Table 2.
Clinical phase I and phase II trial of DNA/RNA vaccines against COVID-19
| S. no. | First submitted date/date of registration | Study phase/recruitment status | ID | Project title | Nucleic acid as vaccine agent | Participants (number, age, sex) | Intervention |
|---|---|---|---|---|---|---|---|
| 1 | April 27, 2020 |
Phase 1 Phase 2 |
NCT04368728 | Study to describe the safety, tolerability, immunogenicity, and potential efficacy of RNA vaccine candidates against COVID-19 in healthy adults | RNA |
Enrolment: 7600 Age: 18 years to 85 years Sex: All |
Biological: BNT162a1 0.5 mL intramuscular injection Biological: BNT162b1 0.5 mL intramuscular injection Biological: BNT162b2 0.5 mL intramuscular injection Biological: BNT162c2 0.5 mL intramuscular injection Other: Placebo 0.5 mL Intramuscular injection |
| 2 | February 21, 2020 | Phase 1 | NCT04283461 | Safety and immunogenicity study of 2019-nCoV vaccine (mRNA-1273) for prophylaxis of SARS-CoV-2 infection (COVID-19) | mRNA |
Enrolment: 105 Age: 18 years to 99 years Sex: All |
Biological: mRNA-1273 Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA drug substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG |
| 3 | April 3, 2020 | Phase 1 | NCT04336410 | Safety, tolerability and immunogenicity of INO-4800 for COVID-19 in healthy volunteers | INO-4800 (DNA) |
Enrolment: 40 Age: 18 years to 50 years Sex: All |
Drug: INO-4800 INO-4800 will be administered ID on day 0 and week 4 |