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Published on: December 19, 2020
Interchangeability of conjugated Haemophilus influenzae type b vaccines in infants
E L Anderson1, M D Decker, J A Englund
1Department of Medicine, Saint Louis (Mo) University School of Medicine.
Insights
Sequential Haemophilus influenzae type b (Hib) vaccine combinations were safe and effective. Serial administration of PRP-OMP and HbOC vaccines demonstrated comparable or superior immunogenicity to single-product regimens in infants.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
- Immunology
Background:
- Haemophilus influenzae type b (Hib) conjugate vaccines are crucial for preventing invasive Hib disease.
- Two primary conjugate vaccines, PRP-OMP and HbOC, exist, utilizing different carrier proteins.
- Evaluating serial combinations of these vaccines is important for optimizing infant immunization schedules.
Purpose of the Study:
- To assess the safety and immunogenicity of sequential administration of two Hib conjugate vaccines: PRP-OMP and HbOC.
- To compare the immunogenicity of serial combinations against single-product regimens.
- To evaluate the priming effect of unconjugated PRP at 15 months.
Main Methods:
- A randomized, double-blind clinical trial involving 497 healthy 2-month-old infants.
- Five different Hib vaccination regimens were administered, including serial combinations of PRP-OMP and HbOC.
- Antibody concentrations were measured after primary series and booster doses; safety was monitored.
Main Results:
- Significant differences in geometric mean antibody concentrations were observed among groups after the second and third immunizations, and after booster doses.
- Serial combinations of PRP-OMP and HbOC achieved antibody concentrations equal to or greater than single-product groups.
- No significant variations in adverse reactions were noted between the different vaccination groups.
Conclusions:
- Sequential administration of Hib conjugate vaccines (PRP-OMP and HbOC) is safe.
- These serial combinations are at least as immunogenic as using a single vaccine product.
- The findings support the flexibility of using serial combinations in infant immunization schedules.
Objective:
To evaluate the safety and immunogenicity of two Haemophilus influenzae type b (Hib) conjugate vaccines when administered in serial combination. These vaccines consisted of Hib capsular polysaccharide polyribosyl-ribitol phosphate (PRP) conjugated to the meningococcal outer membrane protein (OMP) complex (PRP-OMP) and H influenzae oligosaccharide conjugated to a mutant toxin (CRM197) isolated from Corynebacterium diphtheriae (HbOC).
Design:
Randomized, double-blind, clinical trial evaluating five Hib vaccination regimens.
Setting:
Vaccine Treatment and Evaluation Units and affiliated private pediatric practices at Saint Louis (Mo) University, Vanderbilt University, Nashville, Tenn, and Baylor College of Medicine, Houston, Tex.
Patients:
A total of 497 healthy 2-month-old infants scheduled to receive routine immunization.
Intervention:
Participants received either PRP-OMP or HbOC given as recommended by the manufacturer, PRP-OMP at 2 and 6 months, HbOC at 2 months, then PRP-OMP at 4 and 6 months, or PRP-OMP at 2 months and then HbOC at 4 and 6 months. Unconjugated PRP was given at 15 months to evaluate priming.
Results:
Geometric mean antibody concentrations differed significantly among the groups following the second and third immunizations of the primary series and following booster immunization with unconjugated PRP. On each occasion, the groups receiving serial combinations of PRP-OMP and HbOC achieved mean antibody concentrations that equalled or exceeded those of the groups receiving a single product. Adverse reactions did not vary by group.
Conclusions:
The studied sequential combinations of Hib vaccines were safe and at least as immunogenic as either vaccine alone.
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