Safety, immunogenicity, and induction of immunologic memory by a serogroup C meningococcal conjugate vaccine in infants: A randomized controlled trial.

Abstract

CONTEXT:

Neisseria meningitidis is a common cause of meningitis and septicemia in infants worldwide. Whether a meningococcal C conjugate vaccine protects infants against the serogroup C strain is unknown.

OBJECTIVES:

To determine whether a meningococcal C conjugate vaccine is safe and immunogenic and induces immunologic memory in infants.

DESIGN:

Single-center, double-blind, randomized controlled trial in 1995 and 1996.

SETTING:

Community, Oxfordshire, England.

PARTICIPANTS:

One hundred eighty-two healthy infants.

INTERVENTIONS:

Participants were randomly assigned to receive vaccination with 0. 5-mL doses of 1 of 2 lots of meningococcal C conjugate vaccine (groups 1 and 2; n=60 in each group) or a hepatitis B control vaccine (group 3; n=62), administered with routine immunizations at 2, 3, and 4 months of age. Approximately half of each group received meningococcal C conjugate vaccine and half received plain meningococcal polysaccharide vaccine (MPS) at 12 months of age.

MAIN OUTCOME MEASURES:

Serum antibodies to meningococcal C polysaccharide, assayed by enzyme-linked immunosorbent assay, and serum bactericidal activity (SBA), at 2, 3, 4, 5, 12, and 13 months of age; local and systemic reactions, recorded for 6 days after each vaccination, compared by intervention group.

RESULTS:

Meningococcal C conjugate vaccine was well tolerated. After 3 doses, children in groups 1 and 2 achieved significantly higher meningococcal C IgG geometric mean concentrations (21 and 17 U/mL, respectively, vs 0.20 U/mL; P<.001) and SBA titers (629 and 420, respectively, vs 4.1; P<. 001) than controls. At 12 months, antibody concentrations had decreased in all groups but remained significantly higher in children vaccinated with meningococcal C conjugate vaccine (SBA, 24 and 16 in groups 1 and 2, respectively, vs 4.2 in group 3; P<.001). Following vaccination with MPS at 12 months of age, SBA in the meningococcal C conjugate vaccine group was significantly higher than in controls (SBA, 789 vs 4.5; P<.001).

CONCLUSIONS:

Our data indicate that meningococcal C conjugate vaccine is safe and immunogenic and results in immunologic memory when given with other routinely administered vaccines to infants at 2, 3, and 4 months of age. JAMA. 2000;283:2795-2801

• Authors: J M MacLennan, F Shackley, P T Heath, J J Deeks, C Flamank, M Herbert, H Griffiths, E Hatzmann, C Goilav, E R Moxon
• Journal: JAMA (JAMA) Vol. 283 Issue 21 Pg. 2795-801 (Jun 07 2000) ISSN: 0098-7484 [Print] United States
• PMID: 10838647 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Bacterial
• Bacterial Vaccines
• Immunoglobulin G
• Meningococcal Vaccines
• Vaccines, Conjugate
• serogroup C meningococcal conjugate vaccine

Topics

• Analysis of Variance
• Antibodies, Bacterial (biosynthesis, immunology)
• Bacterial Vaccines (administration & dosage, immunology)
• Blood Bactericidal Activity
• Double-Blind Method
• Enzyme-Linked Immunosorbent Assay
• Female
• Humans
• Immunization, Secondary
• Immunoglobulin G (immunology)
• Immunologic Memory
• Infant
• Male
• Meningococcal Vaccines
• Neisseria meningitidis (classification, immunology)
• Probability
• Serotyping
• Vaccines, Conjugate (administration & dosage, immunology)