Clinical Trials for Other Diseases (T only) / Related Use or Platform (V only)
FDA-Approved Indications
Sources
Date Last Updated
Beijing Institute of Biological Products/ Sinopharm
Phase III
Inactivated virus
Inactivated, (BBIBP-CorV)
Phase I/II results published October 2020; Phase III trial began July 2020; Received early approval for emergency use in China (Aug 2020) and the UAE (Sep 2020)
ChiCTR2000032459, ChiCTR2000034780, NCT04560881
Unknown
The Lancet (https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30831-8/fulltext)
Received approval for Phase I/II trial in adolescents and children in September 2020; Phase III trial began end of July 2020; Phase II began June 2020, mid-phase II results released August 2020; Preliminary results from Phase I/II trials released June and September 2020 (aged 60+) 2020; Received early approval for emergency use in China in August 2020
Phase III trial began July 2020; Phase I/II early trial results released June 2020, Phase I/II interim analysis published August 2020; Received early approval for emergency use in China (Aug 2020) and the UAE (Sep 2020)
CanSino Biologics/ Beijing Institute of Biotechnology/ Canada's National Research Council/ Petrovax
Phase III
Non-replicating viral vector
Non-replicating viral vector; Adenovirus Type 5 vector (Ad5-nCoV)
Phase III dosed September 2020; Phase II began April 2020, initial results released May 2020, mid-phase results released July 2020; Received early approval for military use in China in June 2020
The Lancet (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31208-3/fulltext), The Lancet (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31605-6/fulltext)
Phase III (post-registration) trial began September 2020; Phase I/2 began June 2020, results published September 2020; Received early approval for use in Russia in August 2020, Mass production expected to begin September 2020
Janssen Pharmaceutical Companies/ Beth Israel Deaconess Medical Center/ Emergent BioSolutions/ Catalent/ Biological E/ Grand River Aseptic Manufacturing (GRAM)
Phase III
Non-replicating viral vector
Ad26.COV2-S, Non replicating viral vector; Ad26 (alone or with MVA boost)
Phase III trial (ENSEMBLE) resumed recruitment on 10/23/2020; Janssen Pharmaceutical Companies of Johnson & Johnson voluntarily paused dosing to allow independent review of safety data on 10/12/2020; Phase III trial (ENSEMBLE) began and study protocol released September 2020; Phase I/IIa began end of July 2020, interim results released September 2020; Animal study results published July and September 2020; Selected for US Operation Warp Speed in February 2020 and awarded funding in August 2020
NCT04436276, NCT04505722
Biomedical Advanced Research and Development Authority (BARDA)
Same platform as vaccine candidates for Ebola, HIV, RSV
University of Oxford, Oxford Biomedica, Vaccines Manufacturing and Innovation Centre, Pall Life Sciences, Cobra Biologics, HalixBV, Advent s.r.l., Merck KGaA, the Serum Institute, Vaccitech, Catalent, CSL, and AstraZeneca/IQVIA
Study protocol for late-stage clinical trials released September 2020; AstraZeneca clinical trials resumed globally (in the UK on 9/14/2020, Brazil and South Africa on 9/15/2020, Japan on 10/2/2020, and the US on 10/23/2020); AstraZeneca voluntarily paused vaccination to allow independent review of safety data on 9/8/2020; Phase III trial began Jun 2020 and expanded into US in Aug 2020; Phase II/III began May 2020; Interim results from Phase I/II trial released Jul 2020; Selected for US Operation Warp Speed in May 2020
Coalition for Epidemic Preparedness Innovations (CEPI)/ UK Government/ Biomedical Advanced Research and Development Authority (BARDA)/ Gavi, the Vaccine Alliance
The Lancet (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext)
Same platform as vaccine candidates for influenza, TB, Chikungunya, Zika, MenB, plague
Novavax/Emergent Biosolutions/ Praha Vaccines/ Biofabri/ Fujifilm Diosynth Biotechnologies/ FDB/ Serum Institute of India/ SK bioscience/ Takeda Pharmaceutical Company Limited/ AGC Biologics/ PolyPeptide Group/ Endo
Phase III
Protein subunit
Protein subunit; Full-length recombinant SARS COV-2 glycoprotein nanoparticle vaccine adjuvanted with Matrix M (NVX-CoV2373)
Phase III expected to begin in the US by end of November 2020; Phase III dosed in the UK in October 2020, interim data expected to be released in Q1 2021; Phase IIb trial began Aug 2020; Selected for US Operation Warp Speed July 2020; Phase I/II began end of May 2020, interim data expected to be released on 10/30/2020; Animal study & preliminary Phase I results released Aug 2020, Phase I results published Sept 2020
UK Medicines and Healthcare products Regulatory Agency (MHRA) started rolling review process on 10/27/2020; EMA confirmed marketing authorization submission eligibility on 10/14/2020; Health Canada rolling submission initiated on 10/13/2020; Study protocol for late-stage clinical trials released September 2020; Phase I interim data from older adult cohorts released Aug 2020 and published Sep 2020; Phase III COVE study began July 2020, completed enrollment on 10/22/2020; Animal study results published July/Aug 2020; Phase I interim results published July 2020; FDA fast track designation granted May 2020; Selected for US Operation Warp Speed in April 2020
NCT04283461, NCT04405076, NCT04470427
Coalition for Epidemic Preparedness (CEPI)/ Biomedical Advanced Research and Development Authority (BARDA)
Moderna (https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-interim-phase-1-data-its-mrna-vaccine), NEJM (https://www.nejm.org/doi/full/10.1056/NEJMoa2022483), NEJM (https://www.nejm.org/doi/full/10.1056/NEJMoa2028436)
Same platform as vaccine candidates for multiple candidates
Phase III interim analysis results announced 11/09/2020; Phase I data published October 2020; FDA approved late-stage trial enrollment of children 12 years and older in October 2020; EMA rolling submission initiated on 10/6/2020; Study protocol for late-stage clinical trials released Sept 2020; Amended protocol to FDA to expand trial enrollment to 44,000 participants; Phase IIb/III trial began Jul 2020; FDA granted Fast Track designation for BNT162b1 and BNT162b2 in Jul 2020; Selected for US Operation Warp Speed in Jul 2020; Phase I/II began Apr 2020; preliminary data released Jul 2020, additional data published Aug 2020 and Sept 2020; Animal study data released Sept 2020
Phase IIb/III trial expected to begin by the end of 2020; Phase IIa trial began end of September 2020; Phase I trial began June 2020, interim results reported November 2020; Pre-clinical data released October 2020
NCT04449276, NCT04515147
Coalition for Epidemic Preparedness (CEPI); European Commission; Gates Foundation; Defense Advanced Research Projects Agency (DARPA); German Government; European Investment Bank (EIB); German Federal Ministry of Education and Research (BMBF)
Same platform as vaccine candidates for RABV, LASV, YFV, MERS, InfA, ZIKV, DengV, NIPV
Genexine Consortium (GenNBio, International Vaccine Institute, Korea Advanced Institute of Science and Technology (KAIST), Pohang University of Science and Technology (POSTECH)/ Binex/ PT Kalbe Pharma
Phase I/II
DNA-based
DNA; (GX-19)
Phase I/II study: Phase I began end of June 2020, preliminary data expected September 2020; Animal study results announced August 2020
Inovio Pharmaceuticals/ Beijing Advaccine Biotechnology/ VGXI Inc./ Richter-Helm BioLogics/ Ology Bioservices/ International Vaccine Institute/ Seoul National University Hospital/ Thermo Fisher Scientific
Phase I/II
DNA-based
DNA; (INO-4800) plasmid vaccine with electroporation
FDA partial clinical hold for planned Phase II/ III trial reported on 9/28/2020; Phase I/IIa trial began July 2020; Animal study results released July 2020; Joined US Operation Warp Speed in June 2020; Phase I began April 2020, interim data of ongoing study released June 2020
NCT04336410, NCT04447781
Coalition for Epidemic Preparedness (CEPI) / Gates Foundation / US Department of Defense
Bharat Biotech/ Indian Council of Medical Research/ National Institute of Virology
Phase I/II
Inactivated virus
Inactivated; whole-virion (COVAXIN) (BBV152)
Phase III expected to begin mid-October 2020; Phase I/II study: Phase I began July 2020 and Phase II began September 2020, initial results expected September 2020; Animal study results released September 2020
Phase I interim data announced November 2020; Pre-clinical data released November 2020; Phase I dosed October 2020; Animal study results released August 2020; Selected for US Operation Warp Speed in May 2020
NCT04591717
Unknown
Same platform as vaccine candidates for flu, Chik, Zika, EBOV, LASV, HIV/SIV, cancer
Phase I dosed October 2020; FDA clearance for Phase I trial received September 2020, recruiment expected to begin September 2020; Pre-clinical results released September 2020; Data from ongoing animal challenge study expected in October 2020
NCT04563702
Unknown
Same platform as vaccine candidates for InfA, CHIKV, LASV, NORV, EBOV, RVF, HBV, VEE
Protein subunit, native like trimeric subunit spike protein
Pre-clinical results released September 2020; CEPI partnership expanded in July and November 2020, Phase I trial began June 2020, preliminary results expected in the near future; Phase II/III expected to begin before the end of 2020
NCT04405908
Coalition for Epidemic Preparedness (CEPI)
Same platform as vaccine candidates for HIV, RSV, Influenza
MVC-COV1901 vaccine injection; S-2 P protein + CpG 1018
Phase I dosed in early October 2020; Received conditional approval for clinical testing on Aug 31 and was given full approval on Sept 30; Animal study data released August 2020
Ege University Drug Development and Pharmacokinetic Research Application Center (ARGEFAR)/ Scientific and Technological Research Council of Turkey (TUBITAK)
OPENCORONA Project: Karolinska Institute/ Justus Liebig University Giessen/ Public Health Agency of Sweden (FoHM)/ IGEA/ Cobra Biologics/ Adlego Biomedical/ Region Stockholm
German Center for Infection Research (DZIF)/ IDT Biologika GmbH/ Universitätsklinikum Hamburg-Eppendorf/ Philipps University Marburg Medical Center/ Ludwig-Maximilians University of Munich
Pre-clinical
Non-replicating viral vector
Non-replicating viral vector; MVA-S encoded
Phase I expected to be dosed mid-October 2020
NCT04569383
Unknown
Same platform as vaccine candidates for many pathogens
IMV, Inc., Canadian Center for Vaccinology at Dalhousie University, Izaak Walton Killam Health Center, Nova Scotia Health Authority, Canadian Immunization Research Network, University of Laval, Global Urgent and Advanced Research and Development in Canada
Pre-clinical
Protein subunit
Protein subunit; DPX-COVID-19, protein subunit, peptide antigens formulated in LNP
Phase I to start by Summer 2020, results expected by Fall 2020; Phase II expected to start in the second half of 2020
National Research Council of Canada Industrial Research Assistance Program (NRC IRAP), Atlantic Canada Opportunities Agency (ACOA), and Next Generation Manufacturing Canada (NGen)
Same platform as vaccine candidates for cancer and infectious diseases, including malaria and anthrax
PREVENT-nCoV consortium (AdaptVac, Institute for Tropical Medicine at University of Tubingen, Leiden University Medical Center, University of Copenhagen, ExpreS2ion Biotechnologies, Wageningen University)/ Bavarian Nordic
Preliminary pre-clinical results are expected in the second half of 2020, Phase I trial is expected to begin thereafter; Selected by BARDA DRIVe for support in August 2020
Biomedical Advanced Research and Development Authority (BARDA) Division of Research, Innovation, and Ventures (DRIVe)
LV-SMENP-DC Dendritic cells modified with lentiviral vector expressing synthetic minigene based on domains of selected viral proteins; administered with antigen-specific cytotoxic T lymphocytes