Experience with monocomponent acellular pertussis combination vaccines for infants, children, adolescents and adults-A review of safety, immunogenicity, efficacy and effectiveness studies and 15 years of field experience

Vaccine

Volumn 31, Issue 45, 2013, Pages 5178-5191

  Thierry Carstensen, Birgit ^a   Dalby, Tine ^a   Stevner, Michael A ^a   Robbins, John B ^b   Schneerson, Rachel ^b   Trollfors, Birger ^c  

^a STATENS SERUM INSTITUT   (Denmark)

^b EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^c SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

AP vaccine; Clinical trial; Hydrogen peroxide inactivated pertussis toxoid; Statens Serum Institut; Whooping cough

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS VACCINE; DIPHTHERIA TETANUS VACCINE; GLUTARALDEHYDE; HYDROGEN PEROXIDE; IMMUNOGLOBULIN G; PERTUSSIS VACCINE;

ANTIBODY RESPONSE; BORDETELLA PERTUSSIS; COHORT ANALYSIS; CONTACT ALLERGY; CONTACT DERMATITIS; DENMARK; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEVER; HERD IMMUNITY; HOSPITALIZATION; HUMAN; IMMUNOGENICITY; INCIDENCE; INJECTION SITE NODULE; INJECTION SITE PAIN; INJECTION SITE SWELLING; IRRITABILITY; MALAISE; MASS IMMUNIZATION; NONHUMAN; PERTUSSIS; POLAND; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RHINITIS; SIDE EFFECT; SOMNOLENCE; SWEDEN;

AP VACCINE; CLINICAL TRIAL; HYDROGEN PEROXIDE INACTIVATED PERTUSSIS TOXOID; STATENS SERUM INSTITUT; WHOOPING COUGH;

ADOLESCENT; ADULT; CHILD; CHILD, PRESCHOOL; DENMARK; HUMANS; INFANT; PERTUSSIS VACCINE; VACCINATION; VACCINES, ACELLULAR; VACCINES, COMBINED; WHOOPING COUGH;

EID: 84885959168     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.08.034     Document Type: Review

References (75)

1. Heron I., Chen F.M., Fusco J. DTaP vaccines from north american vaccine (NAVA): composition and critical parameters. Biologicals 1999, 27(June (2)):91-96.
2. Ibsen P.H. The effect of formaldehyde, hydrogen peroxide and genetic detoxification of pertussis toxin on epitope recognition by murine monoclonal antibodies. Vaccine 1996, 14(April (5)):359-368.
3. Vaccine Assessment and Monitoring team of the Department of Vaccines and Biologicals. WHO-recommended standards for surveillance of selected vaccine-preventable diseases 2003, World Health Organization, Report No.: WHO/V&B/03.01.
4. Zepp F., Heininger U., Mertsola J., et al. Rationale for pertussis booster vaccination throughout life in Europe. Lancet Infect Dis 2011, 11(July (7)):557-570.
5. Octavia S., Sintchenko V., Gilbert G.L., et al. Newly emerging clones of Bordetella pertussis carrying prn2 and ptxP3 alleles implicated in Australian pertussis epidemic in 2008-2010. J Infect Dis 2012, 205(April (8)):1220-1224.
6. Heininger U., Cherry J.D. Pertussis immunisation in adolescents and adults - Bordetella pertussis epidemiology should guide vaccination recommendations. Expert Opin Biol Ther 2006, 6(July (7)):685-697.
7. Mooi F.R., van Loo I.H., van G.M., et al. Bordetella pertussis strains with increased toxin production associated with pertussis resurgence. Emerg Infect Dis 2009, 15(August (8)):1206-1213.
8. Mooi F.R., van der Maas N.A., De Melker H.E. Pertussis resurgence: waning immunity and pathogen adaptation - two sides of the same coin. Epidemiol Infect 2013, (February):1-10.
9. Poolman J.T., Hallander H.O. Acellular pertussis vaccines and the role of pertactin and fimbriae. Expert Rev Vaccines 2007, 6(February (1)):47-56.
10. Robbins J.B., Schneerson R., Keith J.M., Miller M.A., Kubler-Kielb J., Trollfors B. Pertussis vaccine: a critique. Pediatr Infect Dis J 2009, 28(March (3)):237-241.
11. Vidor E., Plotkin S.A. Immunogenicity of a two-component (PT & FHA) acellular pertussis vaccine in various combinations. Hum Vaccin 2008, 4(September (5)):328-340.
12. Taranger J., Trollfors B., Bergfors E., et al. Immunologic and epidemiologic experience of vaccination with a monocomponent pertussis toxoid vaccine. Pediatrics 2001, 108(December (6)):E115.
13. Sekura R.D., Fish F., Manclark C.R., Meade B., Zhang Y.L. Pertussis toxin, affinity purification of a new ADP-ribosyltransferase. J Biol Chem 1983, 258(December (23)):14647-14651.
14. Sekura R.D., Zhang Y.L., Roberson R., et al. Clinical, metabolic, and antibody responses of adult volunteers to an investigational vaccine composed of pertussis toxin inactivated by hydrogen peroxide. J Pediatr 1988, 113(November (5)):806-813.
15. Krantz I., Sekura R., Trollfors B., et al. Immunogenicity and safety of a pertussis vaccine composed of pertussis toxin inactivated by hydrogen peroxide, in 18- to 23-month-old children. J Pediatr 1990, 116(April (4)):539-543.
16. Isacson J., Trollfors B., Taranger J., et al. Safety, immunogenicity and an open, retrospective study of efficacy of a monocomponent pertussis toxoid vaccine in infants. Pediatr Infect Dis J 1994, 13(January (1)):22-27.
17. Trollfors B., Taranger J., Lagergard T., et al. A placebo-controlled trial of a pertussis-toxoid vaccine. N Engl J Med 1995, 333(October (16)):1045-1050.
18. Gyhrs A., Lyngholm E., Larsen S.O., Aggerbeck H., Heron I. Immunogenicity and safety of a tetravalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine. Scand J Infect Dis 1999, 31(6):579-585.
19. Knutsson N., Trollfors B., Taranger J., et al. Immunogenicity and reactogenicity of diphtheria, tetanus and pertussis toxoids combined with inactivated polio vaccine, when administered concomitantly with or as a diluent for a Hib conjugate vaccine. Vaccine 2001, 19(August (31)):4396-4403.
20. Pietrzyk J.J., Wysocki J., Pejcz J., et al. Safety and immunogenicity of a DTaP-IPV(Vero) (serum-free) combination vaccine in comparison to DTaP-IPV(Mkc) when administered simultaneously with Haemophilus influenzae type B conjugate vaccine (PRP-T) in children at 2, 3.5, 5 and 16 months of age. Vaccine 2008, 26(September (41)):5296-5303.
21. Blatter M. Open trial to evaluate the safety and immunogenicity of a fifth (booster) dose of diphtheria, tetanus, acellullar pertussis vaccine in healthy children 1996, Unpublished; Jun 26. Report No.: Internal clinical trial report (014).
22. Taranger J., Trollfors B. Safety and Immunogenicity of combined vaccines against diphtheria, tetanus, pertussis and polio at six years of age 2001, Unpublished; Jan 12. Report No.: Internal clinical trial report (007B).
23. Trollfors B., Knutsson N., Taranger J., et al. Diphtheria, tetanus and pertussis antibodies in 10-year-old children before and after a booster dose of three toxoids: implications for the timing of a booster dose. Eur J Pediatr 2006, 165(January (1)):14-18.
24. Netterlid E., Hallander H.O., Nilsson L., Ljungman M., Gothefors L., Gustafsson L. An immunogenenicity and safety study of combined adsorbed tetanus, low dose diphtheria and acellular partussis vaccine given as a school leaving booster to 14-15 year olds primed with a five component acellular pertussis vaccine at 3, 5 and 12 months of age and a booster dose at 51/2 years of age. Poster session at Nordic Vaccine meeting 5-7 September 2012 2012.
25. Thierry-Carstensen B., Jordan K., Uhlving H.H., et al. A randomised, double-blind, non-inferiority clinical trial on the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as booster vaccinations to healthy adults. Vaccine 2012, 30(August (37)):5464-5471.
26. Keitel W.A., Muenz L.R., Decker M.D., et al. A randomized clinical trial of acellular pertussis vaccines in healthy adults: dose-response comparisons of 5 vaccines and implications for booster immunization. J Infect Dis 1999, 180(August (2)):397-403.
27. Hviid A., Stellfeld M., Andersen P.H., Wohlfahrt J., Melbye M. Impact of routine vaccination with a pertussis toxoid vaccine in Denmark. Vaccine 2004, 22(September (27/28)):3530-3534.
28. Taranger J., Trollfors B., Bergfors E., et al. Mass vaccination of children with pertussis toxoid - decreased incidence in both vaccinated and nonvaccinated persons. Clin Infect Dis 2001, 33(October (7)):1004-1010.
29. Taranger J., Trollfors B., Lagergard T., et al. Unchanged efficacy of a pertussis toxoid vaccine throughout the two years after the third vaccination of infants. Pediatr Infect Dis J 1997, 16(February (2)):180-184.
30. Trollfors B., Taranger J., Lagergard T., et al. Efficacy of a monocomponent pertussis toxoid vaccine after household exposure to pertussis. J Pediatr 1997, 130(April (4)):532-536.
31. Trollfors B., Taranger J., Lagergard T., et al. Immunization of children with pertussis toxoid decreases spread of pertussis within the family. Pediatr Infect Dis J 1998, 17(March (3)):196-199.
32. Taranger J., Trollfors B., Lagergard T., et al. Correlation between pertussis toxin IgG antibodies in postvaccination sera and subsequent protection against pertussis. J Infect Dis 2000, 181(March (3)):1010-1013.
33. Gustafsson L., Hallander H.O., Olin P., Reizenstein E., Storsaeter J. A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine. N Engl J Med 1996, 334(February (6)):349-355.
34. Greco D., Salmaso S., Mastrantonio P., et al. A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. Progetto Pertosse Working Group. N Engl J Med 1996, 334(February (6)):341-348.
35. Taranger J., Trollfors B., Lagergard T., Robbins J.B. Protection against pertussis with a monocomponent pertussis toxoid vaccine. Int J Infect Dis 1997, 1:148-151.
36. Granstrom M. The history of pertussis vaccination: from whole cell to subunit vaccines. Vaccinia, vaccination and vaccinology: Jenner, Pasteur and their successors 1996, 104-114. Elsevier, Paris.
37. Decker M.D., Edwards K.M., Steinhoff M.C., et al. Comparison of 13 acellular pertussis vaccines: adverse reactions. Pediatrics 1995, 96(September (3 Pt 2)):557-566.
38. Rennels M.B., Deloria M.A., Pichichero M.E., et al. Extensive swelling after booster doses of acellular pertussis-tetanus-diphtheria vaccines. Pediatrics 2000, 105(January (1)):e12.
39. Knuf M., Habermehl P., Faber J., et al. Assessment of nine candidate DTP-vaccines with reduced amount of antigen and/or without adjuvant as a fourth (booster-) dose in the second year of life. Vaccine 2006, 24(July (27/28)):5627-5636.
40. Jacquet J.M., Begue P., Grimprel E., et al. Safety and immunogenicity of a combined DTPa-IPV vaccine administered as a booster from 4 years of age: a review. Vaccine 2006, 24(March (13)):2440-2448.
41. Zepp F., Habermehl P., Knuf M., Mannhardt-Laakman W., Howe B., Friedland L.R. Immunogenicity of reduced antigen content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine. Vaccine 2007, 25(July (29)):5248-5252.
42. Blatter M., Friedland L.R., Weston W.M., Li P., Howe B. Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19-64 years of age. Vaccine 2009, 27(January (5)):765-772.
43. Trollfors B., Dotevall L., Sundh V., Welinder-Olsson C. Pertussis after end of a mass vaccination project-End of the "vaccination honey-moon". Vaccine 2011, 29(February):2444-2450.
44. Carlsson R.M., Trollfors B. Control of pertussis - lessons learnt from a 10-year surveillance programme in Sweden. Vaccine 2009, 27(September (42)):5709-5718.
45. Nilsson L., von Segebaden K., Kling A.-M., Grünewald M. Fourteen year report - pertussis in Gothenburg study area 2012 July, Smittskyddsinstitutet, Sweden, Report No.: 2012-18-2.
46. Bergfors E., Trollfors B., Inerot A. Unexpectedly high incidence of persistent itching nodules and delayed hypersensitivity to aluminium in children after the use of adsorbed vaccines from a single manufacturer. Vaccine 2003, 22(December (1)):64-69.
47. Thierry-Carstensen B., Stellfeld M. Itching nodules and hypersensitivity to aluminium after the use of adsorbed vaccines from SSI. Vaccine 2004, 22(May (15/16)):1845.
48. Netterlid E., Bruze M., Hindsen M., Isaksson M., Olin P. Persistent itching nodules after the fourth dose of diphtheria-tetanus toxoid vaccines without evidence of delayed hypersensitivity to aluminium. Vaccine 2004, 22(September (27/28)):3698-3706.
49. Trollfors B., Bergfors E., Inerot A. Vaccine related itching nodules and hypersensitivity to aluminium. Vaccine 2005, 23(January (8)):975-976.
50. Bergfors E., Trollfors B. Sixty-four children with persistent itching nodules and contact allergy to aluminium after vaccination with aluminium-adsorbed vaccines-prognosis and outcome after booster vaccination. Eur J Pediatr 2013, 172(February (2)):171-177.
51. Frederiksen M.S., Tofte H. Immunisation with aluminium-containing vaccine of a child with itching nodule following previous vaccination. Vaccine 2004, 23(November (1)):1-2.
52. Croce S., Lhermitte B., Tomasetto C., Guillard O., Bellocq J.P., Chenard M.P. [Late-onset vaccination-induced subcutaneous pseudolymphoma]. Ann Pathol 2008, 28(April (2)):146-149.
53. Andersen PH. Pertussis 2002-2004. EPI-NEWS 2005 Nov 16;Week 46.
54. Andersen PH. Pertussis 2008. EPI-NEWS 2009 Oct 28;Week 44.
55. Andersen PH. Pertussis 2010. EPI-NEWS 2011 Oct 26;Week 42-43.
56. Andre P., Caro V., Njamkepo E., Wendelboe A.M., Van R.A., Guiso N. Comparison of serological and real-time PCR assays to diagnose Bordetella pertussis infection in 2007. J Clin Microbiol 2008, 46(May (5)):1672-1677.
57. Dragsted D.M., Dohn B., Madsen J., Jensen J.S. Comparison of culture and PCR for detection of Bordetella pertussis and Bordetella parapertussis under routine laboratory conditions. J Med Microbiol 2004, 53(August (Pt 8)):749-754.
58. van der Zee A., Agterberg C., Peeters M., Mooi F., Schellekens J. A clinical validation of Bordetella pertussis and Bordetella parapertussis polymerase chain reaction: comparison with culture and serology using samples from patients with suspected whooping cough from a highly immunized population. J Infect Dis 1996, 174(July (1)):89-96.
59. Yih W.K., Lett S.M., des Vignes F.N., Garrison K.M., Sipe P.L., Marchant C.D. The increasing incidence of pertussis in Massachusetts adolescents and adults, 1989-1998. J Infect Dis 2000, 182(November (5)):1409-1416.
60. Quinn H.E., McIntyre P.B. Pertussis epidemiology in Australia over the decade 1995-2005 - trends by region and age group. Commun Dis Intell 2007, 31(June (2)):205-215.
61. Nielsen A., Larsen S.O. Epidemiology of pertussis in Denmark: the impact of herd immunity. Int J Epidemiol 1994, 23(December (6)):1300-1308.
62. Sheridan S.L., Ware R.S., Grimwood K., Lambert S.B. Number and order of whole cell pertussis vaccines in infancy and disease protection. JAMA 2012, 308(August (5)):454-456.
63. Klein N.P., Bartlett J., Fireman B., Rowhani-Rahbar A., Baxter R. Comparative effectiveness of acellular versus whole-cell pertussis vaccines in teenagers. Pediatrics 2013, 131(June (6)):e1716-e1722.
64. Wendelboe A.M., Van R.A., Salmaso S., Englund J.A. Duration of immunity against pertussis after natural infection or vaccination. Pediatr Infect Dis J 2005, 24(May (5 Suppl.)):S58-S61.
65. McIntyre P.B., Burgess M.A., Egan A., Schuerman L., Hoet B. Booster vaccination of adults with reduced-antigen-content diphtheria, Tetanus and pertussis vaccine: immunogenicity 5 years post-vaccination. Vaccine 2009, 27(February (7)):1062-1066.
66. Booy R., Van Der Meeren O., Ng S.P., Celzo F., Ramakrishnan G., Jacquet J.M. A decennial booster dose of reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (Boostrix) is immunogenic and well tolerated in adults. Vaccine 2010, 29(December (1)):45-50.
67. Edelman K., He Q., Makinen J., et al. Immunity to pertussis 5 years after booster immunization during adolescence. Clin Infect Dis 2007, 44(May (10)):1271-1277.
68. Barreto L., Guasparini R., Meekison W., Noya F., Young L., Mills E. Humoral immunity 5 years after booster immunization with an adolescent and adult formulation combined tetanus, diphtheria, and 5-component acellular pertussis vaccine. Vaccine 2007, 25(November (48)):8172-8179.
69. Tran Minh N.N., He Q., Edelman K., et al. Immune responses to pertussis antigens eight years after booster immunization with acellular vaccines in adults. Vaccine 2000, 18(April (19)):1971-1974.
70. Edelman K.J., He Q., Makinen J.P., et al. Pertussis-specific cell-mediated and humoral immunity in adolescents 3 years after booster immunization with acellular pertussis vaccine. Clin Infect Dis 2004, 39(July (2)):179-185.
71. Mertsola J., Van Der Meeren O., He Q., et al. Decennial administration of a reduced antigen content diphtheria and tetanus toxoids and acellular pertussis vaccine in young adults. Clin Infect Dis 2010, 51(September (6)):656-662.
72. Edwards K.M., Meade B.D., Decker M.D., et al. Comparison of 13 acellular pertussis vaccines: overview and serologic response. Pediatrics 1995, 96(September (3 Pt 2)):548-557.
73. Sutherland J.N., Chang C., Yoder S.M., Rock M.T., Maynard J.A. Antibodies recognizing protective pertussis toxin epitopes are preferentially elicited by natural infection versus acellular immunization. Clin Vaccine Immunol 2011, 18(June (6)):954-962.
74. Sutherland J.N., Maynard J.A. Characterization of a key neutralizing epitope on pertussis toxin recognized by monoclonal antibody 1B7. Biochemistry 2009, 48(December (50)):11982-11993.
75. Dalby T., Petersen J.W., Harboe Z.B., Krogfelt K.A. Antibody responses to pertussis toxin display different kinetics after clinical Bordetella pertussis infection than after vaccination with an acellular pertussis vaccine. J Med Microbiol 2010, 59(September (Pt 9)):1029-1036.