Table 5.
mRNA vaccine candidates for COVID-19 currently in clinical trials
| Vacine name/Developer(s) | Antigen/Delivery vehicles | Route of administration/Schedule/Dose | Phase | Identifier (Number of participants; Location) | Outcomes |
|---|---|---|---|---|---|
| mRNA type: nucleoside-modified | |||||
| BNT162b2/BioNTech,Pfizer | Transmembrane prefusion spike/LNP | IM/Day 0 + 21/30 μg | IV | NCT05057182 (300 participants; Hong Kong) | Fully approved for use in individuals aged 16 or older483; EUA for use in individuals aged 5 or older106; EUA for use as a single booster in individuals aged 18 or older395,396; 95% overall efficacy385 |
| NCT04852861 (150 participants; Belgium) | |||||
| NCT04952766 (240 participants; France) | |||||
| NCT04961229 (504 participants; Not Provided) | |||||
| NCT05057169 (400 participants; Hong Kong) | |||||
| NCT04969250 (640 participants; Nigeria, Spain, Switzerland, Uganda, United States) | |||||
| NCT05168709 (60 participants; Australia) | |||||
| NCT04775069 (900 participants; Hong Kong) | |||||
| III | NCT04816669 (610 participants; USA) | ||||
| NCT04805125 (431 participants; Switzerland) | |||||
| NCT04800133 (900 participants; Hong Kong) | |||||
| NCT04713553 (1,530 participants; USA) | |||||
| II/III | NCT04368728 (43,998 participants; Argentina, Brazil, Germany, South Africa, Turkey, USA) | ||||
| NCT04754594 (700 participants; Brazil, South Africa, Spain, UK, USA) | |||||
| II | ISRCTN73765130 (2,886 participants; UK) | ||||
| NCT04894435 (1,200 participants; Canada) | |||||
| NCT04761822 (3,400 participants; USA) | |||||
| NCT04824638 (300 participants; France) | |||||
| NCT04860739 (676 participants; Spain) | |||||
| EUCTR2021-001978-37 (600 participants; Spain) | |||||
| NCT04649021 (950 participants; China) | |||||
| ISRCTN69254139 (820 participants; UK) | |||||
| NCT04907331 (3,000 participants; Austria) | |||||
| NCT04895982 (360 participants; Brazil, Germany, USA) | |||||
| I/II | EUCTR2020-001038-36, NCT04380701 (476 participants; Germany) | ||||
| NCT04889209 (800 participants; USA) | |||||
| NCT04588480 (160 participants; Japan) | |||||
| II | NCT04839315 (100 participants; USA) | ||||
| NCT04816643 (4, 500 participants; Finland, Poland, Spain, USA) | |||||
| mRNA-1273/Moderna, NIAID, BARDA | Transmembrane prefusion spike/LNP | IM/Day 0 + 28/100 μg | IV | NCT04952402 (700 participants; Puerto Rico, United States) | EUA obtained in several countries; EUA as a single booster in individuals aged 18 or older396; 100% efficacy against B.1.1.7; 95.7% efficacy against B.1.35 in Qatar417; 94.1% efficacy at preventing COVID-19 infections, including severe cases in the US410 |
| NCT04969250 (640 participants; Nigeria, Spain, Switzerland, Uganda, United States) | |||||
| NCT05030974 (460 participants; Netherlands) | |||||
| NCT05079633 (220 participants; Taiwan) | |||||
| NCT04978038 (414 participants; Canada, Ontario) | |||||
| NCT04760132 (10,000 participants; Denmark) | |||||
| III | NCT04811664 (37,500 participants; USA) | ||||
| NCT04470427 (30,420 participants; USA) | |||||
| NCT04860297 (240 participants; USA) | |||||
| NCT04806113 (220 participants; Canada) | |||||
| NCT04805125 (431 participants; Switzerland) | |||||
| II/III | NCT04649151 (3,732 participants; USA) | ||||
| NCT04796896 (6,975 participants; USA) | |||||
| II | ISRCTN73765130 (2,886 participants; UK) | ||||
| NCT04847050 (120 participants; USA) | |||||
| NCT04894435 (1,200 participants; Canada) | |||||
| NCT04748471 (180 participants; France) | |||||
| NCT04761822 (3,400 participants; USA) | |||||
| NCT04405076 (660 participants; USA) | |||||
| I/II | NCT04889209 (800 participants; USA) | ||||
| I | NCT04785144 (135 participants; USA) | ||||
| NCT04813796 (125 participants; USA) | |||||
| NCT04839315 (100 participants; USA) | |||||
| NCT04283461 (120 participants; USA) | |||||
| BNT162b1/BioNTech,Pfizer | Secreted spike RBD/LNP | IM/Day 0 + 21/10, 20, 30 or 100 μg | II/III | NCT04368728 (43,998 participants; Argentina, Brazil, Germany, South Africa, Turkey, USA) | 8–50-fold increase in GMCs of RBD-binding IgG; 1.9–4.6-fold neutralizing GMTs compared to the convalescent panel; higher rate of systemic events compared to BNT162b2278 |
| II/II | EudraCT 2020-001038-36, NCT04380701 (476 participants; Germany) | ||||
| I | ChiCTR2000034825, NCT04523571(144 participants; China) | ||||
| BNT162b3/BioNTech,Pfizer | Transmembrane spike RBD/LNP | IM/Day 0 + 21/30 μg | I/II | NCT04537949, EUCTR2020-003267-26- DE (96 participants; Germany) | Unknown |
| mRNA-1273.211/Moderna, NIAID, BARDA | Transmembrane prefusion spike/LNP | IM/Day0 + 28/20, 50 μg | II | NCT04405076 (660 participants; USA) | Increased neutralizing GMTs when used as a booster415 |
| mRNA-1273.351/Moderna, NIAID, BARDA | Transmembrane prefusion spike/LNP | IM/Day0 + 28/20 or 50 μg | I | NCT04785144 (135 participants; USA) | Increased neutralizing GMTs when used as a booster415 |
| mRNA-1283/Moderna, NIAID, BARDA | Transmembrane prefusion spike/LNP | IM/Day0 + 28/NA | I | NCT04813796 (125 participants; USA) | Unknown |
| TAK-919/Takeda, Moderna | Transmembrane prefusion spike/LNP | IM/Day0 + Day29/100 μg | I/II | NCT04677660 (200 participants; Japan) | Approved in Japan484 |
| ChulaCov19/Chulalongkorn University | Transmembrane spike/LNP | IM/Day0 + 21/10, 25 or 50 μg | I/II | NCT04566276 (96 participants; Thailand) | Unknown |
| PTX-COVID19-B/Providence Therapeutics | Transmembrane spike/LNP | IM/Day0 + 28/16, 40 or 100 μg | I | NCT04765436 (60 participants; Canada) | High neutralization titers against VOCs432 |
| mRNA type: unmodified nucleosides | |||||
| CVnCoV/CureVac | Transmembrane prefusion spike/LNP | IM/Day0 + 29/12 μg | III | NCT04652102, EUCTR2020-003998-22(39,693 participants; Argentina, Belgium, Colombia, Dominican Republic, Germany, Mexico, Netherlands, Panama, Peru, Spain) | 48.2% efficacy425; EMA terminated rolling review429 |
| NCT04860258 (1,200 participants; Belgium) | |||||
| NCT04848467 (1,000 participants; Argentina, Colombia, Peru) | |||||
| II | ISRCTN73765130 (2,886 participants; UK) | ||||
| NCT04515147, PER-054-20 (674 participants; Panama, Peru) | |||||
| I | NCT04449276 (280 participants; Belgium, Germany) | ||||
| ARCoV/Abogen, Walvax Biotechnology, PLA | Secreted spike RBD/LNP | IM/ Day0 + 28/15 μg | III | NCT04847102 (28,000 participants; China, Mexico) | 2-fold neutralizing GMTs compared to convalescent panel.439 |
| II | ChiCTR2100041855(420 participants; China) | ||||
| I | ChiCTR2000034112(568 participants; China) | ||||
| BNT162a1/BioNTech, Pfizer | Secreted spike RBD/LNP | IM/NA/NA | I/II | EudraCT 2020-001038-36, NCT04380701 (476 participants; Germany) | Unknown |
| MRT5500/Sanofi, Translate Bio | Transmembrane prefusion spike/LNP | IM/Day0 + 21/NA | I/II | NCT04798027 (333 participants; Honduras, USA) | Terminated436; 91–100% seroconversion rate437 |
| mRNA-type: self-amplifying RNA | |||||
| ARCT-021/Arcturus Therapeutics | Transmembrane prefusion spike/LNP | IM/Day0 + 28/5.0 μg or 7.5 μg | II | NCT04668339 (600 participants; Singapore, USA) | Seroconversion in most participants441 |
| NCT04728347 (106 participants; Singapore) | |||||
| I/II | NCT04480957 (92 participants; Singapore) | ||||
| ARCT-165/Arcturus Therapeutics | NA/LNP | IM/Day0 + 29/ NA | I/II | NCT05037097 (72 participants; Singapore, USA) | Unknown |
| ARCT-154/Arcturus Therapeutics | NA | IM/Day0 + 29/ 5 μg | I/II/III | NCT05012943 (2,1000 participants; Vietnam) | Unknown |
| BNT162c2/BioNTech, Pfizer | Transmembrane prefusion spike/LNP | IM/Day0 + 21/ NA | I/II | EudraCT 2020-001038-36, NCT04380701 (476 participants; Germany) | Unknown |
| LNP-nCoV saRNA/Imperial College London, Acuitas Therapeutics | Transmembrane prefusion spike/LNP | IM/NA/0.1~10 μg | I | ISRCTN17072692 (320 participants; UK) | 39–61% seroconversion rate212 |
| EXG-5003/lixirgen Therapeutics/ Fujita Health University | NA/LNP | ID/Day0/NA | I/II | NCT04863131 (60 participants; Japan) | Unknown |
| HDT-301/SENAI CIMATEC; HDT | NA/LION | IM/Day0 + 28/ 1 μg, 5 μg or 25 μg | I | NCT04844268 (90 participants; NA) | Unknown |
| LNP-nCOV saRNA02/RC/ UVRI and LSHTM Uganda Research Unit | NA/LNP | IM/Day 0 + 28/ 5.0 μg | I | NCT04934111 (42 participants; Uganda) | Unknown |
| SAM-LNP-S/Gristone Oncology, NIAID | Transmembrane spike/LNP | IM/Day0 + 30 or Day0 + 85~130/ 30 μg or 3 μg | I | NCT04776317 (147 participants; USA) | Unknown |
| CoV2 SAM (LNP)/GlaxoSmithKline | Transmembrane spike/LNP | IM/Day0 + 30/ 1.0 μg | I | NCT04758962 (10 participants; USA) | Unknown |
IM: intramuscular; ID: intradermal; BARDA: Biomedical Advanced Research and Development Authority; EUA: emergency use authorization; LNP: lipid nanoparticle; NIAID: National Institute of Allergy and Infectious Diseases; PLA: People Liberation Army; RBD: receptor-binding domain; VOCs: variant of concerns; GMCs: geometric mean concentrations, GMTs: geometric mean titers; NA: not applicable; Clinical trials are regularly updated, therefore locations and the number of participants of clinical trials reported above are subjected to change.