TaMoVac I: “A Phase I/II trial to assess safety and immunogenicity of ID DNA priming and IM MVA boosting in healthy volunteers in Tanzania and to develop further HIV vaccine trial capacity building in Tanzania.”
Purpose
The TaMoVac I study is following the HIVIS 03 (HIV Vaccine Immunogenicity Study) phase I HIV vaccine trial which was led by the Karolinska Institute in Sweden and which took place at the Muhimbili University of Health and Allied Science (MUHAS) in Dar es Salaam. The trial evaluated the safety and immunogenicity of multiclade (A, B, C) plasmid-DNA priming, heterologous MVA-CMDR (CRF01A_E) boosted vaccine regime comparing clinical and immunological endpoint between IM versus ID delivery of the DNA vaccine candidate.
TaMoVac I is a randomized, controlled, double blinded study enrolling 120 healthy, HIV negative, low risk volunteers from MMRC/Mbeya and MUHAS/Dar es Salaam, Tanzania. The objectives of the TaMoVac I trial are to determine the safety and immunogenicity of the HIVIS-DNA at a dose of 600 µg or 1000 µg delivered ID in combined or separate plasmid pools followed by IM MVA-CMDR boost.
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Team
Leonard Maboko (Principal Investigator), Arne Kroidl, Bahati Kaluwa, Philip Mann (Clinical Research Coordinator)
Approach
Volunteers are randomized into three different DNA dosing groups (600 µg combined plasmid pool, 600 µg separated plasmid pool, 1000 µg separated plasmid pool) in a vaccine/placebo ratio of 9:1.
The HIV-1 DNA encodes the following genes:
1. Pool 1
a. env, from HIV-1 subtypes A, B, C
b. rev, from HIV-1 subtype B
2. Pool 2
a. gag, from HIV-1 subtypes A, B
b. RTmut (enzymatically inactive mutated reverse transcriptase), from HIV-1 subtype B
Boosting is effected by a Modified Vaccinia Ankara vaccine (MVA-CMDR) which is an attenuated recombinant poxvirus vector expressing the following HIV-1 genes:
1. gp150 (Subtype E, CM235)
2. gag and pol (integrase-deleted and reverse transcriptase non functional, Subtype A, CM240).
DNA priming is performed at weeks 0, 4 and 12 followed by MVA boosting at weeks 30 and 46. The total follow-up period is 84 weeks.
Study Status
Study enrolment in Mbeya started in June 2010 and was closed having enrolled 60 participants in October 2010. MVA vaccinations started in January 2011. The last study visits are expected to be done in December 2011.
Sponsor
The TaMoVac I Trial is funded by the European and Developing Countries Clinical Trials Partnership Programme (EDCTP). The Muhimbili University of Health and Allied Science (MUHAS) act as the Sponsor in collaboration with the Swedish Institute for Infectious Disease Control (SMI)
Partners
- Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania
- NIMR-Mbeya Medical Research Center (MMRC), Mbeya, Tanzania
- National Institute for Medical Research (NIMR), Tanzania
- Central Hospital, Maputo, Mozambique
- Instituto Nacional de Saude (NIH), Mozambique
- Karolinska Institute (KI), Stockholm, Sweden
- Swedish Institute for Infectious Disease Control (SMI), Solna, Sweden
- University of Munich, Munich, Germany
- Imperial College of Science, Technology & Medicine, London, UK
- Medical Research Council Clinical Trial Unit (MRC CTU), London, UK
- Walter Reed Army Institute of Research (WRAIR), U.S. Military HIV Research Program (MHRP), Rockville, USA
The LMU Department of Infectious Diseases and Tropical Medicine participate in this trial providing study coordination, data base development and data management as well as management of the laboratory and immunology services. Logistical support is provided through the Munich office within the NIMR-MMRC collaboration.
