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Virus Therapy

COVAC-2 for COVID-19

Phase 1
Waitlist Available
Led By Joanne M Langley, MD
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 7, 14, 28, 35, 42, 56, 90, 120, and 365
Awards & highlights

Study Summary

This trial is designed to test the safety and effectiveness of a new potential vaccine for COVID-19. The vaccine will be given to people in two groups, those aged 18-54 and those aged 55 and over. The trial will test different doses of the vaccine to see which is the most effective.

Eligible Conditions
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 7, 14, 28, 35, 42, 56, 90, 120, and 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 7, 14, 28, 35, 42, 56, 90, 120, and 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of AEs from the second injection to Day 56 (28 days post injection), in all participants, in all groups
Occurrence of adverse events (AEs) from the first injection to Day 28, in all participants, in all groups
Secondary outcome measures
Specific antibody response induced by the vaccine against the SARS-CoV-2 S protein as measured by ELISA
Vaccines
Other outcome measures
Specific antibody response induced by the vaccine against the SARS-CoV-2 RBD protein as measured by ELISA
Vaccines

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I-2Experimental Treatment1 Intervention
COVAC-2 50 µg: 8 healthy adults ≥ 55 years of age receive the vaccine on Day 0, followed by a second dose on Day 28.
Group II: Group G-2Experimental Treatment1 Intervention
COVAC-2 25 µg: 8 or 9 healthy adults ≥ 55 years of age receive the vaccine on Day 0, followed by a second dose on Day 28.
Group III: Group E-2Experimental Treatment1 Intervention
COVAC-2 100 µg: 8 healthy adults 18 to 54 years of age receive the vaccine on Day 0, followed by a second dose on Day 28.
Group IV: Group C-2Experimental Treatment1 Intervention
COVAC-2 50 µg: 8 healthy adults 18 to 54 years of age receive the vaccine on Day 0, followed by a second dose on Day 28.
Group V: Group A-2Experimental Treatment1 Intervention
COVAC-2 25 µg: 8 healthy adults 18 to 54 years of age receive the vaccine on Day 0, followed by a second dose on Day 28.
Group VI: Group H-2Placebo Group1 Intervention
Placebo Control: 4 or 5 healthy adults ≥ 55 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of normal saline (placebo) on Day 28.
Group VII: Group F-2Placebo Group1 Intervention
Placebo Control: 4 healthy adults 18 to 54 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of saline placebo on Day 28.
Group VIII: Group J-2Placebo Group1 Intervention
Placebo Control: 4 healthy adults ≥ 55 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of saline placebo on Day 28.
Group IX: Group B-2Placebo Group1 Intervention
Placebo Control: 4 healthy adults 18 to 54 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of normal saline (placebo) on Day 28.
Group X: Group D-2Placebo Group1 Intervention
Placebo Control: 4 healthy adults 18 to 54 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of saline placebo on Day 28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
COVAC-2
2021
Completed Phase 1
~70

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vaccine Formulation Institute (VFI)UNKNOWN
2 Previous Clinical Trials
210 Total Patients Enrolled
1 Trials studying COVID-19
60 Patients Enrolled for COVID-19
Government of SaskatchewanOTHER_GOV
4 Previous Clinical Trials
257 Total Patients Enrolled
2 Trials studying COVID-19
107 Patients Enrolled for COVID-19
SeppicIndustry Sponsor
10 Previous Clinical Trials
779 Total Patients Enrolled
2 Trials studying COVID-19
96 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment have any vacancies for participants?

"Clinicaltrials.gov does not list this medical trial as actively recruiting patients, noting that it was initially posted on February 10th 2021 and last updated on November 15th 2022. Nevertheless, there are over a thousand other trials currently enrolling participants at the moment."

Answered by AI

How perilous is COVAC-2 for those in treatment?

"With limited clinical data to go off of, COVAC-2 was deemed a 1 on the Power team's safety scale. This is due to it being in Phase 1 and thus lacking significant evidence regarding efficacy or security."

Answered by AI
~15 spots leftby Apr 2025