Safety and Immunogenicity of Glycovax-002 Vaccine in Healthy Adults

NCT05799651 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: GLY-GVX-002-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0 - 360

Secondary Outcomes (2)

• To assess the immunogenicity induced by Glycovax-002 in healthy adults

  Day 0 - 120

• To assess the virus-neutralizing antibody response induced by Glycovax-002 in healthy adults

  Day 0 - 56

Study Arms (3)

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).

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).

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).

Biological: Glycovax-002

Interventions

Glycovax-002 BIOLOGICAL

Intramuscular injection of vaccine against SARS-CoV-2

Step 1 (Low Dose); Step 2 (Medium Dose); Step 3 (High Dose)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• Participants will be excluded if any of the following criteria are met:
• 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;
• 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.

Sponsors & Collaborators

• Glycovax Pharma Inc.: lead
• Government of Canada: collaborator
• JSS Medical Research Inc.: collaborator
• Avance Clinical Pty Ltd.: collaborator
• Seppic: collaborator

Study Sites (1)

Q-Pharm Pty Ltd

Herston, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kristi McLendon, MD

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 5, 2023
• Study Start: April 28, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

AU (1)