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Combined diphtheria, tetanus, pertussis, and Haemophilus influenzae type b vaccines for primary immunisation
1University of Department of Paediatrics, Sheffield Children's Hospital.
Insights
Combining diphtheria, tetanus, pertussis (DTP) and Haemophilus influenzae type b (Hib) vaccines in one syringe is safe and effective for infant immunization. This approach yields comparable antibody responses and adverse event profiles to separate injections.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Infant immunization schedules often involve multiple injections.
- Combined vaccines can simplify administration and potentially improve compliance.
- Assessing the safety and immunogenicity of combined DTP-Hib vaccines is crucial.
Purpose of the Study:
- To evaluate the antibody response to a combined diphtheria, tetanus, pertussis (DTP) and Haemophilus influenzae type b (Hib) tetanus toxoid conjugate (PRP-T) vaccine.
- To assess adverse events following immunization with the combined DTP-Hib vaccine.
- To compare the efficacy of combined versus separate DTP and PRP-T vaccine administration.
Main Methods:
- 146 infants received combined DTP-Hib (PRP-T) vaccine at 2, 3, and 4 months.
- Adverse events were recorded by parents in a diary.
- Antibody titers for diphtheria, tetanus, pertussis, and Hib were measured before and after vaccination.
- Data were compared to historical controls receiving separate vaccines.
Main Results:
- The combined vaccine was well tolerated with similar local and general reactions compared to separate injections.
- All infants achieved protective antibody titers for diphtheria and tetanus.
- 98% of infants achieved protective Hib antibody titers (>0.15 µg/ml), with 82.5% reaching >1.0 µg/ml.
- Significant increases in pertussis antibody titers were observed post-immunization.
Conclusions:
- Combined DTP-Hib (PRP-T) vaccine is safe and immunogenic in infants.
- Antibody responses and adverse effects are comparable to separate vaccine administration.
- The combined vaccine is suitable for inclusion in primary immunization schedules.
Abstract:
A total of 146 infants were immunised at ages 2, 3, and 4 months with a combined diphtheria, tetanus, pertussis (DTP)--Haemophilus influenzae type b (Hib) tetanus toxoid conjugate (PRP-T) vaccine (Pasteur Merieux) to assess the antibody response and adverse events associated with immunisation. Adverse events, including fever, were recorded by parents in a diary for three days following each injection. Blood was taken before the first immunisation and four weeks after the third immunisation to assess antibody response. Data were compared with those from historical controls who had received DTP and PRP-T vaccines by separate injection. The combined vaccine was well tolerated. Rates of local and general reactions were similar to those reported for infants immunised by separate injection. All infants achieved protective antibody titres (> 0.01 IU/ml) for diphtheria and tetanus; 98% acquired Hib (PRP) antibody > 0.15 microgram/ml and 82.5% > 1.0 microgram/ml. Pertussis antibody titres (pertussis toxin, filamentous haemagglutinin, total agglutinins, and agglutinins 2 and 3) showed appreciable rise following immunisation. DTP and PRP-T vaccines provide similar antibody responses and adverse effects whether mixed in the same syringe or administered by separate injection. The vaccines could be combined for use in the United Kingdom primary immunisation schedule.