Complete and Current Phase I Trials
| Protocol | Title | Principal Investigator | Study Coordinator | Funder |
| MTBVAC | A randomized, double-blind, dose-escalation clinical trial of the safety, reactogenicity and immunogenicity of MTBVAC compared to BCG Vaccine SSI, in newborns living in a tuberculosis endemic region with a safety arm in adults | Michele Tameris | Y Gregg | Biofabri |
|
Protocol Number |
Title | Principal Investigator | Funder & Sponsor | Publications | |
|
IDRI-TBVPX-114 (ID 93) |
A Phase Ib Randomized, Double-blind, Placebo-controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the ID93+GLA-SE vaccine in BCG-vaccinated Healthy Adults.
|
Dr Michele Tameris | Partners: AERAS Global TB Vaccine Foundation, IDRI | ||
| Protocol 008 (MVA 85 A) | 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.
|
Prof Greg Hussey Co-PI: Prof Helen McShane | Partners: Oxford University, Wellcome Trust | ||
| Vaccine Protocol 011 (MVA 85A) | A Phase I study evaluating the safety and immunogenicity of a new TB vaccine, MVA85A, in asymptomatic volunteers who ar e infected with either Mycobacterium tuberculosis (M.tb.), Human Immunodeficiency Virus (HIV) or both.
|
Prof Greg Hussey | Frances Ratangee | Partners: Oxford University, EuropAID, Wellcome Trust. | |
|
Vaccine Protocol 003 (AERAS 402) |
Phase I Double-Blind, Randomized, Placebo Controlled, Dose Escalation Study to Evaluate Safety and Immunogenicity of AERAS-402 in HIV-negative, BCG- Vaccinated Males and Females in South Africa Without Evidence of Tuberculosis.
|
Prof Greg Hussey | Partner: AERAS Global TB Vaccine Foundation | Am J Respir Crit Care Med. 2010 | |
|
Vaccine Protocol 018 (AERAS 402 ) |
Phase I Double-blind Randomized Controlled Dose Escalation Study to Evaluate Safety and Immunogenicity of AERAS-402 in BCG vaccinated, HIV-negative Infants at Least 6 Months of Age without Evidence of Tuberculosis.
|
Dr Michele Tameris | Partner: AERAS Global TB Vaccine Foundation | ||
|
C-011-404 (AERAS-404 ) |
A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS‑404 When Administered as a Single Adjuvant Amount with Different Antigen Amounts in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection.
|
Dr Hassan Mahomed | Partner: AERAS Global TB Vaccine Foundation | ||
|
C-032-456 (AERAS- 456) |
A phase I, open label, dose-escalation study to evaluate the safety and immunogenicity of H56:IC31 (AERAS-456) in HIV-negative adults with and without latent tuberculosis infection. | Dr Angelique Luabeya | B Pienaar | AERAS |
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