SARS-CoV-2Phase 1NCT05799651
Safety and Immunogenicity of Glycovax-002 Vaccine in Healthy Adults
A Phase 1 study testing Glycovax-002 in people with SARS-CoV-2, run by Glycovax Pharma Inc. at 1 site in Australia.
Trial summary
Glycovax Pharma has developed a glycoconjugate vaccine candidate called Glycovax-002 to fight the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the origin of COVID-19. The aim of the study is to assess the safety, reactogenicity and immunogenicity of Glycovax-002 in humans. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Glycovax-002
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Apr 2023to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All the following criteria need to be met for inclusion:
- Adults in good health as determined by the Principal Investigator or Sub-Investigator between 18 - 55 years old inclusively.
- Able to provide informed consent and willing to comply with the study procedures.
- BMI ≥ 18.0 kg/m2 and ≤ 35.0 kg/m2, with weight ≥ 45 kg for female subjects and ≥ 50 kg for male subjects.
- Vital signs within the following limits: systolic blood pressure (BP) 90 - 140 mmHg, inclusive; diastolic BP 40 - 90 mmHg, inclusive; heart rate 40 - 100 bpm, inclusive; respiratory rate 10 - 22 bpm, inclusive; temperature 35.5 - 37.5 °C, inclusive.
- Women of child-bearing potential should have a negative serum pregnancy test at Screening and a confirmatory negative urine pregnancy test at Baseline (Day 0, defined as enrolment), one before the second administration (Day 14) and one before the third and last dose administration (Day 28).
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- Agrees to practice acceptable contraception during the study if female of child-bearing potential or male partner of female of child-bearing potential.
- Physical examination, clinical assessments, and laboratory values within normal limits during Screening, unless assessed as not clinically significant by Investigator or Delegate.
- Has received a dose or multiple doses, of a registered COVID-19 vaccine, with the last dose more than two months prior to enrolment.
Who cannot join
- Participants will be excluded if any of the following criteria are met:
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator, that could adversely affect the safety of the participant or confound the results of the study. Fully resolved childhood asthma is not exclusionary.
- History of malignancy, except for non-melanoma skin cancer when excised more than two years ago and cervical intraepithelial neoplasia that has been successfully cured more than two years prior to Screening.
- Any of the following specific conditions:
- Autoimmune conditions;
- Metabolic disorders;
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- Glycosyl transferase disorders (including disorders of fucosyl transferase and fucose metabolism);
- Tn polyagglutination of erythrocyte syndrome, deficiency of galactosyl transferase, anemia, leukopenia, or thrombocytopenia;
- Known bacterial infections involving neuraminidase-expressing bacteria.
- Use of any prescription medication that, in the Investigator's judgment, can interfere with the interpretation of the study tests or in the opinion of the Investigator may be contra-indicated for use with Glycovax-002. Medications that have been stable in the past 3 months may be allowed, for instance medications for hypertension, hypercholesterolemia, and gastroesophageal reflux disease (e.g. proton pump inhibitors).
- Receipt of chronic systemic treatment with known immunosuppressant medications, or radiotherapy, within 60 days prior to enrolment.
- Receipt of chronic systemic immunostimulant therapy (such as interferons or interleukins) within 60 days prior to enrolment.
- Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days within 28 days prior to enrolment.
- Receipt of blood/plasma products or immunoglobulins within 6 months prior to enrolment.
- Receipt of any anticoagulation treatment (other than low dose aspirin).
- History of myocarditis or pericarditis.
- Presence of any sign or symptom that may suggest an active respiratory infection including COVID-19 at enrolment.
- Any vaccination other than for influenza within 60 days prior to enrolment, or an influenza vaccination within 30 days prior to enrolment.
- Planning to receive vaccination within 60 days after enrolment in the study.
- Positive testing for COVID-19 within 3 months of enrolment or positive PCR testing for COVID-19 at enrolment.
- Diagnosed with Influenza within 30 days prior to enrolment.
- Positive for infection with HIV or with hepatitis B or C at Screening.
- Receipt of an investigational drug within 30 days or 5 half-lives (whichever is longer) before study enrolment. For studies involving investigational products that fall within the categories mentioned in other Inclusion Criteria, the respective timelines should be respected.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis).
- History of hypersensitivity or allergic reaction to any of the components of GVX-002, including diphtheria toxoid, or squalene-based adjuvants, including Sepivac SWE™ and MF59.
- History of drug or alcohol abuse, or positive detection test at Screening or prior to Study Drug administration for alcohol or any illicit drug including cannabis.
- Current smoking (more than 10 cigarettes/week), current vaping (more than 80 puffs/week), current cannabis use, alcohol abuse (defined as regularly consuming more than 14 units of alcohol per week), or current drug abuse (as tested at Screening), to avoid possible impairment of immune function.
- Presence of tattoos or scars on the upper arms that would preclude visualising any injection site reactions.
- Any other reason (e.g., poor venous access) at the Investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Dose-Escalation Phase I Study in Healthy Adults to Assess the Safety, Tolerability and Immunogenicity of Glycovax-002, a Novel Vaccine Candidate Against COVID-19
Glycovax Pharma has developed a glycoconjugate vaccine candidate called Glycovax-002 to fight the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the origin of COVID-19.
The aim of the study is to assess the safety, reactogenicity and immunogenicity of Glycovax-002 in humans. The study is a phase I, placebo-controlled, dose-escalation study conducted in 36 healthy females and males aged between 18 and 55 years old. The vaccine will be administered three times with a two-week time interval between each dose.
Dose escalation is conducted in three steps. At each step, 9 participants receiving the vaccine will be randomized with 3 participants receiving placebo (normal saline). Progression to next step is conditional to a DSMB's approval.
- Conditions
- SARS-CoV-2
- Being tested
- Glycovax-002
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycovax-002Biological
Intramuscular injection of vaccine against SARS-CoV-2
| Study group | Role | What they receive |
|---|---|---|
| Step 1 (Low Dose) | Experimental | A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 Low Dose or placebo (ratio 3:1). Receives: Biological: Glycovax-002 |
| Step 2 (Medium Dose) | Experimental | A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 Medium Dose or placebo (ratio 3:1). Receives: Biological: Glycovax-002 |
| Step 3 (High Dose) | Experimental | A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 High Dose or placebo (ratio 3:1). Receives: Biological: Glycovax-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the overall safety and reactogenicity of the Glycovax-002 conjugated vaccine administered at three different doses in healthy adults.
Safety:
- Incidence of Adverse Events (AEs) in all participants.
- Occurrence of each solicited local and systemic AE, during each 7-day follow-up period after injection.
- Occurrence of any AEs until 28 days after the last injection.
- Occurrence of serious AEs until one year after the first injection.
- Assessment of safety will involve blood tests for biochemistry, hematology, serum chemistry and immunogenicity, urine tests for urinalysis, and participant diaries.
Reactogenicity:
Reactogenicity will be assessed by the incidence of the following solicited reactions for the first 7 days after each administration:
Local:
- Swelling at injection site
- Erythema at injection site
- Pain at injection site
General (systemic):
- Fever
- Fatigue
- Chills
- Diarrhea
- Myalgia
- Arthralgia
- Headache
- Nausea/Vomiting
Measured: Day 0 - 360
Secondary outcomes (2)
To assess the immunogenicity induced by Glycovax-002 in healthy adults
Immunogenicity will be assessed prior to each dose of Glycovax-002 and then at 1 and 3 months after the last dose, i.e. at Days 0, 14, 28, 56 and 120, except otherwise stated.
- Serum anti-TF IgG
- Total serum IgG, IgA, and IgM
- Cytokine (Th1 and Th2) concentration in serum, at baseline and six hours after the last Glycovax-002 administration on Day 28:
- IFN-γ
- TNF-α
- IL-2
- IL-4
- IL-13
- CD4 and CD8 T-cell and B-cell counts and CD4/CD8 ratio.
Measured: Day 0 - 120
To assess the virus-neutralizing antibody response induced by Glycovax-002 in healthy adults
SARS-CoV-2 virus-neutralising antibody levels in serum, on Days 0 and 56 only, by a pseudovirus neutralisation assay
- based on the original Wuhan viral strain, and
- based on the latest Variant of Concern available for testing at time of study initiation.
Measured: Day 0 - 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start28 Apr 2023
- Primary completion30 Jun 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glycovax Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Government of Canada, JSS Medical Research Inc., Avance Clinical Pty Ltd., Seppic
- Responsible party
- Sponsor
- Investigators
- Kristi McLendon, MD, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799651
- Sponsor's protocol ID
- GLY-GVX-002-001
- Status last verified
- Sep 2024
- First submitted
- 10 Mar 2023
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Dose-Escalation Phase I Study in Healthy Adults to Assess the Safety, Tolerability and Immunogenicity of Glycovax-002, a Novel Vaccine Candidate Against COVID-19
- ClinicalTrials.gov ID
- NCT05799651
- Acronym / sponsor ID
- GLY-GVX-002-001
- Conditions
- SARS-CoV-2
- Keywords
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Glycovax Pharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Government of Canada, JSS Medical Research Inc., Avance Clinical Pty Ltd., Seppic
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glycovax Pharma has developed a glycoconjugate vaccine candidate called Glycovax-002 to fight the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the origin of COVID-19.
The aim of the study is to assess the safety, reactogenicity and immunogenicity of Glycovax-002 in humans. The study is a phase I, placebo-controlled, dose-escalation study conducted in 36 healthy females and males aged between 18 and 55 years old. The vaccine will be administered three times with a two-week time interval between each dose.
Dose escalation is conducted in three steps. At each step, 9 participants receiving the vaccine will be randomized with 3 participants receiving placebo (normal saline). Progression to next step is conditional to a DSMB's approval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Step 1 (Low Dose) | Experimental | Biological: Glycovax-002A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 Low Dose or placebo (ratio 3:1). |
| Step 2 (Medium Dose) | Experimental | Biological: Glycovax-002A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 Medium Dose or placebo (ratio 3:1). |
| Step 3 (High Dose) | Experimental | Biological: Glycovax-002A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 High Dose or placebo (ratio 3:1). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adults in good health as determined by the Principal Investigator or Sub-Investigator between 18 - 55 years old inclusively.
- Able to provide informed consent and willing to comply with the study procedures.
- BMI ≥ 18.0 kg/m2 and ≤ 35.0 kg/m2, with weight ≥ 45 kg for female subjects and ≥ 50 kg for male subjects.
- Vital signs within the following limits: systolic blood pressure (BP) 90 - 140 mmHg, inclusive; diastolic BP 40 - 90 mmHg, inclusive; heart rate 40 - 100 bpm, inclusive; respiratory rate 10 - 22 bpm, inclusive; temperature 35.5 - 37.5 °C, inclusive.
- Women of child-bearing potential should have a negative serum pregnancy test at Screening and a confirmatory negative urine pregnancy test at Baseline (Day 0, defined as enrolment), one before the second administration (Day 14) and one before the third and last dose administration (Day 28).
Key exclusion criteria (29 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator, that could adversely affect the safety of the participant or confound the results of the study. Fully resolved childhood asthma is not exclusionary.
- History of malignancy, except for non-melanoma skin cancer when excised more than two years ago and cervical intraepithelial neoplasia that has been successfully cured more than two years prior to Screening.
- Any of the following specific conditions:
- Use of any prescription medication that, in the Investigator's judgment, can interfere with the interpretation of the study tests or in the opinion of the Investigator may be contra-indicated for use with Glycovax-002. Medications that have been stable in the past 3 months may be allowed, for instance medications for hypertension, hypercholesterolemia, and gastroesophageal reflux disease (e.g. proton pump inhibitors).
- Receipt of chronic systemic treatment with known immunosuppressant medications, or radiotherapy, within 60 days prior to enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycovax-002Intramuscular injection of vaccine against SARS-CoV-2 | Biological | Step 1 (Low Dose), Step 2 (Medium Dose), Step 3 (High Dose) |
Primary outcome
To assess the overall safety and reactogenicity of the Glycovax-002 conjugated vaccine administered at three different doses in healthy adults.
Time frame: Day 0 - 360
Safety: * Incidence of Adverse Events (AEs) in all participants. * Occurrence of each solicited local and systemic AE, during each 7-day follow-up period after injection. * Occurrence of any AEs until 28 days after the last injection. * Occurrence of serious AEs until one year after the first injection. * Assessment of safety will involve blood tests for biochemistry, hematology, serum chemistry and immunogenicity, urine tests for urinalysis, and participant diaries. Reactogenicity: Reactogenicity will be assessed by the incidence of the following solicited reactions for the first 7 days after each administration: Local: * Swelling at injection site * Erythema at injection site * Pain at injection site General (systemic): * Fever * Fatigue * Chills * Diarrhea * Myalgia * Arthralgia * Headache * Nausea/Vomiting
2 secondary outcomes
To assess the immunogenicity induced by Glycovax-002 in healthy adults
Time frame: Day 0 - 120
To assess the virus-neutralizing antibody response induced by Glycovax-002 in healthy adults
Time frame: Day 0 - 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristi McLendon, MD principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glycovax-002 in people with SARS-CoV-2, run by Glycovax Pharma Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the overall safety and reactogenicity of the Glycovax-002 conjugated vaccine administered at three different doses in healthy adults. (time frame: Day 0 - 360). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.