Related Experiment Video
Updated: May 5, 2026
Inducing Meningococcal Meningitis Serogroup C in Mice via Intracisternal Delivery
Published on: November 5, 2019
Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial
Matthew D Snape1, Kirsten P Perrett, Karen J Ford
1Oxford Vaccine Group, University of Oxford, England. matthew.snape@paediatrics.ox.ac.uk
Insights
A new meningococcal ACWY vaccine (MenACWY) shows strong immunogenicity in infants, with high antibody titers against serogroups A, C, W-135, and Y. This novel vaccine is well-tolerated and offers protection during early childhood.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Immunology
Background:
- Current meningococcal ACWY vaccines are not sufficiently immunogenic in infants.
- Infancy is a critical period for meningococcal disease, with the highest incidence rates observed.
Purpose of the Study:
- To evaluate the immunogenicity and safety of a novel tetravalent CRM(197)-conjugated meningococcal vaccine (MenACWY) in infants.
Main Methods:
- A randomized, open-label, controlled study involving 2-month-old infants in the UK and Canada.
- Infants received different MenACWY vaccination schedules or a control vaccine (MenC).
- Human complement serum bactericidal activity (hSBA) titers were measured post-primary immunization and after a booster dose.
Main Results:
- High percentages of infants achieved protective hSBA titers (>or=1:4) against serogroups A, C, W-135, and Y after primary MenACWY immunization.
- Booster doses at 12 months further increased antibody titers, with at least 95% achieving protective levels for C, W-135, and Y.
- The MenACWY vaccine was well-tolerated, with mild and infrequent adverse events such as pain on leg movement and fever.
Conclusions:
- The novel MenACWY vaccine is both well-tolerated and immunogenic in infants.
- This vaccine holds promise for protecting infants against invasive meningococcal disease.
Context:
Immunization with a meningococcal tetravalent (serogroup ACWY) glycoconjugate vaccine is recommended for all US adolescents. However, the currently licensed vaccine is poorly immunogenic in infancy, when the highest rates of disease are observed.
Objective:
To determine the immunogenicity of a novel tetravalent CRM(197)-conjugated meningococcal vaccine (MenACWY) in infants.
Design, Setting, And Participants:
Randomized, open-label, controlled study of 225 UK and 196 Canadian 2-month-olds from August 2004 to September 2006.
Intervention:
UK infants received a primary course of MenACWY (at 2, 3, and 4 months or 2 and 4 months) or Neisseria meningitidis serogroup C monovalent meningococcal glycoconjugate vaccine (MenC) (at 2 and 4 months). All received MenACWY at 12 months. Canadian infants received MenACWY at 2, 4, and 6 months or 2 and 4 months; at 12 months they received MenACWY, a plain tetravalent polysaccharide vaccine, or no vaccine.
Main Outcome Measure:
Percentage of infants with a human complement serum bactericidal activity (hSBA) titer >or=1:4 after a primary course of MenACWY and after a 12-month booster. Safety and reactogenicity of MenACWY were also assessed.
Results:
According to the prespecified per-protocol analysis, the percentages (95% CIs) of MenACWY 2-, 3-, and 4-month recipients with hSBA titers >or=1:4 after primary immunization were serogroup A, 93% (84%-98%); C, 96% (89%-99%); W-135, 97% (90%-100%); and Y, 94% (86%-98%). With a post hoc intention-to-treat analysis with imputed values for missing data, these values were unchanged for serogroups C and Y; for serogroup A, values were 92% (84%-97%), and for W-135, 97% (91%-99%). For the per-protocol analysis of MenACWY 2-, 4-, and 6-month recipients, the percentages (95% CIs) of responders were A, 81% (71%-89%); C, 98% (92%-100%); W-135, 99% (93%-100%); and Y, 98% (92%-100%). With the imputed value analysis, these values were A, 83% (74%-89%); C, 98% (93%-99%); W-135, 99% (94%-100%); and Y, 98% (92%-99%). At least 84% of MenACWY 2- and 4-month recipients achieved hSBA titers >or=1:4 for serogroups C, W-135, and Y after primary immunization, as did at least 60% for serogroup A (per-protocol and imputation analysis). At least 95% of primary and booster MenACWY recipients achieved hSBA titers >or=1:4 for serogroups C, W-135, and Y at 13 months, as did at least 84% for serogroup A (per-protocol and imputation analysis). During the primary immunization course, postimmunization pain on leg movement was observed in 2% of UK MenACWY 2- and 4-month recipients and 4% of MenC 2- and 4-month recipients; a temperature of 38 degrees C or greater was observed in 4% and 2% in these groups, respectively.
Conclusion:
MenACWY is well tolerated and immunogenic in infancy. Trial Registration clinicaltrials.gov Identifier: NCT00262002.
Related Concept Videos
01:22Development of Immunocompetence
The initial cells that migrate from the fetal thymus settle within the skin and epithelial tissues lining the mouth, digestive tract, and in females, the uterus and vagina. These cells, including skin-based dendritic cells, serve as antigen-presenting cells, playing a key role in T cell activation.
Subsequent T...
01:22Bacterial Meningitis I: Introduction
01:26Bacterial Meningitis II: Pathophysiology