COVAC-2 / University of Saskatchewan - LARVOL DELTA

Safety and immunogenicity of COVAC-2, a Sepivac SWE™ adjuvanted SARS-CoV-2 recombinant protein vaccine in healthy adults; a randomized controlled first-in-human dose-escalation trial. (PubMed, Vaccine) - "This Phase 1 trial indicated that COVAC-2 is safe and induces high levels of both antigen-specific binding and neutralizing antibodies by Day 42-56 with levels beginning to wane by Day 120."

First-in-human • Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases • IFNG • IL5

Clinical Trial to Study the COVAC-2 Booster Dose (for COVID-19) in Generally Healthy Adults. (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: University of Saskatchewan | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC-2 in Adults (clinicaltrials.gov) - P2 | N=150 | Completed | Sponsor: University of Saskatchewan | Active, not recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ Mar 2024

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Clinical Trial to Study the COVAC-2 Booster Dose (for COVID-19) in Generally Healthy Adults. (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: University of Saskatchewan | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC-2 in Healthy Adults (clinicaltrials.gov) - P1 | N=61 | Completed | Sponsor: University of Saskatchewan | Active, not recruiting ➔ Completed | Trial completion date: Apr 2023 ➔ Nov 2022

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC-2 in Adults (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: University of Saskatchewan | Recruiting ➔ Active, not recruiting | N=300 ➔ 150 | Trial completion date: Aug 2023 ➔ Aug 2024 | Trial primary completion date: May 2023 ➔ Feb 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Clinical Trial to Study the COVAC-2 Booster Dose (for COVID-19) in Generally Healthy Adults. (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: University of Saskatchewan | Phase classification: P1/2 ➔ P1 | N=380 ➔ 60

Enrollment change • Phase classification • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC-2 in Adults (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: University of Saskatchewan | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Clinical Trial to Study the COVAC-2 Booster Dose (for COVID-19) in Generally Healthy Adults. (clinicaltrials.gov) - P1/2 | N=380 | Recruiting | Sponsor: University of Saskatchewan | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC-2 in Adults (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: University of Saskatchewan | Initiation date: Jun 2022 ➔ Sep 2022

Trial initiation date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC-2 in Healthy Adults (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: University of Saskatchewan | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Clinical Trial to Study the COVAC-2 Booster Dose (for COVID-19) in Generally Healthy Adults. (clinicaltrials.gov) - P1/2 | N=380 | Not yet recruiting | Sponsor: University of Saskatchewan | Initiation date: Mar 2022 ➔ Jun 2022

Trial initiation date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC-2 in Adults (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: University of Saskatchewan | Initiation date: Feb 2022 ➔ Jun 2022

Trial initiation date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Clinical Trial to Study the COVAC-2 Booster Dose in Generally Healthy Adults. (clinicaltrials.gov) - P1/2 | N=380 | Not yet recruiting | Sponsor: University of Saskatchewan

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC-2 in Adults (clinicaltrials.gov) - P2; N=300; Not yet recruiting; Sponsor: University of Saskatchewan

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC-2 in Healthy Adults (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: University of Saskatchewan; N=108 ➔ 72

Enrollment change • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC-2 in Healthy Adults (clinicaltrials.gov) - P1; N=108; Recruiting; Sponsor: University of Saskatchewan; Phase classification: P1/2 ➔ P1

Phase classification • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC Vaccines in Healthy Adults (clinicaltrials.gov) - P1/2; N=108; Recruiting; Sponsor: University of Saskatchewan; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Trial of COVAC Vaccines in Healthy Adults (clinicaltrials.gov) - P1/2; N=108; Not yet recruiting; Sponsor: University of Saskatchewan

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases