SARS-CoV-2

SARS-CoV-2

Since the beginning of the pandemic, we have believed that a highly mutable spike (S)-only focused, antibody-based vaccine approach that could require boosters approximately every six months would prove insufficient to overcome viral evolution. We hypothesized that T-cell responses would be critical for viral clearance and long-term immunity, thus we focused on a vaccine strategy that would also include the more highly conserved SARS-CoV-2 nucleocapsid (N) protein, known to stimulate T-cell activity. Based on data from a viral challenge study of our S + N vaccine in non-human primates and early clinical trial results – and given the mass adoption of S-only vaccines – we are now assessing S- and N- based vaccines as universal T-cell booster candidates in a set of trials currently underway in South Africa.

COVID 4.015 – THEMBA self-amplifying (sa)RNA Vaccine Boost—South Africa

The THEMBA trials, initiated in South Africa in 2022, are the first clinical studies of our joint venture AAHI-SC series saRNA vaccine technology delivered with next-generation nano-lipid carriers (NLCs). The Phase 1 trial to assess different doses of S- and N-based vaccines as boosters for previously vaccinated and/or infected individuals is ongoing in the first quarter of 2023. The safety, reactogenicity, and immunogenicity of the saRNA-based AAHI-SC vaccines as boosters will be studied in a Phase 1/2 trial. In a planned Phase 2 trial, the AAHI-SC vaccines will be compared to the currently available Janssen, Moderna or Pfizer-BioNTech vaccines.