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Complete and Current Phase I Trials

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

J Infect Dis. 2008

Eur J Immunol. 2010

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