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COVI VAC

Drug Profile

COVI VAC

Alternative Names: 2019-nCoV vaccine - Codagenix/Serum Institute of India; CDX 005; Coronavirus vaccine - Codagenix/Serum Institute of India; COVI-VAC; COVID-19 vaccine - Codagenix/Serum Institute of India; CoviLivTM; SARS-CoV-2 Vaccine - Codagenix/Serum Institute of India

Latest Information Update: 28 Jan 2024

At a glance

  • Originator Codagenix; Serum Institute of India
  • Class Antivirals; Attenuated vaccines; COVID-19 vaccines; Viral vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III COVID 2019 infections

Most Recent Events

  • 28 Jan 2024 No recent reports of development identified for phase-I development in COVID-2019-infections(Prevention) in United Kingdom (Intranasal)
  • 11 Oct 2023 Immunogenicity data from a phase I trial in COVID-2019 infection presented at IDWeek 2023 (IDW-2023)
  • 11 Oct 2023 Updated immunogenicity data from a phase I trial in COVID-2019 infection released by Codagenix

Development Overview

Introduction

COVI VAC (formerly CDX 005) is a non-pathogenic, live-attenuated vaccine against SARS-CoV-2 coronavirus, being developed by Codagenix (a spin-off of Stony Brook University), in collaboration with Serum Institute of India, for prevention of COVID-2019 infections. Codagenix will make use of its proprietary deoptimisation technology, Synthetic Attenuated Virus Engineering (SAVE) platform that uses synthetic biology to re-code the genes of viruses into safe and stable vaccines to synthesise the live-attenuated vaccine. Viral genomes are processed by Codagenix’s computer-based algorithm for inducing multiple silent mutations into the genome to use codon pairs that are underrepresented in human cells. The genome that is de-optimised for translation in the human host cell is synthesised from scratch, assembled into a whole genome, transfected into cells and live, de-optimised, attenuated viruses are recovered for animal studies. The vaccine can be useful against multiple antigens of the virus and has the ability to scale for mass production. Preclinical development is underway in the US and India. Clinical development is underway in the UK and an undisclosed country.

As at January 2024, no recent reports of development had been identified for phase-I development in COVID-2019-infections (Prevention) in United Kingdom (Intranasal).

Company Agreements

In September 2020, Codagenix, entered into a manufacturing agreement with the Serum Institute of India, to manufacture COVI VAC for the treatment of COVID-2019 infections. After receiving approval from the Review Committee on Genetic Manipulation (RCGM)of India's Department of Biotechnology (DBT), Serum Institute will initiate manufacturing for large-scale safety and efficacy studies in addition to preparing to meet global vaccine supply requirements. [1]

In February 2020, Codagenix entered into a collaboration with the Serum Institute of India to rapidly co-develop a live-attenuated vaccine against the COVID-2019 infections. Codagenix has designed multiple nCoV vaccine candidate genomes using its proprietary deoptimisation technology. The vaccine viruses will be grown and tested in vivo by contracted laboratories suitable for containment, prior to testing in clinical trials. The Serum Institute of India will then scale-up the manufacture of the vaccine to ensure its availability to meet a critical public health need. Codagenix and Serum Institute are pursuing an accelerated development pathway with built-in redundancies to increase speed and likelihood of success. [2]

Key Development Milestones

In October 2022, Codagenix initiated the phase III Solidarity Trial Vaccines trial to evaluate the safety, efficacy, and immunogenicity of CoviLiv against circulating SARS-CoV-2 strains as compared to placebo in up to 20,000 healthy adults in countries with low-vaccination rates on the continents of Africa and possibly South America and Asia. The primary endpoint of the trial is efficacy against confirmed disease. The first patient has been dosed in the phase III trial of COVI VAC in patients with COVID-2019 infections [3] [4] .

As of March 2022, Codagenix is conducting a phase II trial of COVI VAC, for the prevention of COVID-2019 infections (Codagenix pipeline, March 2022).

In May 2022, Codagenix and the Serum Institute of India completed a first-in-human phase I trial that evaluated the safety and immune response of COVI VAC in healthy young adults (NCT04619628; CDX-CoV-001). Primary endpoint of the trial is to determine percentage of volunteers with reactogenicity events. The randomised, double-blind, placebo-controlled, dose-escalation trial initiated in December 2020 enrolled 48 volunteers in UK [5] . In December 2020, Codagenix and the Serum Institute of India received regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) for this phase I trial. In January 2021, the first patient has been dosed in the trial. In June 2021, Codagenix reported completion of COVI VAC dosing at three dose levels in the trial. In September 2021, Codagenix presented data from the trial at the IDWeek 2021 (IDW-2021) [6] [7] [8] [9] [10] . In March 2022, the company released updated efficacy data from the trial [11] . In October 2023, results form the trial were released by company [12] .In October 2023, results form the trial were presented at IDWeek 2023 (IDW-2023) [13] .

In June 2021, Codagenix released results from preclinical studies which evaluated COVI VAC in in vivo models, in which the vaccine elicited robust immune and antibody response and provided protection against COVID-19 infection in the infected animals [8] .

COVI VAC was protective and prevented weight loss following challenge with the heterologous variant of SARS-CoV-2, B.1.351/Beta. By presenting all viral antigens, COVI-VAC will be less affected by viral evolution than spike-based vaccines [14] .

In December 2020, Codagenix and the Serum Institute of India reported that, COVI VAC was safe and efficacious in preclinical animal studies [10] .

In June 2020, Codagenix announced the successful synthesis of COVI VAC, as a readily-scalable live-attenuated vaccine candidate against COVID-19. As of June 2020, the vaccine was undergoing safety and efficacy studies in animals and appeared markedly attenuated compared to wild-type SARS-CoV-2. COVI VAC will be manufactured by the Serum Institute and tested in a phase I clinical trial slated to begin in the fall of 2020. Serum Institute will simultaneously scale manufacturing for large-scale safety and efficacy studies, in addition to preparations necessary to meet global vaccine supply requirements. [15] .

As of February 2020, Codagenix had designed several genomes for the coronavirus vaccine candidate [2] .

Drug Properties & Chemical Synopsis

  • Route of administration Intranasal
  • Formulation unspecified
  • Class Antivirals, Attenuated vaccines, COVID-19 vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7 (Vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Phase III Africa, Asia, South America Intranasal / unspecified Codagenix 27 Oct 2022
COVID 2019 infections - Prevention Preclinical India, USA Intranasal / unspecified Codagenix, Serum Institute of India 18 Jun 2020
COVID 2019 infections - Prevention No development reported (I) United Kingdom Intranasal / unspecified Codagenix, Serum Institute of India 28 Jan 2024

Commercial Information

Involved Organisations

Organisation Involvement Countries
Codagenix Originator USA
Serum Institute of India Originator India
Serum Institute of India Owner India
Codagenix Owner USA

Scientific Summary

Adverse Events

Updated results of the randomised, double-blind, placebo-controlled, first-in-human phase I trial showed that COVI VAC was safe and well tolerated in healthy young adults (n = 48). There has been no trend in solicited reactogenicity events, and all unsolicited adverse events reported to date have been mild. There have been no SAEs or grade 3 or 4 events [6] . No significant adverse events reported [7] [5] .

Pharmacodynamics

Summary

In Preclinical studies, COVI VAC is well tolerated and immunogenic, and induces broad cellular immunity including coverage against all known variants of SARS-CoV-2 [3] .

In preclinical studies, COVI VAC elicited robust immune response with generation of antibody responses against multiple strains of SARS-COV-2 virus equivalent to or greater than the wild-type virus. The vaccine provided significant and robust protection against COVID-19 infection in the infected animals [8] .

Immunogenicity

Summary

Results from phase I trial in participants in the high-dose cohort of 5x106 pfu (n=6/group) demonstrated that two doses of COVI VAC induced a poly-antigenic immune response with specificity to targets beyond spike, including highly conserved viral proteins. After 2 doses of CoviLiv, all participants exceeded a 2-fold increase in spike-specific IgG with a geometric mean fold rise of 19.5 (95% CI 3.4-113.8) on day 57. Neutralizing antibodies at this timepoint were induced 2.6-fold (CI 1.0-7.0) and 4.9-fold (CI 1.4-16.6) using MNT and PVN. On day 36 post-vaccination, IFNγ response by ELISpot after restimulation with the SNMO peptide pool increased 4.5-fold (CI 2.8-7.4) in the 2-dose cohort and 2.5-fold (CI 1.4-4.2) in the 1-dose cohort. No increase in IFNγ response was observed after placebo vaccination or in any group after restimulation with spike-only peptides. ICS confirmed significant regimen-dependent SNMO-specific increases in IFNγ, IL-2 and TNFα response especially in the CD4+ T cell subset, including induction of polyfunctional CD4+ T cells. TCR repertoire mapping revealed increases in both depth and breadth of CD4+ T cell clones specific for spike, nucleocapsid phosphoprotein and membrane glycoprotein. CD8+ T cell responses were less pronounced with CoviLiv-induced responses directed against nucleocapsid and ORF1ab [17] .According to updated results from the phase I trial, participants who received two doses of 5x106 PFU CoviLiv demonstrated significant induction of both humoral and cellular immune responses. T cell response was shown to be selective for a variety of viral antigens other than the regularly changing spike protein [12] . Earlier interim results showed that COVI VAC vVaccination showed an over four-fold rise in responses to a peptide pool spanning five different SARS-CoV-2 proteins, including but not limited to spike. It suggested that the induced T cell responses are specific to non-spike proteins, which are highly conserved across the different variants of concern. The peptide pool tested was observed to be >99.2% identical to omicron strain BA.2. Moreover, it also showed increased T cell immune responses, attributable to non-spike proteins that are uniquely present in COVI VAC as a live-attenuated virus, indicating potential for immune protection across variants of concern. COVI VAC also induced a mucosal antibody response and blocked nasal replication indicating potential to reduce viral transmission [11] . Earlier results of the randomized, double-blind, placebo-controlled, first-in-human phase I trial in healthy young adults (n = 48) showed that COVI VAC vVaccination resulted in minimal viral shedding without sequence instability. Vaccine virus from anonymized subjects was shed at levels lower than that likely to result in onward transmission, and the deoptimized sequence of the shed virus remained unchanged compared to the original vaccine sequence. COVI VAC generated a robust serum (IgG) antibody response as well as induced mucosal immunity in the nose, with 40% of participants presenting anti-COVID immunoglobulin A (IgA) antibodies [6] . Interim results demonstrated that administration of intranasal vaccine resulted in minimal viral shedding, recorded at levels lower than those likely to result in subsequent transmission of COVID-2019 infections. In addition, COVI-VAC also stimulated both serum and mucosal antibody immune responses [7] [5] .

Future Events

Expected Date Event Type Description Updated
30 Jun 2021 Trial Update Codagenix and Serum Institute of India plans a advanced clinical testing for COVID-2019 infections in mid-2021 [10] 11 Mar 2022
31 Dec 2020 Trial Update Codagenix plans a phase I trial for COVID-2019 infections (Prevention) in United Kingdom in December 2020 (Intranasal) (700327058) (NCT04619628) 17 Dec 2020

Development History

Event Date Update Type Comment
28 Jan 2024 Phase Change - No development reported No recent reports of development identified for phase-I development in COVID-2019-infections(Prevention) in United Kingdom (Intranasal) Updated 28 Jan 2024
11 Oct 2023 Scientific Update Immunogenicity data from a phase I trial in COVID-2019 infection presented at IDWeek 2023 (IDW-2023) [13] Updated 09 Feb 2024
11 Oct 2023 Scientific Update Updated immunogenicity data from a phase I trial in COVID-2019 infection released by Codagenix [12] Updated 16 Oct 2023
31 Oct 2022 Scientific Update Pharmacodynamics data from a phase III trial in COVID-19 infections released by Codagenix [3] Updated 10 Nov 2022
27 Oct 2022 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Prevention) (Intranasal) [3] Updated 10 Nov 2022
27 Oct 2022 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Prevention) in Africa (Intranasal) [3] Updated 10 Nov 2022
27 Oct 2022 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Prevention) in Asia (Intranasal) [3] Updated 10 Nov 2022
30 May 2022 Trial Update Codagenix completes a phase I trial for COVID-2019 infections (Prevention) in United Kingdom (Intranasal) (NCT04619628) Updated 06 Jul 2022
17 Mar 2022 Scientific Update Updated immunogenicity data from a phase I trial in COVID-2019 infection released by Codagenix Updated 21 Mar 2022
11 Mar 2022 Phase Change - II Phase-II clinical trials in COVID-2019 infections (Prevention) (Intranasal), prior to March 2022 (Codagenix pipeline, March 2022) Updated 11 Mar 2022
10 Feb 2022 Trial Update Codagenix plans a phase I trial in COVID-2019 infections (Prevention) (Intranasal) (NCT05233826) Updated 15 Feb 2022
29 Sep 2021 Scientific Update Immunogenicity and adverse events data from preclinical studies in COVID-2019 infections presented at the IDWeek 2021 (IDW-2021 ) [6] Updated 07 Feb 2022
29 Sep 2021 Scientific Update Immunogenicity and adverse events data from a phase I trial in COVID-2019 infections released by Codagenix [7] Updated 05 Oct 2021
22 Sep 2021 Trial Update Codagenix plans a phase II/III trial for COVID-2019 infections Updated 20 Oct 2021
30 Jun 2021 Scientific Update Pharmacodynamics data from preclinical trials in COVID-2019 infections released by Codagenix [8] Updated 08 Jul 2021
14 Dec 2020 Trial Update Codagenix and Serum Institute of India plans a advanced clinical testing for COVID-2019 infections in mid-2021 [10] Updated 11 Mar 2022
14 Dec 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (Prevention) in United Kingdom (Intranasal) [10] (NCT04619628) Updated 17 Dec 2020
14 Dec 2020 Regulatory Status Codagenix and the Serum Institute of India receives regulatory approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for phase I clinical trial of COVI VAC in COVID-2019 infections [10] Updated 17 Dec 2020
06 Sep 2020 Trial Update Codagenix plans a phase I trial for COVID-2019 infections (Prevention) in United Kingdom in December 2020 (Intranasal) (NCT04619628) Updated 17 Dec 2020
17 Aug 2020 Trial Update Codagenix plans phase I clinical trial in COVID-2019 infections in the UK (Intranasal) Updated 26 Aug 2020
18 Jun 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA and India (Intranasal) before June 2020 [15] Updated 23 Jun 2020
13 Feb 2020 Licensing Status Codagenix and Serum Institute of India agree to co-develop Coronavirus vaccine for COVID-2019-infections [2] Updated 18 Feb 2020
13 Feb 2020 Phase Change Early research in COVID-2019-infections (Prevention) in USA and India (Intranasal) [2] Updated 18 Feb 2020

References

  1. Serum Institute of India Initiates Manufacturing of Codagenix's Intranasal Live-Attenuated COVID-19 Vaccine Candidate.

    Media Release
  2. Codagenix and Serum Institute of India Initiate Co-Development of a Scalable, Live-Attenuated Vaccine Against the 2019 Novel Coronavirus, COVID-19.

    Media Release
  3. Codagenix Initiates Dosing in Phase 3 Efficacy Trial of Intranasal COVID-19 Vaccine as Part of WHO-Sponsored Solidarity Trial Vaccines.

    Media Release
  4. A global, placebo-controlled Phase 2/3 efficacy trial of CoviLiv for COVID-19

    ctiprofile
  5. First-in-human, Randomised, Double-blind, Placebo-controlled, Dose-escalation Study in Healthy Young Adults Evaluating the Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Candidate for Prevention of COVID-19

    ctiprofile
  6. Tasker S, Bendel D, Bevan M, Mueller S, Kushnir A, Londt B, et al. Phase 1 Placebo-Controlled Trial of COVI-VAC(TM), an Intranasal, Live Attenuated COVID-19 Vaccine. IDW-2021 2021; abstr. 584.

    Available from: URL: https://academic.oup.com/ofid/article/8/Supplement_1/S394/6450074
  7. Codagenix Presents Positive Phase 1 Data for COVI-VAC Intranasal COVID-19 Vaccine at IDWeek 2021.

    Media Release
  8. Intranasal COVID-19 vaccine demonstrates single-dose efficacy in preclinical studies, in parallel with achievement of Phase 1 clinical milestone.

    Media Release
  9. Codagenix and Serum Institute of India Initiate Dosing in Phase 1 Trial of COVI-VAC, a Single Dose, Intranasal, Live Attenuated Vaccine for COVID-19.

    Media Release
  10. Codagenix and Serum Institute of India Announce Commencement of First-in-Human Trial of COVI-VAC, A Single Dose, Intranasal Live Attenuated Vaccine for COVID-19.

    Media Release
  11. Codagenix Intranasal COVID-19 Vaccine Shows Potent Cellular Immune Response Against Conserved Viral Proteins, Indicating Potential for Immunogenicity Against Omicron and Future Variants in Phase 1 Data.

    Media Release
  12. Codagenix Announces Late-Breaking Presentation of Positive Clinical Immunogenicity Data For COVID-19 Vaccine Candidate CoviLiv(Tm) at IDWeek 2023.

    Media Release
  13. Diadem Presents Data at 2022 Alzheimer's Association International Conference(R) Showing Its Blood-Based Biomarker Test Can Both Diagnose and Predict Alzheimer's Disease.

    Media Release
  14. Kushnir A, Mueller S, Tasker S, Coleman JR. COVI-VAC(TM), a Live Attenuated COVID-19 Vaccine, Provides Single Dose Protection Against Heterologous Challenge with SARS-CoV-2 Beta (B.1.351) in the Syrian Golden Hamster Model. IDW-2021 2021; abstr. 577.

    Available from: URL: https://academic.oup.com/ofid/article/8/Supplement_1/S390/6450006
  15. Codagenix Announces the Synthesis and Preliminary Safety of Scalable, Live-attenuated Vaccine Candidate Against COVID-19.

    Media Release
  16. Serum Institute to be ready with coronavirus vaccine by 2022 .

    Media Release
  17. Daewoong Pharmaceutical Announces 2023 Financial Results.

    Media Release
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