Table 4.
Self-amplifying mRNA vaccines in clinical trials
| Name | Developer | Clinical phase, trial identifier | Dose, regimen | Antigen coding sequence | LNP features | Clinical outcome |
|---|---|---|---|---|---|---|
| LNP-nCoVsaRNA | Imperial College London | phase I/II, ISRCTN17072692 | 0.1 to 10 μg, p-b, 4 weeks | full-length S, prefusion-stabilized | LNP | dose-dependent immunological effect up to 5 μg, seroconversion 8%–61% by ELISA, 46%–87% by immunoblot assay159 |
| LNP-nCOV saRNA-02 | Imperial College London/MRC/UVRI/LSHTM/Uganda Research Unit | phase I, NCT04934111 | 5 μg, p-b, 4 weeks | full-length S, prefusion-stabilized | LNP | not published |
| EXG5003 | Elixirgen Therapeutics | phase I/II, NCT04863131 | N/A μg, one dose | RBD | LNP | not published |
| ARCT 021 ARCT 154 ARCT 165 |
Arcturus Therapeutics/Duke-NUS Medical School | phase II/III, NCT05012943 phase I/II, NCT04480957 phase II, NCT04728347 phase I/II NCT05037097 |
0.2 to 10 μg ARCT 021: 5 μg, one dose or p-b, 4 weeks | full-length S, prefusion-stabilized | LUNAR | dose-dependent binding and neutralizing antibody responses in interim data160 |
| CoV2 SAM LNP | GSK | phase I, NCT04758962 | 1 μg, p-b | full-length S | LNP | not published |
| HDT301 (repRNA-CoV2S; HGCO19) | SENAI Cimatec/HDT/Gennova/Quratis | phase I, NCT04844268 | 1, 5, 25 μg, one dose or p-b in 4 or 8 weeks | full-length S | LION | not published |
| VLPCOV-01 | VLP Therapeutics Japan | phase I, jRCT2071210067 | N/A | N/A | N/A | not published |
| SAM-SARS-CoV-2 | Gritstone | phase I | 10 μg, one dose as booster | full-length S, perfusion stabilized, mutated furin cleavage site | LNP | not published |
GSK, GlaxoSmithKline; LION, lipid inorganic nanoparticles; LNP, lipid nanoparticle; LSHTM, London School of Hygiene and Tropical Medicine; LUNAR, lipid-enabled nucleic acid delivery reagent; MRC, Medical Research Council; N/A, not applicable/not disclosed; p-b, prime-boost regimen; RBD, receptor binding domain; S, spike protein; UVRI, Uganda Virus Research Institute.