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 AsWellcome 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 AsWellcome 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 |
SATVI Worcester Site Office:
SATVI Project Office, University of Cape Town, Brewelskloof Hospital, Haarlem Street, WORCESTER, 6850.
Tel: +27 23 346 5400
Fax: +27 23 346 5406
Email: Field Site Manager
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Map to Worcester Field Office