Role of whole-cell pertussis vaccine in severe local reactions to the preschool (fifth) dose of diphtheria-pertussis-tetanus vaccine.
OBJECTIVE
To estimate the contribution of whole-cell pertussis vaccine to severe local reactions after the preschool (fifth) dose of adsorbed diphtheria toxoid-pertussis vaccine-tetanus toxoid (DPT) vaccine.


METHODS
Double-blind randomized controlled trial.


METHODS
Urban community.


METHODS
Volunteer sample of 200 healthy children 4 to 6 years old who were eligible for the fifth dose of DPT vaccine.


METHODS
Children received, in both arms, either diphtheria toxoid-tetanus toxoid (DT) and monovalent pertussis vaccines (group A, 99 children) or DPT and meningococcal vaccines (group B, 101 children). All were licensed products from single lots. The children were assessed 24 hours later by a trained observer. Serum samples obtained before vaccination were tested for antibodies to tetanus and diphtheria toxins and five pertussis antigens by means of enzyme-linked immunosorbent assay.


METHODS
Rates of severe local reactions (an area of redness or swelling or both of 50 mm or greater) 24 hours after vaccination. Relation between serum antibody levels before vaccination and rates of severe local reactions to corresponding vaccines.


RESULTS
All of the subjects were followed up 24 hours after vaccination. Severe redness was present in 38% given DPT vaccine, 29% given intramuscular pertussis vaccine and 9% given DT vaccine (p < or = 0.002, three-way comparison). Severe swelling was common after vaccination with all three products. After intramuscular pertussis vaccination a relation was evident between the prevaccination levels of antibody to whole-cell pertussis bacteria and the rates of redness (p < 0.02) but not between the prevaccination subcellular antibody levels and the rates of redness.


CONCLUSIONS
That pertussis vaccine resembled the DPT vaccine in causing severe redness suggests that it is the principal cause of such reactions after DPT vaccination. The DT vaccine was also reactogenic; thus, cumulative sensitization to one or more of its constituents may be a factor.
Scheifele
D W
DW
Vaccine Evaluation Center, British Columbia's Children's Hospital, Vancouver.
Bjornson
G
G
Halperin
S H
SH
Mitchell
L
L
Boraston
S
S
D000907:Antibodies, Bacterial / Q000097:blood; D001428:Bacterial Vaccines / Q000009:adverse effects; D001886:Bordetella pertussis / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects* / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D022401:Meningococcal Vaccines; D009345:Neisseria meningitidis / Q000276:immunology; D010567:Pertussis Vaccine / Q000009:adverse effects* / Q000276:immunology
D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022401:Meningococcal Vaccines; D010567:Pertussis Vaccine