Search

Home > Research > Clinical Trials > Phase II Trials

Current and Complete Phase II Trials

Current and Complete Phase II Trials

Protocol G1100570-1

(MVA85A)

Phase II Randomised Controlled Trial to Evaluate Safety and Immunogenicity of MVA85A and Selective, Delayed Bacille Calmette-Guerin (BCG)
Vaccination in Infants of HIV Infected Mothers
 

Mark Hatherill

SI: Michele Tameris

D van As

Wellcome Trust

MRC

DFID

Joint Global Health Trials Scheme

Study in Progress.

Thyb-04

(Ag85B-ESAT-6 + IC31®)


A phase II, randomized, observer-blinded, single centre trial evaluating the immunogenicity and safety of 2 doses of an adjuvated TB subunit vaccine (Ag85B-ESAT-6 + IC31®) using 2 different vaccination schedules in healthy adolescents.
  Hennie Geldenhuys Frances Ratangee SSI Study in Progress

C-040-404

(AERAS-404)

A randomized placebo-conrtolled partially blinded Phase II study to evaluate safety, immunogenicity, and Prevention of Infection with Mycobacterium Tuberculosis of AERAS 404 and BCG revaccination in healthy adolescents Mark Hatherill Frances Ratangee AERAS   - See more at: http://mig.satvi.uct.ac.za/phase-ii-trials#sthash.vUqop91d.dpuf

Title Title

Principal

Investigator

Study Coordinator Funder Publication
VPM 1002 Phase II double-blind, randomized, controlled study to evaluate safety and immunogenicity of VPM1002 in comparison with BCG in HIV-exposed and HIV-unexposed, BCG-naive newborn infants. Dr Michele Tameris E Schoeman Serum Institute India  
IMPAACT P1113 / Aeras C-015-404 Phase I/II, safety and Immunogenicity study of a recombinant protein Tuberculosis Vaccine (AERAS-404) in BCG-primed infants. Dr M Tameris R Oelofse AERAS  

Protocol G1100570-1

(MVA85A)

Phase II Randomised Controlled Trial to Evaluate Safety and Immunogenicity of MVA85A and Selective, Delayed Bacille Calmette-Guerin (BCG)
Vaccination in Infants of HIV Infected Mothers

Assoc Prof Mark Hatherill

SI: Dr Michele Tameris

D van As

Wellcome Trust

MRC

DFID

Joint Global Health Trials Scheme

MTB

Thyb-04

(Ag85B-ESAT-6 + IC31®)

A phase II, randomized, observer-blinded, single centre trial evaluating the immunogenicity and safety of 2 doses of an adjuvated TB subunit vaccine (Ag85B-ESAT-6 + IC31®) using 2 different vaccination schedules in healthy adolescents.
 
Dr Hennie Geldenhuys Frances Ratangee   MtC

C-040-404

(AERAS-404)

A randomized placebo-conrtolled partially blinded Phase II study to evaluate safety, immunogenicity, and Prevention of Infection with Mycobacterium Tuberculosis of AERAS 404 and BCG revaccination in healthy adolescents   Assoc Prof Mark Hatherill Frances Ratangee SSI  

DRI-TBVPX-203

(ID 93 + GLA -SE)

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial study to evaluate safety and immunogenicity of the ID93 + GLA-SE Vaccine in HIV uninfected adult TB patients after treatment completion. Assoc Prof Mark Hatherill Cynthia Ontong IDRI  

Protocol G1100570-1

(MVA85A)

Phase II Randomised Controlled Trial to Evaluate Safety and Immunogenicity of MVA85A and Selective, Delayed Bacille Calmette-Guerin (BCG)
Vaccination in Infants of HIV Infected Mothers
 

Mark Hatherill

SI: Michele Tameris

D van As

Wellcome Trust

MRC

DFID

Joint Global Health Trials Scheme

Study in Progress.

Thyb-04

(Ag85B-ESAT-6 + IC31®)


A phase II, randomized, observer-blinded, single centre trial evaluating the immunogenicity and safety of 2 doses of an adjuvated TB subunit vaccine (Ag85B-ESAT-6 + IC31®) using 2 different vaccination schedules in healthy adolescents.
  Hennie Geldenhuys Frances Ratangee SSI Study in Progress

C-040-404

(AERAS-404)

A randomized placebo-conrtolled partially blinded Phase II study to evaluate safety, immunogenicity, and Prevention of Infection with Mycobacterium Tuberculosis of AERAS 404 and BCG revaccination in healthy adolescents Mark Hatherill Frances Ratangee AERAS   - See more at: http://mig.satvi.uct.ac.za/phase-ii-trials#sthash.vUqop91d.dpuf
Study Title Principal Investigator Study Coordinator Funder/Sponsor Publication

AERAS 402 (Aeras 029-402)

 

Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter, Proof-of-concept Study to Evaluate the Safety and Immunogenoicity of AERAS-402 in BCG-vaccinated, HIV-uninfected Infants Without Evidence of Tuberculosis.
 
Assoc Prof Mark Hatherill   AERAS  

MVA 85 A Vaccine Protocol 014
 

A Phase II study evaluating the safety and immunogenicity of a new TB vaccine, MVA85A, in healthy children and infants after BCG vaccination at birth.
 
Prof Greg Hussey Frances Ratangee Partners: Oxford University, Europe Aid  

GSK 72 Vaccine Protocol 010
 

A Phase II, open-label, single-centre study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' candidate tuberculosis vaccine (M72/AS01E) when administered intramuscularly according to a 0, 1 month schedule to healthy adults age.
 
Prof Greg Hussey   Partners: AERAS, Global TB Vaccine Foundation and Glaxo Smith-Kline  
GSK 72 Vaccine Protocol 012   Dr Hennie Geldenhuys   Partners: AERAS, Global TB Vaccine Foundation and Glaxo Smith-Kline.  
Jet Injector A randomized clinical trial in adults and newborns in South Africa to compare the safety and immunogenicity of Bacille Calmette-Guérin (BCG) vaccine administration via a disposable-syringe jet injector to conventional technique with needle and syringe Dr Hennie Geldenhuys M Van Rooyen Path Care Vaccine April 2015