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Broad Health Condition Infection
Specific Health ConditionOther infectious diseases
Other respiratory disorders / diseases
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Sydney Adventist Hospital - Wahroonga
3065 - Fitzroy
2076 - Wahroonga
Anticipated date of last participant enrolment31/10/2022
Phase of TrialPhase 1 / Phase 2
Has the study received ethics approval?Approved
This is the initial Phase I/IIa, first-in-human study of EDV nanocells packaged with SARS-CoV-2 spike protein and alpha galacosylceramide adjuvant (EDV-plasmid-spike-GC) as a COVID-19 vaccine. The study follows an open label, non-randomised dose escalation study design across three dose levels, whereby the EDV-plasmid-spike-GC is administered intramuscularly (IM) at a dosage dependent on the cohort in order to assess the safety and tolerability of the vaccine in healthy volunteers 18 years and older. Up to a total of 200 participants will be recruited to the study, at 6 per cohort during dose escalation. Each cohort follows the same timepoints of dosing on Days 1 and 21, followed by subsequent visits at 28 days, 2 months, 3 months and 6 months. Adverse events and DLT evaluation will occur between Day 1 and 28 in order to assess the safety and tolerability of each dose level before continuing to the next cohort. Once a recommended dose level has been identified from one of the cohorts, recruitment will continue until a maximum of 200 participants.
Key inclusion criteria
1. Volunteers (male or female) non-COVID-19 infected. 2. Aged greater than or equal to 18 years. 3. No medical history of SARS-CoV-2 infection within 4 months of Day 1. 4. The subject (or subject’s legally authorised representative) has provided voluntary signed informed consent. 5. Subject should be willing to comply with protocol scheduled study visits or procedures, to the best of the subject and Investigator’s knowledge. 6. Have a baseline body temperature of less than or equal to 37·5°C and have general good health as established by medical history and physical examination. 7. Reproductive criteria as follows: • Female subjects who are of non-reproductive potential (i.e., post menopausal by history - no menses for greater than or equal to 1 year and follicle-stimulating hormone (FSH) level consistent with post-menopausal status; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). • Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose. • Female subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration. Highly effective methods of birth control include sexual abstinence, hormonal birth control, or intrauterine device (women), vasectomy or a condom with spermicide (men) in combination with barrier methods. • Male subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration. • All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.
Minimum age18 Years
GenderBoth males and females
Can Healthy volunteers participate? Yes
Key exclusion criteria
1. Prior intervention for SARS-CoV-2 prophylaxis within 4 months of Day 1. 2. Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma within 4 months of Day 1. 3. Significant pericardial effusions, pleural effusions or ascites. 4. Subject has experienced a history of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg), or cardiac arrhythmias requiring anti-arrhythmic therapy. 5. History of uncontrolled arterial or venous thrombosis. Subjects with a history of arterial or venous thrombosis are eligible if the subject is controlled via ongoing therapeutic intervention. 6. Active or uncontrolled severe infection. 7. Received the following procedures within 28 days prior to receiving their first dose (Day 1), (or has not recovered from the toxic effects of such therapy) including: • radiotherapy • major surgery. 8. History of myocarditis. 9. QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging considered as substitutes. 10. Known allergy/hypersensitivity to investigational components or excipients (monoclonal antibody infusions, interferon therapy or bacterial vaccines). 11. Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 12. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. 13. Platelet disorder or other bleeding disorder that may cause contraindication to injection. 14. Prior administration of other investigational agents less than or equal to 15 days prior to study Day 1. 15. Prior administration of attenuated vaccine in last 30 days. 16. Prior administration of inactivated vaccine in last 14 days.
Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: EnGeneIC Pty Limited
Primary Sponsor Address: Building 2/25 Sirius Rd. Lane Cove West NSW 2066
Primary Sponsor Country: Australia
Contact person for information and recruitmentMr
EnGeneIC Pty Limited Building 2/25 Sirius Rd. Lane Cove West, NSW 2066
+61 02 94205844
Email contact firstname.lastname@example.orgAustralia