Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460590
Status:
COMPLETED
Last Update Posted:
2008-08-07
First Post:
2007-04-13
Brief Title:
Safety and Immunogenicity of MVA85A in Healthy Volunteers in Cape Town
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 Mtb
Sample size
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
1 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
2 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
Sample size
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
1 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
2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None