World-class scientists have accelerated the clinical trial process to develop COVID-19 preventive vaccine candidates. As of November 20, 2020, the U.S. FDA has not approved any preventive vaccines for Emergency Use against the newly identified SARS-CoV-2 coronavirus.
The vaccine development landscape includes innovative platforms such as nucleic acid (DNA and RNA), virus-like particle, peptide, viral vector (replicating and non-replicating), recombinant protein, live attenuated virus, and inactivated virus approaches.
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COVID-19 Vaccines: Limited Experimental Use
CHINA: Ad5-nCoV SARS-CoV-2 vaccine
The Ad5-nCoV vaccine candidate is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein. The vaccine candidate is built upon CanSinoBIO’s adenovirus-based viral vector vaccine technology platform. This vaccine candidate is a single-dose regimen.
RUSSIA: Sputnik V Vaccine
The COVID-19 vaccine Sputnik V is an adenoviral-based vaccine against the SARS-CoV-2 coronavirus. Sputnik V deploys two different types of adenovirus vectors (rAd26 and rAd5) for the first and second vaccination, boosting the effect of the vaccine. On August 1, 2020, the Russian Health Minister Mikhail Murashko announced 'clinical trials had been declared completed.'
COVID-19 Vaccine: Phase 3 Clinical Trials
Pfizer and BioNTech's BNT162b2 mRNA vaccine candidate encodes an optimized SARS-CoV-2 full-length spike glycoprotein, in a 2-dose (0, 21d) regimen. In the phase 3 study, the vaccine candidate was found to be more than 90% effective in preventing COVID-19 in (94) participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.
Johnson and Johnson's Janssen Vaccines & Prevention B.V. investigational SARS-CoV-2 viral vector vaccine is an adenovirus serotype 26 (Ad26) vector-based vaccine. Announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate in a single-dose regimen.
AstraZeneca/University of Oxford's Jenner Institute's AZD1222 vaccine uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (ChAdOx1) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. This viral vector vaccine candidate will require a two-dose regimen (0, 28d)
Moderna's mRNA-1273 is an mRNA vaccine candidate against the SARS-CoV-2 betacoronavirus encoding for a prefusion stabilized form of the Spike protein. The Phase 3 COVE study is being conducted in collaboration with the NIH and the BARDA, which began on July 27, 2020, and enrollment of approximately 30,000 participants. mRNA-1273 is a two-dose (0, 28d) regimen.
An inactivated 'new crown' vaccine created by Wuhan Institute of Biological Products under the China National Pharmaceutical Group, Sinopharm, and the Wuhan Institute of Virology entered phase 3 clinical trial in Morocco.
Sinovac Biotech's CoronaVac SARS-CoV-2 Vaccine candidate is based on an inactivated pathogen. A phase II clinical trial showed that the vaccine-induced neutralizing antibodies 14 days after the vaccination with a 0 and 14-day schedule. The neutralizing antibody seroconversion rate is above 90%, which indicates the vaccine candidate can induce a positive immune response. A phase 3 trial is underway in Turkey, Brazil, and Indonesia to assess the efficacy, safety and immunogenicity, and lot-to-lot consistency evaluation.
Russia's Vektor State Research Center of Virology and Biotechnology EpiVacCorona vaccine contains fragments extracted from the virus — synthetic peptide antigens. The antigens-based vaccine provokes an immune reaction against COVID-19 and promotes the further development of immunity.
COVID-19 Vaccine: Phase 2 Clinical Trials
Novavax's NVX-CoV2373 is a prefusion protein subunit coronavirus vaccine candidate created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. This vaccine will require a two-dose (0, 21d) regimen. Phase 1/2 clinical trial has completed enrollment.
Sanofi and GSK announced the start of the Phase 1/2 clinical trial for their adjuvanted COVID-19 protein subunit vaccine. Over 400 participants being enrolled in the Phase 1/2 study. If Phase 1/2 data positive, companies aim to move into a Phase 3 trial by end of 2020.
CureVac's CVnCoV is an mRNA vaccine candidate that utilizes nucleotides without chemical modifications in the mRNA. On September 29, 2020, the first participant was dosed in a Phase 2a clinical trial of its COVID-19 vaccine candidate, CVnCoV. The dose-confirmation study, entitled CV-NCOV-002, is being conducted in Peru and Panama.
RedHill Biopharma novel COVID-19 candidate RHB-107 (upamostat) is an orally administered novel serine protease inhibitor, with demonstrated antiviral and potential tissue-protective effects. RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in a human bronchial cell model and targets a host cell component involved in viral replication, minimizing the potential for resistance due to viral mutations.
COVID-19 Vaccine: Phase 1 Clinical Trials
Inovio's DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body. On July 30, 2020, Inovio announced INO-4800 vaccination generated antibodies neutralizing both the earlier strain of the coronavirus, as well as the mutant variant (D614G), that has emerged with greater infectivity, and now accounts for about 80% of newly circulating virus.
The Israel Institute for Biological Research Indiana vesiculovirus (VSV) COVID-19 vaccine candidate will begin the first phase of the testing process with two initial participants, increasing to 80 over the month of November. If they respond well to the vaccine and develop antibodies against the virus, the testing will expand to 960 people beginning in December 2020.
Vaxart's VXA-CoV2-1 vaccine candidate is based upon an oral H1 flu tablet which has shown positive results in clinical studies. The Phase 1, open-label, dose-ranging study will be conducted in healthy adults ages 18 to 55 years old. The study’s primary objective is to examine the safety and reactogenicity of 2-doses of the vaccine.
Merck's V591 SARS-CoV-2 replicating viral vector vaccine candidate uses a measles virus vector platform to deliver the antigens to the immune system to spur antibody production against the SARS-CoV-2 virus. The Phase 1/2 clinical trial is currently recruiting and will Assess Safety, Tolerability, and Immunogenicity of V591 in Healthy Participants.
Valneava's VLA2001 is a Vero-cell based, highly purified inactivated vaccine candidate against the SARS-COV-2 virus, leveraging the manufacturing technology for Valneva’s Japanese Encephalitis Vaccine. The VLA2001 vaccine candidate is expected to enter initial clinical studies by the end of 2020.
The University of Queensland announced on July 13, 2020, it has dosed the initial participant in phase 1 clinical trial in Brisbane, Australia. CSL and the Australian Government agreed to supply 51 million doses of the UQ COVID-19 vaccine to Australia, with the first doses scheduled for release from mid-2021 following successful clinical trials.
Aivita Biomedical's AV-COVID-19 AuDendritic cell vaccine candidate consists of autologous dendritic cells which are loaded with antigens from SARS-CoV-2. It is in a Phase 1/2 clinical trial "Adaptive Phase IB-II Randomized Clinical Trial Of Preventive Vaccine Consisting Of Autologous Dendritic Cells Loaded With Antigens From Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), With Or Without GM-CSF, In Subjects Negative For COVID-19 Infection And Anti-SARS-CoV-2 Antibodies".
The Sichuan 'Clover' Biopharmaceuticals S-Trimer (SCB-2019) recombinant subunit vaccine candidate is targeted for the SARS-CoV-2 virus that causes COVID-19 disease. The vaccine is conducting phase 1 clinical trial in Australia testing different boosters provided by GSK and Dynavax. Clover's S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.
A randomized, double-blind, placebo parallel controlled phase I/II clinical trial to evaluate the safety and immunogenicity of the new inactivated coronavirus vaccine (2019-CoV) (Vero cells) in healthy people aged 3 years and older
Covaxin is an inactivated SARS-CoV-2 vaccine candidate. The coronavirus strain was isolated from an asymptomatic COVID-19 patient at NIV, Pune.
The GSK and Medicago collaboration intends to develop a COVID-19 candidate vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. CoVLPs mimic the structure of the virus responsible for COVID-19 disease, allowing them to be recognized by the immune system. On November 10, 2020, the companies reported '100 % of subjects who received an adjuvanted vaccine candidate developed significant antibody and cellular immune responses after two doses.'
Corvus is studying an agonistic (immunostimulatory) humanized monoclonal antibody, designated as CPI-006, which has demonstrated a potential new approach to immunotherapy of infectious diseases and cancer. To date, over 90 cancer patients have been treated with CPI-006 in the Corvus Phase 1/1b study, with dosing as high as 24 mg/kg every three weeks.
AdCOVID is based on Altimmune Inc.'s adenovirus-based intranasal vaccine platform and expresses the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. AdCOVID is designed to guard the respiratory tract from viral invasion and to provide downstream protection against the viral spread through stimulation of both mucosal and systemic antibodies (IgA and IgG) as well as cell-mediated immunity.
Elixirgen Therapeutics's EXG-5003 is a temperature-sensitive self-replicating RNA vaccine expressing the receptor-binding domain of the SARS-CoV-2 spike protein. EXG-5003 was optimized for intradermal injection with potential dose-sparing and safety benefits. Human clinical trials are expected to begin at Fujita Health University Hospital in Aichi, Japan in Q1 2021.
ReiThera Srl RT-CoV-2 is a Phase I, open-label, dose-escalation multicenter clinical trial to assess the safety and immunogenicity of the candidate vaccine GRAd-COV2 in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based on a novel replication-defective Gorilla Adenovirus and encodes for SARS-COV-2 full-length prefusion stabilized Spike protein.
CDX-005 is an intranasal, live-attenuated vaccine candidate that is generated using Codagenix’s proprietary deoptimization technology. CDX-005 is designed to produce immunity against all SARS-CoV-2 proteins, not just the spike surface protein.
ImmunityBio hAd5 COVID-19 vaccine candidate targets the inner nucleocapsid and the outer spike protein, engineered to activate both T cells and antibodies against the SARS-CoV-2 coronavirus. Phase 1 study launched in California during October 2020.
Medicago's Coronavirus Virus-Like Particle vaccine began Phase 1 testing in human volunteers on July 14, 2020. Medicago plans to initiate Phase 2 trials in early November, and Phase 3 trials shortly after, in December 2020.
The Phase 1 trial of bacTRL-Spike™ Vaccine for Prevention of COVID-19 is being conducted in partnership with Nucleus Network in Brisbane, Australia. Preliminary data are anticipated in early 2021.
Cadila Healthcare (Zydus Cadila) said it has completed enrolment and dosing of 1,000 volunteers in phase-2 clinical trials of its potential Covid-19 vaccine, ZyCoV-D, and plans to submit the data to the Drug Controller General of India.
OSE Immunotherapeutics's CoVepiT is a prophylactic vaccine based on optimized epitopes selected to induce a lasting sentinel T lymphocyte immune response against SARS-CoV-2, the virus that causes COVID-19.
Arcturus is combining its self-replicating mRNA STARR™ Technology with its LUNAR® RNA medicine delivery technology to developing a prophylactic vaccine against COVID-19. Arcturus's LUNAR-COV19 vaccine is developed in collaboration with the Duke-National University of Singapore Medical School is developing an mRNA vaccine to prevent COVID19 coronavirus infection.
ImmunityBio and NantKwest are currently enrolling 35 healthy adults aged 18 to 55 years old in the Phase 1 study for the hAd5-COVID-19 vaccine candidate. This study shows hAd5 S+N COVID-19 vaccine candidate, which delivers two distinct proteins, stimulates T-cell responses of volunteers recovered from SARS-CoV-2 infection, demonstrating that the S and N antigens from the vaccine are recognized by SARS-COV-2 reactive human T cells.
Biological E. Limited a Hyderabad-based vaccines and pharmaceutical company initiated a Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India. The Phase I/II clinical trial will evaluate the safety and immunogenicity of the vaccine candidate consisting of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years. The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart.
The City of Hope announced it has initiated a phase 1 clinical trial for the investigational vaccine, known as COH04S1, which aims to stimulate the immune system to produce antibodies, that can block the SARS-CoV-2 coronavirus from entering cells, and also spur abundant T cells that are thought to provide the elusive long-term protection that could protect against future outbreaks.
Vaccination decisions during the COVID-19 pandemic should be discussed between patients and their healthcare providers, says the U.S. CDC.
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