Table 2.
Clinical trial status of some promising vaccines for the prophylaxis of SARS-CoV-2 infection (www.clinicaltrials.gov) Accessed on May 5, 2021.
| Candidate and clinical trial identifier number | Sponsor | Study title and Clinical trial status |
Characteristics/ Description |
Actual enrolment | Actual study start date and estimated study completion date |
|---|---|---|---|---|---|
| mRNA-1273 NCT04283461 |
National Institute of Allergy and Infectious Diseases (NIAID) | Safety and immunogenicity study of 2019-nCoV vaccine (mRNA-1273) for prophylaxis of SARS-CoV-2 infection (COVID-19) Phase 1 Open-label, dose-ranging study to determine the safety and immunogenicity of mRNA-1273 |
mRNA-based vaccine is encapsulated in a lipid nanoparticle that encodes for a full length, S protein of SARS-CoV-2. | 120 participants | March 16, 2020 November 22, 2022 |
| LV-SMENP NCT04276896 |
Shenzhen Geno-Immune Medical Institute | Immunity and safety of Covid-19 synthetic minigene vaccine Phase 1/2Multicentre study to determine the safety and efficacy of Lentiviral Minigene Vaccine (LV-SMENP) |
LV-SMENP vaccine is prepared by modifying dendritic cells with lentivirus vectors expressing COVID-19 minigene SMENP and immune modulatory genes | 100 participants (estimated) |
March 24, 2020 December 31, 2024 |
| INO-4800 NCT04336410 |
Inovio Pharmaceuticals | Safety, tolerability and immunogenicity of INO-4800 for COVID-19 in healthy volunteers Phase 1 Open-label study to determine the safety, tolerability and immunogenicity of INO-4800 |
Contains the plasmid PGX9501 which encodes full length S protein (Vaccine is administered intradermally followed by electroporation using CELLECTRA® 2000 | 120 participants | April 3, 2020 January 2022 |
| COV001 NCT04324606 |
University of Oxford | A study of a candidate COVID-19 vaccine (COV001) Phase 1/2 Single-blinded, randomized multicentre study to determine the efficacy, safety and immunogenicity of ChAdOx1 nCoV-19 |
ChAdOx1 nCoV-19 is a Chimpanzee adenovirus vectored vaccine expressing the SARS-CoV-2 spike protein | 1090 participants | April 23, 2020 October 2021 |
| BNT162b1 and BNT162b2 NCT04368728 |
BioNTech SE | Study to describe the safety, tolerability, immunogenicity, and efficacy of RNA vaccine candidates against COVID-19 in healthy individuals Phase 2/3 A placebo- controlled, randomized, observer-blind, dose finding study to determine the safety, tolerability, immunogenicity and efficacy |
BNT162b1 is a lipid nanoparticle formulated, nucleoside modified mRNA vaccine that encodes the trimerized receptor binding domain of spike glycoprotein of SARS-CoV-2 | 46,663 participants (estimated) | April 29. 2020 April 6, 2023 |
| Recombinant novel coronavirus vaccine (adenovirus type 5 vector) NCT04313127 |
CanSino Biologicals Inc. | Phase I clinical trial of a COVID-19 vaccine in 18–60 healthy adults (CTCOVID-19) Phase 1Single centre opel-label, dose-escalating study to determine the safety, reactogenicity and immunogenicity of recombinant novel coronavirus vaccine (adenovirus type 5 vector) |
Recombinant novel coronavirus vaccine (adenovirus type 5 vector) | 108 participants | March 16, 2020 December 20, 2022 |
| Pathogen-specific artificial antigen presenting cell (aAPC) NCT04299724 |
Shenzhen Geno-Immune Medical Institute | Safety and immunity of Covid-19 aAPC vaccine Phase 1 Open-label study to determine the safety and immunity of artificial antigen presenting cell vaccine |
aAPC vaccine is prepared by modifying lentivirus including immune modulatory genes and the viral minigenes to the artificial antigen presenting cells | 100 participants (estimated) |
February 15, 2020 December 31, 2024 |
| GX-19 NCT04445389 |
Genexine, Inc. | Safety and immunogenicity study of GX-19, a COVID-19 preventive DNA vaccine in healthy adults Phase 1/2 Multicenter, randomized, double blind, placebo controlled study to study the safety, tolerability and immunogenicity of GX-19 |
GX-19 is a SARS-CoV-2 spike (S) DNA based vaccine | 210 participants (estimated) | June 17, 2020 June 17, 2022 |
| Ad26.COV2.S NCT04505722 |
Janssen Vaccines & Prevention B.V. | A study of Ad26.COV2.S for the prevention of SARS-CoV-2-mediated COVID-19 in adult participants (ENSEMBLE) Phase 3 Randomized, double-blind, placebo controlled study to investigate the efficacy and safety of Ad26.CoV2.S. |
Ad26.COV2.S is a recombinant, replication-incompetent adenovirus serotype 26 vector encoding a SARS-CoV-2 spike protein. |
44,325 participants | September 7, 2020 January 2, 2023 |
| Gam-COVID-Vac NCT04436471 |
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation | An open study of the safety, tolerability and immunogenicity of the drug “Gam-COVID-Vac” vaccine against COVID-19 Phase 1/2 An open two stage non-randomized study to assess the safety, tolerability and immunogenicity of Gam-COVID-Vac |
Gam-COVID-Vac is a recombinant adenovirus vector based on human adenovirus type 26 containing the SARS-CoV-2 S protein | 38 participants | June 17, 2020 August 10, 2020 |
| SARS-CoV-2rS/Matrix-M1 Adjuvant NCT04611802 |
Novavax | A study to evaluate the efficacy, immune response, and safety of COVID-19 vaccine in adults ≥ 18 years with a pediatric expansion in adolescents (12–17 years) at risk for SARS-CoV-2 Phase 3 Randomized, observer blinded, placebo controlled study to determine the efficacy, safety and immunogenicity of SARS-CoV-2 rS/Matrix-M1 adjuvant |
SARS-CoV-2 rS/Matrix-M1 is a SARS-CoV-2 recombinant spike protein nanoparticle vaccine with Matrix-M1 adjuvant | 33,000 participants (estimated) |
December 27, 2020 June 30, 2023 |
| BBV152 NCT04641481 |
Bharat Biotech International Limited | An efficacy and safety clinical trial of an investigational COVID-19 vaccine (BBV152) in adult volunteers Phase 3 Event-driven, randomized, double blind, placebo controlled, multicentre study to evaluate the efficacy, safety and immunogenicity of BBV152. |
BBV152 is a whole virion inactivated SARS-CoV-2 vaccine. | 25,800 participants | November 16, 2020 December 2022 |