1 4.12 PERTUSSIS...1 1 4.12 PERTUSSIS 2 4.12.1 Bacteriology 3 Pertussis (whooping cough) is caused...

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1 4.12 PERTUSSIS 1 4.12.1 Bacteriology 2 Pertussis (whooping cough) is caused by Bordetella pertussis, a fastidious, Gram-negative, pleomorphic bacillus. There 3 are other organisms (such as Bordetella parapertussis, Mycoplasma pneumoniae and Chlamydia pneumoniae) that can 4 cause a pertussis-like syndrome. 1 5 4.12.2 Clinical features 6 Pertussis is a respiratory infection with an incubation period of 7 to 20 days. In unvaccinated persons, B. pertussis is 7 highly infectious, spreading by aerosols to 90% of susceptible household contacts. 2 Natural infection does not provide 8 long-term protection and repeat infection can occur. 2 The characteristic paroxysmal cough with inspiratory whoop seen 9 in unvaccinated children is less common in individuals who have varying degrees of immunity acquired from 10 vaccination or infection. 3 It has been estimated that B. pertussis accounts for up to 7% of cough illnesses per year in 11 adults and, each year, more than 25% of adults experience a coughing illness of at least 5 days duration. 4 Even in adults, 12 pertussis can be associated with significant morbidity, with cough persisting for up to 3 months, and other significant 13 symptoms, such as sleep disturbance or, rarely, rib fracture. 5 Identification of pertussis is limited by patient and 14 physician awareness and, in some cases, the limited sensitivity of diagnostic tests; it is generally believed to be 15 significantly under-diagnosed (see 4.12.11 Public health management of pertussis below). 16 Death due to pertussis is rare in people aged 1070 years. However, the case-fatality rate in unvaccinated infants 17 <6 months of age is estimated to be 0.8%. 6,7 The most common cause of death in persons with pertussis infection is 18 pertussis pneumonia, sometimes complicated by seizures and hypoxic encephalopathy. 3 19 4.12.3 Epidemiology 20 Despite a long-standing immunisation program, pertussis remains highly prevalent in Australia and the least well 21 controlled of all vaccine-preventable diseases. Epidemics occur every 3 to 4 years. In unvaccinated populations, these 22 outbreaks can be very large. In vaccinated populations, outbreaks are smaller, with greatly reduced mortality and 23 morbidity, and may continue to occur every 3 to 4 years or be more widely spaced. 8 The maximal risk of infection and 24 severe morbidity is before infants are old enough to have received at least 2 vaccine doses. 9 In recent years, among 25 highly immunised communities, many cases of pertussis have occurred in adults and adolescents due to waning 26 immunity. 8,10 These persons are a significant reservoir of infection. Evidence from several studies of infant pertussis 27 cases indicates that family members, particularly parents, are the source of infection in more than 50% of cases where a 28 primary case can be identified, and the presumed source in a higher proportion. 11 There have also been case reports 29 documenting nosocomial infection in young infants acquired from healthcare workers. 12-15 Pertussis hospitalisation rates 30 for persons aged ≥60 years are higher than for other adults. 16 31 Between 2000 and 2010, multiple epidemics of pertussis occurred in Australia; however, the timing and frequency of 32 these varied by geographical location. More than 139 000 cases were reported over this 11-year period, with the highest 33 annual incidence of notifications (156 cases per 100 000 population) reported in 2010. 17 34 There have been a number of changes introduced to the NIP schedule over time in an attempt to improve control of 35 pertussis. Introduction of a 5th dose of diphtheria, tetanus and whole-cell pertussis vaccine (DTPw) for 45-year-old 36 children in August 1994 was followed by a decrease in notifications consistent with a vaccine effect; first among 37 children aged 5 and 6 years, then by those in the 79 years age group. 8,18 Subsequently, the average age of pertussis 38 notifications continued to increase. By 2005, the proportion of notifications in adults >20 years of age had reached 39 83%, 8 compared with 40% in the early 1990s. 40 Acellular pertussis vaccine (DTPa) replaced DTPw for booster doses in 1997, and for all doses from 1999. In 2003, the 41 DTPa booster dose at 18 months of age was removed from the NIP, moving the 1st booster dose to 4 years of age. The 42 removal of the 18-month booster dose from the schedule was based on evidence from an Italian longitudinal study of 43 DTPa trial participants. The study found that a primary DTPa course at 2, 4 and 6 months of age provided 76 to 80% 44 protection from prolonged cough disease and this was maintained until 6 years of age. 19 45 In 20092010, in contrast to previous epidemics, the highest notification rates in Australia were in children <10 years of 46 age; the proportion of notifications in adults >20 years of age decreased to 57%. The greatest increase in notification 47 rate occurred in 3-year-old children. Although increased and more sensitive diagnostic testing using polymerase chain 48 reaction (PCR) has contributed to this rise, vaccine effectiveness among 3-year olds has been estimated at around 49 60%, 20 consistent with waning of immunity following the primary DTPa course. In contrast to notifications, 50 hospitalisation and death rates from pertussis in the most recent epidemic periods have not increased substantially. 21 A 51 high proportion of hospitalisations, and almost all deaths, attributed to pertussis occur in infants too young to have 52 received more than 1 dose of pertussis-containing vaccine. 16,22 53

Transcript of 1 4.12 PERTUSSIS...1 1 4.12 PERTUSSIS 2 4.12.1 Bacteriology 3 Pertussis (whooping cough) is caused...

  • 1

    4.12 PERTUSSIS 1

    4.12.1 Bacteriology 2

    Pertussis (whooping cough) is caused by Bordetella pertussis, a fastidious, Gram-negative, pleomorphic bacillus. There 3

    are other organisms (such as Bordetella parapertussis, Mycoplasma pneumoniae and Chlamydia pneumoniae) that can 4

    cause a pertussis-like syndrome.1 5

    4.12.2 Clinical features 6

    Pertussis is a respiratory infection with an incubation period of 7 to 20 days. In unvaccinated persons, B. pertussis is 7

    highly infectious, spreading by aerosols to 90% of susceptible household contacts.2 Natural infection does not provide 8

    long-term protection and repeat infection can occur.2 The characteristic paroxysmal cough with inspiratory whoop seen 9

    in unvaccinated children is less common in individuals who have varying degrees of immunity acquired from 10

    vaccination or infection.3 It has been estimated that B. pertussis accounts for up to 7% of cough illnesses per year in 11

    adults and, each year, more than 25% of adults experience a coughing illness of at least 5 days duration.4 Even in adults, 12

    pertussis can be associated with significant morbidity, with cough persisting for up to 3 months, and other significant 13

    symptoms, such as sleep disturbance or, rarely, rib fracture.5 Identification of pertussis is limited by patient and 14

    physician awareness and, in some cases, the limited sensitivity of diagnostic tests; it is generally believed to be 15

    significantly under-diagnosed (see 4.12.11 Public health management of pertussis below). 16

    Death due to pertussis is rare in people aged 10–70 years. However, the case-fatality rate in unvaccinated infants 17

    20 years of age had reached 39

    83%,8 compared with 40% in the early 1990s. 40

    Acellular pertussis vaccine (DTPa) replaced DTPw for booster doses in 1997, and for all doses from 1999. In 2003, the 41

    DTPa booster dose at 18 months of age was removed from the NIP, moving the 1st booster dose to 4 years of age. The 42

    removal of the 18-month booster dose from the schedule was based on evidence from an Italian longitudinal study of 43

    DTPa trial participants. The study found that a primary DTPa course at 2, 4 and 6 months of age provided 76 to 80% 44

    protection from prolonged cough disease and this was maintained until 6 years of age.19

    45

    In 2009–2010, in contrast to previous epidemics, the highest notification rates in Australia were in children 20 years of age decreased to 57%. The greatest increase in notification 47

    rate occurred in 3-year-old children. Although increased and more sensitive diagnostic testing using polymerase chain 48

    reaction (PCR) has contributed to this rise, vaccine effectiveness among 3-year olds has been estimated at around 49

    60%,20

    consistent with waning of immunity following the primary DTPa course. In contrast to notifications, 50

    hospitalisation and death rates from pertussis in the most recent epidemic periods have not increased substantially.21

    A 51

    high proportion of hospitalisations, and almost all deaths, attributed to pertussis occur in infants too young to have 52

    received more than 1 dose of pertussis-containing vaccine.16,22

    53

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    The prevention of severe pertussis morbidity and deaths, particularly in infants

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    polymyxin and neomycin; and a vial containing a lyophilised pellet of 10 µg purified Hib capsular 1

    polysaccharide (PRP) conjugated to 20–40 µg tetanus toxoid. May contain yeast proteins. 2

    Infanrix IPV – GlaxoSmithKline (DTPa-IPV; diphtheria-tetanus-acellular pertussis-inactivated poliovirus). 3

    Each 0.5 mL pre-filled syringe contains ≥30 IU diphtheria toxoid, ≥40 IU tetanus toxoid, 25 µg PT, 25 µg FHA, 4

    8 µg PRN, 40 D-antigen units inactivated poliovirus type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 32 5

    D-antigen units type 3 (Saukett), adsorbed onto aluminium hydroxide; traces of formaldehyde, polysorbate 80, 6

    polymyxin and neomycin. 7

    Pediacel – Sanofi Pasteur Pty Ltd (DTPa-IPV-Hib; diphtheria-tetanus-acellular pertussis-inactivated poliovirus-8

    Haemophilus influenzae type b). Each 0.5 mL monodose vial contains ≥30 IU diphtheria toxoid, ≥40 IU tetanus 9

    toxoid, 20 µg PT, 20 µg FHA, 3 µg PRN, 5 µg pertussis fimbriae (FIM) 2+3, 40 D-antigen units inactivated 10

    poliovirus type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 32 D-antigen units type 3 (Saukett), 10 µg 11

    Hib capsular polysaccharide conjugated to 20 µg tetanus protein; 1.5 mg aluminium phosphate; ≤50 ng bovine 12

    serum albumin; phenoxyethanol as preservative; traces of formaldehyde, glutaraldehyde, polysorbate 80, 13

    polymyxin, neomycin and streptomycin. 14

    Quadracel – Sanofi Pasteur Pty Ltd (DTPa-IPV; diphtheria-tetanus-acellular pertussis-inactivated poliovirus). 15

    Each 0.5 mL monodose vial contains ≥30 IU diphtheria toxoid, ≥40 IU tetanus toxoid, 20 µg PT, 20 µg FHA, 16

    3 µg PRN, 5 µg FIM 2+3, 40 D-antigen units inactivated poliovirus type 1 (Mahoney), 8 D-antigen units type 2 17

    (MEF-1) and 32 D-antigen units type 3 (Saukett); 1.5 mg aluminium phosphate; ≤50 ng bovine serum albumin; 18

    phenoxyethanol as preservative; traces of formaldehyde, glutaraldehyde, polysorbate 80, polymyxin and 19

    neomycin. 20

    Tripacel – Sanofi Pasteur Pty Ltd (DTPa; diphtheria-tetanus-acellular pertussis). Each 0.5 mL monodose vial 21

    contains ≥30 IU diphtheria toxoid, ≥40 IU tetanus toxoid, 10 µg PT, 5 µg FHA, 3 µg PRN, 5 µg FIM 2+3; 22

    1.5 mg aluminium phosphate; 3.4 mg phenoxyethanol. 23

    Reduced antigen formulations for adults, adolescents and children aged 10 years 24

    Adacel – Sanofi Pasteur Pty Ltd (dTpa; diphtheria-tetanus-acellular pertussis). Each 0.5 mL monodose vial 25

    contains ≥2 IU diphtheria toxoid, ≥20 IU tetanus toxoid, 2.5 µg PT, 5 µg FHA, 3 µg PRN, 5 µg FIM 2+3; 26

    0.33 mg aluminium as aluminium phosphate; phenoxyethanol as preservative; traces of formaldehyde and 27

    glutaraldehyde. 28

    Adacel Polio – Sanofi Pasteur Pty Ltd (dTpa-IPV; diphtheria-tetanus-acellular pertussis-inactivated poliovirus). 29

    Each 0.5 mL monodose vial or pre-filled syringe contains ≥2 IU diphtheria toxoid, ≥20 IU tetanus toxoid, 2.5 µg 30

    PT, 5 µg FHA, 3 µg PRN, 5 µg FIM 2+3, 40 D-antigen units inactivated poliovirus type 1 (Mahoney), 8 D-31

    antigen units type 2 (MEF-1) and 32 D-antigen units type 3 (Saukett); 0.33 mg aluminium as aluminium 32

    phosphate; phenoxyethanol as preservative; traces of formaldehyde, glutaraldehyde, polysorbate 80, polymyxin, 33

    neomycin and streptomycin. 34

    Boostrix – GlaxoSmithKline (dTpa; diphtheria-tetanus-acellular pertussis). Each 0.5 mL monodose vial or pre-35

    filled syringe contains ≥2 IU diphtheria toxoid, ≥20 IU tetanus toxoid, 8 µg PT, 8 µg FHA, 2.5 µg PRN, 36

    adsorbed onto 0.5 mg aluminium as aluminium hydroxide/phosphate; traces of formaldehyde, polysorbate 80 37

    and glycine. 38

    Boostrix-IPV – GlaxoSmithKline (dTpa-IPV; diphtheria-tetanus-acellular pertussis-inactivated poliovirus). Each 39

    0.5 mL pre-filled syringe contains ≥2 IU diphtheria toxoid, ≥20 IU tetanus toxoid, 8 µg PT, 8 µg FHA, 2.5 µg 40

    PRN, 40 D-antigen units inactivated poliovirus type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 32 D-41

    antigen units type 3 (Saukett), adsorbed onto 0.5 mg aluminium as aluminium hydroxide/phosphate; traces of 42

    formaldehyde, polysorbate 80, polymyxin and neomycin. 43

    4.12.5 Transport, storage and handling 44

    Transport according to National vaccine storage guidelines: Strive for 5.41

    Store at +2°C to +8°C. Do not freeze. Protect 45

    from light. 46

    Infanrix hexa must be reconstituted by adding the entire contents of the syringe to the vial and shaking until the pellet is 47

    completely dissolved. Reconstituted vaccine should be used as soon as practicable. If storage is necessary, hold at room 48

    temperature for not more than 8 hours. 49

    4.12.6 Dosage and administration 50

    The dose of all pertussis-containing vaccines is 0.5 mL to be given by IM injection. 51

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    Do not mix DTPa- or dTpa-containing vaccines with any other vaccine in the same syringe, unless specifically 1

    registered for use in this way. 2

    4.12.7 Recommendations 3

    Infants and children 4

    Pertussis-containing vaccine is recommended in a 3-dose primary schedule for infants at 2, 4 and 6 months of age. Due 5

    to the high morbidity and occasional mortality associated with pertussis in the first few months of life, the 1st dose can 6

    be given as early as 6 weeks of age (see Table 2.1.5 Minimum acceptable age for the 1st dose of scheduled vaccines in 7

    infants in special circumstances). Giving a 1st dose at 6 weeks of age rather than 2 months of age is estimated to 8

    prevent an additional 8% of infant pertussis cases. The next scheduled doses should still be given at 4 months and 6 9

    months of age.28,42

    10

    A booster dose of pertussis-containing vaccine, usually provided as DTPa-IPV, is recommended at 4 years of age, but 11

    can be given as early as 3.5 years of age. This booster dose is essential as waning of pertussis immunity occurs 12

    following receipt of the primary schedule.2,31

    For this booster dose, all brands of DTPa-containing vaccines are 13

    considered interchangeable. 14

    Where required, DTPa-containing vaccines can be given for catch-up for either the primary doses or booster dose in 15

    children aged

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    Persons in contact with infants and others at increased risk from pertussis 1

    There is significant morbidity associated with pertussis infection in infants

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    Persons with a history of pertussis infection 1

    Administration of pertussis vaccine in children, adolescents or adults who have had laboratory-confirmed pertussis 2

    infection is safe and is necessary, as natural immunity does not confer life-long protection. In particular, incompletely 3

    vaccinated infants

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    dTpa-containing vaccines in adolescents and adults 1

    Reduced antigen content dTpa vaccines are safe and well-tolerated in adults.32,65,66

    The incidence of fever is low, and 2

    comparable in vaccine and placebo recipients in clinical trials.32,65,66

    Studies investigating revaccination within 10 years 3

    (and some within 2 years) after a tetanus toxoid-, dT- or dTpa-containing vaccine in non-pregnant adolescents and 4

    adults have found no increase in moderate or severe adverse events or subjective fever. However, an increase in mild 5

    transient injection site pain is often reported following dTpa-containing booster doses.36,53,54,67

    Limb swelling reactions 6

    after dTpa-containing booster doses are rare.36,37,67

    7

    Brachial neuritis (inflammation of a nerve in the arm, causing weakness or numbness) has been described following the 8

    administration of tetanus toxoid-containing vaccines, with an estimated excess risk of approximately 0.5–1 in 100 000 9 doses in adults.

    68,69 10

    dTpa vaccines in pregnant women 11

    Studies have found no evidence of an increased risk of adverse pregnancy outcomes (such as stillbirth, pre-eclampsia, 12

    fetal distress, low birth weight or neonatal renal failure) related to pertussis vaccination during pregnancy.49,70-74

    13

    While dTpa vaccine is generally safe and well-tolerated in adults, there is a small risk that significant injection site 14

    reactions following subsequent doses might occur in some women who receive dTpa vaccines during successive closely 15

    spaced pregnancies. This low risk is considered to be balanced by the benefit to each infant of protection against 16

    pertussis. 17

    4.12.11 Public health management of pertussis 18

    Pertussis (both suspected and confirmed) is a notifiable disease in all states and territories in Australia. Detailed 19

    information regarding case definitions and the management of pertussis cases and contacts can be found in the national 20

    guidelines for control of pertussis75

    (www.health.gov.au/cdnasongs). 21

    Further instructions about the public health management of pertussis can also be obtained from state/territory public 22

    health authorities (see Appendix 1 Contact details for Australian, state and territory government health authorities and 23

    communicable disease control). 24

    Suspected cases of pertussis should be investigated, regardless of vaccination status, as immunisation is not 100% 25

    effective and immunity wanes over time. The diagnosis of pertussis can be confirmed by either culture or nucleic acid 26

    testing of a per-nasal swab or nasopharyngeal aspirate specimen, or by serology. The appropriate diagnostic test 27

    depends on the age, vaccination history and duration of symptoms. PCR is usually the diagnostic method of choice, 28

    particularly if pertussis is suspected in someone who has received a pertussis-containing vaccine within the previous 5 29

    years.76

    30

    To reduce the risk of transmission of B. pertussis, persons with pertussis infection should commence appropriate 31

    antibiotic therapy on clinical suspicion, if within 21 days of the onset of coryza. Antibiotic treatment does not shorten 32

    the course of the illness, but reduces infectivity if provided early in the illness. Detailed information regarding 33

    appropriate macrolide antibiotics and dosing can be found in the national guidelines for control of pertussis.75,77

    34

    Management of contacts of cases 35

    Vaccination 36

    Since a primary vaccination course requires three or more injections to protect against pertussis, infant vaccination 37

    cannot be effectively used to protect unimmunised infants. Vaccination has not been shown to have a role in controlling 38

    outbreaks at any age, even in closed settings. However, unvaccinated or partially vaccinated contacts, up to their 10th 39

    birthday, should be offered DTPa-containing vaccines, and older contacts should be offered dTpa (see 2.1.5 Catch-up). 40

    Passive immunisation with normal human immunoglobulin is not effective in the prevention of pertussis. 41

    Chemoprophylaxis 42

    The benefit of chemoprophylaxis in preventing the secondary transmission of pertussis is limited due to multiple 43

    factors, including delayed clinical presentation, delayed diagnosis and imperfect compliance.78

    The use of 44

    chemoprophylaxis for prevention of secondary cases should be limited to close contacts of cases in the household 45

    setting who are vulnerable to severe complications of pertussis, or who, in settings such as early childhood education 46

    and care or healthcare facilities, may transmit pertussis to vulnerable contacts. Further recommendations regarding 47

    chemoprophylaxis of close contacts can be found in the national guidelines for control of pertussis.75

    48

    4.12.12 Variations from product information 49

    The product information for Infanrix hexa states that this vaccine is indicated for primary immunisation of infants from 50

    the age of 6 weeks. The ATAGI recommends that this vaccine may also be used for catch-up of the primary schedule in 51

    children

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    The product information for Infanrix IPV states that this vaccine is indicated for use in a 3-dose primary schedule for 1

    immunisation of infants from the age of 6 weeks and as a single booster dose for children ≤6 years of age who have 2

    previously been vaccinated against diphtheria, tetanus, pertussis and poliomyelitis. In addition, the ATAGI recommends 3

    that this product may also be used for catch-up of the primary schedule or as a booster in children

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    and Mortality Weekly Report 2005;54:1283-6. 6

    8. Quinn HE, McIntyre PB. Pertussis epidemiology in Australia over the decade 1995–2005 – trends by region 7

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    9. Munoz FM. Pertussis in infants, children, and adolescents: diagnosis, treatment, and prevention. Seminars in 9

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    10. Güriş D, Strebel PM, Bardenheier B, et al. Changing epidemiology of pertussis in the United States: increasing 11

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    the United States, 1993 to 2004. Pediatrics 2008;121:484-92. 4

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    31. Gustafsson L, Hessel L, Storsaeter J, Olin P. Long-term follow-up of Swedish children vaccinated with 7

    acellular pertussis vaccines at 3, 5, and 12 months of age indicates the need for a booster dose at 5 to 7 years of 8

    age. Pediatrics 2006;118:978-84. 9

    32. Blatter M, Friedland LR, Weston WM, Li P, Howe B. Immunogenicity and safety of a tetanus toxoid, reduced 10

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    2009;27:765-72. 12

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    34. Schwartz AT. FDA clinical briefing document for GlaxoSmithKline (GSK) Biologicals tetanus toxoid, 17

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    Biological Products Advisory Committee meeting, March 15, 2005. Available at: 19

    http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4097b1.htm (accessed Aug 2011). 20

    35. Van Damme P, McIntyre P, Grimprel E, et al. Immunogenicity of the reduced-antigen-content dTpa vaccine 21

    (Boostrix®) in adults 55 years of age and over: a sub-analysis of four trials. Vaccine 2011;29:5932-9. 22

    36. Booy R, Van der Meeren O, Ng SP, et al. A decennial booster dose of reduced antigen content diphtheria, 23

    tetanus, acellular pertussis vaccine (BoostrixTM

    ) is immunogenic and well tolerated in adults. Vaccine 24

    2010;29:45-50. 25

    37. Mertsola J, Van Der Meeren O, He Q, et al. Decennial administration of a reduced antigen content diphtheria 26

    and tetanus toxoids and acellular pertussis vaccine in young adults. Clinical Infectious Diseases 2010;51:656-27

    62. 28

    38. Amirthalingam G, Andrews N, Campbell H, et al. Effectiveness of maternal pertussis vaccination in England: 29

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    39. Healy CM, Rench MA, Baker CJ. Importance of timing of maternal combined tetanus, diphtheria, and 31

    acellular pertussis (Tdap) immunization and protection of young infants. Clinical Infectious Diseases 32

    2013;56:539-44. 33

    40. Leuridan E, Hens N, Peeters N, et al. Effect of a prepregnancy pertussis booster dose on maternal antibody 34

    titers in young infants. Pediatric Infectious Disease Journal 2011;30:608-10. 35

    41. National vaccine storage guidelines: Strive for 5. 2nd ed. Canberra: Australian Government Department of 36

    Health and Ageing, 2013. Available at: 37

    www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/IMM77-cnt (accessed Nov 2013). 38

    42. Shinall MC, Jr., Peters TR, Zhu Y, Chen Q, Poehling KA. Potential impact of acceleration of the pertussis 39

    vaccine primary series for infants. Pediatrics 2008;122:1021-6. 40

    43. Rennels MB. Extensive swelling reactions occurring after booster doses of diphtheria-tetanus-acellular 41

    pertussis vaccines. Seminars in Pediatric Infectious Diseases 2003;14:196-8. 42

    44. Quinn HE, McIntyre PB. The impact of adolescent pertussis immunization, 2004–2009: lessons from 43

    Australia. Bulletin of the World Health Organization 2011;89:666-74. 44

    45. Liu BC, McIntyre P, Kaldor JM, et al. Pertussis in older adults: prospective study of risk factors and morbidity. 45

    Clinical Infectious Diseases 2012;55:1450-6. 46

    46. Hoel T, Wolter JM, Schuerman LM. Combined diphtheria-tetanus-pertussis vaccine for tetanus-prone wound 47

    management in adults. European Journal of Emergency Medicine 2006;13:67-71. 48

    47. Weston W, Messier M, Friedland LR, Wu X, Howe B. Persistence of antibodies 3 years after booster 49

    vaccination of adults with combined acellular pertussis, diphtheria and tetanus toxoids vaccine. Vaccine 50

    2011;29:8483-6. 51

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    48. Englund JA. The influence of maternal immunization on infant immune responses. Journal of Comparative 1

    Pathology 2007;137 Suppl 1:S16-9. 2

    49. Munoz FM, Bond NH, Maccato M, et al. Safety and immunogenicity of tetanus diphtheria and acellular 3

    pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. JAMA 4

    2014;311:1760-9. 5

    50. Hardy-Fairbanks AJ, Pan SJ, Decker MD, et al. Immune responses in infants whose mothers received Tdap 6

    vaccine during pregnancy. Pediatric Infectious Disease Journal 2013;32:1257-60. 7

    51. David ST, Hemsley C, Pasquali PE, et al. Enhanced surveillance for vaccine-associated adverse events: dTap 8

    catch-up of high school students in Yukon. Canada Communicable Disease Report 2005;31:117-26. 9

    52. Tremblay M, Grenier JL, De Serres G, et al. Adverse events after vaccination with dTap in high school 10

    students who have previously been vaccinated with d2T5. Canada Communicable Disease Report 2006;32:25-11

    8. 12

    53. Halperin SA, Sweet L, Baxendale D, et al. How soon after a prior tetanus-diphtheria vaccination can one give 13

    adult formulation tetanus-diphtheria-acellular pertussis vaccine? Pediatric Infectious Disease Journal 14

    2006;25:195-200. 15

    54. Talbot EA, Brown KH, Kirkland KB, et al. The safety of immunizing with tetanus-diphtheria-acellular 16

    pertussis vaccine (Tdap) less than 2 years following previous tetanus vaccination: experience during a mass 17

    vaccination campaign of healthcare personnel during a respiratory illness outbreak. Vaccine 2010;28:8001-7. 18

    55. Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, 19

    reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine from the Advisory Committee on 20

    Immunization Practices, 2010. MMWR Morbidity and Mortality Weekly Report 2011;60:13-5. 21

    56. Decker MD, Edwards KM, Steinhoff MC, et al. Comparison of 13 acellular pertussis vaccines: adverse 22

    reactions. Pediatrics 1995;96:557-66. 23

    57. Centers for Disease Control and Prevention (CDC), Kroger AT, Sumaya CV, Pickering LK, Atkinson WL. 24

    General recommendations on immunization – recommendations of the Advisory Committee on Immunization 25

    Practices (ACIP). [erratum appears in MMWR Recomm Rep. 2011 Jul 29;60:993]. MMWR Recommendations 26

    and Reports 2011;60(RR-2):1-61. 27

    58. Mahajan D, Menzies R, Roomiani I, Lawrence G. Supplementary report: surveillance of adverse events 28

    following immunisation among children aged less than seven years in Australia, 1 January to 30 June 2009. 29

    Communicable Diseases Intelligence 2010;34:49-53. 30

    59. Goodwin H, Nash M, Gold M, Heath TC, Burgess MA. Vaccination of children following a previous 31

    hypotonic–hyporesponsive episode. Journal of Paediatrics and Child Health 1999;35:549-52. 32

    60. Moore DL, Le Saux N, Scheifele D, Halperin SA, Members of the Canadian Paediatric Society/Health Canada 33

    Immunization Monitoring Program, Active (IMPACT). Lack of evidence of encephalopathy related to 34

    pertussis vaccine: active surveillance by IMPACT, Canada, 1993–2002. Pediatric Infectious Disease Journal 35

    2004;23:568-71. 36

    61. Brotherton JM, Hull BP, Hayen A, Gidding HF, Burgess MA. Probability of coincident vaccination in the 24 37

    or 48 hours preceding sudden infant death syndrome death in Australia. Pediatrics 2005;115:e643-6. 38

    62. Jonville-Bera AP, Autret E, Laugier J. Sudden infant death syndrome and diphtheria-tetanus-pertussis-39

    poliomyelitis vaccination status. Fundamental and Clinical Pharmacology 1995;9:263-70. 40

    63. Mitchell EA, Stewart AW, Clements M, Ford RP, New Zealand Cot Death Study Group. Immunisation and the 41

    sudden infant death syndrome. Archives of Disease in Childhood 1995;73:498-501. 42

    64. Fleming PJ, Blair PS, Platt MW, et al. The UK accelerated immunisation programme and sudden unexpected 43

    death in infancy: case-control study. BMJ 2001;322:822-5. 44

    65. Turnbull FM, Heath TC, Jalaludin BB, Burgess MA, Ramalho AC. A randomized trial of two acellular 45

    pertussis vaccines (dTpa and pa) and a licensed diphtheria-tetanus vaccine (Td) in adults. Vaccine 46

    2000;19:628-36. 47

    66. Pichichero ME, Rennels MB, Edwards KM, et al. Combined tetanus, diphtheria, and 5-component pertussis 48

    vaccine for use in adolescents and adults. [erratum appears in JAMA. 2005 Dec 28;294(24):3092]. JAMA 49

    2005;293:3003-11. 50

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    67. Halperin SA, McNeil S, Langley J, et al. Tolerability and antibody response in adolescents and adults 1

    revaccinated with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap) 4–2

    5 years after a previous dose. Vaccine 2011;29:8459-65. 3

    68. Hamati-Haddad A, Fenichel GM. Brachial neuritis following routine childhood immunization for diphtheria, 4

    tetanus, and pertussis (DTP): report of two cases and review of the literature. Pediatrics 1997;99:602-3. 5

    69. Institute of Medicine. Stratton KR, Howe CJ, Johnston RB, Jr., eds. Adverse events associated with childhood 6

    vaccines: evidence bearing on causality. Washington, D.C.: National Academy Press, 1994. 7

    70. Donegan K, King B, Bryan P. Safety of pertussis vaccination in pregnant women in UK: observational study. 8

    BMJ 2014;349:g4219. 9

    71. Shakib JH, Korgenski K, Sheng X, et al. Tetanus, diphtheria, acellular pertussis vaccine during pregnancy: 10

    pregnancy and infant health outcomes. Journal of Pediatrics 2013;163:1422-6. 11

    72. Gall SA, Myers J, Pichichero M. Maternal immunization with tetanus-diphtheria-pertussis vaccine: effect on 12

    maternal and neonatal serum antibody levels. American Journal of Obstetrics and Gynecology 13

    2011;204:334.e1-5. 14

    73. Zheteyeva YA, Moro PL, Tepper NK, et al. Adverse event reports after tetanus toxoid, reduced diphtheria 15

    toxoid, and acellular pertussis vaccines in pregnant women. American Journal of Obstetrics and Gynecology 16

    2012;207:59.e1-7. 17

    74. Kharbanda EO, Vazquez-Benitez G, Lipkind HS, et al. Evaluation of the association of maternal pertussis 18

    vaccination with obstetric events and birth outcomes. JAMA 2014;312:1897-904. 19

    75. Communicable Diseases Network Australia (CDNA). Pertussis: CDNA national guidelines for public health 20

    units (Pertussis SoNG Version 2.0). Canberra: Australian Government Department of Health, 2013. Available 21

    at: http://www.health.gov.au/cdnasongs (accessed Nov 2014). 22

    76. Communicable Diseases Network Australia (CDNA). Surveillance case definitions for the Australian National 23

    Notifiable Diseases Surveillance System. Available at: 24

    http://www.health.gov.au/internet/main/publishing.nsf/Content/cdna-casedefinitions.htm (accessed Nov 2014). 25

    77. Antibiotic Expert Group. Therapeutic guidelines: antibiotic. Version 14. Melbourne: Therapeutic Guidelines 26

    Limited, 2010. 27

    78. Altunaiji SM, Kukuruzovic RH, Curtis NC, Massie J. Antibiotics for whooping cough (pertussis). Cochrane 28

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  • 13

    RELEVANT TEXT FROM OTHER CHAPTERS OF THE AUSTRALIAN IMMUNISATION 1 HANDBOOK 10TH EDITION 2

    UPDATED TO ALIGN WITH CHANGED RECOMMENDATIONS IN CHAPTER 4.12 3 PERTUSSIS 4

    5

    3.3 GROUPS WITH SPECIAL VACCINATION REQUIREMENTS 6

    3.3.2 Vaccination of women who are planning pregnancy, pregnant or breastfeeding, 7 and preterm infants 8

    Women planning pregnancy 9

    The need for vaccination, particularly for hepatitis B, measles, mumps, rubella and varicella should be assessed as part 10

    of any pre-conception health check. Where previous vaccination history or infection is uncertain, relevant serological 11

    testing can be undertaken to ascertain immunity to hepatitis B, measles, mumps and rubella. Routine serological testing 12

    for varicella does not provide a reliable measure of vaccine-induced immunity, although can indicate whether previous 13

    natural infection has occurred (see 4.22 Varicella). Influenza vaccine is recommended for any person who wishes to be 14

    protected against influenza and is recommended for women planning pregnancy. Those with risk factors for 15

    pneumococcal disease, including smokers and Aboriginal and Torres Strait Islander women, should be assessed for 16

    pneumococcal vaccination. Women who receive live attenuated viral vaccines should be advised against falling 17

    pregnant within 28 days of vaccination. 18

    19

    Pregnant women 20

    Table 3.3.1 summarises the recommendations for vaccine use in pregnancy. More detailed information is also provided 21

    under the ‘Pregnancy and breastfeeding’ sections of each disease-specific chapter in Part 4 of this Handbook. 22

    Seasonal influenza and dTpa are the only vaccines that are routinely recommended for pregnant women. 23

    24

  • 1

    Table 3.3.1: Recommendations for vaccination in pregnancy (see also disease-specific chapters in Part 4) 1

    Vaccines routinely recommended in pregnancy

    Inactivated viral vaccines Recommendation Comments

    Influenza vaccine Recommended for all pregnant women at any stage of pregnancy,

    particularly those who will be in the second or third trimester

    during the influenza season.

    There is evidence from clinical trial data and observational studies that

    there is no increased risk of congenital defects or adverse effects in the

    fetuses of women who are vaccinated against influenza in pregnancy.

    Influenza immunisation protects the mother, as pregnancy increases her

    risk of severe influenza, and also protects her newborn baby in the first

    few months after birth (see 4.7 Influenza).

    Diphtheria-, tetanus-, and pertussis-

    containing vaccines (dTpa)

    dTpa recommended as a single dose during the third trimester of

    each pregnancy

    Pertussis vaccination during the third trimester of pregnancy has been

    shown to be more effective in reducing the risk of infant pertussis than

    maternal vaccination post partum.

    Studies have found no evidence of an increased risk of adverse

    pregnancy outcomes related to pertussis vaccination during pregnancy.

    (See 4.12 Pertussis for more details.)

    Vaccines not routinely recommended in pregnancy

    Inactivated bacterial vaccines Recommendation Comments

    Diphtheria-tetanus vaccine (dT) Not routinely recommended

    Can be given under certain circumstances, such as for

    management of a tetanus-prone wound.

    Tetanus- and diphtheria-containing vaccines have been used

    extensively in pregnant women, with no increased risk of congenital

    abnormalities in fetuses of women who were vaccinated during

    pregnancy.16-18

    (See 4.2 Diphtheria and 4.19 Tetanus for more details.)

    2

  • 1

    4.2 DIPHTHERIA 1

    4.2.8 Pregnancy and breastfeeding 2

    Although dT vaccines are not routinely recommended for pregnant women, they can be given under certain 3

    circumstances, such as for management of a tetanus-prone wound (see 4.19 Tetanus).14

    4

    dTpa vaccine is recommended for pregnant women (in the third trimester of each pregnancy) to prevent pertussis in 5

    pregnant women and their newborns (see 4.12 Pertussis). 6

    4.2.12 Variations from product information 7

    The product information for Adacel and Boostrix states that these vaccines should not be used in pregnancy unless there 8

    is a high risk of acquiring pertussis. The ATAGI recommends that pregnant or post-partum women receive a dose with 9

    every pregnancy. 10

    The product information for Adacel states that there are currently no data upon which to base a recommendation for the 11

    optimal interval for administering subsequent booster doses to maintain antibody levels against pertussis; however, the 12

    ATAGI recommends that pregnant or post-partum women receive a booster dose with every pregnancy and that other 13

    adults in contact with infants and/or at increased risk from pertussis can receive a booster dose every 10 years. 14

    15

    4.19 TETANUS 16

    4.19.8 Pregnancy and breastfeeding 17

    Although dT vaccines are not routinely recommended for pregnant women, they can be given under certain 18

    circumstances, such as for management of a tetanus-prone wound (see 4.19.9 Tetanus-prone wounds below).17

    19

    dTpa vaccine is recommended for pregnant women (in the third trimester of each pregnancy) to prevent pertussis in 20

    pregnant women and their newborns (see 4.12 Pertussis). 21

    4.19.14 Variations from product information 22

    The product information for Adacel and Boostrix states that these vaccines should not be used in pregnancy unless there 23

    is a high risk of acquiring pertussis. The ATAGI recommends that pregnant or post-partum women receive a dose with 24

    every pregnancy. 25

    The product information for Adacel states that there are currently no data upon which to base a recommendation for the 26

    optimal interval for administering subsequent booster doses to maintain antibody levels against pertussis; however, the 27

    ATAGI recommends that pregnant or post-partum women receive a booster dose with every pregnancy and that other 28

    adults in contact with infants and/or at increased risk from pertussis can receive a booster dose every 10 years. 29

    30