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|[[RNA vaccine|RNA]]
|[[RNA vaccine|RNA]]
|{{ClinicalStudyInfo|align=left|phase=1|endphase=3|participants=21000|description=Phase I/II/III (100+300+600+20,000=21,000): Randomized, double-blinded, placebo controlled.<ref>{{#invoke:Cite web| |date=2 August 2021|title=Arcturus to start clinical trial of COVID-19 vaccine in Vietnam|work=[[Reuters]]|url=https://www.reuters.com/business/healthcare-pharmaceuticals/arcturus-start-clinical-trial-covid-19-vaccine-vietnam-2021-08-02/}}</ref><ref>{{#invoke:Cite web| |date=2 August 2021|title=Arcturus Therapeutics lines up Phase 1/2/3 trial for next-generation mRNA COVID-19 vaccine|work=Biopharma Reporter|url=https://www.biopharma-reporter.com/Article/2021/08/02/Arcturus-Therapeutics-lines-up-clinical-trials-for-next-generation-mRNA-vaccine}}</ref>
|{{ClinicalStudyInfo|align=left|phase=1|endphase=3|participants=21000|description=Phase I/II/III (100+300+600+20,000=21,000): Randomized, double-blinded, placebo controlled.<ref>{{#invoke:Cite web| |date=2 August 2021|title=Arcturus to start clinical trial of COVID-19 vaccine in Vietnam|work=[[Reuters]]|url=https://www.reuters.com/business/healthcare-pharmaceuticals/arcturus-start-clinical-trial-covid-19-vaccine-vietnam-2021-08-02/}}</ref><ref>{{#invoke:Cite web| |date=2 August 2021|title=Arcturus Therapeutics lines up Phase 1/2/3 trial for next-generation mRNA COVID-19 vaccine|work=Biopharma Reporter|url=https://www.biopharma-reporter.com/Article/2021/08/02/Arcturus-Therapeutics-lines-up-clinical-trials-for-next-generation-mRNA-vaccine}}</ref>
|whenwhere=Aug-Oct 2021, Vietnam<ref>{{cite document |title=The ARCT-154 Self-Amplifying RNA Vaccine Efficacy Study (ARCT-154-01) (ARCT-154-01) |date=19 August 2021 |url=https://clinicaltrials.gov/ct2/show/NCT05012943 |publisher=United States National Library of Medicine |id=NCT05012943 |access-date=19 August 2021 }}</ref>
|whenwhere=Aug-Oct 2021, Vietnam<ref>{{cite web |title=The ARCT-154 Self-Amplifying RNA Vaccine Efficacy Study (ARCT-154-01) (ARCT-154-01) |date=19 August 2021 |url=https://clinicaltrials.gov/ct2/show/NCT05012943 |publisher=United States National Library of Medicine |id=NCT05012943 |access-date=19 August 2021 }}</ref>
}}
}}
|{{ClinicalStudyInfo|align=left|phase=pre
|{{ClinicalStudyInfo|align=left|phase=pre
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|China
|China
| [[Subunit vaccine|Subunit]]
| [[Subunit vaccine|Subunit]]
|{{ClinicalStudyInfo|align=left|phase=1|endphase=2|participants=150|references=<ref>{{cite document |title=Immunogenicity and Safety of Adjuvanted SCB-2020S Vaccines in Adults |date=6 July 2021 |url=https://clinicaltrials.gov/ct2/show/NCT04950751 |publisher=United States National Library of Medicine |id=NCT04950751 |access-date=6 July 2021 }}</ref>|description=Randomized, controlled, observer-blind.
|{{ClinicalStudyInfo|align=left|phase=1|endphase=2|participants=150|references=<ref>{{cite web |title=Immunogenicity and Safety of Adjuvanted SCB-2020S Vaccines in Adults |date=6 July 2021 |url=https://clinicaltrials.gov/ct2/show/NCT04950751 |publisher=United States National Library of Medicine |id=NCT04950751 |access-date=6 July 2021 }}</ref>|description=Randomized, controlled, observer-blind.
|whenwhere=Aug 2021{{snd}}Apr 2022, Australia
|whenwhere=Aug 2021{{snd}}Apr 2022, Australia
}}
}}

Revision as of 00:54, 15 September 2021

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COVID‑19 vaccine candidates in Phase I–III trials[1][2][3]
()
Vaccine candidates,
developers, and sponsors
Country of origin Type (technology) Current phase (participants)
design
Completed phase[a] (participants)
Immune response
Pending authorization
Novavax COVID-19 vaccine (Covovax)[4][5]
Novavax, CEPI
United States Subunit[6][7][8]/virus-like particle[9][10] (SARS‑CoV‑2 recombinant spike protein nanoparticle with adjuvant) Phase III (49,600)
Randomised, observer-blinded, placebo-controlled trial[11]
Sep 2020 – Jan 2021, UK (15,000); Dec 2020 – Jun 2023, US, Mexico, Puerto Rico (33,000);[12] India (Phase II/III: 1,600)[13][14]
Phase I–II (131)
IgG and neutralizing antibody response with adjuvant after booster dose.[15]
Emergency (11)
Sanofi–GSK COVID-19 vaccine (VAT00008, Vidprevtyn)
Sanofi Pasteur, GSK
France, United Kingdom Subunit (SARS-CoV-2 S adjuvanted recombinant protein) Phase III (37,430)[27][28]
A Parallel-group, Phase III, Multi-stage, Modified Double-blind, Multi-armed Study to Assess the Efficacy, Safety, and Immunogenicity of Two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Monovalent and Bivalent) for Prevention Against COVID-19 in Adults 18 Years of Age and Older.
May 2021 – Jan 2023, Colombia, Dominican Republic, Ghana, Honduras, India (3,000), Japan, Kenya,[29] Mexico,[30] Nigeria, Pakistan, Sri Lanka, Uganda, United States
Phase I–II (1,160)
Phase I-IIa (440): Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine Formulations (With or Without Adjuvant) in Healthy Adults 18 Years of Age and Older.[31]
Phase IIb (720): Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine With AS03 Adjuvant in Adults 18 Years of Age and Older.[32]
Sep 2020 – Apr 2022, United States
Emergency (4)
CureVac COVID-19 vaccine (CVnCoV)
CureVac, CEPI
Germany RNA (unmodified RNA)[37] Phase III (44,433)[38][39][40][41][42]
Phase 2b/3 (39,693): Multicenter efficacy and safety trial in adults.
Phase 3 (2,360+180+1,200+1,000=4,740): Randomized, placebo-controlled, multicenter, some observer-blinded, some open-labeled.
Nov 2020 – Jun 2022, Argentina, Belgium, Colombia, Dominican Republic, France, Germany, Mexico, Netherlands, Panama, Peru, Spain[43]
Phase I–II (944)[44][45]
Phase I (284): Partially blind, controlled, dose-escalation to evaluate safety, reactogenicity and immunogenicity.
Phase IIa (660):Partially observer-blind, multicenter, controlled, dose-confirmation.
Jun 2020 – Oct 2021, Belgium (phase I), Germany (phase I), Panama (phase IIa), Peru (phase IIa)
Emergency (2)
CoVLP[48][49]
Medicago, GSK
Canada, United Kingdom Virus-like particles[b] (recombinant, plant-based with AS03) Phase III (30,918)
Event-driven, randomized, observer blinded, placebo-controlled[51]
Nov 2020 – Dec 2021, Brazil, Canada, United Kingdom, United States
Phase I (180)
Neutralizing antibodies at day 42 after the first injection (day 21 after the second injection) were at levels 10x that of COVID-19 survivors.
Jul 2020 – Sept 2021, Canada[52]
Emergency (1)
Valneva COVID-19 vaccine[54][unreliable source?][55]
Valneva
France Inactivated SARS‑CoV‑2 Phase III (4,769)[56][57][58]
Phase III (4,019+750): Randomized, observer-blind, controlled, non-inferiority.
Apr–Dec 2021, New Zealand, United Kingdom
Phase I–II (3,039)
Phase I/II (153): Randomized, multi-center, double-blinded.
Phase II (2,886): A randomised, phase II UK multi-centre study to determine reactogenicity and immunogenicity of booster vaccination against ancestral and novel variants of SARS-CoV-2.[59]
Dec 2020 – Jun 2021, United Kingdom
Emergency (2)
Nanocovax[62]
Nanogen Pharmaceutical Biotechnology JSC
Vietnam Subunit (SARS‑CoV‑2 recombinant spike protein with aluminum adjuvant)[63][64] Phase III (13,000)[65][66]
Adaptive, multicenter, randomized, double-blind, placebo-controlled
Jun 2021 – Jul 2022, Vietnam
Phase I–II (620)[67]
Phase I (60): Open label, dose escalation.
Phase II (560): Randomization, double-blind, multicenter, placebo-controlled.
Dec 2020 – Jun 2021, Vietnam
Emergency (1)
UB-612
United Biomedical,Inc, Vaxxinity, DASA
Brazil, United States Subunit (Multitope peptide based S1-RBD-protein based vaccine) Phase III (18,320)[69][70]
Phase IIb/III (7,320): Randomized, Multicenter, Double-Blind, Placebo Controlled, Dose-Response.
Phase III (11,000)
Jan 2021 – Mar 2023, Taiwan (phase 2b/3), India (phase 3)[71]
Phase I–II (3,910)[72]
Phase 1 (60): Open-label study
Phase IIa (3,850): Placebo-controlled, Randomized, Observer-blind Study.
Sep 2020 – Jan 2021, Taiwan
Emergency (1)
Razi Cov Pars[74][75]
Razi Vaccine and Serum Research Institute
Iran Subunit (Recombinant Spike protein) Phase III (41,128)[76]
Two parallel and equal groups, randomized, double blind, non-inferiority design, compared to Sinopharm vaccine.
Sep–Dec 2021, Iran
Phase I–II (633)[77]
Phase I (133): Randomized, double blind, placebo controlled.
Phase II (500): Two parallel groups, randomized, double blind, placebo controlled.[78]
Jan–Jun 2021, Iran
TURKOVAC
Health Institutes of Turkey
Turkey Inactivated SARS‑CoV‑2 Phase III (40,800)[79]
Randomized, double-blinded, multi-center, active-controlled.
Jun 2021 – Sep 2021, Turkey
Phase I–II (294)[80][81]
Phase I (44): Study for the Determination of Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC, Given Twice Intramuscularly to Healthy Volunteers, in a Placebo Controlled Study Design.
Phase 2 (250): Study for the Determination of Efficacy, Immunogenicity and Safety of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC, in a Placebo Controlled, Randomized, Double Blind Study Design.
Nov 2020 – Apr 2021, Turkey
West China Hospital COVID-19 vaccine
Jiangsu Province Centers for Disease Control and Prevention, West China Hospital (WestVac Biopharma), Sichuan University
China Subunit (recombinant with Sf9 cell) Phase III (40,000)[82]
Multicenter, randomized, double-blind, placebo-controlled.
Jun 2021 – Feb 2022, Indonesia, Kenya, the Philippines (5,000)[83]
Phase I–II (5,128)[84][85][86]
Phase I (168): Single-center, Randomized, Placebo-controlled, Double-blind.
Phase IIa (960):Single-center, Randomized, Double-Blinded, Placebo-Controlled.
Phase IIb (4,000):Single-center, Randomized, Double-Blinded, Placebo-Controlled.
Aug 2020 – May 2021, China
SCB-2019[87][88]
Clover Biopharmaceuticals,[89][90] Dynavax Technologies,[91] CEPI
China Subunit (spike protein trimeric subunit with combined CpG 1018 and aluminium adjuvant) Phase III (29,300)
Phase II/III (29,000): Randomized, double-blind, controlled.
Phase III (300): Double-blind, randomized, controlled.[92]
Mar 2021 – Oct 2022, Belgium, Brazil, Colombia, Dominican Republic, Germany, Nepal, Panama, the Philippines, Poland, South Africa, Ukraine
Phase I–II (950)
Phase I (150): Randomized, Double-blind, Placebo-controlled, First-in-human.
Phase II (800): Multi-center, Double-blind, Randomized, Controlled.[93]
Jun 2020 – Oct 2021, Australia (phase 1), China (phase 2)
Walvax COVID-19 vaccine (ARCoV)[94]
PLA Academy of Military Science, Walvax Biotech,[95] Suzhou Abogen Biosciences
China RNA Phase III (28,000)[96]
Multi-center, Randomized, Double-blind, Placebo-controlled
May–Nov 2021, China,[97] Colombia, Indonesia, Malaysia, Mexico, Nepal, Pakistan, Turkey
Phase I–II (908)
Phase I (168)
Phase II (420)
Phase I/II (320)[98]
Jun 2020 – Oct 2021, China[99]
COVAX-19 (SpikoGen)[100]
Vaxine Pty Ltd,[101] Cinnagen[102]
Australia, Iran Subunit (recombinant protein) Phase III (16,876)[103]
Randomized, Two-armed, Double-blind, Placebo controlled
Aug – Sep 2021, Iran
Phase I–II (440)[104]
Phase I (40)
Phase II (400): Randomized, Two-armed, Double-blind, Placebo controlled.[105]
Jun 2020 – Jul 2021, Adelaide, Iran
GRAd-COV2[106][107]
ReiThera, Lazzaro Spallanzani National Institute for Infectious Diseases
Italy Adenovirus vector (modified gorilla adenovirus vector, GRAd) Phase III (10,300)[108][109]
Randomized, stratified, observer-blind, placebo-controlled.
Mar–Oct 2021, Italy
Phase I (90)[110]
Subjects (two groups: 18–55 and 65–85 years old) randomly receiving one of three escalating doses of GRAd-COV2 or a placebo, then monitored over a 24-week period. 93% of subjects who received GRAd-COV2 developed anti-bodies.
Aug–Dec 2020, Rome
Zhongyianke Biotech–Liaoning Maokangyuan Biotech COVID-19 vaccine
Zhongyianke Biotech, Liaoning Maokangyuan Biotech, Academy of Military Medical Sciences
China Subunit (Recombinant) Phase III (14,600)[111]
International multicenter, randomized, double-blind, placebo-controlled.
Sep 2021–?, China
Phase I–II (696)[112]
Phase I (216): Randomized, placebo-controlled, double-blind.
Phase II (480): Single-center, randomized, double blinded, placebo controlled.[113]
Oct 2020 – Jul 2021, China
GBP510
SK Bioscience Co. Ltd., GSK
South Korea, United Kingdom Subunit (Recombinant protein nanoparticle with adjuvanted with AS03) Phase III (4,000)[114]
Randomized, active-controlled, observer-blind, parallel-group, multi-center.[115]
Aug 2021-Mar 2022, South Korea
Phase I–II (580)[116][117]
Phase I-II (260-320): Placebo-controlled, randomized, observer-blinded, dose-finding.
Jan–Aug 2021, South Korea
Unnamed
National Vaccine and Serum Institute, Lanzhou Institute of Biological Products Co., Ltd., Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd., Zhengzhou University
China Subunit (Recombinant) Phase III (1,800)[118]
Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above.
Sep 2021 – Nov 2023, United Arab Emirates
Phase I–II (3,580)[119]
Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy People Aged 3 Years and Older.
Apr 2021 – Oct 2022, China
Bio E COVID-19 (Corbevax)[120][121][122]
Biological E. Limited, Baylor College of Medicine,[123] CEPI
India, United States Subunit (using an antigen) Phase III (1,268)[124]
Phase 2b/3: Single Arm, Prospective, multicentre.[125]
Apr – Aug 2021, India
Phase I–II (360)[126]
Randomized, Parallel Group Trial
Nov 2020 – Feb 2021, India
Inovio COVID-19 Vaccine (INO-4800)[127][128]
Inovio, CEPI, Korea National Institute of Health, International Vaccine Institute
South Korea, United States DNA vaccine (plasmid delivered by electroporation) Phase II–III (6,578)
Phase II/III (6,578): Randomized, placebo-controlled, multi-center.[129]
Nov 2020 – Sep 2022, United States (phase II/III)[c]
Phase I–II (920)
Phase Ia (120): Open-label trial.
Phase Ib-IIa (160): Dose-Ranging Trial.[130]
Phase II (640): Randomized, double-blinded, placebo-controlled, dose-finding.[131]
April 2020 – Feb 2022, China (phase II), South Korea (phase Ib-IIa), United States
HGC019[132]
Gennova Biopharmaceuticals, HDT Biotech Corporation[133]
India, United States RNA Phase II–III (4,400)[134]
A prospective, multicentre, randomized, active-controlled (with COVISHIELD), observer-blind study to evaluate safety, tolerability and immunogenicity in healthy adults.
Phase II (400)
Phase III (4,000)
Sep 2021 – ?, India
Phase I–II (620)[135][136][137]
Randomized, phase I/II, placebo-controlled, dose-ranging, parallel-group, crossover, multi-centre study to evaluate the safety, tolerability and immunogenicity in healthy adult subjects.
Phase I (120) open-label study in healthy 18-70 year-olds.
Phase II (500) observer-blind study in healthy 18-75 year-olds.
Apr 2021 – Oct 2021, India
AG0302-COVID‑19[138][139]
AnGes Inc.,[140] AMED
Japan DNA vaccine (plasmid) Phase II–III (500)
Randomized, double-blind, placebo controlled[141]
Nov 2020 – Apr 2021, Japan
Phase I–II (30)
Randomized/non-randomized, single-center, two doses
Jun–Nov 2020, Osaka
202-CoV
Shanghai Zerun Biotechnology Co., Ltd., Walvax Biotech
China Subunit (Spike protein (CHO cell) 202-CoV with CpG / alum adjuvant) Phase II (1,056)[142]
Randomized, Double-blinded, Placebo-controlled.
July–Dec 2021, China
Phase I (144)[143]
Randomized, double-blinded, placebo-controlled.
July–Dec 2021, China
V-01
Livzon Mabpharm, Inc.
China Subunit (SARS-CoV-2 recombinant fusion protein) Phase II (880)[144]
Randomized, double-blind, and placebo-controlled.
Mar–May 2021, China
Phase I (180)[145]
Single-center, randomized, double-blind and placebo-controlled.
Feb–Mar 2021, China
DelNS1-2019-nCoV-RBD-OPT (DelNS1-nCoV-RBD LAIV)
Beijing Wantai Biological Pharmacy, University of Hong Kong
China, Hong Kong Replicating Viral vector (flu-based-RBD[clarification needed]) Phase II (720)[146]
Nov 2020 – Dec 2021, China
Phase I (175)[147]
Sep 2020 – Sep 2022, China (60), Hong Kong (115)
BriLife (IIBR-100)[148]
The Israel Institute for Biological Research
Israel Vesicular stomatitis vector (recombinant) Phase II–III (550)[149]
Phase IIb/III (550): Randomized, multi-center, placebo-controlled.
Aug – Oct 2021, Israel
Phase I–II (1,040)[150]
Randomized, multi-center, placebo-controlled, dose-escalation.
Oct 2020 – May 2021, Israel
Unnamed
Ihsan Gursel, Scientific and Technological Research Council of Turkey
Turkey Virus-like particle Phase II (330)[151]
Randomized, parallel dose assigned, double blind, multi center.
Jun – Sep 2021, Turkey
Phase I (36)[152]
double-blinded, randomised, placebo controlled.
Mar – May 2021, Turkey
COH04S1
City of Hope Medical Center
United States Viral vector Phase II (240)[153]
Multi-center, observer-blinded, EUA vaccine-controlled, randomized.
Aug 2021 – Jun 2023, California
Phase I (129)[154]
Dose Escalation Study.
Dec 2020 – Nov 2022, California
Unnamed
Tsinghua University, Tianjin Medical University,[155] Walvax Biotech
China Viral vector Phase II (180)[156]
Jul–Nov 2021, China
Phase I (30)[157]
May–Jun 2021, China
ABNCoV2
Bavarian Nordic.[158] Radboud University Nijmegen
Denmark, Netherlands Virus-like particle Phase II (150)[159]
Single center, sequential dose-escalation, open labelled trial.
Aug 2021–2022, Denmark, Netherlands
Phase I (42)[160]
Single center, sequential dose-escalation, open labelled trial.
Mar–Dec 2021, Netherlands
ARCT-154 (VBC-COV19-154 in Vietnam)[161][162][163]
Arcturus Therapeutics, Vinbiocare
United States, Vietnam RNA Phase I–III (21,000)
Phase I/II/III (100+300+600+20,000=21,000): Randomized, double-blinded, placebo controlled.[164][165]
Aug-Oct 2021, Vietnam[166]
Preclinical
SCB-2020S
Clover Biopharmaceuticals[167]
China Subunit Phase I–II (150)[168]
Randomized, controlled, observer-blind.
Aug 2021 – Apr 2022, Australia
Preclinical
NDV-HXP-S (ButanVac [pt], COVIVAC, HXP-GPOVac, Patria)
Icahn School of Medicine at Mount Sinai, Institute of Vaccines and Medical Biologicals,[169] Butantan Institute, Laboratorio Avimex, National Council of Science and Technology, Mahidol University, University of Texas at Austin
Brazil, Mexico, Thailand, United States, Vietnam Newcastle disease virus (NDV) vector (expressing the spike protein of SARS-CoV-2, with or without the adjuvant CpG 1018)/Inactivated SARS‑CoV‑2 Phase I–II (6,439)
Randomized, placebo-controlled, observer-blind.
Mar 2021 – May 2022; Brazil (5,394), Mexico (Phase I: 90), Thailand (460),[170] Vietnam (495)[171][172]
Preclinical
ARCT-021[173][174]
Arcturus Therapeutics, Duke–NUS Medical School
United States, Singapore RNA Phase I–II (798)
Phase I/II (92): Randomized, double-blinded, placebo controlled
Phase II (600): Randomized, observer-blind, placebo-controlled, multiregional, multicenter trial in healthy adults to evaluate the safety, reactogenicity, and immunogenicity.[175]
Phase IIa (106): Open label extension trial to assess the safety and long-term immunogenicity by giving single-dose vaccine to the participants from the parent study that received placebo or were seronegative at screening.[176]
Aug 2020 – Apr 2022, Singapore, United States (phase IIa)
Preclinical
VBI-2902[177]
Variation Biotechnologies
United States Virus-like particle Phase I–II (780)[178]
Randomized, observer-blind, dose-escalation, placebo-controlled
Mar 2021 – Jun 2022, Canada
Preclinical
ICC Vaccine[179]
Novavax
United States Subunit Phase I–II (640)[180]
Randomized, observer-blinded.
Sep 2021 – Mar 2022, Australia
Preclinical
Sanofi–Translate Bio COVID-19 vaccine (MRT5500)[181]
Sanofi Pasteur and Translate Bio
France, United States RNA Phase I–II (415)[182]
Interventional, randomized, parallel-group, sequential study consisting of a sentinel cohort followed by the full enrollment cohort. The sentinel cohort is a open-label, step-wise, dose-ranging study to evaluate the safety of 3 dose levels with 2 vaccinations. The full enrollment cohort is a quadruple-blinded study of safety and immunogenicity in 2 age groups, with half receiving a single injection, and the other half receiving 2 injections.
Mar 2021 – Sep 2022, Honduras, United States, Australia
Preclinical
EuCorVac-19[183]
EuBiologics Co
South Korea Subunit (spike protein using the recombinant protein technology and with an adjuvant) Phase I–II (280)
Dose-exploration, randomized, observer-blind, placebo-controlled
Feb 2021 – Mar 2022, the Philipppines (phase II), South Korea (phase I/II)
Preclinical
RBD SARS-CoV-2 HBsAg VLP
SpyBiotech
United Kingdom Virus-like particle Phase I–II (280)[184]
Randomized, placebo-controlled, multi-center.
Aug 2020 – ?, Australia
Preclinical
GX-19 (GX-19N)[185][186][187]
Genexine consortium,[188][189] International Vaccine Institute
South Korea DNA Phase I–II (410)
Phase I-II (170+210+30): Multi-center, some open-labeled, some double-blinded, single arm, randomized, placebo-controlled
Jun 2020 – Jul 2021, Seoul
Preclinical
AV-COVID-19
AIVITA Biomedical, Inc., Ministry of Health (Indonesia)
United States, Indonesia Dendritic cell vaccine (autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF) Phase I–II (202)[190][191]
Adaptive.
Dec 2020 – Feb 2022, Indonesia (phase I), United States (phase I/II)
Preclinical
COVID-eVax
Takis Biotech
Italy DNA Phase I–II (160)[192]
Multicenter, open label.
Phase I: First-in-human, dose escalation.
Phase II: single arm or two arms, randomized, dose expansion.
Feb–Sep 2021, Italy
Preclinical
BBV154[193]
Bharat Biotech[194]
India Adenovirus vector (intranasal) Phase I–II (375)[193][195]
Phase I (175): Randomized, double-blinded, multicenter.
Phase II (200): Randomized, double blind, multicenter.[196]
Mar 2021–?, India
Preclinical
ChulaCov19
Chulalongkorn University
Thailand RNA Phase I–II (72)[197]
Phase 1 (72): single-center, dose-escalation, first in human study in 2 age groups: 18-55 years-old and 56-75 years-old.
Phase 2: Multi-center, observer-blinded, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity in healthy adults between 18-75 years old.
May-September 2021, Thailand
Preclinical
COVID‑19/aAPC[198]
Shenzhen Genoimmune Medical Institute[199]
China Lentiviral vector (with minigene modifying aAPCs) Phase I (100)[198]
Single group, open-label study to evaluate safety and immunity.
Feb 2020 – Dec 2024, Shenzhen
Preclinical
LV-SMENP-DC[200]
Shenzhen Genoimmune Medical Institute[199]
China Lentiviral vector (with minigene modifying DCs) Phase I–II (100)[200]
Single-group, open label, multi-center study to evaluate safety and efficacy.
Mar 2020 – Dec 2024, Shenzhen
Preclinical
ImmunityBio COVID-19 vaccine (hAd5)
ImmunityBio
United States Viral vector Phase I–II (540)[201][202][203][204][205]
Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of a Subcutaneously- and Orally- Administered Supplemental Spike & Nucleocapsid-targeted COVID-19 Vaccine to Enhance T Cell Based Immunogenicity in Participants Who Have Already Received Prime + Boost Vaccines Authorized For Emergency Use.
Oct 2020  – Sep 2021, South Africa, United States
Preclinical
PTX-COVID19-B[206]
Providence Therapeutics
Canada RNA Phase I (60)[206]
First-in-Human, Observer-Blinded, Randomized, Placebo Controlled.[207]
Jan–May 2021, Canada
Preclinical
COVAC-2[208]
VIDO (University of Saskatchewan)
Canada Subunit (spike protein + SWE adjuvant) Phase I (108)[208]
Randomized, observer-blind, dose-escalation.[209]
Feb 2021 – Oct 2022, Halifax
Preclinical
COVI-VAC (CDX-005)[210]
Codagenix Inc.
United States Attenuated Phase I (48)[211]
First-in-human, randomised, double-blind, placebo-controlled, dose-escalation
Dec 2020 – Jun 2021, United Kingdom
Preclinical
CoV2 SAM (LNP)
GSK
United Kingdom RNA Phase I (40)[212]
Open-label, dose escalation, non-randomized
Feb–Jun 2021, United States
Preclinical
COVIGEN[213]
Bionet Asia, Technovalia, University of Sydney
Australia, Thailand DNA Phase I (150)[214]
Double-blind, dose-ranging, randomised, placebo-controlled.
Feb 2021 – Jun 2022, Australia, Thailand
Preclinical
MV-014-212[215]
Meissa Vaccine Inc.
United States Attenuated Phase I (130)[216]
Randomized, double-blinded, multicenter.
Mar 2021 – Oct 2022, United States
Preclinical
S-268019
Shionogi
Japan Subunit Phase I–II (300)[217]
Randomized, double-blind, placebo-controlled, parallel-group.
Dec 2020 – Jun 2022, Japan
Preclinical
KBP-201
Kentucky Bioprocessing
United States Subunit Phase I–II (180)[218]
First-in-human, observer-blinded, randomized, placebo-controlled, parallel group
Dec 2020 – May 2022, United States
Preclinical
AdCLD-CoV19
Cellid Co
South Korea Viral vector Phase I–II (150)[219]
Phase I: Dose Escalation, Single Center, Open.
Phase IIa: Multicenter, Randomized, Open.
Dec 2020 – Jul 2021, South Korea
Preclinical
AdimrSC-2f
Adimmune Corporation
Taiwan Subunit (Recombinant RBD +/− Aluminium) Phase I (70)[220]
Randomized, single center, open-label, dose-finding.
Aug–Nov 2020, Taiwan
Preclinical
AKS-452
University Medical Center Groningen
Netherlands Subunit Phase I–II (130)[221]
Non-randomized, Single-center, open-label, combinatorial.
Apr–Jun 2021, Netherlands
Preclinical
GLS-5310
GeneOne Life Science Inc.
South Korea DNA Phase I–II (345)[222]
Multicenter, Randomized, Combined Phase I Dose-escalation and Phase IIa Double-blind.
Dec 2020 – Jul 2022, South Korea
Preclinical
Covigenix VAX-001
Entos Pharmaceuticals Inc.
Canada DNA Phase I–II (72)[223]
Placebo-controlled, randomized, observer-blind, dose ranging adaptive.
Mar–Aug 2021, Canada
Preclinical
NBP2001
SK Bioscience Co. Ltd.
South Korea Subunit (Recombinant protein with adjuvanted with alum) Phase I (50)[224]
Placebo-controlled, Randomized, Observer-blinded, Dose-escalation.
Dec 2020 – Apr 2021, South Korea
Preclinical
CoVac-1
University of Tübingen
Germany Subunit (Peptide) Phase I–II (104)[225][226]
Phase I (36): Placebo-controlled, Randomized, Observer-blinded, Dose-escalation.
Phase I/II (68): B-pVAC-SARS-CoV-2: Phase I/II Multicenter Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults With Bcell/ Antibody Deficiency.
Nov 2020 – Feb 2022, Germany
Preclinical
bacTRL-Spike
Symvivo
Canada DNA Phase I (24)[227]
Randomized, observer-blind, placebo-controlled.
Nov 2020 – Feb 2022, Australia
Preclinical
CORVax12
Providence Health & Services
United States DNA Phase I (36)[228]
Open-label, non-randomized, parallel assignment study to evaluate the safety of prime & boost doses with/without the combination of electroporated IL-12p70 plasmid in 2 age groups: 18-50 years-old and > 50 years-old.
Dec 2020 – Jul 2021, United States
Preclinical
ChAdV68-S (SAM-LNP-S)
NIAID, Gritstone Oncology
United States Viral vector Phase I (150)[229]
Open-label, dose and age escalation, parallel design.
Mar 2021 – Sep 2022, United States
Preclinical
VXA-CoV2-1 (VXA-NVV-104)
Vaxart
United States Viral vector Phase I (83)[230][231]
Phase Ia (35): Double-blind, randomized, placebo-controlled, first-in-Human.
Phase Ib (48): Multicenter, randomized, double-blind, placebo-controlled.
Sep 2020 – Aug 2021, United States
Preclinical
SpFN COVID-19 vaccine
United States Army Medical Research and Development Command
United States Subunit Phase I (72)[232]
Randomized, double-blind, placebo-controlled.
Apr 2021 – Oct 2022, United States
Preclinical
MVA-SARS-2-S (MVA-SARS-2-ST)
University Medical Center Hamburg-Eppendorf
Germany Viral vector Phase I–II (270)[233][234]
Phase I (30): Open, Single-center.
Phase Ib/IIa (240): Multi-center, Randomized Controlled.
Oct 2020 – Mar 2022, Germany
Preclinical
ReCOV
Jiangsu Rec-Biotechnology Co Ltd
China Subunit (Recombinant two-component spike and RBD protein (CHO cell)) Phase I (160)[235]
First-in-human, randomized, double-blind, placebo-controlled, dose-finding.
Jun–Dec 2021, New Zealand
Preclinical
Koçak-19 Inaktif Adjuvanlı COVID-19 vaccine
Kocak Farma
Turkey Inactivated SARS‑CoV‑2 Phase I (38)[236]
Phase 1 Study for the Determination of Safety and Immunogenicity of Different Strengths of Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine, Given Twice Intramuscularly to Healthy Volunteers, in a Placebo Controlled Study Design.
Mar–Jun 2021, Turkey
Preclinical
mRNA-1283
Moderna
United States RNA Phase I (106)[237]
Randomized, observer-blind, dose-ranging study.
Mar 2021 – Apr 2022, United States
Preclinical
DS-5670[238]
Daiichi Sankyo[239]
Japan RNA Phase I–II (152)[240]
A Phase 1/2 Study to Assess the Safety, Immunogenicity and Recommended Dose of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects.
Mar 2021 – Jul 2022, Japan
Preclinical
CoV2-OGEN1
Syneos Health, US Specialty Formulations
United States Subunit Phase I (45)[241]
First-In-Human
Jun–Dec 2021, New Zealand
Preclinical
KD-414
KM Biologics Co
Japan Inactivated SARS‑CoV‑2 Phase I–II (210)[242]
Randomized, double blind, placebo control, parallel group.[243]
Mar 2021 – Dec 2022, Japan
Preclinical
CoVepiT
OSE Immunotherapeutics
France Subunit Phase I (48)[244][245]
Randomized, open label.
Apr–Sept 2021, France
Preclinical
HDT-301
Senai Cimatec
Brazil RNA Phase I (90)[246]
Randomized, open-label, dose-escalation.
Aug 2021–Sep 2022, Brazil
Preclinical
SC-Ad6-1
Tetherex Pharmaceuticals
United States Viral vector Phase I (40)[247]
First-In-Human, Open-label, Single Ascending Dose and Multidose.
Jun–Dec 2021, Australia
Preclinical
Unnamed
Osman ERGANIS, Scientific and Technological Research Council of Turkey
Turkey Inactivated SARS‑CoV‑2 Phase I (50)[248]
Phase I Study Evaluating the Safety and Efficacy of the Protective Adjuvanted Inactivated Vaccine Developed Against SARS-CoV-2 in Healthy Participants, Administered as Two Injections Subcutaneously in Two Different Dosages.
Apr–Oct 2021, Turkey
Preclinical
EXG-5003
Elixirgen Therapeutics, Fujita Health University
Japan, United States RNA Phase I–II (60)[249]
First in Human, randomized, placebo-controlled.
Apr 2021 – Jan 2023, Japan
Preclinical
mRNACOVID-19 Vaccine
Stemirna Therapeutics Co. Ltd.
China RNA Phase I (240)[250]
Randomized, double-blind, placebo-controlled.
Mar–Jul 2021, China
Preclinical
IVX-411
Icosavax, Seqirus Inc.
United States Virus-like particle Phase I–II (168)[251][252]
Phase I/II (84): Randomized, observer-blinded, placebo-controlled.
Jun 2021–2022, Australia
Preclinical
QazCoVac-P[253]
Research Institute for Biological Safety Problems
Kazakhstan Subunit Phase I–II (244)[254]
Phase I: Randomized, blind, placebo-controlled.
Phase II: Randomized, open phase.
Jun – Dec 2021, Kazakhstan
Preclinical
LNP-nCOV saRNA-02
MRC/UVRI & LSHTM Uganda Research Unit
Uganda RNA Phase I (42)[255]
A Clinical Trial to Assess the Safety and Immunogenicity of LNP-nCOV saRNA-02, a Self-amplifying Ribonucleic Acid (saRNA) Vaccine, in SARS-CoV-2 Seronegative and Seropositive Uganda Population.
Sep 2021 – Jun 2022, Uganda
Preclinical
Noora[256]
Baqiyatallah University of Medical Sciences
Iran Subunit (RBD protein recombinant vaccine) Phase I (70)[257]
Randomized, double-blinded, placebo-controlled.
Jun–Aug 2021, Iran
Preclinical
Baiya SARS-CoV-2 Vax 1[258]
Baiya Phytopharm Co Ltd.
Thailand Plant-based Subunit (RBD-Fc + adjuvant) Phase I (96)[259]
Randomized, open-label, dose-finding.
Sep–Dec 2021, Thailand
Preclinical
CVXGA1
CyanVac LLC
United States Viral vector Phase I (80)[260]
Open-label
July–Dec 2021, United States
Preclinical
Unnamed
St. Petersburg Scientific Research Institute of Vaccines and Sera of Russia at the Federal Medical Biological Agency
Russia Subunit (Recombinant) Phase I–II (200)[261]
July–? 2021, Russia
Preclinical
LVRNA009
Liverna Therapeutics Inc.
China RNA Phase I (24)[262]
July–Nov 2021, China
Preclinical
PHH-1V
Hipra[263]
Spain Subunit Phase I–II (30)[264]
Randomized, controlled, observer-blinded, dose-escalation.
Aug–Nov 2021, Spain
Preclinical
Versamune-CoV-2FC [pt]
Farmacore Biotechnology, PDS Biotechnology Corporation, Faculty of Medicine of Ribeirão Preto
Brazil, United States Subunit Phase I–II (360)[265]
Double-blind, randomized controlled.
Nov 2021–Mar 2022, Brazil
Preclinical
ARCT-165
Arcturus Therapeutics
United States RNA Phase I–II (72)[266]
Randomized, observer-blind.
Aug 2021–Mar 2023, Singapore, United States
Preclinical
BCD-250
Biocad
Russia Viral vector Phase I–II (160)[267]
Randomized, double-blind, placebo-controlled, adaptive, seamless phase I/II.
Aug 2021–Aug 2022, Russia
Preclinical
Unnamed
North's Academy of Medical Science Medical biology institute
North Korea Subunit (spike protein with Angiotensin-converting enzyme 2) Phase I–II (?)[268]
Jul 2020, North Korea
Preclinical
Unnamed
Sinopharm
China Subunit Phase I–II (?)[269]
Apr 2021–?, China
Preclinical
Vabiotech COVID-19 vaccine
Vaccine and Biological Production Company No. 1 (Vabiotech)
Vietnam Subunit Preclinical
Awaited for the conduct on Phase I trial.[270]
?
INO-4802
Inovio
United States DNA Preclinical
Awaited for the conduct on Phase I/II trials.[271]
?
Bangavax (Bancovid)[272][273]
Globe Biotech Ltd. of Bangladesh
Bangladesh RNA Preclinical
Awaiting for approval from Bangladesh government to conduct the first clinical trial.[274]
?
Unnamed
Indian Immunologicals, Griffith University[275]
Australia, India Attenuated Preclinical ?
EPV-CoV-19[276]
EpiVax
United States Subunit (T cell epitope-based protein) Preclinical ?
Unnamed
Intravacc[277]
Netherlands Subunit Preclinical ?
CV2CoV[278]
CureVac, GSK
Germany, United Kingdom RNA Preclinical ?
DYAI-100[279] Sorrento Therapeutics, Dyadic International, Inc.[280] United States Subunit Preclinical ?
Unnamed[281]
Ministry of Health (Malaysia), Malaysia Institute of Medical Research Malaysia, Universiti Putra Malaysia
Malaysia RNA Preclinical ?
AdCOVID
Altimmune Inc.
United States Viral vector Terminated (180)[282][283]
Double-blind, randomized, placebo-controlled, first-in-Human.
Feb 2021 – Feb 2022, United States
Preclinical
LNP-nCoVsaRNA[284]
MRC clinical trials unit at Imperial College London
United Kingdom RNA Terminated (105)
Randomized trial, with dose escalation study (15) and expanded safety study (at least 200)
Jun 2020 – Jul 2021, United Kingdom
?
TMV-083
Institut Pasteur
France Viral vector Terminated (90)[285]
Randomized, Placebo-controlled.
Aug 2020 – Jun 2021, Belgium, France
?
SARS-CoV-2 Sclamp/V451[286][287][unreliable source?]
UQ, Syneos Health, CEPI, Seqirus
Australia Subunit (molecular clamp stabilized spike protein with MF59) Terminated (120)
Randomised, double-blind, placebo-controlled, dose-ranging.
False positive HIV test found among participants.
Jul–Oct 2020, Brisbane
?
V590[288] and V591/MV-SARS-CoV-2[289] Merck & Co. (Themis BIOscience), Institut Pasteur, University of Pittsburgh's Center for Vaccine Research (CVR), CEPI United States, France Vesicular stomatitis virus vector[290] / Measles virus vector[291][unreliable source?] Terminated
In phase I, immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines.[292]
  1. ^ Latest Phase with published results.
  2. ^ Virus-like particles grown in Nicotiana benthamiana[50]
  3. ^ Phase I–IIa in South Korea in parallel with Phase II–III in the US

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