A randomized trial assessing the immunogenicity and reactogenicity of two hexavalent infant vaccines concomitantly administered with group b meningococcal vaccine

Journal article

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.

Authors: Rajan, M; Marchevsky, N; Sinclair, G; O'Brien, K; Jefferies, K

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: Lippincott, Williams & Wilkins
• Journal: Pediatric Infectious Disease Journal
• Volume: 42
• Issue: 1
• Pages: 66-73
• Place of publication: United States
• Publication date: 2022-09-12
• Acceptance date: 2022-08-30
• DOI: 10.1097/inf.0000000000003753
• EISSN: 1532-0987
• ISSN: 0891-3668
• Pmid: 36476534
• Language: English
• Keywords: humans; meningococcal infections; combined; infant; immunoglobulin g; vaccines; europe; meningococcal vaccines