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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05799651
Registration number
NCT05799651
Ethics application status
Date submitted
10/03/2023
Date registered
5/04/2023
Date last updated
21/03/2024
Titles & IDs
Public title
Safety and Immunogenicity of Glycovax-002 Vaccine in Healthy Adults
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Scientific 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
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Secondary ID [1]
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GLY-GVX-002-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Glycovax-002
Experimental: Step 1 (Low Dose) - A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 Low Dose or placebo (ratio 3:1).
Experimental: Step 2 (Medium Dose) - A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 Medium Dose or placebo (ratio 3:1).
Experimental: Step 3 (High Dose) - A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 High Dose or placebo (ratio 3:1).
Other interventions: Glycovax-002
Intramuscular injection of vaccine against SARS-CoV-2
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To assess the overall safety and reactogenicity of the Glycovax-002 conjugated vaccine administered at three different doses in healthy adults.
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Assessment method [1]
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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
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Timepoint [1]
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Day 0 - 360
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Secondary outcome [1]
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To assess the immunogenicity induced by Glycovax-002 in healthy adults
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Assessment method [1]
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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-?
TNF-a
IL-2
IL-4
IL-13
CD4 and CD8 T-cell and B-cell counts and CD4/CD8 ratio.
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Timepoint [1]
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Day 0 - 120
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Secondary outcome [2]
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To assess the virus-neutralizing antibody response induced by Glycovax-002 in healthy adults
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Assessment method [2]
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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.
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Timepoint [2]
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Day 0 - 56
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Eligibility
Key inclusion criteria
All the following criteria need to be met for inclusion:
1. Adults in good health as determined by the Principal Investigator or Sub-Investigator
between 18 - 55 years old inclusively.
2. Able to provide informed consent and willing to comply with the study procedures.
3. BMI = 18.0 kg/m2 and = 35.0 kg/m2, with weight = 45 kg for female subjects and = 50 kg
for male subjects.
4. 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.
5. 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).
6. Agrees to practice acceptable contraception during the study if female of
child-bearing potential or male partner of female of child-bearing potential.
7. Physical examination, clinical assessments, and laboratory values within normal limits
during Screening, unless assessed as not clinically significant by Investigator or
Delegate.
8. Has received a dose or multiple doses, of a registered COVID-19 vaccine, with the last
dose more than two months prior to enrolment.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria:
Participants will be excluded if any of the following criteria are met:
1. 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.
2. 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.
3. Any of the following specific conditions:
1. Autoimmune conditions;
2. Metabolic disorders;
3. Glycosyl transferase disorders (including disorders of fucosyl transferase and
fucose metabolism);
4. Tn polyagglutination of erythrocyte syndrome, deficiency of galactosyl
transferase, anemia, leukopenia, or thrombocytopenia;
5. Known bacterial infections involving neuraminidase-expressing bacteria.
4. 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).
5. Receipt of chronic systemic treatment with known immunosuppressant medications, or
radiotherapy, within 60 days prior to enrolment.
6. Receipt of chronic systemic immunostimulant therapy (such as interferons or
interleukins) within 60 days prior to enrolment.
7. Receipt of systemic corticosteroids (=20 mg/day of prednisone or equivalent) for =14
days within 28 days prior to enrolment.
8. Receipt of blood/plasma products or immunoglobulins within 6 months prior to
enrolment.
9. Receipt of any anticoagulation treatment (other than low dose aspirin).
10. History of myocarditis or pericarditis.
11. Presence of any sign or symptom that may suggest an active respiratory infection
including COVID-19 at enrolment.
12. Any vaccination other than for influenza within 60 days prior to enrolment, or an
influenza vaccination within 30 days prior to enrolment.
13. Planning to receive vaccination within 60 days after enrolment in the study.
14. Positive testing for COVID-19 within 3 months of enrolment or positive PCR testing for
COVID-19 at enrolment.
15. Diagnosed with Influenza within 30 days prior to enrolment.
16. Positive for infection with HIV or with hepatitis B or C at Screening.
17. 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.
18. History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (e.g., anaphylaxis).
19. 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.
20. 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.
21. 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.
22. Presence of tattoos or scars on the upper arms that would preclude visualising any
injection site reactions.
23. Any other reason (e.g., poor venous access) at the Investigator's discretion.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2024
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Q-Pharm Pty Ltd - Herston
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Recruitment postcode(s) [1]
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4006 - Herston
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Glycovax Pharma Inc.
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Government of Canada
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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JSS Medical Research Inc.
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Address [2]
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Country [2]
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Other collaborator category [3]
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Commercial sector/Industry
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Name [3]
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Avance Clinical Pty Ltd.
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Address [3]
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Country [3]
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Other collaborator category [4]
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Commercial sector/Industry
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Name [4]
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Seppic
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05799651
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kristi McLendon, MD
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Address
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Nucleus Network
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05799651
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