COVID-19 vaccine development tracker

Companies are scrambling to put new vaccines into development to potentially prevent new infections by the SARS-CoV-2 virus. Based on a review by AgencyIQ of ClinicalTrials.gov, company announcements and media reports, there are at least 11 vaccines candidates in various stages of clinical testing to assess their potential safety and efficacy against SARS-CoV-2.

 

Many of these products remain in the early stages of testing, and it could be months—even years—before a viable vaccine product is shown to be worthy of meeting the FDA’s approval standards. Based on evidence from recent studies, the chances of clinical success are low. Just 31.6% of all vaccines that enter Phase 1 testing go on to obtain FDA approval.

 

The size of the development pipeline and interest in COVID-19 may indicate that several of these products will go on to obtain approval, but the safety and efficacy of these products is far from guaranteed. As companies try to bring whatever compounds they have into clinical testing as fast as they can, it’s possible that few, if any, of these products will ultimately prove safe or effective.

 

For our analysis, AgencyIQ looked at each vaccine candidate and tried to assess how these products would be tested based on publicly-available information. These data include the product’s history, its stage of development, the size of the clinical trial, the primary endpoints being studied in the trial, and its anticipated date of conclusion. It’s worth noting that while many sponsors expect data in 2021 and later, interim analysis of data is likely to accelerate the development of many of these products.

 

Moderna

Vaccine: mRNA 1273

 

Developer Profile: Moderna was founded in 2010 on a platform of mRNA science. The company defines its therapeutic areas as infectious diseases, immuno-oncology, rare diseases, cardiovascular disease and autoimmune diseases.

 

Name: mRNA 1273

 

Sponsor(s): Moderna (Developer), National Institute for Allergy and Infectious Diseases (NIAID)

 

How it Works: Fat-encased molecule contains mRNA that makes cells produce the characteristic spike protein that defines the surface structure of SARS-CoV-2. This stimulates immune response that will target the novel coronavirus.

 

Phase: Phase I (Phase II IND submitted on April 27, 2020)

 

Trial Overview: This is a phase I, open-label, dose ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2.

 

Enrollment: 105 persons

 

Expected Date of Trial Completion: September 20, 2021

 

Primary Outcome Measures:

  1. Frequency of solicited local reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
  2. Frequency of any medically-attended adverse events (MAAEs)
  3. Frequency of any new-onset chronic medical conditions (NOCMCs)
  4. Frequency of any serious adverse events (SAEs)
  5. Frequency of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
  6. Frequency of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
  7. Grade of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
  8. Grade of solicited local reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
  9. Grade of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]

 

Results: N/A

Sources:
Media Update
Company announcement
Company Status Update
NCT04283461
HHS Press Release

 

CanSino Biologics

Vaccine: Ad5-nCoV

 

Developer Profile: CanSino is a Chinese-based vaccine developer with four proprietary platforms, including the recombinant adenovirus viral vector. It currently has 13 vaccine candidates at the clinical or pre-clinical development stages for various diseases.

 

Name: Ad5-nCoV

 

Sponsor(s): CanSino Biologics, Inc. (Phase I)
Insitute of Biotechnology, Academy of Military Medical Sciences, PLA of China (Phase II)

 

How it Works: An adenovirus vector is encoded with genetic information for the SARS-CoV-2 spike protein is delivered to produce an immune response to a signature component of the virus.

 

Phase: Phase II

 

Trial Overview: This is a phase II, randomized, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age, inclusive, who meet all eligibility criteria. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2. 500 subjects will be enrolled, 250 subjects in middle-dose vaccine group, 125 subjects in low-dose and placebo group, respectively. Immunogenicity will be tested on days 0, 14 and 28, and 6 months after vaccination.

 

Enrollment: 500 persons

 

Expected Date of Trial Completion: January 31, 2021

 

Primary Outcome Measures:

  1. Occurrence of adverse reactions [ Time Frame: 0-14 days post vaccination ]
  2. Anti SARS-CoV-2 S antibody response (ELISA) [ Time Frame: 28 days post vaccination ]
  3. Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 28 days post vaccination ]

 

Results: N/A

 

Sources:
Company announcement
Development Pipeline
Media
NCT04341389

 

Oxford Vaccine Group

Vaccine: ChAdOx1

 

Developer Profile: The Oxford Vaccine Group (OVG) is an academic research arm at the University of Oxford. It has been active since 1994 and includes an interdisciplinary team of medical scientists. AstraZeneca has partnered with OVG for COVID-19 vaccine development.

 

Name: ChAdOx1 nCoV-19

 

Sponsor(s): University of Oxford (Developer); AstraZeneca (Partner)

 

How it Works: An adenovirus vector encoded with genetic information for the SARS-CoV-2 spike protein is delivered to produce an immune response to a signature component of the virus.

 

Phase: Phase I/II

 

Trial Overview: A phase I/II single-blinded, randomized, multi-center study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM).

 

Enrollment: 1,112 persons

 

Expected Date of Trial Completion: January 31, 2021

 

Primary Outcome Measures:

  1. Number of virologically confirmed (PCR positive) symptomatic cases [ Time Frame: 6 months ]
  2. Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19
  3. Occurrence of serious adverse events (SAEs) [ Time Frame: 6 months ]
  4. Occurrence of serious adverse events (SAEs) throughout the study duration

Results: N/A

 

Sources:
Company announcement
NCT04324606

 

Symvivo

Vaccine: bacTRL-Spike

 

Developer Profile: Symvivo specializes in oncology, ischemic heart disease, vaccines and rare diseases. Their novel vaccine delivery platform uses a probiotic gene delivery system. The company currently has five products in preclinical and clinical development stages.

 

Name: bacTRL-Spike

 

Sponsor(s): Symvivo

 

How it Works: Uses a genetically modified bacterium that expresses the SARS-CoV-2 spike protein to trigger an immune response.

 

Phase: Phase I

 

Trial Overview: Protocol bacTRL-Spike-1 will be the first-in-human study of bacTRL-Spike, and the first-in-human use of orally delivered bacTRL. Each oral dose of bacTRL-Spike contains bacterial medium with either 1 billion (Group 1A), 3 billion (Group 2A) or 10 billion (Group 3A) colony-forming-units of live Bifidobacterium longum, which has been engineered to deliver plasmids containing synthetic DNA encoding spike protein from SARS-CoV-2. Placebo will consist of bacterial medium without bacteria.

 

Enrollment: 84 persons


Expected Date of Trial Completion: August 31, 2021

 

Primary Outcome Measures:

  1. Frequency of Adverse Events [ Time Frame: Up to 12 months post-vaccination ]
  2. Adverse events (specifically including incidence of gastrointestinal-associated events) following administration of oral bacTRL-Spike

Results: N/A
Sources: NCT04334980

 

Shenzhen Geno-immune Medical Institute

Vaccine: aAPC

 

Developer Profile: SGMI is a governmental research institute for cell-based immunotherapy. They specialize in lentiviral vectors, CAR-T and gene therapy.

 

Name: Artificial antigen presenting cell (aAPC)

 

Sponsor(s):Shenzhen Geno-immune Medical Institute

 

How it Works: This process will introduce viral proteins and immune modulatory genes to modify aAPCs and activate T-cell response.

 

Phase: Phase I

 

Trial Overview: This open-label trial proposes to test the safety of aAPC by giving participants three injections of 5×10^6 each Covid-19/aAPC vaccine via subcutaneous injections. Injections will be given at days 0, 14 and 28. The study also aims to evaluate the immune reactivity of the genetically modified aAPC vaccine.

 

Enrollment: 100 persons

 

Expected Date of Trial Completion:July 31, 2023


Primary Outcome Measures:

  1. Frequency of vaccine events [Time Frame: Measured from Day 0 through Day 28]. Frequency of vaccine events such as fever, rash, and abnormal heart function.
  2. Frequency of serious vaccine events [Time Frame: Measured from Day 0 through Day 28]. Frequency of serious vaccine events.
  3. Proportion of subjects with positive T cell response [Time Frame: 14 and 28 days after randomization]

Results:N/A


Sources:NCT04299724

 

UMC Utrecht and Murdoch

Vaccine: BCG


Developer Profile: Two clinical trials in the Netherlands and Australia are engaged in researching the efficacy of a vaccine used outside the US for tuberculosis prevention.

 

Name: BCG Vaccine

 

Sponsor(s): UMC Utrecht and Murdoch

 

How it Works: Bacille Calmette-Guerin (BCG) was developed for tuberculosis nearly a century ago. It introduces weakened bacteria to trigger immune response. The immune response may be effective against certain respiratory viruses.

 

Phase: Phase III

 

Trial Overview:(NE) The hypothesis is that BCG vaccination induces (partial) protection against susceptibility to and/or severity of Covid-19 infection based on three factors: Its capacity to reduce the incidence of respiratory tract infections in children; to exert antiviral effects in experimental models; and to reduce viremia in an experimental human model of viral infection. This study evaluates the efficacy of BCG to improve the clinical course of Covid-19 infection and to prevent absenteeism in order to safeguard continuous patient care.

 

(AUS) Participants will be healthcare workers in Australian hospital sites. They will be randomised to receive a single dose of BCG vaccine, or no BCG vaccine. Participants will be followed-up for 12 months with regular mobile phone text messages (up to weekly) and surveys to identify and detail COVID-19 infection. Additional information on severe disease will be obtained from hospital medical records and government databases. Blood samples will be collected prior to randomisation and at 12 months to determine exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Where required, swab/blood samples will be taken at illness episodes to assess SARS-CoV-2 infection.

 

Enrollment:1,500 (NE) and 4,170 (AUS) persons

 

Expected Date of Trial Completion: October 25, 2020 (NE) and October 30, 2020 (AUS)

 

Primary Outcome Measures:

  1. COVID-19 disease incidence [Time Frame: Measured over the 6 months following randomization]
  2. Severe COVID-19 disease incidence [Time Frame: Measured over the 6 months following randomization]
  3. Health Care Workers absenteeism [Time Frame: Maximum of 180 days]. Number of days of unplanned absenteeism for any reason

Results: N/A

 

Sources:
NCT04328441 (NE)
NCT04327206 (AUS)

 

BioNTech

Vaccine: BNT162

 

Developer Profile: BioNTech focuses on developing personalized medicine using gene and immunotherapies for cancer. It is engaged in a partnership with Pfizer for this vaccine product.

 

Name: BNT162

 

Sponsor(s): BioNTech
(Pfizer as Collaborator)

 

How it Works: This vaccine will introduce RNA that codes for pieces of the SARS-CoV-2 virus in order to train the body to recognize the virus.

 

Phase: Phase I/II

 

Trial Overview: This is a Phase 1/2, randomized, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study in healthy adults. The study will evaluate the safety, tolerability, immunogenicity, and potential efficacy of up to 4 different SARS-CoV-2 RNA vaccine candidates against COVID-19: As a 2-dose or single-dose schedule; At up to 3 different dose levels; and in three age groups (18 to 55, 65 to 85, and 18 to 85 years of age).

 

The continuous study consists of 3 stages. Stage 1: to identify preferred vaccine candidate(s), dose level(s), number of doses, and schedule of administration (with the first 15 participants at each dose level of each vaccine candidate comprising a sentinel cohort); Stage 2: an expanded-cohort stage; and Stage 3; a final candidate/dose large-scale stage.

 

Enrollment: 7,600 persons

 

Expected Date of Trial Completion: January 27, 2023

 

Primary Outcome Measures:

  1. Percentage of participants reporting local reactions [Time Frame: For 7 days after dose 1 and dose 2]. Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
  2. Percentage of participants reporting systemic events [Time Frame: For 7 days after dose 1 and dose 2]. Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
  3. Percentage of participants reporting adverse events [Time Frame: From dose 1 through 1 month after the last dose]
  4. Percentage of participants reporting serious adverse events [Time Frame: From dose 1 through 6 months after the last dose]
  5. Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values [Time Frame: 1 day after dose 1]
  6. Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values [Time Frame: 7 days after dose 1]
  7. Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values [Time Frame: 7 days after dose 2]
  8. Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments [Time Frame: Between baseline and 1 day after dose 1]
  9. Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments [Time Frame: Between baseline and 7 days after dose 1]
  10. Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments [Time Frame: Between before dose 2 and 7 days after dose 2]

Results: N/A

 

Sources:

NCT04368728
Company Announcement

 

Inovio

Vaccine: INO-4800

 

Developer Profile: Inovio is a developer of vaccines and immunotherapies that specializes in DNA plasmid vaccines. The company has created an electroporation delivery system that enhances immune response.

 

Name: INO-4800 Vaccine

 

Sponsor(s): Inovio

 

How it Works: This system introduces antigen-specific DNA into cells via plasmids to trigger T-cell and antibody response to the SARS-CoV-2 virus.

 

Phase: Phase I

 

Trial Overview: An open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA 2000 device in healthy adult volunteers. Volunteers in the two groups will receive either one or two doses of the vaccine.

 

Enrollment: 40 persons

 

Expected Date of Trial Completion: April 2021

 

Primary Outcome Measures:

  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Week 52]
  2. Percentage of Participants with Administration (Injection) Site Reactions [ Time Frame: Day 0 up to Week 52]
  3. Percentage of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to Week 52]
  4. Change from Baseline in Antigen-Specific Binding Antibody Titers [ Time Frame: Baseline up to Week 52]
  5. Change from Baseline in Antigen-Specific Interferon-Gamma (IFN-γ) Cellular Immune Response [ Time Frame: Baseline up to Week 52]

Results: N/A

Sources:
Company announcement
NCT04336410
Media Update

 

Sinovac

Vaccine: Inactivated SARS-CoV-2 Vaccine

 

Developer profile: Sinovac is a Chinese vaccine producer established in 1993. The company was the first to develop an H1N1 vaccine in 2009.

 

Name: Inactivated SARS-CoV-2 Vaccine

 

Sponsor(s): Sinovac

 

How it Works: This vaccine will use a weakened form of the virus that causes COVID-19 to stimulate immune response.

 

Phase: Phase I

 

Trial Overview: A randomized, double-blinded, single-center, placebo-controlled phase 1/2 clinical trial in adults aged 18-59 years. The purpose of this study is to evaluate the immunogenicity and safety of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 744 subjects will be enrolled, with 144 at phase I, and 600 at phase II. Participants will be assigned to receive two doses of experimental vaccine or placebo on the schedule of days 0 and 14, or days 0 and 28.

 

Enrollment: 744 persons

 

Expected Date of Trial Completion: August 13, 2020

 

Primary Outcome Measures:
1. Safety indexes of adverse reactions [ Time Frame: From the beginning of the vaccination to 28 days after the whole schedule vaccination]. Measured as the occurrence of adverse reactions following vaccination.
2. Immunogenicity indexes of neutralizing-antibody seroconversion rates for the emergency vaccination schedule (day 0,14). [Time Frame: The 14th day after two doses of vaccination].
3. Immunogenicity indexes of neutralizing-antibody seroconversion rates for the routine vaccination schedule (day 0,28) [ Time Frame: The 28th day after two doses of vaccination].

 

Results: N/A


Sources: NCT04352608

 

Novavax

Vaccine: SARS-CoV-2 rS

 

Developer Profile: Novavax is an American vaccine developer that has been successful in developing maternal immunizations and focuses on respiratory viruses and other infectious diseases. Its proprietary recombinant nanoparticle technology is key to its delivery platform.

 

Name: SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with or without MATRIX-M Adjuvant

 

Sponsor(s): Novavax

 

How it Works: This system introduces antigen-specific DNA into cells via plasmids to trigger T-cell and antibody response to the SARS-CoV-2 virus.

 

Phase: Phase I

 

Trial Overview: For Phase 1 only. Additional information will be provided if Phase 2 is implemented. 2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial designed to evaluate the immunogenicity and safety of SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in healthy participants ≥ 18 to 59 (inclusive) years of age. The study will be conducted in 2 parts. In Part 1, at least 1 and up to two SARS-CoV-2 rS constructs will be evaluated in up to 2 cohorts, which may be enrolled in parallel. An interim analysis of Part 1 safety and immunogenicity data will be performed prior to an optional expansion to Part 2.

 

Enrollment: 131 persons

 

Expected Date of Trial Completion: December 31, 2020

 

Primary Outcome Measures:

  1. Subjects with solicited adverse events (AEs) – Phase I [Time Frame: 28 days]. Numbers and percentages (with 95% CIs) of subjects with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 21) by severity score, duration, and peak intensity. In the case of no reactogenicity, a toxicity score of zero (0) will be applied.
  2. Safety Laboratory Values (serum chemistry, hematology) – Phase I. [Time Frame: 28 days]. Safety laboratory values (serum chemistry, hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
  3. Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) – Phase 1 [Time Frame: 35 days]. Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA at Day 21 and Day 35. Endpoints based on these data will include geometric mean enzyme-linked immunosorbent assay (ELISA) units, geometric mean fold rise, and seroconversion rate (proportion of subjects with ≥4-fold rises in ELISA units).

Results: N/A


Sources: NCT04368988

 

Immunitor

Vaccine: Tableted V-SARS

 

Developer profile: Immunitor, founded in 2000, specializes in the development of orally administered vaccines. The company focuses on a broad array of diseases, from HIV to cancer.

 

Name: Tableted V-SARS

 

Sponsor(s): Immunitor

 

How it Works: This vaccine uses orally administered tablets containing heat-inactivated SARS-CoV-2 virus.

 

Phase: Phase I

 

Trial Overview: Experimental batch of tableted thermostable vaccine obtained from pooled plasma of COVID-19 patients is produced. The goal of this trial is test safety and immunogenicity of once-per-day day administered orally to volunteers for 15 days. Baseline and post-treatment standard safety parameters will be compared. Blood samples from volunteers will be monitored and immunogenicity lab assays will be undertaken to characterize immune response.

 

Enrollment: 20 persons

 

Expected Date of Trial Completion: May 15, 2021

 

Primary Outcome Measures:

  1. Effect on complete blood count (CBC). [Time Frame: 15 Days]. Routine laboratory CBC count at pre- and post-treatment periods by automated CBC counter. Routine laboratory CBC. Routine clinical laboratory CBC parameters at pre- and post-treatment periods.
  2. Effect on biochemistry parameters as per CTCAE v4.0 [Time Frame: 15 Days]. Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer.

Results: N/A


Sources: NCT04380532

 

For questions or concerns, please contact:

Alexander Gaffney, RAC
Senior Director, Research
agaffney@agencyiq.com

Aaron Badida, JD
Research Analyst
abadida@agencyiq.com

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