Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine (ETH-TVT)
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.
- 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.
- 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.
- 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
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase II Open and Parallel Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Polysaccharide Vaccine Comparing Three Groups: 2 - 4 Year, 5 - 14 Year and 15 - 29 Year Old Ethiopians|
- To evaluate point estimates and trends in immunogenicity after not less than 28 days (+6 days) among children 2 - 4 years as compared to children 5 - 14 years and adolescents/adults 15 - 29 years (all ages inclusive) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- To assess the incidence of adverse events following vaccination at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination. [ Time Frame: 28days ] [ Designated as safety issue: Yes ]
- To assess the immunogenicity at 11 months and 23 months (inclusive) postvaccination. [ Time Frame: 23 month ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||November 2007|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Biological: Mencevax ACW Vaccine
|Butajira, Southern Nationality, Ethiopia|
|Principal Investigator:||Abraham Aseffa Aseffa, M.D, PhD||Senior Sientist,Deputy Director, AHRI|
|Principal Investigator:||Ahmed Bedru Omer, M.D,Pediatrician||Clinical Trial coordinator,AHRI|