Rosalie Sagraves, Pharm.D., FCCP
Spring 1998
Rosalie Sagraves, Pharm.D., FCCP
Spring 1998
Pediatric
Infectious Diseases: Part II
Immunizations
The following goals, objectives and readings are for Pediatric Infectious Diseases Parts II and III.
Goal: The student should familiarize him/herself with current recommendations for childhood immunizations and the pharmacotherapy of common childhood infections.
Objectives:
1. List the recommended schedule for the following immunizations for healthy infants and children:
Hepatitis B
Diphtheria, Tetanus, Pertussis (DTP)
H. influenzae type B
Polio
Measles, Mumps, Rubella (MMR)
Varicella Zoster
2. List two reasons why microorganisms that cause diseases in the neonate are different from those that later cause disease in childhood or adulthood.
3. List adverse reactions or special limitations of the following antibiotics that must be considered when used in the therapy of neonates or young infants:
Penicillins Sulfonamides Aminoglycosides Tetracyclines Chloramphenicol Cephalosporins
4. For each of the following pediatric infectious diseases and age groups, list the most common causative organisms, initial empirical antibiotic therapy, clinical features (i.e., associated risk factors, signs and symptoms), duration of therapy, and supportive/adjunctive care:
Neonatal sepsis
Neonatal meningitis
Meningitis in infants 1 - 3 months of age
Meningitis in children 3 months - 6 years of age
Meningitis in children > 6 years of age
5. Discuss antibiotic prophylaxis for meningococcal and H. influenza type b meningitis.
Required readings:
Bertino JS, Casto DT. Vaccines, Toxoids and other Immunobiologics. In: Pharmacotherapy, A Pathophysiologic Approach, 3rd edition. DiPiro JT, Talbert RL, Wells BG, Yee GC, Matzke GR, Posey LM (eds). Appleton and Lange, Samford, CT 1997; 2319-52.
Suggested Reading:
1. Casto DT. Recent Developments in Vaccines and Immunization Practices. Pharmacotherapy 1992;12(6 Pt 2):94S-103S.
2. Madaras-Kelly KJ, Ostergaard BE, Rotschafer JC. Central nervous system infections. In: Pharmacotherapy, A Pathophysiologic Approach, 3rd edition. DiPiro JT, Talbert RL, Wells BG, Yee GC, Matzke GR, Posey LM (eds). Appleton and Lange, Samford, CT 1997; 1971-94.
Outline
I. Immunizing Agents
(Please see Table 1 Licensed Vaccines at the end of this handout)
A. Vaccines: derived from infecting organism
1. Viral
a. Live attenuated
b. Killed
1) Whole
2) Split viral particles
3) Specific viral fragments (subunits)
2. Bacterial
a. Killed whole bacteria
b. Specific bacterial wall antigens
3. Live attenuated vs killed
a. Live attenuated
b. Killed
B. Toxoids:
1. Inactivated bacterial toxins
2. Combined with aluminum salts to enhance antigenicity
C. Immune sera
1. Sterile solutions containing antibody
2. Equine or human source
3. Passive immunity
II. National Vaccine Injury Compensation Act (1986)
A. Part A
1. Lists compensation for vaccine related injuries
2. Maximal award $ 250,000
B. Part B
1. "No-fault" provision
2. Frees manufacturers of liability if adequate warnings given
C. Part C - Healthcare providers and manufacturers must report adverse effects to FDA within 7 days
D. Part D - Lists legal recourse against the Secretary of the Department of Health and Human Services for not performing duties as outlined by the act
E. Permanent vaccination records that includes date of immunization, manufacturer, lot number, location of immunization, name of person administering immunization must be kept
III. Recommended Childhood Immunization Schedules
A. Please see Table 2 at the end of this handout for the routine immunization of infants and children
B. Please see Table 3 at the end of this handout for an immunization schedule for children not immunized in the first year of life
IV. Individuals Who Need Modified Immunization Schedules1,2,4,5,11,26
A. Immunization contraindications in an otherwise healthy individual
1. Current moderate or severe illness
2. Patient with a previous anaphylactic reaction to a specific vaccine or other severe hypersensitivity to a vaccine constituent
3. Immunosuppression (see III C)
4. Pregnant woman (for MMR; see III D)
5. Administration of immunoglobulin or blood products
B. No contraindications to immunizing patients with the following problems:
1. Mild, acute illness with a low grade fever and/or diarrhea in otherwise normal child
2. Patient taking antibiotics or recovering from an illness
3. Premature infant
4. Family history of adverse reaction after vaccination
5. Pregnant mother or household contact
6. Breast-feeding
C. Immunosuppression
1. Persons with conditions that cause limited immune deficiency (e.g., renal disease, diabetes, liver disease, asplenia)
a. If the individuals are not receiving immunosuppressants, they can receive vaccines
b. Need to individualize dosing
2. Individuals who are severely immunocompromised but not due to HIV infection (e.g., congenital immunodeficiency, drug or radiation-induced disease, hematological or solid tumors)
a. May receive killed vaccines or toxoids but not live vaccines
b. OPV should not be administered to household contacts
c. May be able to give vaccines to those with leukemia if they have not received chemotherapy for at least 3 months; coordinate so not affect ability to administer chemotherapy
d. See required reading (reference 26) concerning the use of corticosteroids and timing of vaccinations
3. Persons with HIV infection
a. MMR recommended no matter what the HIV status because of the high morbidity of measles infection
b. Use enhanced inactivated polio vaccine (eIPV); OPV should not be given to household contacts
c. H. influenzae vaccine and DTP should be administered to children
V. Haemophilus influenzae type b Infections1,5-7,9-11,24,26
A. H. influenzae type b infections
1. Incidence: 24 - 75 cases/100,000 per year
2. Peak infection between ages 6 and 12 months
3. Problems: invasive systemic disease such as meningitis, osteoporosis, pneumonia, epiglottitis, septic arthritis.
B. Immunization
1. Killed vaccine with diphtheria toxoid or toxin, meningococcal protein, or tetanus toxoid carrier protein are more immunogenic that non-conjugated vaccines
2. Universal immunization of children should begin at age 2 months for all conjugated vaccines which are scheduled at 2, 4, 6 and between 12 and 15 months of age except for PRP-OMP (Pedvax HIB) which does not require a dose at age 6 months.
3. Common adverse reactions: local reactions, fever, vomiting and diarrhea
4. Immunization schedule (see attachment Recommended Childhood Immunization Schedule United States, January - December 1997)
A. Incidence of hepatitis B
1. Approximately 300,000 people in the U.S. have hepatitis B infections annually
2. Approximately 4,000 people die annually in the U.S. from hepatitis B related cirrhosis
B. Spectrum of disease
1. Asymptomatic seroconversion
2. Subacute illness with jaundice and anorexia
3. Fulminant fatal illness
4. Chronic carriers at risk for cirrhosis or hepatocellular carcinoma
C. Immunization recommendations:
1. Pre-exposure prophylaxis of high risk individuals
a. Healthcare workers with occupational risk
b. Clients and staff of institutions for the developmentally disabled
c. Injectable drug users
d. Hemodialysis patients
e. Household and sexual contacts of hepatitis B carriers
f. Bisexual/homosexual men
g. Heterosexual persons with multiple sexual partners
h. Inmates of long term correctional facilities
i. Adoptees from countries where hepatitis B is highly endemic
j. International travelers to a highly endemic hepatitis B regions for > 6 months
k. Uninfected patients with hemophilia and other clotting disorders
l. Populations where hepatitis B is highly endemic
m. All newborn infants
2. A infant born to an HBsAg positive woman should receive 0.5 mL of hepatitis immune globulin (HBIG) within 12 hrs of birth and either 5 mcg of Recombivax HB (Merck) or 10 mcg Engerix-B (SmithKline Beecham) at a separate site. A second dose of hepatitis B vaccine is recommended at age 1 month and a third immunization at age 6 months. Infants should be tested for anti-HBs at 9 months of age or later. A fourth dose of vaccine should be administered to infants who are anti-HB nonresponders or hyporesponders and are HBsAg negative. These children should be tested 1 month later for anti-HBs. If titers of > 10 mlU/mL are still not achieved, two more doses one month apart with anti-HBs one month after the last dose.
See Recommended Childhood Immunization Schedule United States, January-December 1997 and footnotes for immunization information for infants born to HBsAg-negative mothers or when the HBsAg status of the mother is unknown.
VII. Rubella (German Measles)1,2,5-7,11,23,24,26
A. Clinical Manifestations of Acquired Rubella
1. 25 to 50% asymptomatic
2. Maculopapular rash; lymphadenopathy, fever, polyarthralgia, polyarthritis, rarely encephalitis
B. Congenital Rubella Syndrome (CRS)
1. Teratogenic effects: affects organogenesis
2. Inflammatory disease: involves organs, i.e., liver and spleen
3. 80% or more infants have CRS if exposed during first trimester
4. Clinical manifestations: low birth weight, decreased gestation, growth retardation, ocular defects, cardiac defects, deafness, mental retardation, microcephaly
Table 4. Clinical Findings in CRS5,23
• Ophthalmologic (cataracts, glaucoma, microphthalmia, retinitis)
• Cardiac (various anomalies)
• Auditory (sensorineural deafness, cochlear deafness)
• Neurologic (autism, encephalitis, microcephaly, mental retardation)
• Intrauterine growth retardation
• Hepatosplenomegaly
C. Epidemiology
1. Direct or droplet contact from nasopharyngeal secretions
2. Incidence: decreased 95% since vaccination introduced
3. Outbreaks among young adult: 20% of young adults susceptible to rubella
4. Incubation period: 14 to 21 days; rash 14 to 17 days after exposure
5. Adverse reactions include fever, rash, urticaria, malaise, sore throat, headache, lymphadenopathy, joint pain
D. Immunization
1. Administered in conjunction with mumps and measles vaccine
2. Adverse reactions similar to those noted with the disease (see C 5 above); increase with the age of the immunization recipient; joint symptoms occur as late as 1 - 10 weeks after immunization; overt arthritis occurs in less than 1% of vaccine recipients
3. See Recommended Childhood Immunization Schedule United States, January - December 1997 for measles, mumps and rubella immunizations
VIII. Tetanus2,5-7,11,13,24,26
A. Clinical Syndromes
1. Localized: spasm of muscles at site of injury; mild but rare
2. Generalized: 80% of all cases; 50% of the time presents with spasm of mastication muscles, trismus, and involvement of other muscles; hyperreflexia and opisthotonos. May have fever, CNS abnormalities. Death rate about 30%.
3. Cephalic
B. Tetanus neonatorum
C. Epidemiology
1. Clostridium tetani
2. Inoculation 3 days to 3 weeks (dependent on site of wound and inoculation)
3. About 100 cases per year; 66% occurring in people > 50 years of age
D. Active Immunization
1. Tetanus toxoid adsorbed (TTA) is recommended for pediatric use in combination with diphtheria and pertussis vaccination
2. Adverse reactions: local reactions such as pain or tenderness at injection site, edema, and/or induration; rarely see fever , malaise, aches, or neurological problems
3. See Recommended Childhood Immunization Schedule United States, January - December 1997.
E. Passive immunization: tetanus immune globulin (TIG). TIG is used to provide passive tetanus immunization following traumatic wounds in persons who are nonimmunized or suboptimally immunized. A dose of 250 to 500 u are administered IM. If also giving TTA, use separate administration sites.
IX. Pertussis1,2,5-7,11,14,15,24,26
A. Clinical Manifestations
1. Catarrhal stage: mild URI symptoms with cough
2. Paroxysmal stage: paroxysms of cough, whooping, mild fever and vomiting
3. Convalescent stage
4. Complications include apnea, seizures, pneumonia, encephalopathy and death
5. Most severe during the first year of life
B. Epidemiology
1. Bordetella pertussis
2. Man only host; close contact via aerosol droplets from respiratory tract
3. Incubation period: 7 to 10 days
4. Duration of disease: 6 to 10 weeks
C. Immunization
1. Absolute contraindications to pertussis administration include an immediate anaphylactic reaction to previous pertussis dose or encephalopathy within 7 days of a previous dose
2. Whether or not seizures is contraindication to vaccination is debated although seizures themselves are not a contraindication vaccine should be held until a new neurologic disorder has fully evolved.
3. Vaccines available are whole cell vaccine and acellular pertussis vaccine. The acellular vaccine contains only components of the B. pertussis organism and appears as effective with a lower incidence of adverse effects.
4. Adverse reactions include local reactions (pain, redness, swelling at injection site), febrile reactions and also worrisome events including prolonged crying (3%), unusual high-pitched crying (0.1%), convulsions (0.06%), and acute neurologic illness (0.00005%) - these latter adverse reactions occur more frequently with whole cell vaccine.
5. Immunization and when to use whole cell and acellular vaccine – see Recommended Childhood Immunization Schedule United States, January - December 1997.
A. Clinical manifestations: asymptomatic, nonspecific febrile illness, aseptic meningitis or paralytic polio (lower motor neurons involved)
B. Epidemiology
1. Fecal-oral and possibly oral-oral spread
2. Most common in young children; more severe in adults
3. Seasonal pattern in temperate climates
4. Rare, vaccine-associated cases in nonimmunized individuals
5. Communicability: greatest before and after onset of illness, contagious as long as fecal excretion present
6. Incubation for paralytic disease: 7 - 14 days
C. Immunization
1. Two types of vaccine: Trivalent live oral polio virus vaccine (OPV) and trivalent inactivated polio virus vaccine that has been enhanced (eIPV)
2. Adverse reactions:
a. OPV: paralysis in 1 out of 9 million doses in individuals vaccinated; 1 out of 7 million in contacts
b. eIPV: no serious adverse effects; hypersensitivity reactions to antibiotics contained in vaccine preparation
3. OPV is not recommended for persons who are immunodeficient or for normal individuals who reside in a household where a person is immunodeficient; use eIPV
4. Immunization – see Recommended Childhood Immunization Schedule United States, January - December 1997.
A. Children who are susceptible to chicken pox may receive varicella vaccine at any time after their first birthday. If a child has an unreliable history of having had chicken pox or being immunized with varicella vaccine by age 11 or 12 years, he/she should be immunized. At an age = 13 years, a child should receive 2 doses of the vaccine at least 1 month apart.
B. No severe adverse effects to the vaccine have been reported. Local reactions such as pain, local swelling, and erythema at the injection site are reported in up to 25% of patients while fever has been reported in 4 - 10$ of patients and mild upper respiratory symptoms in a small number of those immunized.
REFERENCES
1. Peter G. Childhood immunizations. N Engl J Med 1992;327:1794.
2. Poon CY. Childhood immunization: Part I. J Pediatr Health Care 1992;6:370.
3. Poon CY. Childhood immunization: Part II. J Pediatr Health Care 1993;7:127.
4. Bellanti JA. Basic immunologic principles underlying vaccination procedures. Pediatr Cin North Am 1990;37:513.
5. Committee on Infectious Diseases. Report of the committee on infectious diseases 1994 (1994 Redbook). 23ed. Elk Grove Village, IL:American Academy of Pediatrics.
6. Centers for Disease Control. General recommendations on immunization. MMWR 1989;38:205.
7. Centers for Disease Control. General recommendations on immunization: guidelines from the Immunizations Practice Advisory Committee. Ann Intern Med 1989;111:133.
8. Centers for Disease Control. Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination. MMWR 1991;40 (RR-13):1.
9. Centers for Disease Control. Haemophilus b conjugate vaccines for prevention of Haemophilus influenzae type b disease among infants and children two months of age and older. MMWR 1991;40 (RR-13):1.
10. Centers for Disease Control. Haemophilus type b conjugate vaccines: recommendations for immunization of infants and children 2 months of age and older: update. Pediatr 1991;88:169.
11. Frenkel LD. Routine immunizations for American children in the 1990's. Pediatr Clin North Am 1990;37:531.
12. Centers for Disease Control. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 1988;37:197.
13. Mortimer EA, Jr. Diphtheria toxoid. In: Vaccines. Plotkin SA and Mortimer EA, Jr. eds. Philadelphia:WB Saunders Co. 1988, p 31-44.
14. Edwards KM, Karzon DT. Pertussis vaccines. Pediatr Clin North Am 1990;37:549.
15. Mortimer EA, Jr. Pertussis vaccine. In: Vaccines. Plotkin SA and Mortimer EA, Jr. eds. Philadelphia:WB Saunders Co. 1988, p 74-97.
16. Committee on Infectious Diseases. Report of the Committee on Infectious Diseases 1988 (1988 Redbook). 21st ed. Elk Grove Village, IL:American Academy of Pediatrics, 1988.
17. Howson CP, Fineberg HV. The ricochet of magic bullets: summary of the Institute of Medicine Report, adverse effects of pertussis and rubella vaccines. Pediatrics 1992;89:318.
18. Robbins FC. Polio. In: Vaccines. Plotkin SA and Mortimer EA, Jr. eds. Philadelphia:WB Saunders Co. 1988, p 98-114.
19. Melnick JL. Live attenuated poliovaccines. In: Vaccines. Plotkin SA and Mortimer EA, Jr. eds. Philadelphia:WB Saunders Co. 1988, p 115.
20. Salk J, Drucker J. Noninfectious polio virus vaccine. In: Vaccines. Plotkin SA and Mortimer EA, Jr. eds. Philadelphia:WB Saunders Co. 1988, p 158-81.
21. Preblud SR, Katz SL. Measles vaccine. In: Vaccines. Plotkin SA and Mortimer EA, Jr. eds. Philadelphia:WB Saunders Co. 1988, p 182-222.
22. Weibel RE. Mumps vaccine. In: Vaccines. Plotkin SA and Mortimer EA, Jr. eds. Philadelphia:WB Saunders Co. 1988, p 223-34.
23. Plotkin SA. Rubella vaccine. In: Vaccines. Plotkin SA and Mortimer EA, Jr. eds. Philadelphia:WB Saunders Co. 1988, p 235-62.
24. American Academy of Pediatrics Committee on Infectious Diseases. Recommended childhood immunization schedule – United States, January - December 1997. Pediatrics 1997;99:136-7.
25. Hegland A. Two high-risk infant groups targeted for RSV-IGIV therapy. AAP News. 1997;13 (number 2):1.
26. Bertino JS, Casto DT. Vaccines, Toxoids and other Immunobiologics. In: Pharmacotherapy, A Pathophysiologic Approach, 3rd edition. DiPiro JT, Talbert RL, Wells BG, Yee GC, Matzke GR, Posey LM (eds). Appleton and Lange, Samford, CT 1997; 2319-52.
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