None listed
Conditions
Brief summary
A Phase I/IIa, first-in-human study of EDV nanocells packaged with SARS-CoV-2 spike protein and alpha galacosylceramide adjuvant (COVID-EDV) as a COVID-19 vaccine in immunocompromised patients. COVID-EDVs are being developed as a potential anti-COVID-19 vaccine to protect COVID-vulnerable people such as those suffering from cancer and who have a compromised immune system. This trial is a follow-up of the previous healthy volunteer trial ACTRN12621001159842. The primary objective of this trial is to assess the safety and tolerability of COVID-EDVs administered intramuscularly (IM) in non-COVID-19-infected immunocompromised patients. The study follows an open label, non-randomised study design using a COVID-EDV dose level that was determined previously in a healthy volunteer trial. The study is designed to assess the ability of COVID-EDV to stimulate and support the body’s immune response to produce antibodies that can fight COVID-19. The COVID-EDV vaccine will be administered as three injections on Day 1, 21 and at 4 months. Each participant must have a immunocompromised condition and will be involved in the study for 9 months. A total of 100 participants will be recruited to the study.
Interventions
This is a Phase I/IIa, open label study to determine the safety of EDV nanocells packaged with a plasmid encoding SARS-CoV-2 spike protein and a glycolipid a-galactosyl ceramide in the EDV, called COVID-EDVs, in non-COVID-19 infected immunocompromised patients. Participants must be 18 years and older and will receive the COVID-EDV vaccine administered as a 0.6mL intramuscular injection at a single dose level of 9 billion COVID-EDVs at Day 1, 21 and at 4 months.
Participants will undergo a Scree
This is a Phase I/IIa, open label study to determine the safety of EDV nanocells packaged with a plasmid encoding SARS-CoV-2 spike protein and a glycolipid a-galactosyl ceramide in the EDV, called COVID-EDVs, in non-COVID-19 infected immunocompromised patients. Participants must be 18 years and older and will receive the COVID-EDV vaccine administered as a 0.6mL intramuscular injection at a single dose level of 9 billion COVID-EDVs at Day 1, 21 and at 4 months. Participants will undergo a Screening Visit, 3 injections of the COVID-EDV vaccine, a 28 Day Safety Follow-up Visit and 2 month, 6 month and 9 month follow-up visits. The total treatment duration is 4 months, with a total on study duration of approximately 9 months. All doses will be administered in a clinic with 1 hour of safety monitoring on dosing days. This includes vital signs, laboratory tests and adverse event monitoring. The study will be conducted as a multi-centre trial, enrolling up to 100 participants in total. During the informed consent process, participants are provided a Participant Information Sheet/Consent Form that outlines what participation in the study involves as well as the purpose of the research. During this process, the Principle Investigator counsels the participant on the importance of adhering to the protocol visits. The Study Co-ordinators are responsible for communicating with participants and ensuring they are scheduled for upcoming study visits. All communications are recorded in the source notes and the study monitors assess adherence to study visits both remotely and during on-site monitoring visits.
Sponsors
EnGeneIC Pty Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed