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Immunogenicity and safety in infants of a DTwPHib full liquid vaccine
F I Botet Asensi1, A Veronese, M Del Carmen Otero
1Departamento de Enfermedades Infecciosas, Hospital Infantil-Hospital Universitario La Fé, Valencia, Spain.
Insights
A new combined liquid vaccine (DTwPHib) demonstrated safety and effectiveness in infants, offering a convenient way to increase vaccination coverage. This diphtheria, tetanus, whole cell pertussis, and Haemophilus influenzae type b vaccine is suitable for immunization programs.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Combining paediatric vaccines reduces injection burden, improving compliance and coverage.
- Diphtheria, tetanus, whole cell pertussis (DTwP)-containing combination vaccines are globally utilized.
- This study evaluates a novel liquid combination vaccine against DTwP and Haemophilus influenzae type b (Hib).
Purpose of the Study:
- To assess the immunogenicity and safety of a ready-to-use liquid DTwPHib vaccine in infants.
- To compare the efficacy of the DTwPHib vaccine against separate DTwP and Hib vaccine administration.
Main Methods:
- A comparative study in infants within the Expanded Programme on Immunization (EPI) in Valencia, Spain.
- Infants received either the DTwPHib liquid vaccine or separate DTwP + Hib reference vaccines.
- Safety was monitored through local and systemic reactions and adverse events.
Main Results:
- The DTwPHib vaccine elicited high antibody titres for Hib (97% ≥0.15 μg/mL, 89% ≥1.0 μg/mL) with a significantly higher geometric mean titre compared to separate vaccines.
- Protective antibody levels against diphtheria (99%) and tetanus (100%) were achieved in both groups.
- The DTwPHib vaccine induced significant increases in antibodies against pertussis components (pertactin, Aggregatibacter actinomycetemcomitans serotypes 2 and 3).
Conclusions:
- The combined liquid DTwPHib vaccine is safe and immunogenic in infants.
- This vaccine is suitable for use in the Expanded Programme on Immunization (EPI).
- The DTwPHib vaccine offers a viable alternative for routine infant immunization.
Aim:
Combining paediatric vaccines is a rational solution to reduce the number of injections during a single clinical visit, to maintain parents' compliance and to extend vaccine coverage. Different diphtheria, tetanus and whole cell pertussis (DTwP)-containing combination vaccines are licensed and used world-wide. This study assessed the immunogenicity and safety in infants of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b-CRM197 conjugate full liquid vaccine.
Methods:
The safety and efficacy of a combined ready-to-use liquid vaccine containing diphtheria and tetanus toxoids, cell suspension of Bordetella pertussis and H. influenzae type b-CRM197 conjugate vaccine (DTwPHib) were assessed in infants eligible for the local Expanded Programme on Immunization (EPI) in Valencia, Spain. The comparative group received separate injections of reference vaccines DTwP + Hib.
Results:
Local and systemic reactions and adverse events were generally mild and similar in the two groups. DTwPHib elicited anti-PRP antibody titres > or = 0.15 microg ml(-1) in 97% and DTwP + Hib in 94% of infants. Furthermore, 89% of DTwPHib and 78% of DTwP + Hib recipients attained anti-PRP antibody titres > or = 1.0 microg ml(-1), signifying long-term protection. The anti-PRP geometric mean titre was significantly higher in the combined DTwPHib vaccine group (6.65 vs 3.57 microg ml(-1)). In both groups, 99% of infants achieved protective (> or = 0.01 IU ml(-1)) anti-diphtheria antibody levels and all children achieved protective (> or = 0.1 IU ml(-1)) anti-tetanus antibody levels. DTwPHib caused a > or = 2-fold increase in anti-pertactin antibody titres in 91% and a > or = 4-fold increase in 82% of recipients. The corresponding proportions in the DTwP + Hib group were 95% and 90%. DTwPHib induced a > or = 2-fold increase in anti-Aggl2 and 3 antibody levels in 79% and a > or = 4-fold increase in 73% of recipients. The corresponding proportions among DTwP + Hib infants were 85 and 82%.
Conclusion:
Overall, the combined liquid vaccine DTwPHib is a safe and effective immunogenic vaccine for EPI use in infants.
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