A phase 1 clinical trial to evaluate the safety and immunogenicity of HIV clade C DNA and of MF59-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants,
-To evaluate safety and tolerability of clade C DNA and bivalent gp120 protein and MF59 adjuvant in each vaccine regimen.
-To evaluate immune responses of clade C DNA and bivalent gp120 protein and MF59 adjuvant in each vaccine regimen.
Multicenter, randomized, controlled, double-blind trial conducted in six sites in Southern African countries.
ALISA (ANRS 12221)
“A multicentre phase III trial of second-line antiretroviral treatment strategies in African adults (Tanzania and South Africa): The ALISA Trial”
The ALISA Trial is a second line antiretroviral treatment study
The ALISA trial is a phase III , multicentre, non-inferiority, randomized, non-blinded second line antiretroviral treatment study evaluating the virological response (plasma HIV RNA<50 copies/ml) at 48 weeks of two antiretroviral treatment regimens in HIV-1-infected patients with treatment failure after first line antiretroviral therapy.
The primary objective is to demonstrate the non-inferiority of a generic Lamivudine-Tenofovir-Atazanavir/Ritonavir regimen as compared to a standard Emtricitabine-Eenofovir-Lopinavir/Ritonavir regimen after failing first line antiretroviral treatment including a non nucleoside reverse transcriptase inhibitor at 48 weeks.
Overall 386 HIV infected patients on failing first line antiretroviral therapy defined as confirmed virological failure >1000 copies/ml will be 1:1 randomized into one of the treatment arms.
The Mbeya Referral Hospital (MRH) supported by MMRC will participate in the trial enrolling 193 participants. The trial is expected to provide capacity building for the MRH clinics and laboratories as well as for the Tanzanian Southern Highlands HIV Programme in terms of HIV viral load monitoring and genotypic resistance testing. The trial is expected to start in August 2011.
Issakwisa Mwakyula (Principal Investigator), Tessa Lennemann, Arne Kroidl (Clinical Research Coordinator)
“A Phase I Study of the Safety and Immunogenicity of PENNVAX™-G DNA (Env & Gag) Administered by Intramuscular Biojector® 2000 or by CELLECTRA® Intramuscular Electroporation Device Followed by MVA-CMDR (HIV-1 CM235 env/ CM240 gag/pol) Boost in Healthy, HIV Uninfected Adults”.
RV262 is a phase I HIV vaccine trial to evaluate the safety and tolerability of the DNA vaccine candidates administered either by IM Biojector® 2000 injection or IM CELLECTRA® Electroporation followed by an IM MVA vector boost in healthy HIV-uninfected adult participants. The secondary objective is to evaluate the ability of the DNA/MVA prime/boost strategy to induce HIV antigen specific cellular and humoral immune responses.
Leonard Maboko (Principal Investigator), Arne Kroidl, Philip Mann, Bahati Kaluwa (Clinical Research Coordinator)
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.”
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.
The change in CSFP was -46% ± 14 Full Article Blood pressure monitoring in short-term (<3 months) controlled trials showed no clinically significant The change in CSFP was -46% ± 14.
Leonard Maboko (Principal Investigator), Arne Kroidl, Bahati Kaluwa, Philip Mann (Clinical Research Coordinator)
“A phase I/II clinical trial to evaluate the safety and immunogenicity of a multiclade HIV-1 DNA plasmid vaccine boosted by a multiclade HIV-1 recombinant adenovirus-5 vector vaccine in HIV uninfected adult volunteers in East Africa”
The objectives of the study were to evaluate the safety and immunogenicity of a multiclade A, B and C HIV DNA prime (VRC-HIVDNA016-00-VP) boosted with a multiclade A, B and C recombinant Adenovirus type 5 vector (VRC-HIVADV014-00-VP). The vaccine was provided by the NIH Vaccine Research Center (VRC) consisting of a multiclade A, B and C HIV DNA prime (VRC-HIVDNA016-00-VP) boosted with a multiclade A, B and C recombinant Adenovirus type 5 vector (VRC-HIVADV014-00-VP).
Team: Leonard Maboko (Principal Investigator), Mirjam Schunk, Arne Kroidl (Clinical Research Coordinator)