Safety and Immunogenicity of MVA85A, in Healthy Volunteers in Cape Town
This study is designed to evaluate the safety of MVA85A in healthy volunteers in Cape Town. We have shown that MVA85A is safe and immunogenic in both a mycobacterially naïve population in the UK and in a more mycobacterially exposed population in The Gambia. The studies described here will be to assess the safety of MVA85A in 2 groups of adults, those with and without prior BCG vaccination. Once safety data has been obtained in these 2 groups, we will assess the safety of MVA85A in adolescents who have been previously vaccinated with BCG.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine MVA85A, in Healthy Volunteers With no Evidence of Infection With Mycobacterium Tuberculosis, in Cape Town|
- To assess the safety of a single intradermal injection of 5 x 107pfu MVA85A, when administered to healthy subjects. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events (AEs). [ Time Frame: year ] [ Designated as safety issue: Yes ]
- To assess the immunogenicity of a single vaccination with MVA85A in healthy subjects. The specific endpoints for immunogenicity will be markers of cell-mediated immunity as outlined above [ Time Frame: year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
12 adults with prior BCG
Biological: MVA 85A
12 adults without prior BCG
Biological: MVA 85A
Biological: MVA 85A
This is an open label Phase I safety study of a single intradermal injection of 5 x 107pfu MVA85A, when administered to healthy subjects with no evidence of infection with M.tb
This is an observational and descriptive safety study, 12 subjects with evidence of prior BCG vaccination and 12 adults with no evidence of prior BCG vaccination will be recruited and vaccinated with MVA85A. This sample size should allow determination of the magnitude of the outcome measures, especially of serious and severe adverse events rather than aiming to obtain statistical significance. Once three month follow-up of these two arms of the study is complete, we will recruit 12 adolescent school children (aged 12-14) and assess the safety and immunogenicity of a single immunisation with MVA85A in this group.
Rules for progression from adult studies to adolescents:
No increased incidence in local and systemic side-effects compared with trials with MVA85A in Oxford and The Gambia.
In the trials in the UK and The Gambia, all volunteers experience some mild local side-effects for 1-4 days after vaccination.
Approximately two- thirds of volunteers experience some mild systemic side-effects in the first 24 hours after vaccination. These are self-limiting and all spontaneously resolve.
These side-effects are consistent with data from use with other recombinant MVAs expressing other antigens (Moorthy VS et al, 2003).
- Immune responses measured 1 week after vaccination. We see strong immune responses 1 week after vaccination in the Oxford and Gambian volunteers (McShane et al, 2004). We do not know how long the responses in the South African volunteers will last for, but we would expect to see the induction of significant (compared with baseline) immune responses as measured by the ex-vivo Elispot assay, 1 week after vaccination
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460590
|University Cape Town|
|Cape Town, South Africa, 7925|
|Principal Investigator:||Greg Hussey, Professor||University Cape Town|