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. 2022 Jun 30;17(4):491–522. doi: 10.1016/j.ajps.2022.05.003

Table 9.

LNP-entrapped IVT mRNA vaccines for prevention of COVID-19 in clinical trials.

Vaccine Platform Antigen Delivery Platform Preclinical/ Clinical Setting Immune Response Ref
m1Ѱ IVT mRNA (mRNA-1273) S-2P LNP (ionizable lipid:DSPC: cholesterol:PEG-lipid, 50:10:38.5:1.5) Phase I/II/III (NCT04283461/ NCT04405076/ NCT04470427) - Production of high S-2P and RBD-specific and neutralizing antibodies by 100 µg dose, and Th1-biased CD4+ T cell response without major safety concerns
- Confirmation of safety and immunogenicity of 50–100 µg in a 2 dose-regimen in healthy adults aged 18 and older
- 94.1% efficacy at preventing symptomatic COVID-19 including severe disease in individuals at high risk for SARS-CoV-2
[78], [79], [80]
m1Ѱ IVT Mrna (BNT162b1) RBD in trimeric form LNP Phase I/II (NCT04368728/ NCT04380701) - Safety and immunogenicity of 10–30 µg doses that induced dose-dependent RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers
- Induction by 1–50 µg doses of potent humoral and cellular responses (RBD-specific binding and SARS-CoV-2 neutralizing antibodies, RBD-specific CD4+ Th1 cell responses, IL-2 and IFN-γ producing CD8+ T cells)
[82,83]
m1Ѱ IVT mRNA (BNT162b2) S in prefusion conformatiion LNP Phase I/II/III
(NCT04368728/ NCT04380701/ NCT04368728)
- Safety and immunogenicity of 30 µg dose which induced S-specific CD8+ and Th1-type CD4+ T-cell responses
- 95% efficacy at preventing COVID-19
- Promotion of lower infectiousness in COVID-19 vaccinated patients
- Protection against United Kingdom, South African, Columbus Ohio, and European variants, with partial protection against E484K-containing B.1.1.7 and B.1.351 spike variants
[84], [85], [86], [87], [88], [89], [90]