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
Brief Summary

Glycovax Pharma has developed a glycoconjugate vaccine candidate called Glycovax-002 tofight the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the origin ofCOVID-19.The aim of the study is to assess the safety, reactogenicity and immunogenicity ofGlycovax-002 in humans. The study is a phase I, placebo-controlled, dose-escalation studyconducted in 36 healthy females and males aged between 18 and 55 years old. The vaccinewill 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 thevaccine will be randomized with 3 participants receiving placebo (normal saline).Progression to next step is conditional to a DSMB's approval.

Detailed Description

Not Provided

Active, not recruiting
SARS-CoV-2

Biological: Glycovax-002

Intramuscular injection of vaccine against SARS-CoV-2

Eligibility Criteria

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.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 55 Years
Countries
Australia
Locations

Q-Pharm Pty Ltd
Herston, Queensland, Australia

Kristi McLendon, MD, Principal Investigator
Nucleus Network

Glycovax Pharma Inc.
NCT Number
Keywords
Covid-19