Studies of the SARS-CoV-2 Spike Protein

NIH Pandemic-Era Grants

Pandemic Era Grants

2022

Document text

Principal Investigator: JAY A BERZOFSKY
Organization: DIVISION OF BASIC SCIENCES - NCI
Fiscal Year: 2022
Award: $1,200,057
Funding agency: National Cancer Institute

In vitro studies in macaque bronchioalveolar lavage cells: We found some effects in      vitro on these cells of stimulating them with recombinant spike protein to affect expression      of ACE2 and of interferons, that may play a role in infection. Little effect was seen on other      cytokine or chemokine production. We recently published that S1 protein acts on macaque lung      bronchoalveolar lavage cells to downregulate expression of the ACE2 receptor and also inhibit      type I interferon production. Type I interferons have been shown to be essential for      protection against SARS-CoV-2, and ACE2, besides being a receptor for spike protein, also      protects the lung against respiratory viruses by cleaving angiotensin II, so downregulating      these could worsen COVID-19. In vivo vaccine studies in macaques: Rhesus macaques have been      primed IM with spike in different adjuvants and boosted systemically with spike in alum or      mucosally intranasally with spike in nanoparticles with IL-15 and TLR ligand adjuvants. We      have found and published that nanoparticles containing S1 spike protein delivered intranasally      can boost macaques primed IM with S1 in alum and result in better protection against      respiratory challenge with SARS-CoV-2 than can the IM vaccine alone even though the S1-binding      and neutralizing antibody levels are lower. Other mechanisms must play a role and we have      found correlations with mucosal IgA, dimeric IgA, and type I interferon production in the      lung, and certain types of myeloid cells. We then tested a mucosal nanoparticle boost with the      B1.351 (South African) variant S1 protein to protect against this SARS-CoV-2 variant in      macaques. The beta variant was the most difficult to neutralize before the appearance of the      omicron variant, which had not been identified at the time. The beta variant mucosal      nanoparticle vaccine, given 1 full year after the animals had last been boosted systemically      or mucosally with the original Wuhan strain, induced a 3-log increase in both IgG binding      antibody in both the serum and bronchoalveolar lavage fluid (BAL, representing response in the      lung). Further, it boosted the titer to the original Wuhan strain as much as to the beta      variant. Neutralizing antibody titers were also similar against both virus variants. IgA and      dimeric IgA to both strains were also increased. This suggests a role for original antigenic      sin in determining the fine specificity of antibodies at the time of first primary      vaccination. When challenged, the animals were well protected against intranasal challenge      with the beta variant SARS-CoV-2. Thus, a variant intranasal vaccine can induce strong      protective immunity in the lungs and nasal cavity and eliminate virus from these sites. These      studies suggest that a human intranasal nanoparticle COVID-19 vaccine given to people who had      been previously immunized systemically with one of the approved vaccines, could improve      protection against infection and reduce the risk of forward transmission to others by reducing      intranasal virus, which is especially a problem with the new delta and omicron variants This      second NHP study was also published. In addition, two more studies were carried out in a      hamster model, as hamsters get COVID disease more like humans. The intranasal vaccine was able      to markedly reduce weight loss in the immunized animals compared to controls. In vivo studies      in mice: ACE2-transgenic mice have been purchased despite delays, and are being bred. In wild      type B6 mice, we have immunized with recombinant spike protein S1, S1+S2, or RBD in several      different adjuvants to determine the best formulation. The best combination so far is S1      antigen with IL-15 + ligands for TLR3 and 9, for both antibody and T cell responses. Studies      are in progress to determine which components contribute the most to protection. The DNA      vaccine with spike protein coupled to a chemokine has been constructed and initial results      show that it can induce a strong CD8 T cell response. Human cell lines: We have received the      immortalized human lung epithelial cell lines, which express ACE2, from John Minna at UTSW, as      well as some of his non-small-cell lung cancer cell lines that also express ACE2. We have      obtained an antibody to ACE2 to verify expression. Initial results show that omega-3 fatty      acids and cholesterol differentially affect ACE2 expression on lung cancer cells as well as      TMPRSS2 expression and may help explain how diet and obesity as well as lung cancer can affect      susceptibility to SARS-CoV-2.

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