A Phase 1/2, Randomized, Placebo-Controlled Clinical Study to Investigate the Clinical Safety and Immunogenicity of a Vaccine Candidate DPX-COVID-19

At a glance

Drugs DPX COVID-19 (Primary)
Indications COVID 2019 infections
Focus Adverse reactions; First in man; Pharmacodynamics
Sponsors IMV

Most Recent Events

17 Mar 2021 According to an IMV media release, it intends to submit preclinical study results supporting the Phase 1/2 clinical trial in a peer-reviewed scientific journal in Q2 2021
12 Nov 2020 According to an IMV media release, preliminary results are expected in Q1 2021.
08 Oct 2020 According to an IMV media release, the trial is expected to be initiated before the end of 2020.

Trial Overview

Purpose

This phase I/II, 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

Sponsors IMV
Affiliations IMV

Trial Dates

Other Details

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

Drug Name	Highest Phase	Originator
DPX COVID 19	Preclinical	IMV

Interventions

Drugs	Route	Formulation
DPX COVID-19Primary Drug	Parenteral	-

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 Centres

Centres

Download Data (CSV)

Centre Name	Location	Trial Centre Country
IMV	-	-

Trial History

Event Date	Event Type	Comment
17 Mar 2021	Other trial event	According to an IMV media release, it intends to submit preclinical study results supporting the Phase 1/2 clinical trial in a peer-reviewed scientific journal in Q2 2021 Updated 22 Mar 2021
12 Nov 2020	Other trial event	According to an IMV media release, preliminary results are expected in Q1 2021. Updated 25 Nov 2020
08 Oct 2020	Other trial event	According to an IMV media release, the trial is expected to be initiated before the end of 2020. Updated 25 Nov 2020
08 Oct 2020	Other trial event	According to an IMV media release, the design of this larger study will incorporate the same two-age strata cohorts (18-55 years old and over 55 years old) as originally designed. Updated 14 Oct 2020
08 Oct 2020	Protocol amendment	According to an IMV media release, it decided to combine its original Phase 1 and 2 studies into a single trial with the potential to accelerate the clinical development and the timeline of the overall project. Updated 14 Oct 2020
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

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