The capacities of the BRILLIANT Consortium partners are described briefly below.
The SAMRC is the prime of the consortium. It has successfully sponsored and conducted large international programs and trials, including in Southern and East Africa. The SAMRC has funded HIV vaccine development and sponsored vaccine trials. It has convening ability, strong biostatistical and data management expertise, funds capacity development in vaccine R&D, sub-contracts and supports financial good governance, collaborates in bilateral arrangements, has experience as an investigational new drug holder, sponsors clinical research, experience in management of clinical trial consortia, experience in designing phase 1 FIH studies, and experience with regulators. It supports a non-human primate (NHP) facility that does preclinical studies.
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The SAMRC/Wits/NICD Antibody Immunity Research Unit has a strong track record in HIV vaccine research, as evidenced by seminal studies isolating and defining the ontogeny of bnAbs in PLWH. AIRU is accredited for endpoint assays in the HVTN, performs deep immunological assessments using innovative research assays, and has made major contributions towards defining vaccine correlates of protection. Available platforms for assessing vaccine immunogenicity include i) Serum binding Abs ii) Serum neutralization iii) Measurement of serum Fc effector responses iv) Delineating the ontogeny of HIV-directed B-cell responses v) Isolation and characterization of monoclonal antibodies.
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The Makerere University Walter Reed Project has experience conducting HIV clinical trials and epidemiological studies. It has an extensive biorepository with various biospecimens (including mucosal, lymph node biopsies, PBMCs, cerebral spinal fluid, etc.) from previous and on-going studies and cohorts e.g., AFRICOS. The research infrastructure includes well-equipped clinics, CAP accredited BSL-2 lab with biorepository and liquid nitrogen (LN) production plants, and research sites with access to study populations from both higher and lower HIV risk communities. Its community and research engagement includes advocacy groups, research and academic institutions, and vaccine interest groups.
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Desmond Tutu Health Foundation is an internationally vetted research NGO affiliated to the Infectious Disease and Molecular Medicine Institute (IDM) at the University of Cape Town (UCT). It has multiple unique clinical trial sites in a variety of communities in Western and Eastern Cape provinces and has conducted clinical research into HIV, TB and other infectious diseases since 1995. It has strong links to virology, immunology and pathogenesis laboratories, and expertise and infrastructure to conduct FIH, phase 1-4, pharmacokinetic trials, behavioral and translational research in an iterative bench-to-bedside manner. It conducts invasive sampling, including bronchial lavage, mucosal and lymph node biopsy, leukapheresis and spinal fluid sampling and has robust experience in ethical, regulatory, community engagement and training and capacity enhancing capabilities.
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JCRC is an international center of excellence with experience in Platform trials and FIH vaccines including the first phase 1 trials in HIV prevention and therapeutic vaccine trials in SSA, CD8 T-cell and ELISPOT assays for immunogenicity trials and infrastructure for gene therapy for HIV cure trials. Their CAP Certified Laboratories have 2 BSL-3 labs and NGS molecular sequencing capabilities now supporting the national ART program with HIV drug resistance testing. JCRC is collaborating with UMC for capacity building and technology transfer for trimer vaccine development, germline targeting strategies and bnAb discovery e.g., EAVI2020, GT1.1 germline targeting vaccine, being developed into mRNA and self-replicating RNA with JCRC being a recipient for this tech transfer.
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African Alliance plays a lead and convening role of civil society and community groups across all Consortium countries. A Queer-led, Pan-African NGO with teams in South Africa, Zambia, Kenya and Zimbabwe, the AA will ensure that community-led organizations and engagement approaches in all consortium countries are meaningful, grounded in the local context and will leave no one behind. Conducting multi-sectoral vaccine confidence interventions currently in Burundi, Zambia, Malawi, Democratic Republic of Congo and Rwanda, AA has a long track record of centering communities in clinical research. AA is the African home of the Peoples Vaccine Alliance, with representation from all of Africa’s 5 regions and providing subgrants to partners across the continent. AA also runs a pan-African fellowship, offered to 10 African fellows (2 from each region) to advance the decolonisation of R&D of medical products.
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CAPRISA is an internationally renowned research organization with extensive clinical trial experience and infrastructure. CAPRISA conducts immunology and virology core research, houses a specialist mucosal immunology laboratory and has its own biostatistics and bioinformatics unit. CAPRISA has been at the forefront of isolating bnAbs. They have experience in product development for HIV prevention including the tenofovir gel (CAPRISA004 trial), CAP256V2LS bnAb (CAPRISA012 studies), and tenofovir alafenamide implant (CAPRISA018 study) in Africa. In collaboration with NICD/Wits, the team is preparing the launch of HIV immunogen studies. CAPRISA has world class science leadership and trainee programs with strong national and international collaborations.
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Institute of Human Virology (Nigeria) has been an HIV research and program implementation partner in Nigeria since 2004. It has experience and access to well characterized HIV cohorts in Nigeria including sex workers, MSM, birth cohorts, discordant couples. IHVN has well equipped laboratories for molecular and immunological assays with an NIH funded biorepository for the West African region with capacity for cryopreserved viable cells. It houses a clinical trial unit and has implementation science expertise to translate research findings.
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Centre for Infectious Disease Research in Zambia is a Division of AIDS (DAIDS) approved multisite Clinical Trials Unit with experience in conducting vaccine and therapeutic trials for HIV, TB and other infectious diseases including diarrheal diseases. It has experience in conducting trials across all ages including infants. It established a first paediatric Human Challenge Model for rotavirus vaccine evaluations and has well established facilities and staff, including the International Organization for Standardization (ISO) and DAIDS accredited laboratory with biorepository facility, data management with experience in iMedidata, iData-fax, e-Clinical, Interactive web response systems and InForm Data base. It has prior experience in conducting phase 1-3 trials.
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Polana Canico Health Research and Training Center is a research center with experience in conducting HIV and TB clinical trials and epidemiological studies and surveillance. The center has capabilities to conduct early and late stage vaccine clinical trials, working with different sponsors and local regulators, data management expertise, DAIDS compliant pharmacy, laboratory facilities and experienced staff to perform safety, immunologic, virologic and genomic sequencing testing, including a P3 laboratory. There is a well-established community engagement unit as well as a CAB and stakeholder engagement with a high level of working with trial participants.
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National Institute for Medical Research - Mbeya Medical Research Programme is experienced at conducting HIV and TB phase 1-3 trials including among high-risk cohorts. This is a DAIDS/NIH approved site and pharmacy with a CAP accredited laboratory since 2007. The lab has a capacity for safety analysis and updated infrastructure for T and B-cell immune monitoring. They house a large bio-banking infrastructure with LN tanks, 2 LN plants, and freezers. They have a data management and statistics unit and expertise in clinical trial designs. There is strong community engagement with well experienced staff working with trial participants and advocacy groups.
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HJFMRI - KEMRI/Walter Reed Project, Kericho - Kenya Medical Research Institute/Walter Reed Project Clinical Research Center CRS – ACTG has conducted clinical trials on vaccines and therapeutics, from FIH to phase 4 across all age groups and pregnant women. Its laboratories have been CAP accredited since 2004 and include safety, molecular, micro-bio/mycobacteriology, immunology, and a LN plant-supported biorepository. Additionally, the site has external quality assessment with CAP, UK-NEQAS, virology quality assurance, internal quality assessment and is part of several international research networks. It has helped to mentor and build the capacity of other clinical trial sites in Kenya.
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The T-Cell Research Unit, a contractor at UCT performs cellular immune endpoints for clinical trials and is currently conducting T-cell immunogenicity readouts for six COVID-19 vaccine trials. T-CRU can develop, optimize, and validate cellular immunologic assays for vaccine evaluation, clinical immunology research and capacity building. T-cell readouts include intracellular cytokine staining (ICS) and enzyme linked immunospot (ELISPOT) for rapid characterization of CD4 and CD8 responses in peripheral blood mononuclear cells (PBMC).
The Vaccine Research Group and Biopharming Research Unit at UCT have over 20 years of experience in HIV vaccine development with expertise in DNA, subunit, Spycatcher-based nanoparticles, poxvirus, and Bacille Calmette-Guerin-based vaccine constructs. This group is already exploring novel immunogens based on CAPRISA Envs described above and they have conducted preclinical immunogenicity studies on several such candidates in small animal studies.
The Antiviral Gene Therapy Research Unit at Wits has developed the capacity to design and make mRNA-based vaccines, including self-amplifying RNA. AGTRU is part of a comprehensive vaccine program under the RSA mRNA Technology Transfer Hub.
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The HIV Virus Diversity Group at UCT uses longitudinal PacBio Sequencing of PLWH donors in the CAPRISA cohort to establish the largest longitudinal HIV Env NGS database ever assembled, which is linked to bnAb neutralization data from the Moore lab. This will identify virological traits associated with the development of bnAb breadth to inform immunogen design.
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The School of Chemistry at Wits is developing novel bio-renewable lipid carriers for mRNA vaccine delivery to increase thermostability and reduce cost and reactogenicity.
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BioInformatiCo will design the clinical trial database, provide the clinical trial data management system, safety reports and biostatistical analysis. Data management teams from the consortium will work closely with the safety desk and protocol safety team to generate safety reports. Weekly quality assurance/quality control (QA/QC) reports will be generated including information on data completeness, timeliness, and quality.
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