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A Phase I, Clinical Study to Evaluate Safety and Immunogenicity of the Ii-Key Vaccine

Trial Profile

A Phase I, Clinical Study to Evaluate Safety and Immunogenicity of the Ii-Key Vaccine

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 25 Feb 2021

At a glance

  • Drugs Coronavirus vaccine Generex Biotechnology (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions
  • Most Recent Events

    • 25 Feb 2021 According to a Generex Biotechnology Corporation media release, company plan to submit the IND to the FDA as soon as the GMP production of the Ii-Key vaccine is completed in the coming weeks.
    • 31 Dec 2020 According to a Generex Biotechnology Corporation media release, an IND is being prepared for FDA submission in early 2021.
    • 31 Dec 2020 According to a Generex Biotechnology Corporation media release, with an impending IND submission for human clinical trials to evaluate safety and immunogenicity of the Ii-Key vaccine, NGIO is exploring additional opportunities to deploy the targeted Ii-Key COVID-19 vaccine as a universal booster for RNA, DNA, and inactivated virus vaccines that contain the entire spike protein and have the potential to elicit off-target and over-active immune responses.

Trial Overview

Purpose

This Phase I, clinical study will evaluate the safety and immunogenicity of the Ii-Key vaccine.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Sex male & female

Trial Details

Organisations

  • Affiliations Generex Biotechnology Corporation

Trial Dates

Other Details

  • Design multicentre; prospective
  • Phase of Trial Phase I
  • Location USA
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
Coronavirus vaccine Generex BiotechnologyPrimary Drug
-
-

Trial History

Event Date Event Type Comment
25 Feb 2021 Other trial event According to a Generex Biotechnology Corporation media release, company plan to submit the IND to the FDA as soon as the GMP production of the Ii-Key vaccine is completed in the coming weeks. Updated 01 Mar 2021
31 Dec 2020 Other trial event According to a Generex Biotechnology Corporation media release, an IND is being prepared for FDA submission in early 2021. Updated 06 Jan 2021
31 Dec 2020 Other trial event According to a Generex Biotechnology Corporation media release, with an impending IND submission for human clinical trials to evaluate safety and immunogenicity of the Ii-Key vaccine, NGIO is exploring additional opportunities to deploy the targeted Ii-Key COVID-19 vaccine as a universal booster for RNA, DNA, and inactivated virus vaccines that contain the entire spike protein and have the potential to elicit off-target and over-active immune responses. Updated 06 Jan 2021
07 Oct 2020 Other trial event According to a Generex Biotechnology Corporation media release, the company has received funding which will be used for this study. Updated 12 Oct 2020
27 Jul 2020 Other trial event According to an Generex Biotechnology Corporation media release, FDA has accepted their pre-IND briefing package for the Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine, and will provide a written response by August 24, 2020. Updated 30 Jul 2020
01 Jul 2020 Other trial event According to a Generex Biotechnology Corporation media release, this trial is expected to start in the Fall. Updated 06 Jul 2020
09 Mar 2020 New trial record New trial record Updated 09 Mar 2020
02 Mar 2020 Other trial event According to an Generex Biotechnology Corporation media release, when the optimal vaccine formulation is determined, the company through NGIO intends to initiate the requisite clinical trials of the Ii-Key-nCOV peptide vaccine for approval in the United States. Updated 09 Mar 2020
02 Mar 2020 Other trial event According to an Generex Biotechnology Corporation media release, the company has signed a contract from the Beijing Zhonghua Investment Fund Management Co., LTD. (an affiliate of China Technology Exchange), and Sinotek-Advocates International Industry Development (Shenzhen) Co., LTD. to develop a COVID-19 vaccine using the Ii-Key peptide vaccine platform. Updated 09 Mar 2020

References

  1. Generex Biotechnology Corporation. Generex and NuGenerex Immuno-Oncology Provide Update on Ii-Key COVID-19 Vaccine Development Program and Files Trademark Application for The Complete Vaccine(Tm). Media-Rel 2020;.

    Media Release
  2. James Sherblom Appointed Board Chairman to Lead ReForm Biologics New Business Strategy. Media-Rel 2021;.

    Media Release
  3. Generex Biotechnology Corporation, NuGenerex Immuno-Oncology. NuGenerex Immuno-Oncology Announces Closing of a Licensing & Distribution Agreement with Bintai Kinden to Advance the Clinical Development & Commercialization of Ii-Key-SARS-CoV-2 Coronavirus Vaccine for Global Markets. Media-Rel 2020;.

    Media Release
  4. Generex Biotechnology Corporation, Beijing Zhonghua Investment Fund Management Co., LTD. Generex Signs Contract with Chinese Partners Beijing Zhonghua Investment Fund Management Co., LTD and Sinotek-Advocates International Industry Development (Shenzhen) Co., Ltd. to Develop a COVID-19 Vaccine Using Ii-Key Peptide Vaccine Technology. Media-Rel 2020;.

    Media Release
  5. Generex Biotechnology Corporation. NuGenerex Immuno-Oncology Announces Board of Directors. Media-Rel 2020;.

    Media Release
  6. Generex Biotechnology Corporation. Generex Biotechnology Announces That FDA has Accepted the Pre-IND Briefing Package for the Companys Ii-Key-SARS-CoV-2 Vaccine and Will Provide a Written Response by August 24, 2020. Media-Rel 2020;.

    Media Release
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