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Immunogenicity and Reactogenicity of Takeda Acellular Pertussis-Component Diphtheria-Tetanus-Pertussis Vaccine in 2- and 3-Month-Old Children in Japan FREE

Hitoshi Kamiya, MD; Ritsue Nii, MD; Tadashi Matsuda, MD; Naoki Yasuda, MD; Peter D. Christenson, PhD; James D. Cherry, MD, MSc
[+] Author Affiliations

Accepted for publication June 10, 1992.

Presented in part as a poster at the 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, Ill, October 2,1991.

Reprint requests to Department of Pediatrics, Mie National Hospital, Tsu, Japan (Dr Kamiya).


Am J Dis Child. 1992;146(10):1141-1147. doi:10.1001/archpedi.1992.02160220027015.
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• Objective.  —To compare the reactogenicity and immune response to the Takeda acellular pertussis-component diphtheria-tetanus-pertussis (APDT) vaccine in children when immunization commenced at 2 months (group A) vs 3 months (group B) of age.

Design.  —Longitudinal, nonblinded, comparative study.

Setting.  —Pediatric well-child clinics.

Participants.  —Healthy 50- to 98-day-old infants.

Results.  —Good antibody responses to lymphocytosis-promoting factor, filamentous hemagglutinin, agglutinogens, and pertactin occurred in both age groups after both the third and fourth vaccine doses. Both young age and transplacentally acquired maternal antibody independently and together have a suppressive effect on the response to the four antigens in this APDT vaccine. However, these effects appear to be minor. Vaccine reactions were mild; group A children had slightly but not significantly higher rates than group B children.

Conclusion.  —The present US diphtheria and tetanus toxoids and pertussis vaccine immunization schedule should also be satisfactory with this acellular pertussis component vaccine.(AJDC. 1992;146:1141-1147)

REFERENCES

Kimura M, Kuno-Sakai H.  Developments in pertussis immunization in Japan . Lancet . 1990;;336:30-32.
Kimura M, Kuno-Sakai H.  Pertussis vaccines in Japan . Acta Paediatr Jpn . 1988;;30:143-153.
Kimura M, Kuno-Sakai H.  Experiences with acellular pertussis vaccine in Japan and epidemiology of pertussis . Tokai J Exp Clin Med . 1987;;12:263-273.
Noble GR, Bernier RH, Esber EC, et al.  Acellular and whole cell pertussis vaccines in Japan: report of a visit by US scientists . JAMA . 1987;;257: 1351-1356.
Kimura M, Kuno-Sakai H.  Epidemiology of pertussis in Japan . Tokai J Exp Clin Med . 1988;;13 ( (suppl) ):1-7.
Kimura M, Kuno-Sakai H.  Immunization system in Japan: its history and present situation . Acta Paediatr Jpn . 1988;;30:109-126.
Blumberg DA, Mink CM, Cherry JD.  Comparison of acellular and whole-cell pertussis-component dipththeria-tetanus-pertussis vaccines in infants . J Pediatr . 1991;;119:194-204.
Kimura M, Kuno-Sakai H, Sato Y.  A comparative trial of reactogenicity and immunogenicity of Takeda acellular pertussis vaccine combined with tetanus and diphtheria toxoids . AJDC . 1991;;145:734-741.
Sato Y, Kimura M, Fukumi H.  Development of a pertussis component vaccine in Japan . Lancet . 1984;;1:122-126.
Sato Y, Sato H, Izumiya K, Cowell JL, Manclark CR.  Role of antibody to filamentous hemagglutinin in immunity to pertussis . In: Robbins JB, Hill JC, Sadoff JC, eds. Seminars in Infectious Diseases . New York, NY: Thieme-Stratton Inc; 1982;;4:380-385.
Blumberg DA, Mink CM, Cherry JD, et al.  Comparison of an acellular pertussis-component diphtheria-tetanus-pertussis (DTP) vaccine with a whole-cell pertussis-component DTP vaccine in 17- to 24-month old children, with measurement of a 69-kilodalton outer membrane protein antibody . J Pediatr . 1990;;117:46-51.
Miyamura K, Nishio S, Ito A, Murata K, Kono R.  Micro cell culture method for determination of diphtheria toxin and antitoxin titers using Vero cells, I: studies on factors affecting the toxin and antitoxin titration . J Biol Stand . 1974;;2:189-201.
Kameyama S, Kondo S.  Titration of tetanus antitoxin by passive hemagglutinin, I: titration of guinea-pig antitoxins at various periods of immunization . Jpn J Med Sci Biol . 1975;; 28:127-138.
Savage JV, Decker MD, Edwards KM, Sell SH, Karzon DT.  Natural history of pertussis antibody in the infant and effect on vaccine response . J Infect Dis. 1990;;161:487-492.
Anderson EL, Belshe RB, Bartram J, et al.  Clinical and serologic responses to acellular pertussis vaccine in infants and young children . AJDC . 1987;;141:949-953.
Anderson EL, Belshe RB, Bartram J.  Differences in reactogenicity and antigenicity of acellular and standard pertussis vaccines combined with diphtheria and tetanus in infants . J Infect Dis . 1988;;157:731-737.
Cadoz M, Reinert P, Begue P.  Comparative reactogenicity of two different acellular (AC) vs a conventional whole cell (WC) DTP vaccine in 3-6 month olds . Pediatr Res . 1989;;25:174. Abstract.
Just M, Bogaerts H, Wynan J, Boscia J.  Primary vaccination with acellular pertussis (aP) vaccines containing different doses of pertussis toxoid . Pediatr Res . 1991;;29:159A.
Edwards KM, Decker MD, Bradley R.  Acellular pertussis vaccine: antibody presistence and booster response . Pediatr Res . 1990;;27:170. Abstract.
Pichicero ME, Disney FA, Green JL, Francis AB, Marsocci SM.  Primary immunization of infants at two, four, and six months of age with acellular pertussis vaccine (AP) in a double blind randomized trial . Pediatr Res . 1990;; 27:179. Abstract.
Mortimer EA, Kimura M, Cherry JD, et al.  Protective efficacy of the Takeda acellular pertussis vaccine combined with diphtheria and tetanus toxoids following household exposure of Japanese children . AJDC . 1990;; 144:899-904.
Ad Hoc Group for the Study of Pertussis Vaccines.  Placebo controlled trial of two acellular pertussis vaccines in Sweden: protective efficacy and adverse events . Lancet . 1988;;1:955-960.
Burstyn DG, Baraff LJ, Peppler MS, Leake RD, St Geme J Jr, Manclark CR.  Serologic response to filamentous hemagglutinin and lymphocytosis-promoting toxin of Bordetella pertussis . Infect Immun . 1983;;41:1150-1156.
Baraff LJ, Leake RD, Burstyn TP, et al.  Immunologic response to early and routine DTP immunization in infants . Pediatrics . 1984;;73:37-42.
di Sant'Agnese PA.  Combined immunization against diphtheria, tetanus and pertussis in newborn infants . Pediatrics . 1949;;3:20-32.
Provenzano RW, Wetterlow LH, Sullivan CL.  Immunization and antibody response in the newborn infant . N Engl J Med . 1965;;273:959-965.
Miller JJ, Faber HK, Ryan ML, Silverberg RJ, Lew E.  Immunization against pertussis during the first four months of life . Pediatrics . 1949;;4:468-478.
Sauer LW.  The age factor in active immunization against whooping cough . Am J Pathol . 1941;;17:719-723.

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References

Kimura M, Kuno-Sakai H.  Developments in pertussis immunization in Japan . Lancet . 1990;;336:30-32.
Kimura M, Kuno-Sakai H.  Pertussis vaccines in Japan . Acta Paediatr Jpn . 1988;;30:143-153.
Kimura M, Kuno-Sakai H.  Experiences with acellular pertussis vaccine in Japan and epidemiology of pertussis . Tokai J Exp Clin Med . 1987;;12:263-273.
Noble GR, Bernier RH, Esber EC, et al.  Acellular and whole cell pertussis vaccines in Japan: report of a visit by US scientists . JAMA . 1987;;257: 1351-1356.
Kimura M, Kuno-Sakai H.  Epidemiology of pertussis in Japan . Tokai J Exp Clin Med . 1988;;13 ( (suppl) ):1-7.
Kimura M, Kuno-Sakai H.  Immunization system in Japan: its history and present situation . Acta Paediatr Jpn . 1988;;30:109-126.
Blumberg DA, Mink CM, Cherry JD.  Comparison of acellular and whole-cell pertussis-component dipththeria-tetanus-pertussis vaccines in infants . J Pediatr . 1991;;119:194-204.
Kimura M, Kuno-Sakai H, Sato Y.  A comparative trial of reactogenicity and immunogenicity of Takeda acellular pertussis vaccine combined with tetanus and diphtheria toxoids . AJDC . 1991;;145:734-741.
Sato Y, Kimura M, Fukumi H.  Development of a pertussis component vaccine in Japan . Lancet . 1984;;1:122-126.
Sato Y, Sato H, Izumiya K, Cowell JL, Manclark CR.  Role of antibody to filamentous hemagglutinin in immunity to pertussis . In: Robbins JB, Hill JC, Sadoff JC, eds. Seminars in Infectious Diseases . New York, NY: Thieme-Stratton Inc; 1982;;4:380-385.
Blumberg DA, Mink CM, Cherry JD, et al.  Comparison of an acellular pertussis-component diphtheria-tetanus-pertussis (DTP) vaccine with a whole-cell pertussis-component DTP vaccine in 17- to 24-month old children, with measurement of a 69-kilodalton outer membrane protein antibody . J Pediatr . 1990;;117:46-51.
Miyamura K, Nishio S, Ito A, Murata K, Kono R.  Micro cell culture method for determination of diphtheria toxin and antitoxin titers using Vero cells, I: studies on factors affecting the toxin and antitoxin titration . J Biol Stand . 1974;;2:189-201.
Kameyama S, Kondo S.  Titration of tetanus antitoxin by passive hemagglutinin, I: titration of guinea-pig antitoxins at various periods of immunization . Jpn J Med Sci Biol . 1975;; 28:127-138.
Savage JV, Decker MD, Edwards KM, Sell SH, Karzon DT.  Natural history of pertussis antibody in the infant and effect on vaccine response . J Infect Dis. 1990;;161:487-492.
Anderson EL, Belshe RB, Bartram J, et al.  Clinical and serologic responses to acellular pertussis vaccine in infants and young children . AJDC . 1987;;141:949-953.
Anderson EL, Belshe RB, Bartram J.  Differences in reactogenicity and antigenicity of acellular and standard pertussis vaccines combined with diphtheria and tetanus in infants . J Infect Dis . 1988;;157:731-737.
Cadoz M, Reinert P, Begue P.  Comparative reactogenicity of two different acellular (AC) vs a conventional whole cell (WC) DTP vaccine in 3-6 month olds . Pediatr Res . 1989;;25:174. Abstract.
Just M, Bogaerts H, Wynan J, Boscia J.  Primary vaccination with acellular pertussis (aP) vaccines containing different doses of pertussis toxoid . Pediatr Res . 1991;;29:159A.
Edwards KM, Decker MD, Bradley R.  Acellular pertussis vaccine: antibody presistence and booster response . Pediatr Res . 1990;;27:170. Abstract.
Pichicero ME, Disney FA, Green JL, Francis AB, Marsocci SM.  Primary immunization of infants at two, four, and six months of age with acellular pertussis vaccine (AP) in a double blind randomized trial . Pediatr Res . 1990;; 27:179. Abstract.
Mortimer EA, Kimura M, Cherry JD, et al.  Protective efficacy of the Takeda acellular pertussis vaccine combined with diphtheria and tetanus toxoids following household exposure of Japanese children . AJDC . 1990;; 144:899-904.
Ad Hoc Group for the Study of Pertussis Vaccines.  Placebo controlled trial of two acellular pertussis vaccines in Sweden: protective efficacy and adverse events . Lancet . 1988;;1:955-960.
Burstyn DG, Baraff LJ, Peppler MS, Leake RD, St Geme J Jr, Manclark CR.  Serologic response to filamentous hemagglutinin and lymphocytosis-promoting toxin of Bordetella pertussis . Infect Immun . 1983;;41:1150-1156.
Baraff LJ, Leake RD, Burstyn TP, et al.  Immunologic response to early and routine DTP immunization in infants . Pediatrics . 1984;;73:37-42.
di Sant'Agnese PA.  Combined immunization against diphtheria, tetanus and pertussis in newborn infants . Pediatrics . 1949;;3:20-32.
Provenzano RW, Wetterlow LH, Sullivan CL.  Immunization and antibody response in the newborn infant . N Engl J Med . 1965;;273:959-965.
Miller JJ, Faber HK, Ryan ML, Silverberg RJ, Lew E.  Immunization against pertussis during the first four months of life . Pediatrics . 1949;;4:468-478.
Sauer LW.  The age factor in active immunization against whooping cough . Am J Pathol . 1941;;17:719-723.

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