have adverse reactions should continue the vaccine series in a setting with medical support services.
| Rabies Immunoglobulin
Human rabies Ig is used in conjunction with rabies vaccine as part of postexposure rabies management for previously unvaccinated individuals. The product is derived from plasma obtained from donors who have been hyperimmunized with rabies vaccine and have high titers of circulating antibody.
In persons who previously have not been immunized against rabies, rabies Ig is given simultaneously with HDCV or PCECV rabies vaccine to provide optimal coverage in the interval before immune response to the vaccine occurs. The efficacy of this regimen has been clearly demonstrated. In situations where a vaccine has been used alone, mortality rates of 50% to 60% have been observed. Mortality after the combination vaccine and rabies Ig regimens is exceedingly rare; however, deaths have been reported when the wound was not infiltrated with rabies Ig.
Rabies Ig does not interfere with vaccine-induced antibody formation. Its use is not recommended beyond 8 days after initiation of the vaccine series nor in persons previously immunized to rabies.
Human rabies Ig is administered in a dose of 20 international units/kg (0.133 mL/kg). If anatomically feasible, the entire dose should be infiltrated around the wound(s). Any remaining volume should be administered IM at a site distant from the rabies vaccination site. This product should never be administered by the intravenous route. Because other antibodies in the rabies Ig may interfere with the response to live-virus vaccines (MMR and varicella), it is recommended that these immunizations be delayed for 3 months.
Side effects are rare but may include local soreness at the wound or IM injection site and mild temperature elevations. Caution is advised when administering the product to persons with known systemic allergies to immunoglobulin or thimerosal. Pregnancy is not a contraindication to its use.
| Rubella Vaccine
Rubella (German measles) is characterized by an erythematous rash, lymphadenopathy, arthralgia, and low-grade fever. As many as 20% to 50% of rubella infections are asymptomatic. The most important consequence of rubella infection occurs during pregnancy, particularly during the first trimester. Congenital rubella syndrome is associated with auditory, ophthalmic, cardiac, and neurologic defects. Rubella infection during pregnancy also can result in miscarriage or stillbirth. The primary goal of rubella immunization is to prevent congenital rubella syndrome. Rubella is no longer endemic in the United States, but high immunization rates are necessary to prevent rubella outbreaks from imported cases.
Rubella vaccine contains lyophilized live-attenuated rubella virus grown in human diploid cell culture. The vaccine is available in combination with measles vaccine, mumps vaccine, and varicella vaccine. Each 0.5-mL dose also contains 25 mcg neomycin and is administered subcutaneously.
Rubella vaccine induces antibodies that are protective against wild-virus infection. The duration of immunity has not been established. A second dose is recommended, however, at the same time measles vaccine is administered (as a second dose of MMR). The vaccine is indicated for children older than 1 year of age. Individuals born before 1957 are assumed to be immune to rubella except for women who could become pregnant. Therefore, all women of childbearing potential should have documentation of receiving at least one dose of a rubella-containing vaccine or laboratory evidence of immunity. Recent administration of Ig interferes with rubella vaccine response for at least 3 months and depends on the dose of Ig that is administered. Table 133–1 can be used as a guide for the recommended interval. The vaccine should not be given to immunosuppressed individuals, although MMR vaccine should be administered to young children with HIV infection without severe immunosuppression as soon as possible after their first birthday. The vaccine should not be given to individuals who have experienced anaphylactic reactions to neomycin.
Adverse effects of the rubella virus vaccine tend to increase with the age of the recipient. Mild symptoms are similar to wild-virus infection and include lymphadenopathy, rash, urticaria, fever, malaise, sore throat, headache, myalgias, and paresthesias of the extremities. These symptoms occur 7 to 12 days after vaccination and last 1 to 5 days. Joint symptoms occur more often in susceptible postpubertal females. Arthralgia occurs in 25% of vaccinees, and 10% have arthritis-like symptoms. These symptoms usually begin 1 to 3 weeks after vaccination and persist for 1 day to 3 weeks. A very small excess risk of chronic arthropathy exists. The vaccine may cause suppression of tuberculin skin tests for up to 6 weeks after vaccination. The vaccine virus may be excreted in nose and throat secretions, but it is not contagious.
The rubella vaccine has never been associated with congenital rubella syndrome, but its use during pregnancy is contraindicated. However, routine pregnancy testing prior to vaccination is not recommended. Women should be counseled not to become pregnant for 4 weeks following vaccination. Termination of pregnancy is not indicated in women who are accidentally given the vaccine or who become pregnant during the month after vaccination.
| Varicella and Zoster Vaccines
Varicella is a highly contagious disease caused by varicella-zoster virus. The clinical illness is characterized by the appearance of successive waves of pruritic vesicles that rapidly crust over. Malaise and fever are common and last for 2 to 3 days. The virus remains dormant in the dorsal ganglia and reactivates as herpes zoster, also known as shingles. Although the exact stimulus for reactivation is unknown, a decrease in varicella-specific cell-mediated immunity associated with age or immunosuppression appears to be necessary but not sufficient for reactivation.
| Varicella Vaccine
Live-attenuated varicella vaccine contains the Oka/Merck strain of varicella virus, which was attenuated by propagation through several different cell culture lines. Varicella vaccine is a lyophilized product that must be kept frozen and protected from light. Once reconstituted, it must be administered subcutaneously within 30 minutes. Each 0.5-mL dose contains a minimum of 1,350 plaque-forming units of virus as well as 12.5 mg of hydrolyzed gelatin and trace amounts of neomycin, fetal bovine serum, and residual components from cell culture.
The varicella vaccine is safe and immunogenic in healthy children and adults. In clinical studies, varicella vaccine has been 70% to more than 95% effective in preventing chickenpox. Vaccinated individuals who develop chickenpox typically experience milder disease, with low or no fever and fewer skin lesions, many of which do not vesiculate. Similarly, vaccinated individuals who develop breakthrough infections transmit the varicella virus to others at a lower rate.
The varicella vaccine is recommended for all children at 12 to 18 months of age, with a second dose prior to entering school between ages 4 and 6 years. A second dose is also recommended for patients older than this age if they have not already had chickenpox. Varicella vaccine can be used for postexposure prophylaxis. The vaccine is effective in the prevention or modification of varicella infection when given within 3 days and possibly 5 days of exposure. Because the varicella vaccine is a live vaccine, it is contraindicated in pregnant women and in immunocompromised individuals. An exception is children with asymptomatic or mildly symptomatic HIV infection, who should receive two doses of varicella vaccine 3 months apart. Also, children with humoral immune deficiencies may be immunized. Varicella vaccination is contraindicated in individuals with a history of anaphylactic reaction to any component of the vaccine. Persons who have received blood, plasma, or Ig products in the recent past should not receive varicella vaccine because of concern that passively acquired antibody will interfere with response to the vaccine. The recommended time interval between antibody-containing products and varicella vaccine depends on the dose of immunoglobulin. Although no adverse events associated with salicylate use after vaccination have been reported, salicylates should be avoided for 6 weeks after vaccination because of the association of salicylate use and Reye syndrome following varicella infection.
The varicella vaccine has an excellent safety record. Pain, local swelling, and erythema at the injection site occur in up to 32% of patients and fever in 10% to 15%. A varicella-like rash occurs in approximately 4% of vaccinees, accompanied by few, if any, systemic symptoms. The rash may be localized at the injection site or generalized. Lesions usually are few in number (2–10) and often papular rather than vesicular. Transmission of vaccine virus to susceptible close contacts has occurred but is rare and believed to occur only when the vaccinee develops a rash. Because the risk of vaccine virus transmission is very low and primary infection can be very severe, vaccination of household contacts of immunocompromised patients is recommended to prevent introduction of varicella into the household.
| Zoster Vaccine
After the primary infection with varicella-zoster virus manifested as chicken pox, the virus remains latent in the dorsal ganglia. Herpes zoster, more commonly known as shingles, occurs upon reactivation of varicella-zoster virus replication. Herpes zoster can occur at any age, but the incidence dramatically increases with increasing age. The rate of disease increases sharply beginning in the after age 50 years. The disease rate in individuals older than 80 years of age is 11 cases per 1,000 person-years. Patients with HIV, cancer, or other conditions associated with immunosuppression are at increased risk for disease. The development of the disease is associated with declining cellular immunity to varicella-zoster virus.
The clinical presentation of herpes zoster usually is a vesicular eruption limited to one dermatome. The most common complication is postherpetic neuralgia, which is pain that persists after the skin lesions have healed. The duration and severity of the pain varies. Postherpetic neuralgia can persist for weeks to years. The risk of postherpetic neuralgia increases dramatically with age. Virtually no risk of developing postherpetic neuralgia with herpes zoster exists prior to age 50 years, but the risk increases to 50% to 75% after ages 60 and 75 years, respectively. The pain can be so severe as to limit activities of daily living and quality of life.
The zoster vaccine contains 19,000 plaque-forming units of Oka/Merck strain live varicella-zoster virus. Although the same strain of vaccine virus is contained in the childhood varicella vaccines, the doses of vaccine virus are dramatically different, and the vaccines are not interchangeable. Zoster vaccine reduces the burden of disease by 60%. The burden of disease is a composite measure considering incidence, severity, and duration of herpes zoster. The incidence of zoster is cut in half and the development of postherpetic neuralgia can be decreased by 67%.
The zoster vaccine is recommended for immunocompetent individuals older than 60 years. This live vaccine should not be used in immunocompromised individuals, including those on high dose corticosteroids or with HIV (CD4 cell count <200/mm3) or malignancies. Immunization of some special populations can be done. No evidence of transmission of the live vaccine virus exists, but transmission of the varicella vaccine virus has been documented. Postmarketing surveillance will be used to establish if the theoretical risk is a small clinical problem. The duration of protection is unknown but immunized participants from clinical trials are being followed for immunological markers and clinical efficacy. Future doses may be required for continued protection.
| Varicella-Zoster Immunoglobulin
Varicella-zoster Ig is used after exposure to varicella for passive immunization of susceptible immunodeficient patients or other susceptible individuals at particularly high risk for complications of varicella infection. Varicella-zoster Ig is available only under an investigational new drug protocol.
Postexposure prophylaxis with varicella-zoster Ig is indicated for the following susceptible individuals: (a) immunocompromised patients, (b) neonates whose mothers develop varicella within 5 days before or 2 days after delivery, (c) preterm infants (<28 weeks' gestation or weight <1,000 g) who are exposed to varicella while hospitalized, and (d) susceptible pregnant women. If varicella is prevented, vaccination should be offered at a later date. Exposure to varicella is defined as direct indoor contact for more than 1 hour with an infectious person. A negative history of clinical disease is not a reliable indicator of varicella susceptibility. Most people with a negative clinical history will have detectable antibody on laboratory testing. Caution is warranted when interpreting a low positive result in an immunosuppressed patient who has received blood products or Ig because the circulating antibody may be acquired passively.
For maximum effectiveness, varicella-zoster Ig must be given as soon as possible and not more than 96 hours following exposure. Because this agent may only attenuate infection, patients who receive varicella-zoster Ig still may have a period of communicability, and varicella-zoster Ig may prolong the incubation period to 28 days. Antiviral therapy can be initiated if signs and symptoms of varicella infection become apparent.
Administration of varicella-zoster Ig is by the IM route at doses of 125 plaque-forming units per 10 kg of body weight up to 625 units (five vials) for patients weighing more than 40 kg. The dose for newborn infants is 125 units.
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