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Canada Communicable Disease Report
Volume 29 ACS-5 1 September 2003 An Advisory Committee Statement (ACS)
PREVENTION OF PERTUSSIS IN ADOLESCENTS
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BC |
AB |
SK |
MA |
ON |
QC |
NB |
NS |
PEI |
NFL |
YU |
NWT |
NU |
|
1979 |
Fl
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Fl
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Fl
|
Fl
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Fl
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Fl*
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Fl
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Fl
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Fl
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Fl
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Fl
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Fl
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N/A |
1980 |
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1981 |
Ads |
Ads |
Ads |
Ads |
Ads |
Ads |
Ads |
Ads |
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1982 |
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1983 |
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1984 |
Ads |
Ads |
Ads |
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1985 |
Ads |
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1986 |
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1987 |
|||||||||||||
1995 |
|||||||||||||
1996 |
|||||||||||||
1997 |
Acel |
Acel |
Acel |
Acel |
Acel |
Acel |
Acel |
Acel |
Acel |
Acel |
Acel |
||
1998 |
Acel |
||||||||||||
1999 |
*All provinces used Connaught Laboratories (now Aventis Pasteur) fluid vaccine except Quebec, where the fluid vaccine was produced by Institut Armand-Frappier. All adsorbed vaccines were produced by Connaught Laboratories.
Ads: adsorbed vaccine
Acel: acellular vaccine
FI: fluid vaccine
Figure 1. Reported incidence rate of pertussis among adolescents and adults by age: Canada, 1987-2000
Adolescent and Adult Target Population for Protection against Pertussis
As described earlier, while waning of vaccine-induced protection is a universal phenomenon affecting all adolescents and adults, the Canadian situation is unique because of the presence of a cohort of vulnerable adolescents who were immunized only with the adsorbed whole cell vaccine with a lower protective efficacy(17).
As the adsorbed whole cell vaccine was introduced between 1980 and 1985, depending on the province/territory, the year of birth of the older children belonging to the affected cohort varies accordingly (Table 1). The youngest were born in 1994-1995, and the acellular vaccine was introduced between 1997 and 1998 throughout Canada. Children born since 1995 should be less vulnerable, as they should have received at least one preschool booster of acellular vaccine. Many children in this cohort have been infected by pertussis during the past decade, and the proportion should be greater in the older ones, given their longer cumulative exposure to pertussis. To best protect this cohort a single dose of acellular pertussis vaccine is recommended. If there is no intervention, Canada should anticipate persistence of high transmission in this cohort. However, mathematical modeling predicts that the overall incidence of pertussis in Canada will be lower in the next decade than it was between 1990 and 2000 because of the better protection in younger children vaccinated with the acellular vaccine(1).
For children younger than this cohort who were vaccinated with the acellular pertussis vaccine, the risk of becoming vulnerable in adolescence will depend on the duration of the acellular vaccine-induced immunity. This will only be known in a few years with the long-term follow-up of children who received the vaccine. It will then be possible to determine the necessity and optimal timing of subsequent booster dose(s).
The prevention of pertussis in adults is desirable, and they may be safely and effectively protected by the acellular vaccine. However, the feasibility of a program that would achieve high vaccine coverage has not been demonstrated, and the appropriate interval between booster doses is still unknown.
Preparations Licensed for Immunization
Only acellular vaccines made from purified antigens of B. pertussis are available in Canada. Acellular vaccines have been developed to reduce the frequency and severity of both local and systemic adverse reactions associated with whole cell pertussis vaccines. All the currently available acellular vaccines contain pertussis toxoid (PT), filamentous hemagglutinin (FHA), and pertactin (PRN). Some also have fimbriae (Fim).
The diphtheria and pertussis antigen content of the combined diphtheria-tetanus-acellular adolescent/adult formulation of this vaccine is lower than the one found in the vaccines used in preschool children. Therefore dTap refers to the adolescent/adult formulation of acellular pertussis vaccine, whereas DTaP refers to the infant formulation. Both are adsorbed on aluminum phosphate.
Efficacy and Immunogenicity
In 1995-1996, the results of seven studies of the efficacy of eight DTaP infant vaccines were reported. The studies were not designed to compare the efficacy of the various acellular pertussis vaccines, and they involved different study designs; therefore, few conclusions can be drawn about the relative merits of the various products. All the acellular vaccines were efficacious; most were as effective as or more effective than the whole-cell DTP vaccines included as controls. All acellular pertussis vaccines licensed in Canada have an estimated efficacy of approximately 85%(32).
The duration of protection afforded by acellular pertussis vaccines is not known, but the data seem to indicate that protection does not decline during the first 4 years of follow-up. Long-term follow-up will continue for several of the cohorts that participated in the efficacy studies.
There are limited data about the efficacy of a single dose of adolescent/adult pertussis vaccine given to previously immunized adolescents or adults in the prevention of pertussis infection, disease and transmission. It has been shown that a single dose of vaccine increases pertussis antibody levels far in excess of those observed in Sweden in infants who had received three doses of acellular pertussis vaccine(33,34). As the efficacy demonstrated in the Swedish trial was 85%, it is reasonable to expect that the protection against severe disease in adolescents and adults would be of the same order. The only study that directly assessed vaccine efficacy in adults found that a single dose of a tri-component acellular pertussis vaccine gave significant protection(31). The point estimate of vaccine efficacy for the primary case definition was 92%, but as cases were not numerous the confidence interval (32%-99%) was wide. Indirect evidence supporting the protective efficacy of a single dose of DTaP comes from data showing that infants or preschool-aged children previously immunized with the adsorbed whole-cell vaccine had a significantly lower risk of pertussis after acellular than adsorbed whole-cell pertussis vaccine given as a single booster dose(35).
Adolescents
All preadolescents and adolescents who have not received a dose of acellular vaccine should receive a single dose of the adolescent/adult formulation of acellular pertussis vaccine. A single campaign to vaccinate the entire cohort is the strategy that would prevent most cases. Ideally, adolescents who have already received their Td booster dose would be given monovalent acellular pertussis vaccine, but this product is not currently marketed in Canada. Alternatively, a dose of the combined dTap can be safely used. Limited data based on adults who received two doses of dTap one month apart showed no increase in adverse reactions(33). At a minimum, dTap should replace Td for the regular adolescent booster dose program. Optimally, the timing of the booster dose should be determined according to local epidemiologic patterns.
Adults
For adults who have not previously received a dose of acellular vaccine, it is recommended that a single diphtheria-tetanus (Td) booster dose be replaced by the combined diphtheria-tetanus-acellular pertussis (dTap) vaccine.
Outbreak Control
Acellular pertussis vaccine has been used safely for control of pertussis outbreaks in defined populations such as in schools or hospitals, although data supporting its effectiveness for this purpose are lacking. If dTap is considered for people >= 7 years to achieve outbreak control, this should be undertaken with evaluation of its effectiveness.
The role of chemoprophylaxis in the management of contacts is discussed elsewhere(1).
Schedule and Dosage
Adolescents and adults should receive a single dose of the combined adolescent/adult formulation of dTap.
The duration of protection given by that booster dose is not known, and only one dose is currently recommended. NACI will update this recommendation according to the results of long-term follow-up of children immunized with acellular vaccine.
Route of Administration
All combined acellular pertussis vaccines are adsorbed vaccines and must be given intramuscularly.
Storage Requirements
Pertussis-containing vaccines should be stored between 2° C and 8° C and should not be frozen. As with all adsorbed vaccines, pertussis-containing vaccines that have been frozen should not be used.
Simultaneous Administration with Other Vaccines
Vaccines containing acellular pertussis may be administered simultaneously with other inactivated or live vaccines but at different sites. Not to do so may result in missed opportunities and lower vaccine coverage. None of the products should be mixed in the same syringe with any other vaccines unless specifically advised in the package insert.
Adverse Reactions
In adults, the adverse reaction rate observed with dTap is comparable to that seen with Td (Table 2)(34). Local reaction is the most frequent event, with pain occurring in 89%, erythema in 12%, and swelling in 17%. These local reactions are generally mild and transient. By decreasing order of frequency, the systemic adverse events were headache (39%), decreased energy (29%), generalized body ache (20%), nausea (15%), chills (13%), diarrhea (10%), fever (9%), sore and swollen joints (9%), and vomiting (2%). When compared with Td, there is no clinically significant increase in the frequency of adverse events with dTap (Table 2).
Contraindications and Precautions
Pertussis vaccine should not be given to individuals who have had an anaphylactic reaction to a previous dose or to any constituent of the vaccine (see package insert).
The presence of a large, local reaction to a previous dose should not be considered a contraindication to continuing the recommended schedule.
Other Considerations
The older members of the cohort of children who received the acellular pertussis vaccine for their primary vaccination were born in 1997-1998. To properly determine their need for a booster dose in adolescence, it will be important to actively monitor the duration of their immunity against pertussis over the next several years. Similarly, to formulate a recommendation on the interval between booster doses, research should be conducted to assess the duration of protection afforded by a single booster dose given to adults or to adolescents primed with the whole cell pertussis vaccine. Feasibility research should be done to find effective strategies to obtain high vaccine coverage in adults.
Table 2. Adverse events reported after immunization with adult formulation tetanus-diphtheria toxoid vaccine alone (Td) or in combination with acellular pertussis vaccine (dTap)(34)
Td (n = 151) |
dTap (n = 449) |
|
Erythema >= 10 mm |
2.0% |
5.6% |
Swelling >= 10 mm |
11.4% |
14.1% |
Pain >= moderate |
12.6% |
19.4% |
Fever >= 38.3° C |
1.3% |
2.2% |
Chills >= moderate |
2.0% |
2.4% |
Headache >= moderate |
6.6% |
10.5% |
Body ache >= moderate |
2.0% |
5.8% |
Decreased energy >= moderate |
6.6% |
8.9% |
Sore joints >= moderate |
0.7% |
2.2% |
Nausea >= moderate |
1.3% |
2.4% |
Vomiting >= moderate |
0.0% |
1.8% |
Diarrhea >= moderate | 2.0% |
2.2% |
LEVEL OF EVIDENCE FOR THE RECOMMENDATION
A single booster dose of dTap should be administered to adolescents and adults in place of the current Td to protect against pertussis (A 1).
References
Health Canada. National Consensus Conference on Pertussis. CCDR 2003;29S3:1-33.
Health Canada. Canadian immunization guide, 6th ed. Ottawa: Health Canada, 2002. Cat. No. H49-8-2002E.
Halperin SA, Wang EL, Law B et al. Epidemiological features of pertussis in hospitalized patients in Canada, 1991-1997: report of the Immunization Monitoring Program - Active (IMPACT). Clin Infect Dis 1999;28:1238-43.
De Serres G, Shadmani R, Duval B et al. Morbidity of pertussis in adolescents and adults. J Infect Dis 2000;182:174-9.
Senzilet LD, Halperin SA, Spika JS et al. Pertussis is a frequent cause of prolonged cough illness in adults and adolescents. Clin Infect Dis 2001;32:1691-97.
Lambert HP. Epidemiology of a small pertussis outbreak. Public Health Rep 1965;80:365-69.
Jenkinson D. Duration of effectiveness of pertussis vaccine: evidence from a 10 year community study. Brit Med J 1988;296:612-14.
Cromer BA, Goydos J, Hackell J et al. Unrecognized pertussis infection in adolescents. Am J Dis Child 1993;147:575-77.
Mink CM, Sirota NM, Nugent S. Outbreak of pertussis in a fully immunized adolescent an adult population. Arch Pediatr Adolesc Med 1994;148:153-57.
Wirsing von Konig CH, Postels-Multani S, Bock HL, Schmitt HJ. Pertussis in adults: frequency of transmission after household exposure. Lancet 1995;346:1326-29.
Wright SW, Edwards KM, Decker MD, Zeldin MH. Pertussis infection in adults with persistent cough. JAMA 1995;273:1044-46.
Deville JG, Cherry JD, Chirstenson PD et al. Frequency of unrecognized Bordetella pertussis infections in adults. Clin Infect Dis 1995;1:639-42.
Schmitt-Grohé S, Cherry JD, Heininger U et al. Pertussis in German adults. Clin Infect Dis 1995;21:860-66.
Birkebaek NH, Kristiansen M, Seefeldt T et al. Bordetella pertussis and chronic cough in adults. Clin Infect Dis 1999;29:1239-42.
CDC. Transmission of pertussis from adult to infant - Michigan, 1993. MMWR 1995;44:74-76.
Health Canada. Notifiable diseases annual summary 1998. CCDR 2000;26S5:1-151.
Ntezayabo B, De Serres G, Duval B. Pertussis resurgence in Canada largely caused by a cohort effect. Pediatr Infect Dis J 2003;22:22-7.
Skowronski DM, De Serres G, MacDonald D et al. The changing age and seasonal profile of pertussis in Canada. J Infect Dis 2002;185:1448-53.
Halperin SA, Bortolussi R, MacLean D, Chisholm N. Persistence of pertussis in an immunized population: results of the Nova Scotia enhanced pertussis surveillance program. J Pediatr 1989;115:686-93.
Deeks S, De Serres G, Boulianne N et al. Failure of physicians to consider the diagnosis of pertussis in children. Clin Infect Dis 1999;28:840-46.
De Serres G, Boulianne N, Duval B. Field effectiveness of erythromycin prophylaxis to prevent pertussis within families. Ped Infect Dis J 1995;14:969-75.
De Serres G, Boulianne N, Duval B et al. Effectiveness of a whole cell pertussis vaccine in child-care centers and schools. Ped Infect Dis J 1996;15:519-24.
Bentsi-Enchill AD, Halperin SA, Scott J, MacIsaac K, Duclos P. Estimates of the effectiveness of a whole-cell pertussis vaccine from an outbreak in an immunized population. Vaccine 1997;15:301-06.
Health Canada. Childhood vaccination coverage levels in Canada, 1994-1997: progress towards national targets.Update: Vaccine-preventable Diseases 1998;6(1):2-4.
Health Canada. Canadian national report on immunization, 1996. CCDR 1997;23S4:1-50.
Health Canada. Canadian national report on immunization, 1997. Paediatr Child Health 1998;3(suppl B).
Health Canada. Canadian national report on immunization, 1998. Paediatr Child Health 1999;4(suppl C).
Guris D, Strebel PM, Tachdjian R et al. Effectiveness of the pertussis vaccination program as determined by use of the screening method: United States, 1992-1994. J Infect Dis 1997;176:456-63.
Baron S, Njamkepo E, Grimprel E et al. Epidemiology of pertussis in French hospitals in 1993 and 1994: thirty years after a routine use of vaccination. Pediatr Infect Dis J 1998;17:412-18.
Scheil W, Cameron S, Roberts C, Hall R. Pertussis in South Australia 1893 to 1996. Commun Dis Intell 1998;22:76-80.
Ward J, Partridge S, Chang S et al. Acellular pertussis vaccine efficacy and epidemiology of pertussis in adolescents and adults: NIH multicenter adult pertussis trial (APERT). Acellular Pertussis Vaccine Conference, Bethesda, MD, 2000.
National Advisory Committee on Immunization. Statement on pertussis vaccine. CCDR 1997;23(ACS-3):1-16.
Halperin SA, Smith B, Russell M et al. Adult formulation of a five component acellular pertussis vaccine combined with diphtheria and tetanus toxoids and inactivated poliovirus vaccine is safe and immunogenic in adolescents and adults. Pediatr Infect Dis J 2000;19:276-83.
Halperin SA, Smith B, Russell M et al. An adult formulation of a five-component acellular pertussis vaccine combined with diphtheria and tetanus toxoids is safe and immunogenic in adolescents and adults. Vaccine 2000;18:1312-19.
De Serres G, Shadmani R, Boulianne N et al. Effectiveness of a single dose of acellular pertussis vaccine to prevent pertussis in children primed with pertussis whole cell vaccine. Vaccine 2001;19:3004-08.
PREVENTION OF PERTUSSIS IN ADOLESCENTS AND ADULTS
Vol 29, ACS-5, 1 September 2003
On page 6, under Recommended Usage, section Adolescents, this statement refers to a published study:
"Alternatively, a dose of the combined dTap can be safely used. Limited data based on adults who received two doses of dTap one month apart showed no increase in adverse reactions(33)."
In fact, the referenced study included adults who received one dose of dTap followed one month later by monovalent ap vaccine. Therefore, there are no clinical data describing the safety of two doses of dTap given shortly apart.
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