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A Randomized Trial Assessing the Immunogenicity and Reactogenicity of Two Hexavalent Infant Vaccines Concomitantly
Matthew Rajan1, Natalie Marchevsky1, Gemma Sinclair1
1Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Insights
This study found that Vaxelis (Hex-V) demonstrated superior immunogenicity against Haemophilus influenza type b (Hib) compared to Infanrix-Hexa (Hex-IH) when co-administered with the 4CMenB vaccine. Both vaccines showed similar safety profiles, supporting flexible use in infant immunization schedules.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- Three hexavalent vaccines (DTaP-IPV-Hib-HepB) are available in Europe.
- Vaxelis (Hex-V) uniquely uses a meningococcal outer membrane protein complex as a carrier for Haemophilus influenza type b (Hib), potentially interacting with the 4CMenB vaccine.
Purpose of the Study:
- To compare the immunogenicity and safety of Vaxelis (Hex-V) versus Infanrix-Hexa (Hex-IH) when given with the 4CMenB vaccine in infants.
- To assess noninferiority of anti-PRP (Hib) IgG geometric mean concentrations (GMCs) at 5 months.
Main Methods:
- A single-center, open-label, randomized trial involving 194 infants.
- Infants received either Hex-V or Hex-IH at 2, 3, and 4 months, alongside 4CMenB vaccine at 2, 4, and 12 months.
- Primary outcome: noninferiority of anti-PRP IgG GMCs at 5 months; secondary outcomes: safety, reactogenicity, and immunogenicity at 5 and 13 months.
Main Results:
- Noninferiority of anti-PRP IgG GMCs was established for Hex-V.
- Anti-PRP IgG GMCs were 23 times higher with Hex-V compared to Hex-IH (GMR 23.25).
- Higher serum bactericidal activity titers against MenB strain 5/99 were observed with Hex-V (GMR 1.56); reactogenicity was similar between groups.
Conclusions:
- Hex-V demonstrates superior immunogenicity for Hib compared to Hex-IH when co-administered with 4CMenB.
- The study supports flexible use of either Hex-IH or Hex-V in infant immunization schedules including 4CMenB.
- Hex-V may offer enhanced protection against Hib.
Background:
Three hexavalent (DTaP-IPV-Hib-HepB) vaccines are licensed in Europe, only one of which (Vaxelis, Hex-V), uses a meningococcal outer membrane protein complex as a carrier protein for Hemophilus influenza type b (Hib), creating potential interactions with the meningococcal vaccine 4CMenB.
Methods:
In this single-center open-label randomized trial, infants were randomized in a 1:1 ratio to receive Hex-V or an alternative hexavalent vaccine (Infanrix-Hexa, Hex-IH) at 2, 3, and 4 months with 4CMenB (2, 4, and 12 months) in the UK routine immunization schedule. The primary outcome was noninferiority of geometric mean concentrations (GMCs) of anti-PRP (Hib) IgG at 5 months of age. Secondary outcomes included safety, reactogenicity, and immunogenicity of other administered vaccines measured at 5 and 13 months of age.
Results:
Of the 194 participants enrolled, 96 received Hex-V and 98 Hex-IH. Noninferiority of anti-PRP IgG GMCs at 5 months of age in participants receiving Hex-V was established; GMCs were 23-times higher following three doses of Hex-V than three doses of Hex-IH (geometric mean ratio (GMR) 23.25; one-sided 95% CI 16.21, -). 78/85 (92%) of Hex-V recipients and 43/87 (49%) of Hex-IH recipients had anti-PRP antibodies ≥1.0 µg/mL. At 5 months of age serum, bactericidal activity titers against MenB strain 5/99 were higher following Hex-V than Hex-IH (GMR 1.56; 95% CI, 1.13-2.14). The reactogenicity profile was similar in both groups.
Conclusions:
These data support flexibility in the use of either Hex-IH or Hex-V in infant immunization schedules containing 4CMenB, with the possibility that Hex-V may enhance protection against Hib.
