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March 1993, Vol 147, No. 3 >
Article | March 1993

Comparison of a Diphtheria and Tetanus Toxoids and Bicomponent Acellular Pertussis Vaccine With Diphtheria and Tetanus Toxoids and Whole-Cell Pertussis Vaccine in Infants FREE

Michael E. Pichichero, MD; Anne B. Francis, MD; Steven M. Marsocci, MD; John L. Green, MD; Frank A. Disney, MD
[+] Author Affiliations

Accepted for publication October 13, 1992.

Reprint requests to the Department of Pediatrics, University of Rochester Medical Center, 601 Elmwood Ave, Box 690, Rochester, NY 14642 (Dr Pichichero).


Am J Dis Child. 1993;147(3):295-299. doi:10.1001/archpedi.1993.02160270057018.
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• Objective  —To compare the reactogenicity and immunogenicity of a diphtheria and tetanus toxoids and two-component acellular pertussis (ADTP) vaccine with a US-licensed whole-cell (WDTP) vaccine.

Setting.  —General pediatric practice in suburban Rochester, NY.

Design.  —Prospective, double-blind, randomized study.

Participants.  —One hundred ten infants were studied; 88 (80%) received ADTP and 22 (20%) received WDTP at ages 2, 4, and 6 months.

Intervention.  —Vaccination.

Measurements/Main Results.  —Temperature of 38.3°C or higher (P=.03) and moderate or severe injection-site pain (P=.02) occurred less frequently in infants receiving ADTP than those receiving WDTP for the combined three doses. Following the third dose, ADTP vaccination produced higher antibody responses than WDTP to pertussis toxin (geometric mean enzyme-linked immunosorbent assay IgG was 52.2 vs 12.5; P<.001) and to filamentous hemagglutinin (geometric mean IgG was 182.8 vs 3.5; P<.001). No interference in the diphtheria or tetanus antibody responses was observed in recipients of the ADTP vaccine.

Conclusions.  —This two-component ADTP vaccine, when given as a primary infant series, produces fewer adverse effects and greater immunogenicity to the two pertussis components that it contains than US-licensed WDTP vaccine.(AJDC. 1993;147:295-299)

REFERENCES

1 +
Barkin RM, Pichichero ME.  Diphtheria-pertussis-tetanus vaccine: reactogenicity of commercial products . Pediatrics . 1979;;63:256-260.
2 +
Cody CL, Baraff LJ, Cherry JD, Marcy SM, Manclark CR.  Nature and rates of adverse reactions associated with DTP and DT immunizations in infants and children . Pediatrics . 1981;;68:650-660.
3 +
Edward KM, Karzon DT.  Pertussis vaccines . Pediatr Clin North Am . 1950;;37:549-566.
4 +
Wentz KR, Marcuse EK.  Diphtheria-tetanus-pertussis vaccine and serious neurologic illness: an updated review of the epidemiologic evidence . Pediatrics . 1991;;87:287-297.
5 +
Shields WD, Nielsen C, Buch D, et al.  Relationship of pertussis immunization to the onset of neurological disorders: a retrospective epidemiologic study . J Pediatr. 1988;;113:801-805.
6 +
Walker AM, Jick H, Perera DR, Knauss TA, Thompson RS.  Neurological events following diphtheria-tetanus-pertussis immunization . Pediatrics . 1988;;81:345-349.
7 +
Griffin MR, Ray WA, Mortimer EA, Fenichel GM, Schaffner W.  Risk of seizures and encephalopathy after immunization with diphtheria-tetanuspertussis vaccine . JAMA . 1990;;263:1641-1645.
8 +
Sato Y, Kimura M, Fukumi H.  Development of a component pertussis vaccine in Japan . Lancet . 1984;;1:122-126.
9 +
Romanus V, Jonsell R, Bergquist SO.  Pertussis in Sweden after the cessation of general immunization in 1979 . Pediatr Infect Dis. 1987;;6:364-371.
10 +
Oda M, Cowell JL, Burstyn DG, Manclark CR.  Protective activities of the filamentous hemagglutinin and the lymphocytosis-promoting factor of Bordetella pertussis in mice . J Infect Dis. 1984;;150:822-833.
11 +
Sato Y, Arai H, Suzuki K.  Leukocytosis-promoting factor of Bordetella pertussis, Ill: its identity with protective antigen . Infect Immunol. 1974;;9: 801-810.
12 +
Kimura M, Hikino N.  Results with a new DTP vaccine in Japan . Dev Biol Stand . 1985;;61:545-561.
13 +
Isomura S, Suzuki S, Sato Y.  Clinical efficacy of the Japanese acellular pertussis vaccine after intrafamiliar exposure to pertussis patients . Dev Biol Stand . 1985;;61:531-537.
14 +
Aoyama T, Murase Y, Kato T, Takashi I.  Efficacy of an acellular pertussis vaccine in Japan . J Pediatr. 1985;;107:180-183.
15 +
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.
16 +
Storsaeter J, Olin P, Renemar B, et al.  Mortality and morbidity from invasive bacterial infections during a clinical trial of acellular pertussis vaccines in Sweden . Pediatr Infect Dis J. 1988;;7:637-645.
17 +
Granström M, Thorèn M, Blennow M, et al.  Acellular pertussis vaccine in adults: adverse reactions and immune response . Eur J Clin Microbiol . 1987;;6:18-21.
18 +
Cadoz M, Arminjon F, Quentin-Millet MJ, Armand J, Gillet F.  Vaccins coquelucheux acellulaires: tolérance et immunogénicité chez l'adulte . In: Third International Seminar on Immunizations in Africa . Paris, France: Arnette (Librairie Diffusion Edition); 1987;.
19 +
Rutter DA, Ashworth LAE, Day A, et al.  Trial of a new acellular pertussis vaccine in healthy adult volunteers . Vaccine . 1988;;6:29-32.
20 +
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.
21 +
Peter G, ed. Red Book: Report of the Committee on Infectious Diseases . 21st ed. Elk Grove Village, Ill: American Academy of Pediatrics; 1988;:7-64.
22 +
Manclark CR, Meade BD, Burstyn DG.  Serological response to Bordetella pertussis . In: Rose NR, Friedman H, Fahey JL, eds. Manual of Clinical Laboratory Immunology . 3rd ed. Washington, DC: American Society of Microbiology; 1986;:388-394.
23 +
Karpinski KF, Hayward S, Tryphonas H.  Statistical considerations in the quantitation of serum immunoglobulin levels using the enzyme-linked immunosorbent assay (ELISA) . J Immunol Methods . 1987;;103:189-194.
24 +
Pichichero ME, Christy C, Decker MD, et al.  Defining the key parameters for comparing reactions among acellular and whole-cell DTP vaccines . Pediatr Res. 1992;;31:99A.
25 +
JustM, Kanra G, Bogaerts H, et al.  Two trials of an acellular DTP vaccine in comparison with a whole-cell DTP vaccine in infants: evaluation of two PT doses and two vaccination schedules . Dev Biol Stand . 1991;;73:275-283.
26 +
Pichichero ME, Badgett JT, Rodgers GC Jr, McLinn S, Trevino-Scatterday B, Nelson JD.  Acellular pertussis vaccine: immunogenicity and safety of an acellular pertussis vs a whole cell pertussis vaccine combined with diphtheria and tetanus toxoids as a booster in 18-to 24-month-old children . Pediatr Infect Dis J. 1987;;6:352-363.
27 +
Baraff LJ, Manclark CR, Cherry JD, Christenson P, Marcy SM.  Analyses of adverse reactions to diphtheria and tetanus toxoids and pertussis vaccine by vaccine lot, endotoxin content, pertussis vaccine potency and percentage of mouse weight gain . Pediatr Infect Dis J. 1989;;8:502-507.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

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References

1 +
Barkin RM, Pichichero ME.  Diphtheria-pertussis-tetanus vaccine: reactogenicity of commercial products . Pediatrics . 1979;;63:256-260.
2 +
Cody CL, Baraff LJ, Cherry JD, Marcy SM, Manclark CR.  Nature and rates of adverse reactions associated with DTP and DT immunizations in infants and children . Pediatrics . 1981;;68:650-660.
3 +
Edward KM, Karzon DT.  Pertussis vaccines . Pediatr Clin North Am . 1950;;37:549-566.
4 +
Wentz KR, Marcuse EK.  Diphtheria-tetanus-pertussis vaccine and serious neurologic illness: an updated review of the epidemiologic evidence . Pediatrics . 1991;;87:287-297.
5 +
Shields WD, Nielsen C, Buch D, et al.  Relationship of pertussis immunization to the onset of neurological disorders: a retrospective epidemiologic study . J Pediatr. 1988;;113:801-805.
6 +
Walker AM, Jick H, Perera DR, Knauss TA, Thompson RS.  Neurological events following diphtheria-tetanus-pertussis immunization . Pediatrics . 1988;;81:345-349.
7 +
Griffin MR, Ray WA, Mortimer EA, Fenichel GM, Schaffner W.  Risk of seizures and encephalopathy after immunization with diphtheria-tetanuspertussis vaccine . JAMA . 1990;;263:1641-1645.
8 +
Sato Y, Kimura M, Fukumi H.  Development of a component pertussis vaccine in Japan . Lancet . 1984;;1:122-126.
9 +
Romanus V, Jonsell R, Bergquist SO.  Pertussis in Sweden after the cessation of general immunization in 1979 . Pediatr Infect Dis. 1987;;6:364-371.
10 +
Oda M, Cowell JL, Burstyn DG, Manclark CR.  Protective activities of the filamentous hemagglutinin and the lymphocytosis-promoting factor of Bordetella pertussis in mice . J Infect Dis. 1984;;150:822-833.
11 +
Sato Y, Arai H, Suzuki K.  Leukocytosis-promoting factor of Bordetella pertussis, Ill: its identity with protective antigen . Infect Immunol. 1974;;9: 801-810.
12 +
Kimura M, Hikino N.  Results with a new DTP vaccine in Japan . Dev Biol Stand . 1985;;61:545-561.
13 +
Isomura S, Suzuki S, Sato Y.  Clinical efficacy of the Japanese acellular pertussis vaccine after intrafamiliar exposure to pertussis patients . Dev Biol Stand . 1985;;61:531-537.
14 +
Aoyama T, Murase Y, Kato T, Takashi I.  Efficacy of an acellular pertussis vaccine in Japan . J Pediatr. 1985;;107:180-183.
15 +
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.
16 +
Storsaeter J, Olin P, Renemar B, et al.  Mortality and morbidity from invasive bacterial infections during a clinical trial of acellular pertussis vaccines in Sweden . Pediatr Infect Dis J. 1988;;7:637-645.
17 +
Granström M, Thorèn M, Blennow M, et al.  Acellular pertussis vaccine in adults: adverse reactions and immune response . Eur J Clin Microbiol . 1987;;6:18-21.
18 +
Cadoz M, Arminjon F, Quentin-Millet MJ, Armand J, Gillet F.  Vaccins coquelucheux acellulaires: tolérance et immunogénicité chez l'adulte . In: Third International Seminar on Immunizations in Africa . Paris, France: Arnette (Librairie Diffusion Edition); 1987;.
19 +
Rutter DA, Ashworth LAE, Day A, et al.  Trial of a new acellular pertussis vaccine in healthy adult volunteers . Vaccine . 1988;;6:29-32.
20 +
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.
21 +
Peter G, ed. Red Book: Report of the Committee on Infectious Diseases . 21st ed. Elk Grove Village, Ill: American Academy of Pediatrics; 1988;:7-64.
22 +
Manclark CR, Meade BD, Burstyn DG.  Serological response to Bordetella pertussis . In: Rose NR, Friedman H, Fahey JL, eds. Manual of Clinical Laboratory Immunology . 3rd ed. Washington, DC: American Society of Microbiology; 1986;:388-394.
23 +
Karpinski KF, Hayward S, Tryphonas H.  Statistical considerations in the quantitation of serum immunoglobulin levels using the enzyme-linked immunosorbent assay (ELISA) . J Immunol Methods . 1987;;103:189-194.
24 +
Pichichero ME, Christy C, Decker MD, et al.  Defining the key parameters for comparing reactions among acellular and whole-cell DTP vaccines . Pediatr Res. 1992;;31:99A.
25 +
JustM, Kanra G, Bogaerts H, et al.  Two trials of an acellular DTP vaccine in comparison with a whole-cell DTP vaccine in infants: evaluation of two PT doses and two vaccination schedules . Dev Biol Stand . 1991;;73:275-283.
26 +
Pichichero ME, Badgett JT, Rodgers GC Jr, McLinn S, Trevino-Scatterday B, Nelson JD.  Acellular pertussis vaccine: immunogenicity and safety of an acellular pertussis vs a whole cell pertussis vaccine combined with diphtheria and tetanus toxoids as a booster in 18-to 24-month-old children . Pediatr Infect Dis J. 1987;;6:352-363.
27 +
Baraff LJ, Manclark CR, Cherry JD, Christenson P, Marcy SM.  Analyses of adverse reactions to diphtheria and tetanus toxoids and pertussis vaccine by vaccine lot, endotoxin content, pertussis vaccine potency and percentage of mouse weight gain . Pediatr Infect Dis J. 1989;;8:502-507.

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