Table 3.
Characteristics of included studies.
Type | Authors (Journal & Year) | NCT Number | Phase | Participants | Vaccination Procedures | Outcome Measures on Safety and Immunogenicity | Storage |
---|---|---|---|---|---|---|---|
Protein | Keech et al. (N Engl J Med 2020) [18] | 04368988 | 1 | 131 | Intramuscular injections of NVX-CoV2373 (5, 25 μg) at day 0 or/and 21 | Local, systemic, and unsolicited AEs; anti-S antibody; SARS-CoV-2-neutralizing antibody | 2–8 °C |
Richmond et al. (Lancet 2021) [19] | 04405908 | 1 | 151 | Intramuscular injections of SCB-2019 (3, 9, or 30 μg) at days 0 and 21 | Local and systemic AEs; anti-SCB-2019 antibody; SARS-CoV-2-neutralizing antibody | 2–8 °C | |
Yang et al. (Lancet Infect Dis 2021) [20] | 04445194 & 04466085 | 1 & 2 | 950 | Intramuscular injections of ZF2001 at day 0, 30, 60 for phase 1 trial, and at day 0, 30 or day 0, 30, 60 for phase 2 trial | Local, systemic, and unsolicited AEs; anti-RBD antibody; SARS-CoV-2-neutralizing antibody | 2–8 °C | |
Chappell (Lancet Infect Dis 2021) [21] | 04495933 | 1 | 120 | Intramuscular injections of S-clamp vaccine (5, 15, or 45 μg) at days 0 and 28 | Local, systemic, and unsolicited AEs; Anti-clamp antibody; SARS-CoV-2-neutralizing antibody | 2–8 °C | |
Goepfert et al. (Lancet Infect Dis 2021) [22] | 04537208 | 1 & 2 | 441 | Intramuscular injections of CoV2 preS dTM (1.3 or 2.6 μg) at day 1 for one dose or day 1 and 28 for two doses | Local, systemic, and unsolicited AEs; SARS-CoV-2-neutralizing antibody | 2–8 °C | |
RNA | Anderson et al. (N Engl J Med 2020) [23] | 04283461 | 1 | 40 | Intramuscular injections of mRNA-1273 (25 or 100 μg) at days 1 and 29 | Local and systemic AEs; anti-S-2P antibody; anti-RBD antibody; SARS-CoV-2 neutralizing antibody | −20 °C or 2–8 °C |
Chu et al. (Vaccine 2021) [24] | 04405076 | 2 | 600 | Intramuscular injections of mRNA-1273 (50 or 100 μg) at days 1 and 29 | Local and systemic AEs; Anti-S antibody; SARS-CoV-2-neutralizing antibody | −20 °C or 2–8 °C | |
Jackson et al. (N Engl J Med 2020) [25] | 04283461 | 2 | 45 | Intramuscular injections of mRNA-1273 (25, 100, 250 μg) at days 1 and 29 | Local, systemic, and unsolicited AEs; anti-S-2P antibody; anti-RBD antibody; SARS-CoV-2-neutralizing antibody | −20 °C or 2–8 °C | |
Mulligan et al. (Nature 2020) [26] | 04368728 | 1 & 2 | 45 | Intramuscular injection of BNT162b1 (10, 30 μg) at day 0 and 21 or BNT162b1 (100 μg) at day0 | Local and systemic AEs; anti-RBD antibody; SARS-CoV-2-neutralizing antibody | −80 °C | |
Sahin et al. (Nature 2020) [27] | 04368728 | 1 & 2 | 60 | Intramuscular injections of BNT162b1 (1, 10, 30, 50 μg) at day 1 and 22 or BNT162b1 (60 μg) at day 1 | Local and systemic AEs; anti-RBD antibody; SARS-CoV-2-neutralizing antibody | −80 °C | |
Walsh et al. (N Engl J Med 2020) [28] | 04368728 | 1 & 2 | 195 | Intramuscular injections of BNT162b1 or BNT162b2 (10, 20, 30 μg) at day 0 and 21 | Local and systemic AEs; anti-S1 antibody; SARS-CoV-2-neutralizing antibody | −80 °C | |
DNA | Tebas et al. (EClinicalMedicine 2021) [29] | 04336410 | 1 | 40 | Intrdermal injections of INO-4800 (1, 2 mg) at weeks 0 and 4 | Local and systemic AEs; anti-S antibody; SARS-CoV-2-neutralizing antibody | 2–8 °C |
Viral vector | Zhu et al. (Lancet 2020a) [30] | 04313127 | 1 | 108 | Intramuscular injection of adenovirus type-5 vectored COVID-19 vaccine (5 × 1010, 1 × 1011, and 1.5 × 1011 viral particles) at day 0 | Local and systemic AEs; anti-RBD antibody; SARS-CoV-2 neutralizing antibody | N/A |
Folegatti et al. (Lancet 2020) [31] | 04324606 | 1 & 2 | 1077 | Intramuscular injections of AZD1222 (5 × 1010 viral particles) at days 0 and 28 | Local, systemic, and unsolicited AEs; anti-Spike antibody; SARS-CoV-2 neutralizing antibody | −80 °C or 2–8 K22 | |
Barrett et al. (Nat Med 2021) [32] | 04324606 | 1 & 2 | 52 | Intramuscular injections of AZD1222 (5 × 109 or 2.5 × 1010 viral particles) at days 0 and 28 | Local and systemic AEs; anti-S antibody; anti-RBD antibody; SARS-CoV-2-neutralizing antibody | −80 °C or 2–8 °C | |
Zhu et al. (Lancet 2020b) [33] | 04341389 | 2 | 508 | Intramuscular injection of adenovirus type-5 vectored COVID-19 vaccine (5 × 1010 or 1 × 1011 viral particles) at day 0 | Local, systemic, and unsolicited AEs; anti-RBD antibody; SARS-CoV-2-neutralizing antibody | N/A | |
Ramasamy et al. (Lancet 2021) [34] | 04400838 | 2 & 3 | 560 | Intramuscular injections of AZD1222 (2.2 × 1010 or 3.5–6.5 × 1010 viral particles) at days 0 and 28 | Local and systemic AEs; anti-S antibody; anti-RBD antibody; SARS-CoV-2-neutralizing antibody | −80 °C or 2–8 °C | |
Sadoff et al. (N Engl J Med 2021) [35] | 04436276 | 1 & 2 | 805 | Intramuscular injections of Ad26.COV2.S (5 × 1010 or 1 × 1011 viral particles) at day 1 or/and day 57 | Local, systemic, and severe unsolicited AEs; Anti-S antibody; SARS-CoV-2-neutralizing antibody | 2–8 °C | |
Stephenson et al. (JAMA 2021) [36] | 04436276 | 1 | 25 | Intramuscular injections of Ad26.COV2.S (5 × 1010 or 1 × 1011 viral particles) at day 1 or/and day 57 | Local, systemic, and unsolicited AEs; Anti-S antibody; Anti-RBD antibody SARS-CoV-2-neutralizing antibody | 2–8 °C | |
Logunov et al. (Lancet 2020) [37] | 04436471 & 04437875 | 1 & 2 | 76 | Intramuscular injections of rAd26-S and rAd5-S at day 0 for phase 1 trial, and at day 0 and 21 for phase 2 trial | Local and systemic AEs; anti-RBD antibody; SARS-CoV-2-neutralizing antibody | Frozen: −18 °C & lyophilized: 2–8 °C | |
Inactivated virus | Zhang et al. (Lancet Infect Dis 2021) [38] | 04352608 | 1 & 2 | 744 | Intramuscular injections of CoronaVac (3 or 6 μg) at day 0 and 14 or 28 for phase 1or phase 2 | Local, systemic, and unsolicited AEs; Anti-RBD antibody; SARS-CoV-2-neutralizing antibody | 2–8 °C |
Wu et al. (Lancet Infect Dis 2021) [39] | 04383574 | 1 & 2 | 422 | Intramuscular injections of inactivated CN02 strain at day 0 and 28 for phase 1 trial (3, 6 μg), and at day 0 for phase 2 trial (1.5, 3, 6 μg) | Local and systemic AEs; SARS-CoV-2 neutralizing antibody | 2–8 °C | |
Che et al. (Clin Infect Dis 2020) [40] | 04412538 | 2 | 750 | Injections of inactivated virus (100 EU or 150 EU viral antigen) at day 0 and boost at day 14 or 28 | Local, systemic, and unsolicited AEs; anti-SARS-CoV-2 antibody; SARS-CoV-2-neutralizing antibody | N/A | |
Pu et al. (Vaccine 2021) [41] | 04412538 | 1 | 192 | Intramuscular injections of inactivated virus with a D614G mutation in the S protein (50, 100, or 150 EU) at days 0 and 14 or 28. | Local, systemic, and unsolicited AEs; Anti-S antibody; SARS-CoV-2-neutralizing antibody | N/A | |
Ella et al. (Lancet Infect Dis 2021a) [42] | 04471519 | 1 | 375 | Intramuscular injections of BBV152 (3 or 6 μg) at days 0 and 14 | Local and systemic AEs; anti-S antibody; anti-RBD antibody; SARS-CoV-2 neutralizing antibody | 2–8 °C | |
Ella et al. (Lancet Infect Dis 2021b) [43] | 04471519 | 2 | 380 | Intramuscular injections of BBV152 (3 or 6 μg) at days 0 and 28 | Local and systemic AEs; anti-S antibody; anti-RBD antibody; SARS-CoV-2-neutralizing antibody | 2–8 °C | |
Virus-like particle | Ward et al. (Nat Med 2021) [44] | 04450004 | 1 | 180 | Intramuscular injections of CoVLP (3.75, 7.5, or 15 μg) at days 0 and 21 | Local, systemic, and unsolicited AEs; Anti-S antibody; SARS-CoV-2-neutralizing antibody | 2–8 °C |