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A Phase 1, Randomized, Placebo-Controlled Clinical Study to Investigate the Clinical Safety and Immunogenicity of a Vaccine Candidate DPX-COVID-19

Trial Profile

A Phase 1, Randomized, Placebo-Controlled Clinical Study to Investigate the Clinical Safety and Immunogenicity of a Vaccine Candidate DPX-COVID-19

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 12 Aug 2020

At a glance

  • Drugs DPX COVID-19 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Most Recent Events

    • 12 Aug 2020 According to an IMV media release, the company will receive funds from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP), the Innovation Assistance Program (NRC IAP), the Atlantic Canada Opportunities Agency (ACOA), and from Next Generation Manufacturing Canada (NGen) to support this study.
    • 12 Aug 2020 According to an IMV media release, the company will enroll across two clinical sites including in elderly subjects in this study.
    • 05 Aug 2020 According to an IMV media release, the Company has submitted a clinical trial application for regulatory approval after Health Canada agreed on a Phase 1 trial design protocol that includes patients of 56 years old and above.

Trial Overview

Purpose

This phase I, randomized, placebo-controlled study will investigate the clinical safety and immunogenicity of a vaccine candidate DPX-COVID-19 based on the Company's DPX delivery technology and incorporating peptides targeting novel epitopes from the coronavirus strain.
The will enroll approximately 84 healthy subjects in two age strata and will assess two different doses of DPX-COVID-19. Two age cohorts are: (1) adults between 18-55 years old inclusive and (2) 56 and above.

Other Endpoints

−Clinical safety and immunogenicity of a vaccine candidate DPX-COVID-19 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 84

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient Inclusion Criteria

−Healthy subjects.

Trial Details

Organisations

  • Affiliations IMV

Trial Dates

Other Details

  • Design multicentre; prospective; randomised
  • Phase of Trial Phase I
  • Location Canada
  • Focus Adverse reactions; First in man; Pharmacodynamics

Interventions

Drugs Route Formulation
DPX COVID-19Primary Drug
-
-

Healthy subjects in two age strata will be enrolled and two different doses of DPX-COVID-19 will be assessed.

Vaccine Candidate DPX-COVID-19 (Two dose levels of DPX-COVID-19 will be tested (25μg or 50μg))

Placebo

Trial History

Event Date Event Type Comment
12 Aug 2020 Other trial event According to an IMV media release, the company will receive funds from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP), the Innovation Assistance Program (NRC IAP), the Atlantic Canada Opportunities Agency (ACOA), and from Next Generation Manufacturing Canada (NGen) to support this study. Updated 18 Aug 2020
12 Aug 2020 Other trial event According to an IMV media release, the company will enroll across two clinical sites including in elderly subjects in this study. Updated 18 Aug 2020
05 Aug 2020 Other trial event According to an IMV media release, the Company has submitted a clinical trial application for regulatory approval after Health Canada agreed on a Phase 1 trial design protocol that includes patients of 56 years old and above. Updated 07 Aug 2020
05 Aug 2020 Other trial event According to an IMV media release, Canadian government agencies will contribute up to CA dollar 4.75 million to advance this trial. Updated 07 Aug 2020
14 Jul 2020 Other trial event According to an IMV media release, results from this study are expected in the fall of 2020. Updated 17 Jul 2020
14 Jul 2020 Other trial event According to an IMV media release, the company is please that Health Canada has welcomed the design of this phase 1 study. Updated 17 Jul 2020
21 May 2020 Other trial event According to an IMV media release, it is working to advance DPX-COVID-19 with urgency and remain on track to launch a Phase 1 clinical study in summer 2020 Updated 26 May 2020
15 May 2020 Other trial event Planned number of patients changed from 48 to 84, according to an IMV media release. Updated 22 May 2020
15 May 2020 Other trial event According to an IMV media release, since the recent update, IMV has met with Health Canada in preparation for its clinical trial application (CTA) and is in the process of finalizing its Phase 1 design.IMV has also submitted to relevant authorities requests for grants for its DPX-COVID-19 program. Updated 22 May 2020
15 May 2020 Other trial event According to an IMV media release, IMV is on schedule to complete preclinical studies of DPX-COVID-19, before the end of May and is on track to initiate this Phase 1 clinical study for DPX-COVID-19 this summer. Updated 22 May 2020
30 Mar 2020 Other trial event IMV has initiated discussions with Health Canada in preparation for a Clinical Trial Application (CTA). A meeting is being scheduled in the week of April 20, 2020 with the goal to initiate the clinical study in the summer of 2020. Updated 02 Apr 2020
30 Mar 2020 Other trial event According to an IMV media release, In collaboration with Joanne Langley, M.D. at the Canadian Center for Vaccinology (CCfV) and the Canadian Immunization Research Network (CIRN) the design of this trial has been completed and clinical sites identified in both Nova Scotia and Quebec. Updated 02 Apr 2020
19 Mar 2020 New trial record New trial record Updated 19 Mar 2020
18 Mar 2020 Other trial event According to an IMV media release, the investigators will assist with preclinical and clinical evaluation and with further development strategy in collaboration with the Canadian government and others. Updated 19 Mar 2020
18 Mar 2020 Other trial event According to an IMV media release, the company intends to develop its vaccine candidate DPX-COVID-19 for this phase 1 clinical study in collaboration with lead investigators: Joanne Langley, M.D. and Scott Halperin, M.D., of the CCfV at Dalhousie University, the Izaak Walton Killam Health Center and the Nova Scotia Health Authority and the CIRN, along with Dr. Gary Kobinger, Ph.D., Director of the Research Centre on Infectious Diseases at the University Laval in Quebec City and GUARD in Canada. Updated 19 Mar 2020

References

  1. IMV. IMV Inc. Launches Plans to Advance Clinical Development of a Vaccine Candidate Against COVID-19. Media-Rel 2020;.

    Media Release
  2. IMV. IMV Inc. Provides Clinical and Operational Update and Announces First Quarter 2020 Financial Results. Media-Rel 2020;.

    Media Release
  3. IMV. IMV Inc. Announces Fourth Quarter and Full Year 2019 Financial and Operational Results. Media-Rel 2020;.

    Media Release
  4. IMV. IMV Receives Funding From Canadian Governmental Agencies for COVID-19 Vaccine Phase 1 Clinical Study. Media-Rel 2020;.

    Media Release
  5. IMV. IMV Announces Selection of a Vaccine Candidate Against COVID-19 to Advance Into Human Clinical Studies. Media-Rel 2020;.

    Media Release
  6. IMV. IMV Updates Rapid Progress on COVID-19 Vaccine Program. Media-Rel 2020;.

    Media Release
  7. IMV. IMV Inc. Announces Second Quarter 2020 Financial Results. Media-Rel 2020;.

    Media Release
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