A Phase 1/2 interventional study of Covigenix VAX-001 placebo and Covigenix VAX-001 in SARS-CoV-2, sponsored by Entos Pharmaceuticals Inc.. Completed at 4 sites in 4 countries. Open to participants aged 18 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Entos Pharmaceuticals Inc. · Phase 1/2, Interventional, and Prevention
This study is a Phase I/II clinical study in healthy adults designed to assess the safety, tolerability, and immunogenicity of receiving 2 IM injections of Covigenix VAX-001/-1b, 28 days apart. Covigenix VAX-001/-1b is a plasmid DNA vaccine that expresses key antigenic determinants from SARS-CoV-2 and uses Entos Pharmaceuticals' Fusogenix PLV platform.
The phase I part of this study was completed in Canada. The phase II part of the study will be completed in Burkina Faso, Senegal and South Africa.
Phase I portion of the study:
Study design:
ENTVAX01-101 is a phase I/II, placebo-controlled, randomized, observer-blind, dose ranging clinical trial in males and non-pregnant females, 18 years and older, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, tolerability, and immunogenicity of Covigenix VAX-001 manufactured by Entos Pharmaceuticals. Covigenix VAX-001 is a novel plasmid DNA-based vaccine that encodes for the full-length Spike protein from SARS-CoV-2 (VAX-001 encapsulated in a proprietary Fusogenix Proteo-Lipid Vehicle (PLV)).
Enrollment for the phase I portion of the study will occur at one Canadian site. Thirty-six participants will be enrolled in a staggered manner into one cohort an 3 groups (0.100 mg \& 0.250 mg vs. placebo) in stage I. Participants will receive an intramuscular (IM) injection (0.5 milliliter [mL]) on Days 0 and 14 in the deltoid muscle of alternating arms and will be followed through 12 months post booster vaccination (Day 379). Follow-up visits will occur at Days 7, 14, 17, 21, 28, 42, 196, and 379.
The primary objective is to evaluate the safety of a 2-dose vaccination schedule of the Covigenix VAX-001 vaccine, given 14 days apart. The secondary objectives are to evaluate the humoral immune response as measured by Immunoglobulin G (IgG) ELISA to the SARS-CoV-2 S protein and by pseudo-viral neutralization assay to pseudo-virion following a 2-dose vaccination schedule of Covigenix VAX-001.
Clinical safety data will be collected at the Day 0 of the study and at defined intervals (Dose 1: Days 7, 14; Dose 2: Days: 21, 42).
Clinical safety lab testing
Immunogenicity testing:
The following immunogenicity tests will be performed as exploratory objectives:
Sample size: 36 participants, 24 test subjects and 12 placebo controls;
Study plan:
Table 1. Study groups and treatments Arm Intervention
Enrollment plan:
Enrollment plan: Study participants will be enrolled in a staged manner at each dosage level (Low and High), as described below:
First, three participants of the cohort will be randomized (2:1; Groups 1 and 3) to the low dose of Covigenix VAX-001 or placebo, a minimum of one hour apart. Once three participants have received treatment there will be a 72-hour waiting period, and if no holding rule is met then the remaining participants from Group 1 and 3 will be vaccinated. Similarly, once 7-day safety data are available on a minimum of 75% (n=14) of participants in Groups 1/3, 1) participants of the cohort will be randomized (2:1; groups 2 and 3) to the high dose of Covigenix VAX-001 or placebo.
After review of day 42 data (Day 28 post second dose) on participants in Groups 1/3 (Low dose), it will be decided whether this group will be enrolled in the Ph II of the study.
Infection during the study: During the observation period of the study, if fever and respiratory symptoms with cough develop in a participant, he/she should immediately follow local procedures for care of suspected COVID-19 illness and contact the study team. The participant's nasopharyngeal and throat swab/sputum will be collected and tested for SARS-CoV-2 at a designated provincial testing center. If a COVID-19 infection is found during the study, a case investigation will be undertaken. Careful monitoring for vaccine-related enhanced disease will be undertaken in conjunction with the participant's primary physician.
In addition to the real-time PCR testing for SARS-CoV-2, the collected nasopharyngeal swab/sputum will be tested for other respiratory pathogens.
Participants testing positive for SARS CoV 2 between IP Dose 1 and Dose 2 will not receive Dose 2, but will be followed for safety.
Study duration: 13 months
Study Design for the phase II portion of the study:
For the Phase II part, enrollment will occur at sites globally. Approximately 500 participants will be enrolled into 1 of 5 groups (approximately 100 per group) as safety data emerge from the Phase I portion . Participants will receive an IM injection (0.5 mL) on Days 0 and 14 in the deltoid muscle of alternating arms and will be followed through 12 months post Dose 2. Follow-up visits will occur at Days 14, 28, 42, 196, and 379.
The total duration for an individual participant in the Phase II part will be approximately 13 months.
Study arms are:
Clinical safety lab testing
Immunogenicity testing:
The following immunogenicity tests will be performed as exploratory objectives:
Phase II
The Phase II part will be initiated following DSMC recommendation based on 42-day reviews of each group (complete or partial group) in Phase I Canada part and the enrollment and DSMC recommendations from the Phase II Lead-in groups in South Africa, Burkina Faso, and Senegal. Recruitment will be staggered by group as summarized in Table 5 of the protocol. The Phase II part will consist of a randomized, observer-blinded, multi-center, dose ranging clinical study in males and nonpregnant females, 18 years and older who meet all eligibility criteria. Approximately 500 participants will be enrolled into 1 of 4 cohorts: low dose 0.100 mg as 1 or 2 dose schedule and high dose 0.250 mg as 1 or 2 dose schedules.
Participants will receive an IM injection (0.5 mL) on Days 0 and 28 in the deltoid muscle of alternating arms and will be followed through 12 months post Dose 2 (Table 5).
Follow-up visits will occur at Days 28, 42, 56, 118, 210, and 393. Enrollment in the phase II part of the study will be carried out globally in Burkina Faso, Senegal and South Africa.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 268 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Entos Pharmaceuticals Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Inclusion criteria for Phase I:
Each participant must meet all of the following criteria to be enrolled in the Phase 1 part of the study:
Inclusion criteria for Phase II
Each participant must meet all of the following criteria to be enrolled in Phase II part of the study:
Exclusion Criteria
Exclusion criteria for Phase I
Participants meeting any of the following criteria will be excluded from Phase I of the study:
The participant has a laboratory (hematological and biochemistry) examination that is out of normal range, or greater than a Grade 1 abnormality and as assessed by the investigator including test results for: CBC, PT, , , AST, ALP, T Bil, Cr, lipase, and blood glucose;
The participant has unstable concomitant underlying conditions.
Exclusion criteria for Phase II
Participants meeting any of the following criteria will be excluded from Phase II part of the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose-ranging, 2 dose levels. 24 subjects receiving active i.m. vaccine
Biological: Covigenix VAX-001
Placebo injection. 12 subjects receiving placebo
Biological: Covigenix VAX-001 placebo
Placebo vaccine
Active Covigenix VAX-001
Safety of a 2-dose regimen of VAX-001 when doses are given 14 days apart
Frequency and Grade (mild, moderate, severe, potentially life-threatening; Gr. 1-4, respectively) of solicited injection site and systemic adverse events and unsolicited systemic adverse events
Time frame: Day 0 - 42
Mean change from baseline in safety laboratory measures
Adverse hematology /clinical chemistry parameter changes (mild, moderate, severe, or life-threatening; Gr. 1-4, respectively)
Time frame: Day 0 - 42
Frequency of treatment-emergent Serious Adverse Events (SAE) throughout the study and up to 12 months post-second dose immunization (Day 379).
Frequency of serious AEs
Time frame: Day 0 - 379
Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by IgG ELISA
Percent seroconversion post second dose as measured by ELISA
Time frame: Up to Day 379
Geometric mean neutralizing antibody titers against pseudo-virion after one and two doses
Geometric mean of antibody titers measured by pseudo-viral neutralization assay.
Time frame: Up to Day 379
Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by pseudo-viral neutralization assay.
Seroconversion as measured by pseudo-viral neutralization
Time frame: up to Day 379
Persistence of IgG antibody titers as measured by ELISA and neutralizing antibody titers measured by pseudo-virion neutralization assay, six months after the second vaccine dose
Maintenance of antibody titers up to 12 months post second dose
Time frame: Up to Day 379
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Dec 2023, 31 months.
Of 80 industry-sponsored phase 1/2 interventional studies under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's 31 months is above that.
Counting every sponsor, half of 187 studies reached it within 11 months; a quarter within 4 and three quarters within 20.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Entos Pharmaceuticals Inc.