Literature DB >> 15131466

Dosage escalation, safety and immunogenicity study of four dosages of a tetravalent meninogococcal polysaccharide diphtheria toxoid conjugate vaccine in infants.

Margaret Rennels1, James King, Robert Ryall, Thomas Papa, James Froeschle.   

Abstract

BACKGROUND: Young children have the highest incidence of meningococcal infection. Approximately 50% of disease in United States children less than 2 years of age is caused by serogroups C and Y. In the developing world, serogroups A and W-135 cause outbreaks and epidemics of infection.
METHODS: Three groups of 30 infants were enrolled. The first group of infants was given 3 doses of a quadrivalent (group A, C, Y, W-135) polysaccharide meningococcal vaccine conjugated to diphtheria toxoid (MCV-4) at a dosage of 1 microg of each serogroup polysaccharide. The second group of infants was given MCV-4 at a dosage of 4 microg, and the last group of children received a 10-microg dosage. Vaccinations were given at 2, 4 and 6 months of age.A subset of these children was vaccinated at 15 to 18 months of age with licensed meningococcal polysaccharide (A, C, Y, W-135) vaccine. Serum bactericidal antibody (SBA) titers were measured with baby rabbit complement.
RESULTS: The proportion of infants with local reactions increased significantly with increasing dosages after Injection 1 and 3. Approximately 1 month after completion of the primary series, the proportion of infants with an SBA titer > or = 1/8 ranged from 54 to 92%, depending on the serogroup and dose of polysaccharide contained in the vaccine. The SBA geometric mean titer varied from 17.4 to 101.6. There was no statistically significant difference between the SBA responses among the 3 dosage groups. After vaccination with polysaccharide vaccine at 15 to 18 months of age, mean fold increases in SBA of 4.9 to 170.3 were observed, suggesting an anamnestic response.
CONCLUSIONS: MCV-4 appears to have a reactogenicity profile acceptable to parents and health care providers. It was only modestly immunogenic in infants, but it appeared to prime the immune system of the majority of infants given three doses in infancy. There is no statistically significant immunologic advantage conferred by increasing the dosage beyond 4 microg/ml, and local reactions are more frequent after the 10-microg/ml dosage.

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Year:  2004        PMID: 15131466     DOI: 10.1097/01.inf.0000126297.28952.f8

Source DB:  PubMed          Journal:  Pediatr Infect Dis J        ISSN: 0891-3668            Impact factor:   2.129


  18 in total

1.  Changes in Tdap and MCV4 vaccine coverage following enactment of a statewide requirement of Tdap vaccination for entry into sixth grade.

Authors:  Elyse Olshen Kharbanda; Melissa S Stockwell; James Colgrove; Karthik Natarajan; Vaughn I Rickert
Journal:  Am J Public Health       Date:  2010-07-15       Impact factor: 9.308

2.  Genetic and antigenic analysis of invasive serogroup Y Neisseria meningitidis isolates collected from 1999 to 2003 in Canada.

Authors:  Raymond S W Tsang; Averil M Henderson; Marissa L Cameron; Shaun D Tyler; Shari Tyson; Dennis K S Law; Jan Stoltz; Wendell D Zollinger
Journal:  J Clin Microbiol       Date:  2007-04-18       Impact factor: 5.948

Review 3.  Prospects for vaccine prevention of meningococcal infection.

Authors:  Lee H Harrison
Journal:  Clin Microbiol Rev       Date:  2006-01       Impact factor: 26.132

4.  Conjugates of group A and W135 capsular polysaccharides of neisseria meningitidis bound to recombinant Staphylococcus aureus enterotoxin C1: preparation, physicochemical characterization, and immunological properties in mice.

Authors:  Zhigang Jin; Gregory A Bohach; Joseph Shiloach; Scott E Norris; Darón I Freedberg; Claudia Deobald; Bruce Coxon; John B Robbins; Rachel Schneerson
Journal:  Infect Immun       Date:  2005-12       Impact factor: 3.441

5.  Advice for Consideration of Quadrivalent (A, C, Y, W135) Meningococcal Conjugate Vaccine, for use by Provinces and Territories.

Authors: 
Journal:  Can Commun Dis Rep       Date:  2010-01-26

6.  UPDATE ON THE USE OF QUADRIVALENT CONJUGATE MENINGOCOCCAL VACCINES: An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI).

Authors:  This Statement Was Prepared By Dr B Warshawsky
Journal:  Can Commun Dis Rep       Date:  2013-01-02

Review 7.  Meningococcal glycoconjugate vaccines.

Authors:  Roberto Gasparini; Donatella Panatto
Journal:  Hum Vaccin       Date:  2011-02-01

Review 8.  Protein carriers of conjugate vaccines: characteristics, development, and clinical trials.

Authors:  Michael E Pichichero
Journal:  Hum Vaccin Immunother       Date:  2013-08-16       Impact factor: 3.452

9.  Depressive symptoms and immune response to meningococcal conjugate vaccine in early adolescence.

Authors:  Thomas G O'Connor; Jan A Moynihan; Peter A Wyman; Jennifer Carnahan; Gerry Lofthus; Sally A Quataert; Melissa Bowman; Mary T Caserta
Journal:  Dev Psychopathol       Date:  2014-11

Review 10.  Meningococcal A, C, Y and W-135 polysaccharide-protein conjugate vaccines.

Authors:  David Pace; Andrew J Pollard
Journal:  Arch Dis Child       Date:  2007-10       Impact factor: 3.791

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