SATVI conducts TB vaccine clinical trials, and other general trials, which ensures the safety and effectiveness of new drugs or vaccines for treating, curing or preventing diseases. Clinical trials are conducted in phases amongst small groups of people in the early Phases (Phases I and II) and amongst larger groups of people once safety has been determined (Phases III and IV).

TB vaccine trials conducted at SATVI, 2001 - current
Protocol No. Population Vaccine(s) 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023
N/A Newborns BCG

Clinicaltrials.gov:

Publications:

 Phase 4. 2001-2004.                                      
TB008 Adults and adolescents without TB infection MVA85A

Clinicaltrials.gov:

Publications:

         Phase 1. 2005-2008.                              
C-003-402 Adults without TB infection Aeras-402

SA National Clinical Trials Register:

  • NHREC no. 1381

Publications:

             Phase 1. 2007-2008.                              
Oxford TB011 Adults with TB infection and/or HIV-infection MVA85A

Clinicaltrials.gov:

Publications:

             Phase 1. 2007-2011.                        
Oxford TB014 Children and infants MVA85A

Clinicaltrials.gov:

Publications:

               Phase 2a. 2008-2009.                            
GSK TB010 Adults with/without TB infection M72/AS01E

Clinicaltrials.gov:

Publications:

               Phase 1. 2008-2009.                            
C-011-404 Adults with/without TB infection H4:IC31

Clinicaltrials.gov:

SA National Clinical Trials Register:

  • DoH 27-1108-2525

Publications:

               Phase 1. 2008-2009.                            
C-018-402 Infants Aeras-402

SA National Clinical Trials Register:

  • DOH-27-0209-2655

Publications:

                 Phase 1. 2009-2010.                          
C-020-485 Infants MVA85A

Clinicaltrials.gov:

Publications:

                 Phase 2b. 2009-2012.                      
GSK TB012 Adolescents with/without TB infection M72/AS01E

Clinicaltrials.gov:

Publications:

               Phase 2a. 2008-2009.                            
TBRU 07-0083 Adults with TB infection BCG

Clinicaltrials.gov:

Publications:

                   Phase 1. 2010-2013.                    
C-029-402 Infants Aeras-402

Clinicaltrials.gov:

Publications:

                     Phase 2a. 2011-2013.                    
C-032-456 Adults with/without TB infection H56:IC31

Clinicaltrials.gov:

Publications:

                     Phase 1. 2011-2012.                      
SSI THYB-04 Adults with/without TB infection H1:IC31

SA National Clinical Trials Register:

  • DoH-27-0612-3947

Pan African Clinical Trial Registry:

  • PACTR201403000464306

Publications:

                       Phase 2a. 2012-2014.                  
C-035-456 Adults with/without TB infection H56:IC31

Clinicaltrials.gov:

Publications:

                       Phase 1. 2012-2015.                
G1100570/1 Newborns MVA85A  BCG 

Clinicaltrials.gov:

Publications:

                       Phase 2a. 2012-2015                
UCT HS645 Newborns BCG

Clinicaltrials.gov:

SA National Clinical Trials Register:

  • DoH 27-1108-2525

Publications:

                       Phase 2a. 2012-2013                    
Aeras C-040-404 Adolescents without TB infection H4:IC31  BCG 

Clinicaltrials.gov:

Publications:

   Phase 1                   Phase 2b. 2014-2017.            
IDRI-TBVPX-114 Adults with/without TB infection ID93+GLA-SE

Clinicaltrials.gov:

Publications:

   Phase 2a                   Phase 2a. 2014-2016.              
IDRI-TBVPX-203 Adults who completed TB treatment ID93+GLA-SE

Clinicaltrials.gov:

   Phase 2b                     Phase 2a. 2015-2017.            
GSK TB018 Adults with TB infection M72/AS01E

Clinicaltrials.gov:

Publications:

   Phase 3                     Phase 2b. 2015-2018.          
VPM1002 Newborns VPM1002

Clinicaltrials.gov:

   Phase 4                   Phase 2a. 2015-2018.      
P1113 Infants H4:IC31

Clinicaltrials.gov:

                             Phase 2a. 2015-2018.          
MTBVAC-201 Newborns MTBVAC

Clinicaltrials.gov:

                               Phase 2a. 2016-2018          
MTBVAC-050 Adults without TB infection MTBVAC

Clinicaltrials.gov:

                                   Phase 2a. 2018-2020      
MTBVAC-202 Newborns MTBVAC

Clinicaltrials.gov:

                                   Phase 2a. 2018-2020.      
H56-POR Adults who completed TB treatment H56:IC31

Clinicaltrials.gov:

                                   Phase 2b. 2018-2021    
VPM1002 priMe Newborns VPM1002

Clinicaltrials.gov:

                                     Phase 3. 2019-2021    
BCG REVAX Adolescents without TB infection BCG

Clinicaltrials.gov:

                                       Phase 2b. 2020-2023  
MESA-TB Adults with HIV-infection M72/AS01E

Clinicaltrials.gov:

                                         Phase 2b. 2021-2023
MTBVAC-203 Newborns MTBVAC

Clinicaltrials.gov:

                                           Phase 4. 2022-2023
31 clinical trials, 9 novel candidates plus BCG    

 

COVID-19 vaccine trials conducted at SATVI, 2020 - current
Protocol No. Population Vaccine(s) 2019 2020 2021 2022 2023
Novavax Adult population with and without HIV. NVX-CoV2373

Clinicaltrials.gov:

Publications:

    
Ensemble (Janssen) Adults 18 and older. Ad26.COV2>S

Clinicaltrials.gov:

bioRxiv:

Publications:

    
Sisonke Open Trial COVID-19 Health workers aged 18 and above Ad26.COV2.S COVID-19 vaccine

Clinicaltrials.gov:

Publications:

    
Sisonke Boost Open Label Study Health workers aged 18 and above Ad26.COV2.S COVID-19 vaccine plus a homologous boostwith Ad26.COV2.S COVID-19 vaccine

Clinicaltrials.gov:

    
2 clinical trials, 2 novel COVID-19 candidates