Last updated on January 27th, 2021 at 11:55 am
This article about COVID19 vaccine trials will be regularly updated as new clinical trials are registered or early results are published about an ongoing trial. Again, this article will focus on COVID19 vaccine trials – treatments and diagnostic tests are outside of the scope of this article.
Keeping up with COVID19 vaccine candidates has gotten out of hand, so for brevity, I’ve created a separate list of coronavirus vaccine trials. The interest in clinical trials for a new COVID19 vaccine is unprecedented, so I thought this might be the best way to keep loyal readers up-to-date.
Recently, the World Health Organization (WHO) has listed over 140 COVID19 vaccine candidates, which is amazing, but it is way too difficult to tell which ones have any chance of actually becoming a real product.
Right now, there are at least 30 COVID19 vaccine candidates in clinical trials – this article will analyze these coronavirus vaccine trials. Every single day, a new COVID19 vaccine candidate enters clinical trials, so this may be out of date within a few hours!
Developing a COVID19 vaccine
I wrote previously about how a COVID19 vaccine is developed. But it bears repeating.
An average vaccine takes anywhere from 2-5 years to develop before a clinical trial can begin. With worldwide collaboration and government money, we have seen COVID19 vaccines ready for clinical trials much sooner than that.
Here are vaccine development steps in order:
- Identifying methods to induce an immune response. There have been two peer-reviewed papers recently published (here and here) that may have identified vaccine targets. Generally, better vaccines are developed to target certain glycoproteins on the virus coat which are stable, that is, don’t mutate frequently. Having this kind of early research helps vaccine scientists produce a better vaccine.
- Pre-clinical studies. This step will help scientists understand SARS-CoV-2 characteristics and pathophysiology in humans. Since it would be unethical to do these studies in actual humans, researchers need to develop an animal model that mimics a human. Also, researchers need to determine if the vaccine is safe and triggers an adaptive immune response in that animal model. For the SARS vaccine, ferrets were used, because their physiology and immune responses are similar to humans, so it might be used for a COVID-19 vaccine.
- IND application. The sponsoring organization (probably a Big Pharma company) must make an Investigational New Drug (IND) application to the FDA’s Center for Biologics Evaluation and Research (CBER) to begin clinical trials. CBER reviews the IND, which will include preclinical data, and the sponsor can proceed with the clinical trial within 30 days if the FDA does not find cause to stop it from moving forward. This is the process in the USA, but it’s much the same in most developed countries.
- Clinical trials. Then the sponsoring organization must get Institutional Review Board (IRB) approval to proceed with clinical trials (see this article for more information about the process). The clinical studies must go through three phases like all drugs, although the process could be shortened if the data is very clear and there is a public need (like the COVID-19 pandemic). These clinical trials will be posted to a US government website that tracks all clinical trials worldwide (and must be posted there before a drug can get US FDA approval). Some of the new coronavirus vaccines have entered Phase 1 clinical trials – this phase does not tell us much about the vaccine as it is given to “healthy volunteers”, and it is not randomized or blinded. It usually only includes 50-100 patients. Phase 2 and 3 trials are randomized, double-blind, placebo-controlled clinical trials, with a few hundred and few thousand patients, respectively. No drug (or vaccine) can be approved without Phase 2 and 3 studies successfully completed except in some very rare circumstances.
- Final regulatory approval. After all of the preclinical and clinical is completed, the sponsoring organization must make a Biologics License Application (BLA) to CBER. Although this process is what is done in the USA, it’s similar in most other countries (and some countries accept FDA review for their own country.
- Manufacturing plan. During this research, regulatory agencies must review manufacturing plans for the new vaccine and any pharmaceutical company that intends to produce it must develop a cost-effective and consistent method for production.
I remain convinced that a lot of people, whether they are pro-vaccine or anti-science, think that researchers grab a handful of viruses, a little water, some mercury, an aluminum Diet Coke can, and an aborted fetus, throw it in a Waring blender, put it in a vial, and then inject them into innocent children.
In reality, this process is time-consuming, as it is very difficult. Although some of these steps can be speeded up by a few months, it’s not something that can be done in a few weeks, even in an emergency.
However, there seems to be extraordinary political pressure to get out a COVID19 vaccine, one which may overlook safety and effectiveness issues, like what Russia recently did. And what other national leaders may try to do, looking at Donald Trump.
List of COVID19 vaccine trials
Below, I am going to provide the complete list (as of this date) of companies or sponsoring institutions that are developing coronavirus vaccines or vaccine candidates. With each COVID19 vaccine, I am going to attempt to link to the most recent information about that vaccine with some editorial commentary from me.
I am also going to add the following information:
- Vaccine candidate. Until a vaccine is approved for use, most companies use code names for the vaccine candidate.
- Status. “Phase 1, 2, or 3” means the actual phase of clinical trials.
- Clinical trial identifier. This will give a link to the clinical trials database which tracks all clinical trials around the world for new drugs or vaccines. In general, a clinical trial needs to be listed in this database to be included in any FDA drug applications.
- Clinical trial institution. Location of where the trial will be held.
- Clinical trial design. Description of the clinical trial design.
- Clinical trial status.
- Date of completion of the clinical trial phase.
The coronavirus vaccine trials are listed in alphabetical order by name of the company or sponsoring institution. It does not imply one is better than another.
Because there are so many vaccines in clinical trials, this list is becoming nearly unmanageable. I will attempt to list every clinical trial, but I may not go into much detail unless it shows a lot of promise or will be available widely.
AIVITA Biomedical, Inc.
Vaccine candidate: AV-COVID-19 dendritic cell vaccine
Status: Phase I/II clinical trial
Clinical trial identifier: NCT04386252
Clinical trial institution: Unknown.
Study design: Double-blind, randomized, clinical trial of 180 patients using a vaccine consisting of autologous dendritic cells loaded with antigens from SARS-CoV-2 in frontline healthcare providers and responders.
Clinical trial status: Recruiting patients.
Date of completion: April 2021.
AIVITA Biomedical, Inc. is an Irvine, CA-based biomedical company that has previously been focused on cancer vaccines for treatment. They have registered a clinical trial for a COVID-19 vaccine, although there is not a lot of information available.
Arcturus Therapeutics Inc
Vaccine candidate: ARCT-021 mRNA
Status: Phase I
Clinical trial identifier: NCT04480957
Clinical trial institution: National Taiwan University Hospital
Taipei, Taiwan
Study design: An open-label, dose-ranging clinical trial of 45 healthy participants between 18-55 years old.
Clinical trial status: Will begin recruiting patients in September 2020.
Date of completion: December 2021
Astra-Zeneca/University of Oxford Jenner Institute
Vaccine candidate: ChAdOx1
Research status: Phase I/II clinical trial
Clinical trial identifier: NCT04324606
Clinical trial institution: NIHR WTCRF, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom; CVTM, University of Oxford, Churchill Hospital, Oxford, United Kingdom; John Radcliffe Hospital
Oxford, United Kingdom
Study design: Recruiting four study groups with an anticipated total of 1112 volunteers will be enrolled. The healthy adult volunteers, aged 18-55 years, will be placed in a single-blinded, randomized, placebo-controlled, multi-center study to determine efficacy, safety, and immunogenicity of the ChAdOx1 vaccine candidate. Volunteers will participate in the study for approximately 6 months, with the option to come for an additional follow up visit at Day 364
Clinical trial status: Recruiting patients
Date of completion: May 2021
The Jenner Institute has developed a vaccine candidate based on a chimp adenovirus vector. They have also signed a manufacturing contract.
Despite the hype that the vaccine will be available by late this year, I am very skeptical that it would hit that goal date (let’s call it an aspirational goal). Since this will not be an ethically-suspect challenge study, it may be difficult to determine if the vaccine has any effect beyond placebo. If public health measures, like social distancing, reduce the exposure to the virus, then we might have a statistically measurable difference between the vaccine and the placebo.
This is why vaccine studies often take many years because researchers basically have to wait that amount of time to see if the vaccine is effective.
Bharat Biotech International Limited
Vaccine candidate: BBV152A, BBV152B, and BBV152C inactivated SARS-CoV-2 virion.
Research status: Phase I/II
Clinical trial identifier: NCT04471519
Clinical trial institution: 12 sites in India
Study design: Phase 1 open-label study of healthy volunteers followed by a phase 2 randomized, double-blinded, placebo-controlled study. It will include a total of 1125 subjects.
Clinical trial status: Recruiting starting July 2020
Date of completion: June 2021
Biontech RNA Pharmaceuticals GmbH
Vaccine candidate: BNT162a1, BNT162b1, BNT162b2, BNT162c2
Status: Phase I/II clinical trial
Clinical trial identifier: NCT04380701
Clinical trial institution: Unknown, the study is being performed by a contract research organization.
Study design: Multi-site, Phase I/II, 2-part, dose-escalation trial, investigating the safety and immunogenicity of four SARS-CoV-2 RNA vaccines in 200 participants.
Clinical trial status: Recruiting patients.
Date of completion: August 2020
Vaccine candidate: BNT162a1, BNT162b1, BNT162b2, BNT162c2
Status: Phase I/II clinical trial
Clinical trial identifier: NCT04368728
Clinical trial institution: University of Maryland, Baltimore, MD; NYU Langone Health, New York, New York
Study design: Multi-site, Phase I/II, 2-part, placebo-controlled, randomized, dose-escalation trial, investigating the safety and immunogenicity of four SARS-CoV-2 RNA vaccines in 7600 participants.
Clinical trial status: Recruiting patients in some locations.
Date of completion: January 2023
Notes: This clinical trial is co-sponsored by Pfizer.
Biontech is a German biotechnology company that has focused on cancer treatments using mRNA technology. Since mRNA vaccines have become a key vaccine development focus, they quickly developed a vaccine to enter clinical trials.
They are beginning a non-randomized, non-blinded clinical trial. We will not know if this vaccine is either safe or effective until phase 3 results are available which will take several years.
CanSinoBiologics
Vaccine candidate: Ad5-nCoV
Status: Phase I clinical trial
Clinical trial identifier: NCT04313127
Clinical trial institution: Tongji Hospital; Wuhan, China
Study design: A single-center, open-label, dose-escalating phase I clinical trial in healthy 18 to 60 years of age.
Clinical trial status: Recruiting patients.
Date of completion: Unknown
Vaccine candidate: Ad5-nCoV
Status: Phase I/II clinical trial
Clinical trial identifier: NCT04398147
Clinical trial institution: Canadian Center for Vaccinology, Halifax, Nova Scotia
Study design: A single-center, open-label, dose-escalating phase I clinical trial in healthy 18 to 60 years of age.
Clinical trial status: Recruiting patients.
Date of completion: Unknown
CanSino Biologics has developed a recombinant novel coronavirus vaccine that incorporates the adenovirus type 5 vector (Ad5).
Chinese Academy of Biosciences
Vaccine candidate: Inactivated SARS-CoV-2 vaccine
Research status: Phase I/II clinical trial
Clinical trial identifier: NCT04470609
Clinical trial institution: West China Second University Hospital, Sichuan University / West China women’s and children’s Hospital
Chengdu, Sichuan, China
Study design: Recruiting 471 patients for a multicenter, randomized, quadruple-blinded, placebo-controlled study. Enrollment is by invitation.
This is a “standard” inactivated virus vaccine, similar to many others that are used for other infectious diseases.
China National Biotech
Vaccine candidate: Inactivated SARS-CoV-2 Vaccine (Vero cell)
Research status: Phase III clinical trial
Clinical trial identifier: NCT04510207
Clinical trial institution: Shaikh Khalifa Medical City, SEHA
Abu Dhabi, United Arab Emirates; Al Qarain Primary Health Care Centre-MOHAP Sharjah, United Arab Emirates
Study design: Recruiting 45,000 for a multicenter, randomized, double-blinded, placebo-controlled study.
Clinical trial status: Recruiting patients
Date of completion: March 2021
This is a “standard” inactivated virus vaccine, similar to many others that are used for other infectious diseases.
Clover Biopharmaceuticals AUS Pty Ltd
Vaccine candidate: SCB-2019 trimeric S-subunit protein
Status: Phase I clinical trial
Clinical trial identifier: NCT04405908
Clinical trial institution: Unknown location
Study design: Randomized, double-blinded, placebo-controlled study in 150 healthy volunteers.
Clinical trial status: Planned start for June 2020.
Date of completion: March 2021
Clover Biopharmaceuticals is a China-based pharmaceutical company. Their vaccine candidate, SCB-2019, is a recombinant subunit vaccine for COVID-19. Clover’s vaccine utilizes an S-Trimer subunit that resembles the native trimeric viral spike protein via a mammalian cell-culture production system.
Curevac AG
Vaccine candidate: CVnCoV
Status: Phase I clinical trial
Clinical trial identifier: NCT04449276
Clinical trial institution: Universitair Ziekenhuis Ghent, Ghent, Belgium; Ludwig-Maximilians-Universität München, Munich, Germany; Medical University Hannover, Hannover, Germany; University Hospital Tübingen Institut für Tropenmedizin, Tübingen, Germany
Study design: Randomized, partially-blinded, placebo-controlled study in 168 healthy volunteers.
Clinical trial status: June 2020
Date of completion: March 2021
Curevac is a German biotechnology company that is developing another mRNA vaccine for COVID-19.
Gamaleya Research Institute
Vaccine candidate: Gam-COVID-Vac Lyo
Status: Phase I clinical trial
Clinical trial identifier: NCT04437875 and NCT04436471
Clinical trial institution: Unknown locations in Russia
Study design: Open-label I clinical trial in 38 healthy volunteers.
Clinical trial status: Recruiting patients beginning in June 2020.
Date of completion: August 2021
Gamaleya has developed a recombinant adenovirus vector based on a human adenovirus which contains the SARS-CoV-2 S-protein gene.
As I have written previously, Russia has announced that it will launch the vaccine soon, forgoing phase III clinical trials. This vaccine should be viewed skeptically.
GeneCure Biotechnologies
Vaccine candidate: Covax-19
Status: Phase I clinical trial
Clinical trial identifier: NCT04428073
Clinical trial institution: Unknown
Study design: Non-randomized, open-label study with 32 participants
Clinical trial status: Recruiting patients beginning in July 2020.
Date of completion: December 2021
GeneCure Biotechnologies is a Georgia (USA)-based biotechnology company that utilizes DNA technology to develop vaccines against infectious diseases. It appears that they are in partnership with the Australia-based Vaxine (see below).
Genexine
Vaccine candidate: GX-19
Status: Phase I/IIa clinical trial
Clinical trial identifier: NCT04445389
Clinical trial institution: Severance Hospital, South Korea
Study design: Multi-center, randomized, placebo-controlled, double-blind clinical trial with 190 participants.
Clinical trial status: Recruiting patients beginning in June 2020.
Date of completion: June 2022
Genexine has developed a DNA vaccine, which delivers a genetically-engineered DNA plasmid that encodes for the spike protein of SARS-CoV-2. Although there are several veterinary DNA vaccines, none have been approved for human use.
Immunative Therapies
Vaccine candidate: GX-19
Status: Phase I clinical trial
Clinical trial identifier: NCT04441047
Clinical trial institution: Medical Oncology and Hematology, Bronx, NY
Study design: Open-label study with 40 participants > age 65.
Clinical trial status: Recruiting patients beginning in July 2020.
Date of completion: December 2021
There isn’t much information about Immunative Therapies. Apparently, they have developed a novel universal vaccine concept called “allo-priming” which is designed to protect elderly adults from the progression of any type of viral infection, including possible protection against progression of the current outbreak of COVID-19 infection.
Immunitor LLC
Vaccine candidate: V-SARS
Status: Phase I clinical trial
Clinical trial identifier: NCT04380532
Clinical trial institution: Unknown location in Vancouver, British Columbia, Canada
Study design: Open-label I clinical trial in 20 healthy volunteers.
Clinical trial status: Recruiting patients beginning in June 2020.
Date of completion: June 2021
Immunitor has developed a tablet-based oral vaccine for SARS-CoV-2. The company is small and has never produced an FDA-approved drug or vaccine. However, a new oral vaccine for COVID-19 is interesting, but I’m not sure this company will be a leader in the research for one.
Inovio Pharmaceuticals
Vaccine candidate: INO-4800
Status: Phase I clinical trial
Clinical trial identifier: NCT04336410
Clinical trial institution: Center for Pharmaceutical Research
Kansas City, Missouri, United States; University of Pennsylvania
Philadelphia, Pennsylvania, United States
Study design: Open-label I clinical trial in 40 healthy volunteers.
Clinical trial status: Recruiting patients beginning in April 2020.
Date of completion: November 2020
Inovio is working on a vaccine candidate called INO-4800, and they also have partnered with a Chinese manufacturer to manufacture the vaccine. Since it is still in preclinical studies, we don’t have a good idea as to when it will enter clinical trials.
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Vaccine candidate: CTII-nCoV
Status: Phase II clinical trial
Clinical trial identifier: NCT04341389
Clinical trial institution: Unknown
Study design: Randomized, double-blind, placebo-controlled study with 500 subjects.
Clinical trial status: Recruiting patients began in April 2020.
Date of completion: January 2021
Not much is known about this study as of yet.
Janssen Vaccines & Prevention (Johnson and Johnson)
Vaccine candidate: Ad26.COV2.S, non-replicating adenovirus viral vector
Research status: Phase I/II
Clinical trial identifier: NCT04436276
Clinical trial institution: Around 12 sites in Belgium and the USA.
Study design: Randomized, double-blinded, placebo-controlled study which will include 1,045 subjects.
Clinical trial status: Recruiting patients starting in July 2020.
Date of completion: September 2021
Vaccine candidate: Ad26.COV2.S, non-replicating adenovirus viral vector
Research status: Phase I
Clinical trial identifier: NCT04509947
Clinical trial institution: Souseikai Hakata Clinic, Fukuoka, Japan; SOUSEIKAI PS Clinic, Fukuoka, Japan; Souseikai Fukuoka Mirai Hospital, Fukuoka, Japan
Study design: Randomized, double-blinded, placebo-controlled study which will include 125 subjects.
Clinical trial status: Recruiting patients starting in August 2020.
Date of completion: January 2021
Vaccine candidate: Ad26.COV2.S, non-replicating adenovirus viral vector
Research status: Phase III
Clinical trial identifier: NCT04505722
Clinical trial institution: Around 180 sites across the world.
Study design: Randomized, double-blinded, placebo-controlled study which will include 60,000 subjects.
Clinical trial status: Recruiting patients starting in September 2020.
Date of completion: March 2023
This vaccine from Janssen, a subsidiary of the pharmaceutical giant Johnson and Johnson (JNJ), utilizes a recombined adenovirus vector that expresses the S-subunit of the SARS-CoV-2 virus to induce an immune response. JNJ has announced that it will begin phase III clinical trials prior to the completion of phase I/II trials.
Kentucky BioProcessing Inc
Vaccine candidate: KBP-COVID-19 protein subunit
Status: Phase I/II clinical trial
Clinical trial identifier: NCT04473690
Clinical trial institution: Unknown
Study design: Randomized, double-blind, placebo-controlled study with 180 subjects.
Clinical trial status: Recruiting patients to begin, September 2020.
Date of completion: January 2021
Kentucky BioProcessing Inc, a subsidiary of the giant British-American Tobacco (yes, that’s irony) has developed a COVID-19 vaccine. They are using fast-growing, genetically-modified tobacco plants to produce the S-protein subunit to induce an immune response.
Medicago
Vaccine candidate: Coronavirus-like particle
Status: Phase I clinical trial
Clinical trial identifier: NCT04450004
Clinical trial institution: Unknown
Study design: An open-label, dose-ranging clinical trial of 180 healthy participants between 18-55 years old. Recruiting patients currently.
Clinical trial status: July 2020, recruiting patients.
Date of completion: April 2021
Medigen Vaccine Biologics Corp.
Vaccine candidate: MVC-COV1901
Status: Phase I
Clinical trial identifier: NCT04487210
Clinical trial institution: National Taiwan University Hospital
Taipei, Taiwan
Study design: An open-label, dose-ranging clinical trial of 45 healthy participants between 18-55 years old.
Clinical trial status: Will begin recruiting patients in September 2020.
Date of completion: December 2021
Merck-Themis Bioscience
Vaccine candidate: TMV-083, measles vector
Research status: Phase I clinical trial
Clinical trial identifier: NCT04497298
Clinical trial institution: SGS Life Sciences, Clinical Pharmacology, Antwerp, Belgium; and CIC Cochin, Paris, France
Study design: Total of 90 participants. The first step will be an unblinded escalating dose of a few patients to determine if there are any significant adverse events. This will be followed by a randomized, double-blinded, placebo-controlled study of the remaining patients.
Clinical trial status: Recruiting patients
Date of completion: November 2020
Vaccine candidate: V591
Status: Phase I clinical trial
Clinical trial identifier: NCT04498247
Clinical trial institution: Unknown
Study design: A randomized, triple-blinded (researcher, patient, and treating physicians), placebo-controlled study which will include 260 subjects.
Clinical trial status: Recruitment started in August 2020.
Date of completion: March 2022
Merck recently acquired Themis Bioscience to speed up its entry into the coronavirus vaccine race. Themis had developed a measles virus vector platform licensed from Institut Pasteur. It has engineered the virus to express different antigens, such as proteins on the SARS-CoV-2 virus.
This is an interesting method that could vault Merck to the front of the line of vaccines that I think could work, especially given their long record of developing successful vaccines. Because the measles virus is so immunogenic, it could potentially produce a stronger, longer-lasting immunity with fewer adverse effects than other types of vaccines. But as with everything, the clinical trials are all that matter.
Moderna Therapeutics
Vaccine candidate: mRNA-1273
Status: Phase I clinical trial
Clinical trial identifier: NCT04283461
Clinical trial institution: Kaiser Permanente Washington Health Research Institute – Vaccines and Infectious Diseases, Seattle, Washington, United States; Emory Vaccine Center, Decatur, GA; National Institutes of Health – Clinical Center – Vaccine Research Center Clinical Trials Program
Bethesda, Maryland, United States
Study design: An open-label, dose-ranging clinical trial of 45 healthy participants between 18-55 years old. Recruiting patients currently.
Clinical trial status: Began March 2020, recruiting patients.
Date of completion: September 2021
Vaccine candidate: mRNA-1273
Status: Phase III clinical trial
Clinical trial identifier: NCT04470427
Clinical trial institution: Approximately 89 sites across the USA.
Study design: Double-blinded, randomized, placebo-controlled study with 30,000 subjects.
Clinical trial status: Began July 2020, recruiting patients.
Date of completion: October 2022 (although it is possible that the FDA could approve this vaccine much sooner despite concerns of almost every vaccine scientist).
Moderna has recently announced a COVID-19 vaccine candidate, mRNA-1273. This vaccine relies on RNA to kickstart the endogenous production of proteins similar enough to the virus that they trigger the body’s adaptive immune system to produce antibodies effective against the actual target. So far, there is no information available about the preclinical studies (although it may be on the way in a peer-reviewed journal).
Also, Moderna has several similar vaccines in clinical trials, but none have received FDA approval. Kaiser-Permanente has registered a Phase 1 clinical trial for the mRNA-1273, but we don’t know when it will start. Typically, a Phase 1 clinical trial just tests the vaccine on “healthy adults,” who are either patients or employees of Kaiser-Permanente. Phase 1 trials generally tell us very little about the vaccine’s effectiveness and safety.
Moderna has pushed ahead with the phase III clinical trials, although I have examined Moderna’s claims in more detail here. Edward Nirenberg has written an outstanding article about mRNA vaccines here – he is much more enthusiastic about this vaccine than I am.
More recently, there are reports of rather significant adverse events after receiving the vaccine in Phase I clinical trials.
Novavax
Vaccine candidate: NVX-CoV2373
Status: Phase I/II clinical trial
Clinical trial identifier: NCT04368988
Clinical trial institution: Two sites in Herston, Queensland and Melbourne, Victoria Australia
Study design: A randomized, triple-blinded (researcher, patient, and treating physicians) of 131 patients.
Clinical trial status: To begin May 2021.
Date of completion: July 2021
US-based Novavax has developed a genetically-engineered nanoparticle vaccine using a Matrix-M adjuvant. Novavax has extensive experience in developing these vaccines, although none have received FDA approval as of today.
PT Bio Farma
Vaccine candidate: SARS-CoV-2 vaccine (inactivated)
Status: Phase III clinical trial
Clinical trial identifier: NCT04508075
Clinical trial institution: Hasan Sadikin Hospital/School of Medicine, Padjadjaran University, Bandung, West Java, Indonesia
Study design: Randomized, double-blind, placebo-controlled study with 1620 subjects.
Clinical trial status: Recruitment started in August 2020.
Date of completion: June 2021
Shenzhen Geno-Immune Medical Institute
Vaccine candidate: LV-SMENP-DC
Status: Phase 1 clinical trial
Clinical trial identifier: NCT04276896
Clinical trial institution: Shenzhen Third People’s Hospital and Shenzhen Second People’s Hospital
Study design: Phase 1/2 clinical trial of 100 participants
Clinical trial status: Began February 2020, recruiting patients
Date of completion: July 2023
Vaccine candidate: Pathogen-specific aAPC (artificial Antigen Presenting Cell)
Status: Phase 1 clinical trial
Clinical trial identifier: NCT04299724
Clinical trial institution: Shenzhen Third People’s Hospital and Shenzhen Second People’s Hospital
Study design: Phase 1/2 clinical trial of 100 participants
Clinical trial status: Began February 2020, recruiting patients
Date of completion: July 2023
Shenzhen Geno-Immune Medical institute has developed a synthetic minigene that has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease.
Sinovac Biotech Co., Ltd
Vaccine candidate: inactivated SARS-CoV-2 vaccine
Status: Phase I/II clinical trials
Clinical trial identifier: NCT04383574
Clinical trial institution: Renqiu City Center for Disease Control and Prevention; Renqiu, Hebei, China
Study design: Randomized, double-blinded, placebo-controlled, Phase Ⅰ/Ⅱ clinical trial, to evaluate the safety and immunogenicity of the vaccine in a healthy population of 422 volunteers. aged ≥60 Years
Clinical trial status: Recruiting
Date of completion: July 2020
Vaccine candidate: inactivated SARS-CoV-2 vaccine
Status: Phase I/II clinical trials
Clinical trial identifier: NCT04352608
Clinical trial institution: Canadian Center for Vaccinology
Study design: Randomized, double-blinded, placebo-controlled, Phase Ⅰ/Ⅱ clinical trial, to evaluate the safety and immunogenicity of the vaccine in a healthy population of 696 volunteers aged 18-59 Years in Canada
Clinical trial status: Recruiting
Date of completion: December 2020
Vaccine candidate: inactivated SARS-CoV-2 vaccine
Status: Phase III clinical trials
Clinical trial identifier: NCT04456595
Clinical trial institution: Butantan Institute
Study design: Randomized, double-blinded, placebo-controlled, Phase ⅠII clinical trial, to evaluate the safety and immunogenicity of the vaccine in 8870 healthcare workers in various locations in Brazil
Clinical trial status: Recruiting
Date of completion: December 2020
This is a typical vaccine candidate for viruses, an inactivated version of the virus, much like the flu vaccine. Although this trial will be completed quickly, I am skeptical that it can show either safety or effectiveness of the vaccine, especially if China is more effective at mitigating the spread of the virus than other countries.
Once again, I will push the point that we will need results from a large, phase 3 clinical trial before we can get excited with the results. Moreover, this vaccine will probably never be available outside of China, as there are zero vaccines developed and manufactured in China that are marketed in the USA, EU, or other developed countries.
Symvivo Corporation
Vaccine candidate: oral bacTRL-Spike
Status: Phase 1 clinical trial
Clinical trial identifier: NCT04334980
Clinical trial institution: Vaccine Evaluation Center, BC Children’s Research Institute, University of British Columbia and Canadian Center for Vaccinology Dalhousie University, IWK Health Centre
Study design: Randomized, observer-blind, placebo-controlled trial of 84 healthy volunteers.
Clinical trial status: Not yet recruiting
Date of completion: December 2021
Canada-based Symvivo has developed a genetically-modified, probiotic-based (not one you find on your grocery store shelf) oral vaccine for COVID-19. The study design is a phase 1, randomized, observer-blind, placebo-controlled trial in 84 healthy adults. This trial will last about 12-13 months.
University of Queensland
Vaccine candidate: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine protein subunit
Status: Phase I clinical trial
Clinical trial identifier: NCT04495933
Clinical trial institution: Nucleus Network Brisbane (Q-Pharm Pty Ltd)
Herston, Queensland, Australia
Study design: Randomized, double-blind, placebo-controlled study with 120 subjects divided into four different groups.
Clinical trial status: Started July 2020.
Date of completion: October 2021
The University of Queensland has developed a new vaccine technology using something they call a “molecular clamp.” Basically, it prevents the protein subunits that might cause an immune response to remain stable which should actually improve that response.
Vaxine Pty Ltd
Vaccine candidate: Covax-19
Status: Phase 1 clinical trial
Clinical trial identifier: NCT04453852
Clinical trial institution: Central Adelaide Local Health Network Incorporated, Australia
Study design: Randomized, observer-blind, placebo-controlled trial of 40 healthy adults.
Clinical trial status: June 2020
Date of completion: June 2021
Australia-based Vaxine is in development with several vaccines, and they have recently announced their development of Covax-19.
Summary
I keep writing these same points about COVID19 vaccine trials because there seems to be a lot of confusion as to what it means or doesn’t mean.
- Starting COVID19 vaccine trials means nothing about the safety or effectiveness of the vaccine. It doesn’t mean we have a vaccine right around the corner.
- Most vaccines that enter clinical trials fail, and I have no confidence that any of these COVID19 vaccine trials have any better chance of being successful than previous ones.
- It doesn’t mean that these vaccines in clinical trials (or ones that haven’t yet started) may or may not work, so we don’t know until research is completed.
- That being said, the only thing that matters is data from pivotal, large phase 2 and 3 clinical trials. We need to know that the vaccine is safe and effective, something we do for every vaccine on the market, despite the claims of anti-vaxxers.
- If we lack solid data that the vaccine is safe and effective, you can predict that the anti-vaccine forces will make false claims and refuse to get the vaccine, causing those parents and individuals on the fence to refuse to get the vaccine. This could harm the herd effect in stopping the disease.
- We don’t know the rate of mutation for SARS-CoV-2, which could make any of these COVID19 vaccines ineffective or basically useless.
- Other SARS vaccines have failed in clinical trials, though the efforts for those vaccines weren’t even close to what we are seeing today.
- Because most vaccine clinical trials fail, it’s good that there are nearly 119 vaccines under development, so that we have a better chance of getting one that works.
- The manufacturing of a COVID19 vaccine is problematic. The availability of production facilities, raw materials, and qualified manufacturing personnel is limited across the world.
Looking over the clinical trials, it appears that we will have a lot of Phase 1 clinical trial information prior to early to mid-2021. Then we are going to need another 1-2 years (or more) to complete Phase 2 and 3 clinical trials.
However, it’s good to know that there are several COVID19 vaccine clinical trials already entering phase 1 and/or 2. I still don’t think we’ll see a vaccine within 18 months, it’s still going to take five years at least.
Notes
I intend to update this article frequently as new COVID19 vaccine clinical trials are beginning or ongoing. At this time, I will only include COVID-19 vaccines that are registered with the US clinical trials database, as that is known as the authoritative location for all clinical trials that will be seeking regulatory approval in the USA and other countries.
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