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DTPw-HB and Hib primary and booster vaccination: combined versus separate administration to Latin American children
José Ignacio Santos1, Amando Martin, Tirza De Leon
1Departamento de Medicina Experimental, Facultad de Medicina UNAM and Conrejo Nacional de Vacunación, Ministry of Health, Mexico. jisantos@supernet.com.mx
Insights
This study found that combining diphtheria, tetanus, pertussis, hepatitis B (HB), and Haemophilus influenzae type b (Hib) vaccines is safe and effective. Both mixed and separate injections provide excellent protection against these diseases in children.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Immunology
Background:
- Childhood vaccination programs aim to prevent serious infectious diseases.
- Combination vaccines simplify administration and improve coverage.
- Assessing the safety and efficacy of combined DTPw-HB/Hib vaccines is crucial.
Purpose of the Study:
- To evaluate the reactogenicity and immunogenicity of a combined diphtheria, tetanus, pertussis whole-cell-hepatitis B/Haemophilus influenzae type-b (DTPw-HB/Hib) vaccine.
- To compare a syringe mix formulation with separate injections of the DTPw-HB/Hib vaccine.
- To assess antibody persistence and response to booster doses.
Main Methods:
- A multicentre study involving 400 Latin American children.
- Administration of DTPw-HB/Hib vaccine either as a syringe mix or separate injections.
- Monitoring of reactogenicity and measurement of antibody concentrations (anti-HBs, anti-PRP) post-primary and post-booster vaccination.
Main Results:
- Both vaccine regimens were equally well tolerated.
- Post-primary vaccination achieved near 100% seropositivity for all five antigens.
- Seroprotective antibody levels for hepatitis B (HB) and Haemophilus influenzae type b (Hib) persisted for approximately one year.
- Booster vaccination significantly increased all antibody concentrations.
Conclusions:
- The combined DTPw-HB/Hib vaccine, whether administered as a mix or separate injections, is safe and immunogenic.
- This combination vaccine is an effective strategy for enhancing childhood immunization coverage.
- High and persistent antibody levels indicate long-term protection against targeted diseases.
Abstract:
This multicentre study was designed to establish the reactogenicity and immunogenicity profiles of primary and booster vaccination with diphtheria, tetanus, and pertussis whole-cell-hepatitis B/Haemophilus influenzae type-b (DTPw-HB/Hib) administered as either a syringe mix or as separate injections in 400 Latin American children. Both vaccine regimens were equally well tolerated and elicited post-primary excellent seropositivity rates at or close to 100% for all five component antigens. With regard to HB, 100% of subjects in the combined vaccination group, and 98.8% subjects in the separate injection vaccination group reached seroprotective antibody concentrations (>or=10 mIU/ml) 1 month after the primary vaccination course. Equally high anti-PRP antibody concentrations were reached 1 month after vaccination, with 100% of seroprotected subjects in the combined vaccination group (antibody concentrations >or=0.15 microg/ml), against 99.4% in the separate injection vaccination group. Seroprotective anti-HBs and anti-PRP antibody concentration levels persisted approximately 1 year after the primary vaccination course, just prior to booster vaccination. Finally, a significant increase of all antibody concentrations could be observed after the booster vaccination, since all but one subject in the separate injection vaccination group had protective levels of anti-HBs and anti-PRP antibodies 1 month after the booster dose. These results suggest that the combination of DTPw-HB and Hib vaccines provides an effective means for increasing vaccine coverage in childhood vaccination programmes.
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