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| Sponsor: | University of Oxford |
|---|---|
| Collaborator: |
University of Cape Town |
| Information provided by: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT00480558 |
Purpose
This study is designed to evaluate the safety of MVA85A in asymptomatic volunteers in South Africa who are infected with M.tb, HIV or both. A single vaccination with MVA85A, when administered at a dose of 5 x 107pfu intradermally, is safe and highly immunogenic in mycobacterially naïve individuals, BCG vaccinated individuals and M.tb latently infected individuals. We will use the same vaccination regime in this study. Participants will be defined as being infected with M.tb.if they have a positive Elispot response to ESAT6 or CFP10. Participants will be defined as being infected with HIV.if they have a positive HIV rapid test (Determine®, Abbott Laboratories) followed by a positive HIV ELISA result. Participants will be identified from the general population living in Worcester, Western Cape, South Africa
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections TB |
Biological: MVA 85A |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Asymptomatic Volunteers Who Are Infected With Either Mycobacterium Tuberculosis (M.tb.), Human Immunodeficiency Virus (HIV) or Both |
| Estimated Enrollment: | 48 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Group 1: M. tb
|
Biological: MVA 85A
Modified vaccinia Ankara virus expressing antigen 85A from M. tuberculosis. Dose is 5x10^7
|
|
2: Active Comparator
Group 2: HIV (not on antiretrovirals [ARV])
|
Biological: MVA 85A
Modified vaccinia Ankara virus expressing antigen 85A from M. tuberculosis. Dose is 5x10^7
|
|
3: Active Comparator
Group 3: M. tb and HIV (not on ARV)
|
Biological: MVA 85A
Modified vaccinia Ankara virus expressing antigen 85A from M. tuberculosis. Dose is 5x10^7
|
|
4: Active Comparator
Group 4: M. tb and HIV (on ARV)
|
Biological: MVA 85A
Modified vaccinia Ankara virus expressing antigen 85A from M. tuberculosis. Dose is 5x10^7
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For all groups:
For the M.Tb infected- and M.Tb/HIV coinfected- groups:
• Screening Elispot positive (more than 50 spots/million PBMC): for either the pool of ESAT6 peptides and/or the pool of CFP10 peptides and screening Elispot positive for PPD.
• Positive Mantoux test. (>10mm induration)
For the HIV infected and M.Tb/HIV coinfected groups:
Exclusion Criteria:
For all groups:
For the M.Tb infected group (but not the HIV infected and M.Tb/HIV coinfected groups):
For the HIV infected and M.Tb/HIV coinfected groups (but not the M.Tb infected/HIV uninfected group)
Contacts and Locations
More Information
| Responsible Party: | University of Oxford ( Dr Helen McShane ) |
| Study ID Numbers: | TB011 |
| Study First Received: | May 30, 2007 |
| Last Updated: | February 8, 2010 |
| ClinicalTrials.gov Identifier: | NCT00480558 History of Changes |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
HIV MVA85A TB Tuberculosis Human Immunodeficiency Virus |
Safety Immunogenicity Efficacy Treatment Naive |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |