Vaccine Trials
Early Risk Assessment in TB contacts by new diagnostic tests (ERASE-TB)
Principal Investigators: Katherina Kranzer and Norbert Heinrich
Site Principal Investigator: Dr. Theodora Mbunda
Other Investigators: Dr. Nyanda Elias Ntinginya, Dr. Issa Sabi, Dr. Christina Manyama, Dr. Alfred Mfinanga, Dr. Harieth Mwambola
Research Centre: NIMR -MMRC, Mbeya Tanzania.
Study Duration: 2020-2024
Background / Purpose
The ERASE-TB study is being conducted to fill a critical unmet need for tuberculosis (TB) control. People who encounter an infectious TB case may become infected, and, among those who are do, most will stay healthy. However, some will go on to develop TB and such people would benefit from preventive treatment which would also inhibit the spread of the disease.
Delayed diagnoses hampers tuberculosis (TB) control: globally, over four million TB cases remain undiagnosed each year. Bacterial burden and infectiousness are high, and lung damage is extensive in patients experiencing diagnostic delays.
The aim of this prospective multi-centre cohort study among household contacts (HHC), exposed to smear positive, infectious tuberculosis (TB) index cases is to evaluate new diagnostic tests and algorithms to diagnose TB before transmission occurs, earlier than current diagnostic approaches and to identify those most at risk for developing TB to allow targeted preventive treatment.
Clearly, earlier diagnosis is a prerequisite for successful TB control and ideally, individuals need to be diagnosed while TB is still incipient before becoming infectious. Preventive treatment of incipient TB could prevent long term morbidity, mortality, and onward transmission.
Approach
ERASE-TB will conduct a clinical cohort study among 2100 adolescent and adult household contacts (HHCs) exposed to smear positive, infectious TB in three HIV and TB high-burden Sub-Saharan African countries (Mozambique, Tanzania and Zimbabwe) to generate performance data on a number of new diagnostic assays, sampling strategies and testing algorithms to diagnose sub-clinical TB and accurately predict progression to disease with the aim of WHO endorsement and rapid in-country uptake and roll-out.
Funders
ERASE-TB is an EDCTP project funded by the European Commission under Grant Agreement no. RIA2018D32508.
ERASE-TB Partners:
- Medical Centre of the University of Munich (LMU)
- London School of Hygiene & Tropical Medicine (LSHTM)
- Biomedical Research and Training Institute (BRTI) Zimbabwe
- National Institute for Medical Research (NIMR) Tanzania
- Instituto Nacional de Saude (INS) Mozambique
- Dept. of Clinical Science & Education, Karolinska Institute
Website: https://www.erase-tb.co.uk
Twitter: @EraseTb
HVTN 111
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,
Enrollment Opened
Objectives
-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.
Trial design
Multicenter, randomized, controlled, double-blind trial conducted in six sites in Southern African countries.
Funder/Sponsor
NIH/DAIDS HVTN
ALISA (ANRS 12221)
“A multicentre phase III trial of second-line antiretroviral treatment strategies in African adults (Tanzania and South Africa): The ALISA Trial”
Purpose
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.
Team
Issakwisa Mwakyula (Principal Investigator), Tessa Lennemann, Arne Kroidl (Clinical Research Coordinator)
RV 262
“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”.
Purpose
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.
Team
Leonard Maboko (Principal Investigator), Arne Kroidl, Philip Mann, Bahati Kaluwa (Clinical Research Coordinator)
TaMoVaC I
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.
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.
Team
Leonard Maboko (Principal Investigator), Arne Kroidl, Bahati Kaluwa, Philip Mann (Clinical Research Coordinator)
