The main focus of the Clinical Program is to conduct clinical trials that substantially contribute to the development of an effective HIV vaccine for populations in Africa and beyond. This program will initially evaluate existing vaccine candidates developed by European and US collaborators to test the clinical and laboratory infrastructure in the participating African countries. Two protocols (Brilliant-001 and Brilliant-002) are already in the planning phase, with the aim to implement these trials within the Brilliant Consortium over the first two years of the award.
To achieve this ambitious goal, a strong collaborative effort is needed between clinical and laboratory investigators, HCRISA and BioInformatiCo. This includes clinic and laboratory site assessments across partner institutions, investigational product readiness, building of a robust database with the help of BioInformatiCo, quality safety assessment procedures, and relevant endpoint definitions for immunogenicity studies. In collaboration with the Community Program, a vital part of clinical trial implementation will be the engagement of communities affected by HIV.
The core goal of BRILLIANT is to develop HIV vaccine immunogens derived from the African continent in Africa. From the onset of the award, the Clinical Program is supporting the Laboratory and Vaccine Design Program with this effort. The program will also start planning early for trials with these African immunogens, so that they can start in Year 3,4 and 5 of the award.
The Clinical Program aims to strengthen the clinical and laboratory infrastructure among Consortium member institutions. While Brilliant-001 and Brilliant-002 may take place in 3 or 4 countries, the aim is to expand to other countries and institutions in the Consortium from Year 3. The Clinical Program will work closely with the Capacity Augmentation Program to ensure adequate clinical trial experience so that all Consortium members are ready to effectively participate in the Clinical Program by Year 3 of the award.
There is extensive existing capacity across the BRILLIANT laboratories and their partners for measuring immunogenicity to vaccines, including accredited end-point laboratories for major clinical trial groups that routinely generate high quality B-cell, T-cell, virus sequencing and genetic data. We will leverage existing capabilities for assessing vaccine immunogenicity to support immunogenicity assessments for the clinical trials conducted by the BRILLIANT Consortium. We aim to extend these protocols, assays, and skills to less experienced laboratories within the Consortium. We will perform a comprehensive laboratory audit to identify and enhance capacity for sample processing, specimen storage and shipment, humoral/B cell assays and T cell assays, working towards a model of regional centers of excellence. We will leverage existing candidates to develop and test HIV vaccine immunogens at the preclinical stage, increase capacity to develop mRNA vaccine candidates and SOSIP trimers for preclinical evaluation, and perform basic science studies to support immunogen design. In addition, in collaboration with the capacity augmentation program, a training plan for early career scientists at BRILLIANT sites will be developed, and relevant virtual state of the field teach-ins/journal clubs plus a grant-writing workshop will be conducted.
This activity will, by extension, grow capacity in sub-Saharan Africa (SSA) and create a strong foundation for collaboration to increase opportunities to advance the careers of promising SSA scientists in HIV vaccine research. Since there is existing variable capability across African sites within the BRILLIANT network, we will look to strengthen capabilities based on needs of different sites for the implementation of identified BRILLIANT activities, including leveraging on established North-South and South-South relationships to increase opportunities to establish platforms for collaboration and for technology transfer. Regular revisions of activities will be done as site needs may evolve during the implementation of BRILLIANT.
Ultimately through the envisioned capacity utilization and augmentation approach, BRILLIANT scientists and institutions will be well positioned in HIV vaccines research, design, and innovations with a goal of achieving an African-led efficacious and safe HIV vaccine.
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