A Phase I/II trial to assess safety and immunogenicity of intradermal (ID) DNA priming, intramuscular (IM) MVA and IM rgp140/GLA-AF boosting in healthy volunteers in Tanzania and to develop further HIV vaccine trial capacity building in Tanzania.
The aim of the Tamovac I trial was to further explore the optimal method for delivery of HIV-1 DNA priming.
What was this study about?
HIV is a significant health problem globally, but especially in developing countries. Efforts towards a safe, affordable and efficacious vaccine have seen the development of partnerships between the North and South in the search for an HIV vaccine.
The primary objectives of this study were:
-to determine the safety and immunogenicity of vaccination with HIVIS-DNA at 2 doses delivered ID and boosted with proteins MVA-CMDR and rgp140/GLA-AF.
The secondary objectives were:
-to compare the immunogenicity of HIVIS-DNA at a dose of 600 µg given as combined plasmid pools or separate plasmid pools ID.
-to explore the safety and immunogenicity of boosting with two doses of rgp140 in the adjuvant GLA-AF, administered IM.
-to build and sustain expertise and the capacity to conduct HIV vaccine trials in Tanzania.
What difference did this study make?
This study established that a simplified administration combining HIV-DNA plasmids at a lower dose primed as efficiently as the higher dose of separate HIV-DNA plasmids.
We went on to boost 35 volunteers who had received the DNA and MVA vaccines with the CN54gp140 protein vaccine studied in MucoVacc and UK HIV 003 trials and observed significant boosting of the immune responses.
Type of study
Who funded the study?
European and Developing Countries Clinical Trials Partnership Programme.
When did it take place?
04 March 2008 to 31 December 2012
Where did it take place?
Dar es Salaam and Mbeya, Tanzania.
Who was included?
120 healthy volunteers (a minimum of 30 women) aged 18-40, resident in Dar es Salaam or Mbeya, Tanzania; at low risk from HIV infection.