Results from a Phase I CORAL-BOOST and CORAL-CEPI trial under biotechnology company Gritstone Bio shows their self-amplifying mRNA (samRNA) vaccine can induce a safe, strong, and durable immune response against COVID-19.
BioSpace reports that although the data was preliminary, it could provide the needed technology to fill the unmet needs in the COVID battle.
The trial consisted of three dose levels in CORAL-CEPI, all of which were found to be immunogenic. A spokesperson for Gritstone said their primary goals consisted of “evaluating our self-amplifying mRNA candidates for potential application against COVID, and providing clinical proof-of-concept for the use of the samRNA platform and other infectious diseases.”
The 340 participants in the CORAL-CEPI studies had never been immunized for COVID and are all HIV-positive. The Phase I study is taking place in South Africa, and the initial data comes from the first 120 participants.
The spokesperson added, “By including immunocompromised patients in our trial, including people living with HIV, we are able to evaluate whether our vaccine candidates, which are designed to drive both neutralizing antibodies and T cells utilizing self-amplifying mRNA, could provide better immune protection than the current vaccines for this at-risk population.”
The CORAL-BOOST, on the other hand, is looking at 32 volunteers aged 60 or older who aren't living with HIV.
Both CORAL-CEPI and CORAL-BOOST were found to be safe and well-tolerated, with only mild-to-moderate adverse events that resolved.
Gritstone also has a pre-clinical collaboration in process with the Bill & Melinda Gates Foundation. That trial will evaluate samRNA against HPV for a therapeutic vaccine.