A study of the safety of EDV nanocells packaged with spike-protein plasmid and glycolipid as a COVID-19 vaccine in immunocompromised patients.

Phase 1

Recruiting

• Conditions: Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases; COVID-19

• Registration Number: ACTRN12623000836639
• Lead Sponsor: EnGeneIC Pty Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Participants must have a primary or acquired immunocompromising condition and should be willing to comply with protocol scheduled study visits or procedures, to the best of the subject and Investigator’s knowledge.
Participants must have a Negative COVID-19 test (PCR or equivalent), a baseline body temperature of less than or equal to 37·5°C, an oxygen saturation of at least 92% at baseline and have general good health as established by medical history and physical examination.

Reproductive criteria are 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.

Exclusion Criteria

1. Medical history of SARS-CoV-2 infection within 3 months of Day 1.
2. Prior vaccination with a COVID-19 vaccine or prior participation in a COVID-19 vaccine trial or prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma within 3 months of Day 1.
3. Significant pericardial effusions, pleural effusions or ascites.
4. Subject is currently diagnosed with Acute Respiratory Distress Syndrome.
5. Subject has experienced a history of uncontrolled: coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association greater than Class II), uncontrolled hypertension (systolic greater than 160 mmHg or diastolic greater than 100 mmHg), or cardiac arrhythmias requiring anti-arrhythmic therapy.
6. 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.
7. Current active or uncontrolled severe infection.
8. 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: major surgery.
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. 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.
11. 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.
12. Platelet disorder or other bleeding disorder that may cause contraindication to injection. 13. Prior administration of other investigational agents less than or equal to 28 days prior to study Day 1.
14. Prior administration of attenuated vaccine in last 30 days prior to first dose.
15. Prior administration of inactivated vaccine in last 14 days prior to first dose.

Study & Design

• Study Type: Interventional
• Study Design: Not specified