| Abstract | OBJECTIVE--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. |
| Authors | J D Clemens, C Ferreccio, M M Levine, I Horwitz, M R Rao, K M Edwards, B Fritzell
(Affiliation: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.)
|
| Journal | JAMA : the journal of the American Medical Association
(JAMA)
Vol. 267
Issue 5
Pg. 673-8
(Feb 5 1992)
ISSN: 0098-7484 UNITED STATES |
| PMID | 1731134
(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)
|
