Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine

Summary

Primary objective: To assess the immunogenicity of the Mencevax ACW135 polysaccharide vaccine at 28 days (+6days) post vaccination in 2-4, 5-14, 15-29 year age groups and compare the immunogenicity between these age groups. Secondary Objectives: * To estimate the incidence of common adverse events following immunization (AEFI) of GSK Nm ACW135 polysaccharide vaccine at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination * To assess the persistence of antibody against meningitis A, C and W135 at 11 and 23 months post vaccination in 2-4, 5-14, 15-29 year age groups Study site:Two rural communities (Kebele) in Butajira district, Ethiopia. Methods: * Phase II, open and parallel safety and immunogenicity trial. * 234 younger children (2-4 years), 145 older children (5-14 years) and 33 adults (15-29 years of age) were randomly selected from the demographic surveillance database and enrolled after screening and consenting. * Study participant received Mencevax ACW polysaccharide vaccine 50 mg in 0.5ml subcutaneously. * Blood samples for measuring SBA titres were collected at pre vaccination and on day 28 (+6 days) post vaccination. * Active follow up for AEFI on post vaccination day 0, 1, 2, 3, 7, \& 28. * Primary end point was vaccine response defined as sero-conversion (in subjects initially seronegative) or a 4 fold increase (in subjects initially seropositive) in serum bactericidal antibodies (SBA) against serogroups Men A, C and W135) on post vaccination day 28. In addition seroconversion was assessed by ELISA Men A IgG on day 0 and day 28 post vaccination. * Secondary endpoints were incidence of general and local symptoms and other adverse events following immunisation during the post vaccination period day 0 to 28 and immune persistence on post vaccination month-11 and month-23. Results: * No significant difference in the incidence of general or local AEFI was observed between the age groups * The statistical analysis for the Immunogenicity data is in progress

Timeline

Start

2005-11

Primary completion

2006-01

Completion

2007-11

Publications

• Results Aseffa A, Bedru A, Yamuah L, Arga D, Worku A, Chandramohan D, Nelson CB, Engers HD. Safety of a trivalent meningococcal ACW135 vaccine among young children in Ethiopia. Vaccine. 2007 Sep 3;25 Suppl 1:A79-82. doi: 10.1016/j.vaccine.2007.04.046. Epub 2007 May 4.

Drugs

Indications