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Immunogenicity and Reactogenicity of a Reduced Schedule of a 4-component Capsular Group B Meningococcal Vaccine: A

Marta Valente Pinto1, Daniel O'Connor1, Ushma Galal2

  • 1Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.

Open Forum Infectious Diseases
|June 5, 2020
PubMed

Insights

The 3-dose infant schedule for the 4-component capsular group B meningococcal vaccine (4CMenB) is immunogenic, inducing protective antibody titers and immunological memory after a booster dose. This supports its use in infant immunization programs.

Area of Science:

  • Immunology
  • Vaccinology
  • Pediatrics

Background:

  • The 4-component capsular group B meningococcal vaccine (4CMenB) was approved for a 4-dose infant schedule.
  • The United Kingdom introduced a 3-dose schedule (2, 4, and 12 months) for 4CMenB.
  • This study evaluates the immunogenicity and reactogenicity of the 2+1 schedule.

Purpose of the Study:

  • To assess the immunogenicity of a 3-dose infant schedule of 4CMenB.
  • To evaluate the reactogenicity of the 2+1 schedule for 4CMenB in infants.
  • To determine if the 2+1 schedule establishes immunological memory.

Main Methods:

  • Infants were randomized into a test group (4CMenB at 2, 4, 12 months) and a control group (4CMenB at 6, 8, 13 months).
  • Serum bactericidal antibody (SBA) titers, memory B-cell responses to vaccine antigens (factor H binding protein, Neisseria adhesion protein A, Neisseria heparin binding antigen, Porin A), and reactogenicity were measured.
  • 187 infants were randomized (94 test, 93 control).

Main Results:

  • The 3-dose 4CMenB schedule induced SBA titers above the protective threshold (1:4) in 97% of infants post-booster.
  • Post-booster SBA geometric mean titers (GMT) were numerically higher than post-primary vaccination GMT.
  • Memory B-cell responses increased significantly after the booster dose, and higher rates of local/systemic adverse reactions were observed with 4CMenB.

Conclusions:

  • The reduced 3-dose schedule of 4CMenB is immunogenic in infants.
  • The 2+1 schedule effectively establishes immunological memory after the booster dose.
  • 4CMenB administration was associated with local and systemic adverse reactions.
Abstract

Keywords:
4-component capsular group B meningococcal vaccine4CMenBimmunogenicitymemory B cellsmeningococcal diseasereactogenicityreduced schedule

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