Recombinant Fc-fusion vaccine of RBD induced protection against SARS-CoV-2 in non-human primate and mice (preprint)

The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) continues to infect people globally. The increased COVID-19 cases and no licensed vaccines highlight the need to develop safe and effective vaccines against SARS-CoV-2 infection. Multiple vaccines candidates are under pre-clinical or clinical trails with different strengths and weaknesses. Here we developed a pilot scale production of a recombinant subunit vaccine (RBD-Fc Vacc) with the Receptor Binding Domain of SARS-CoV-2 S protein fused with the Fc domain of human IgG1. RBD-Fc Vacc induced SARS-CoV-2 specific neutralizing antibodies in non-human primates and mice, and the antibodies induced in macaca fascicularis neutralized three divergent SARS-CoV2 strains, supporting broader neutralizing ability. Three times immunizations protected Macaca fascicularis (20ug or 40ug per dose) and mice (10ug or 20ug per dose) from SARS-CoV-2 infection respectively, including the protection against SARS-CoV-2 adapted virus MASCp6 which contains N501Y mutation, a key residue increasing binding affinity to human and murine ACE2. These data support clinical development of SARS-CoV-2 vaccines and provide a promising strategy to prevent different stains of SARS-CoV-2 infection. RBD-Fc Vacc is currently being assessed in randomized controlled phase 1/II human clinical trails

Recombinant Fc-fusion vaccine of RBD induced protection against SARS-CoV-2 in non-human primate and mice (preprint)

The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) continues to infect people globally. The increased COVID-19 cases and no licensed vaccines highlight the need to develop safe and effective vaccines against SARS-CoV-2 infection. Multiple vaccines candidates are under pre-clinical or clinical trails with different strengths and weaknesses. Here we developed a pilot scale production of a recombinant subunit vaccine (RBD-Fc Vacc) with the Receptor Binding Domain of SARS-CoV-2 S protein fused with the Fc domain of human IgG1. RBD-Fc Vacc induced SARS-CoV-2 specific neutralizing antibodies in non-human primates and human ACE2 transgenic mice. The antibodies induced in macaca fascicularis neutralized three divergent SARS-CoV2 strains, suggesting a broader neutralizing ability. Three times immunizations protected Macaca fascicularis (20ug or 40ug per dose) and mice (10ug or 20ug per dose) from SARS-CoV-2 infection respectively. These data support clinical development of SARS-CoV-2 vaccines for humans. RBD-Fc Vacc is currently being assessed in randomized controlled phase 1/II human clinical trails

Multi-parameter formulation development for an HIV-vaccine protein with direct validation of epitope binding integrity and stoichiometry (preprint)

Vaccines are on the front line-of-defense against infectious diseases, ranging from threats we are familiar with, including polio, tuberculosis, or HIV, to novel and emerging threats such as SARS-CoV-2. Successful development of new protein-based vaccines requires sophisticated and efficient development of storage and formulation conditions. Here we demonstrate the combined power of 2bind's sophisticated buffer matrix FORMOscreen(R) and NanoTemper Technologies' novel Prometheus Panta high-throughput Dynamic Light Scattering/Nano Differential Scanning Fluorimetry instrument. We show that this combination can comprehensively improve critical biophysical parameters for the HIV-1 vaccine BG505-SOSIP and find the optimal formulation condition with unmatched efficiency.