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Randomized Controlled Trial
. 2023 Jan 1;42(1):66-73.
doi: 10.1097/INF.0000000000003753. Epub 2022 Nov 1.

A Randomized Trial Assessing the Immunogenicity and Reactogenicity of Two Hexavalent Infant Vaccines Concomitantly Administered With Group B Meningococcal Vaccine

Matthew Rajan  1 , Natalie Marchevsky  1 , Gemma Sinclair  1 , Katie O'Brien  1 , Kimberley Jefferies  1 , Nelly Owino  1 , Bassam Hallis  2 , David Goldblatt  3 , Mary Matheson  4 , Hannah Cuthbertson  4 , Parvinder Aley  1 , Xinxue Liu  1 , Matthew D Snape  1   5
Affiliations
Randomized Controlled Trial

A Randomized Trial Assessing the Immunogenicity and Reactogenicity of Two Hexavalent Infant Vaccines Concomitantly Administered With Group B Meningococcal Vaccine

Matthew Rajan et al. Pediatr Infect Dis J. .

Abstract

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.

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Conflict of interest statement

MDS acts on behalf of the University of Oxford as an Investigator on clinical trials funded or otherwise supported by vaccine manufacturers including MCM vaccines, Janssen, GlaxoSmithKline, Novavax, AstraZeneca and Pfizer. He receives no direct personal financial payment for this work. For remaining authors, there are no conflicts of interest.

References

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