Vigilantibody
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Following up to affirm two things:
Actoverco's data were informative about (positive) safety and immunogenic response in RaDVaC's Gen 8+9 designs. These data aren't immediately straightforward (antibody response was greater in immunologically "primed" individuals than in immunologically naive individuals), but really informative along the line of antigen selection, presentation, and dosing.
We (writ large) need vaccines that can be deployed rapidly and are focused on that rapid accessibility. There's no question that safe & effective vaccines can be made. The question for us is how to make safe & effective vaccines rapidly & simply enough to be widely accessible. Our approach has been to create and share designs openly, that can be (re)produced, adapted, tested, and studied without restriction. We couldn't do every stage of development in our own lab, so we invited others to use their expertise to contribute. Several have and still are, but I agree that it's time for us at RaDVaC to invest more (and more directly) in producing data that we can guarantee be shared openly.
Starting with early generations of RaDVaC vaccine designs, some of our core group engaged in self-experimentation to assess safety, as well as testing of some immuno-efficacy biomarkers. Four of us took a series of blood, saliva, & nasal wash samples over several months to determine antibody response in each. A few others also donated samples, which we also tested. We performed early antibody ELISA testing in our lab with custom tests. In parallel with our own testing efforts, we also established collaborations with academic researchers to perform antibody testing and neutralization assays on our samples, and we connected with colleagues in industry to perform T cell testing of various kinds.
In our lab,... (read 448 more words →)
We're working with outside people and groups to create appropriate trialing models and protocols, including a focus on challenge trials. We're looking to hire at least 2 consultants for the process (medical writing, trial design experts) and at least 2 onsite medical staff with fluency in the regulatory & logistics context of wherever a trial is to be run. (Depending upon location, we may also need an IRB's services to review and approve any trial design; definitely necessary for anything done within the US). One of the groups we are working with, 1DaySooner, has already created and published trial designs, and our trial design will be different but informed by the excellent foundation they've provided. We estimate that this preparatory phase will cost $500k-$1M.
An order-of-magnitude estimate for the full cost of a completed trial would depend on scale and location, but the cost for a relatively small but sufficiently powered trial in our current focus location of the Bahamas is in the $10M range.
Hi all, this is Alex and Preston from RaDVaC. Thank you Eliezer for your thoughtful words of support. And thank you again Jacob L, your ongoing support is very much appreciated. We're also thrilled about receiving an ACX grant; not only is the money enabling, but the added recognition has already been extremely positive, and we have received additional donations following the award announcement. As Eliezer noted, we still don’t have all the funding we need to accelerate badly needed change in vaccine access and independence, but we do have funds to make great progress this year in ongoing projects.
One key goal is to establish an iterative cycle of vaccine improvement and... (read more)
This is correct. RaDVaC is not committed exclusively to a single technology platform; we evaluated (and continuously re-evaluate) the advantages and disadvantages of vaccine platforms like VLP, subunit, peptide, DNA, and mRNA.
All our designs so far have been based on self-assembling nanoparticles transporting peptide antigens, because all materials for both nanoparticle and peptide antigens are highly accessible: readily available, relatively inexpensive, individually safe (not requiring any advanced biosafety conditions for shipping, storage, or use), and quick to source. This design is also very easily produced.
That basic nanoparticle platform (which we've open-sourced, along with our peptide designs) is adaptable to other antigens, such as larger recombinant subunits, which we are working on now,... (read more)