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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05799651




Registration number
NCT05799651
Ethics application status
Date submitted
10/03/2023
Date registered
5/04/2023
Date last updated
24/09/2024

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:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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
31/12/2024
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Glycovax Pharma Inc.
Address
Country

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/study/NCT05799651
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05799651