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Impact of Haemophilus influenzae type b polysaccharide-tetanus protein conjugate vaccine on responses to concurrently administered diphtheria-tetanus-pertussis vaccine.

AbstractOBJECTIVE:
To assess whether serum antibody responses to diphtheria-tetanus-pertussis (DTP) vaccine were affected by coadministration of Haemophilus influenzae type b capsular polyribosylribitol phosphate polysaccharide-tetanus protein (PRP-T) conjugate vaccine when given to patients at 2, 4, and 6 months of age.
DESIGN:
Randomized, double-blind clinical trial.
SETTING:
Urban Santiago, Chile.
PATIENTS:
Healthy infants assembled from health centers. Two hundred seventy-eight (74%) of 375 eligible infants participated; 222, who complied with the complete protocol, constituted the primary group under analysis.
INTERVENTIONS:
One of three vaccine regimens was given to study participants at 2, 4, and 6 months of age, either DTP mixed in the same syringe as PRP-T (group 1); DTP and PRP-T given at separate injection sites (group 2); or DTP without PRP-T (group 3).
PRIMARY OUTCOME MEASURES:
Titers of serum antidiphtheria toxoid, antitetanus toxoid, and pertussis agglutinin antibodies were measured in blood samples taken from patients 2 months after each dose.
RESULTS:
Serum antidiphtheria toxoid and antitetanus toxoid responses showed no important depressions in the patients receiving PRP-T. In contrast, geometric mean titers (GMTs) of pertussis agglutinins, expressed as reciprocal serum dilutions, after both the second and third doses (GMT2, GMT3) were lowest in group 1 (GMT2 = 89; GMT3 = 1230), intermediate in group 2 (GMT2 = 123; GMT3 = 1995), and highest in group 3 (GMT2 = 210; GMT3 = 3090; P less than .05 for trend group 1 less than group 2 less than group 3 after each dose). Antipertussis toxin and antipertussis filamentous hemagglutinin antibody titers also were depressed in patients who received PRP-T. Follow-up of a subset at 18 months revealed an expected decline of pertussis agglutinin titers to near baseline levels in each group.
CONCLUSIONS:
Concurrent administration of PRP-T vaccine with DTP vaccine, either in the same syringe or at different sites, interfered with antipertussis responses to a primary series of immunizations. Although the clinical significance of this antagonism is uncertain, these data underscore the caution required in decisions to add new vaccines to existing immunization regimens.
AuthorsJ D Clemens, C Ferreccio, M M Levine, I Horwitz, M R Rao, K M Edwards, B Fritzell
JournalJAMA (JAMA) Vol. 267 Issue 5 Pg. 673-8 (Feb 05 1992) ISSN: 0098-7484 [Print] United States
PMID1731134 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Bacterial
  • Bacterial Vaccines
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Haemophilus Vaccines
  • Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
  • Tetanus Toxoid
Topics
  • Antibodies, Bacterial (biosynthesis)
  • Bacterial Vaccines (immunology)
  • Bordetella pertussis (immunology)
  • Clostridium tetani (immunology)
  • Corynebacterium diphtheriae (immunology)
  • Diphtheria-Tetanus-Pertussis Vaccine (immunology)
  • Double-Blind Method
  • Female
  • Haemophilus Vaccines
  • Haemophilus influenzae (immunology)
  • Humans
  • Infant
  • Male
  • Tetanus Toxoid (immunology)

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