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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
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
Secondary ID [1] 0 0
GLY-GVX-002-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the overall safety and reactogenicity of the Glycovax-002 conjugated vaccine administered at three different doses in healthy adults.
Timepoint [1] 0 0
Day 0 - 360
Secondary outcome [1] 0 0
To assess the immunogenicity induced by Glycovax-002 in healthy adults
Timepoint [1] 0 0
Day 0 - 120
Secondary outcome [2] 0 0
To assess the virus-neutralizing antibody response induced by Glycovax-002 in healthy adults
Timepoint [2] 0 0
Day 0 - 56

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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Glycovax Pharma Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Government of Canada
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
JSS Medical Research Inc.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Avance Clinical Pty Ltd.
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Seppic
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05799651
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kristi McLendon, MD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries