None listed
Conditions
Brief summary
The receptor-binding domain (RBD) in SARS-CoV-2 S protein has been identified as the component required for coronaviruses to enter the human cells using the human receptor angiotensin converting enzyme 2 (ACE2). The investigational vaccine, RBD SARS-CoV-2 HBsAg VLP vaccine, is a subunit vaccine where the RBD antigen is conjugated to the hepatitis B surface antigen to allow the stimulation of the immune system to produce anti-RBD (CoV2 Receptor binding domain) antibodies. The study will be conducted in two stages: phase I and phase II. Phase I will include healthy adults aged 18 - 45 years and evaluate the safety and immunogenicity reported after two-doses of vaccine when compared with placebo. Phase II will include a separate group of healthy adults participants aged 18 - 79 years and evaluate the safety and immunogenicity reported after receiving a single dose or two-doses of vaccine 28 days apart when compared with placebo.
Interventions
RBD SARS-CoV-2 HBsAg VLP Vaccine, administered at two dose amounts, 5mcg and 25 mcg, by intramuscular injection by Investigators (or delegate) during in-clinic visit. Phase 1 will include three cohorts, to receive either 5mcg dose on Day 0 and 28; 25mcg dose on Days 0 and 28 or placebo on Day 0 and 28.
Phase 2 will evaluate both dose amounts either as single dose (given at day 0, with placebo at Day 28) or two doses (at Days 0 and 28). Participants will be randomised into one of 5 cohorts. The
RBD SARS-CoV-2 HBsAg VLP Vaccine, administered at two dose amounts, 5mcg and 25 mcg, by intramuscular injection by Investigators (or delegate) during in-clinic visit. Phase 1 will include three cohorts, to receive either 5mcg dose on Day 0 and 28; 25mcg dose on Days 0 and 28 or placebo on Day 0 and 28. Phase 2 will evaluate both dose amounts either as single dose (given at day 0, with placebo at Day 28) or two doses (at Days 0 and 28). Participants will be randomised into one of 5 cohorts. These are 1) 5mcg dose administered on Days 0 and 28; 2) 25mcg dose administered on Days 0 and 28; 3) 5mcg dose administered on Days 0 and placebo on Day 28; 4) 25mcg dose administered on Days 0 and placebo on Day 28, or 5) placebo on day 0 and 28. Phase 2 will commence following DSMB review of safety data from Phase 1. Two groups of participants will be enrolled. Phase 1 will include a group of healthy adults aged 18-45. Phase 2 will include a separate group of healthy adults aged 18 - 79 years. Participants will return to site at day 7 and 14 from vaccine administration dates to undergo safety assessments and blood sampling for immunogenicity evaluation. Further on site assessments are conducted monthly or bi-monthly for up to 180 days from date of first vaccine administration.
Sponsors
Accelagen Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or Female aged 18 to 79 years (both inclusive) a. Phase I: Subjects aged 18 to 45 years (both inclusive) b. Phase II: Subjects aged 18 to 79 years (both inclusive) 2. Healthy participants as determined by medical history, physical examination, vital signs and clinical laboratory examination with no clinically significant deviations as judged by the Investigator at screening and randomization (Day 0) 3. Test negative for SARS-CoV-2 infection by RT-PCR test at screening 4. Test negative for SARS-CoV-2 IgG antibody by at screening 5. Capable and willing to provide written informed consent prior to the performance of any study-specific procedures
Exclusion criteria
1. Receipt of medications or vaccines intended to prevent or treat COVID-19 infection in the past 2. Fever (non-axillary temperature > 37.5 ºC) or any other symptoms of infection that have not completely resolved including respiratory symptoms/illnesses within the past 3 days from randomization (Day 0) 3. Participants with a BMI > 35 kg/m2. 4. Presence of current active viral or bacterial infection, at screening and randomization (Day 0), which is determined by the Investigator to be of clinical significance 5. Individuals with history of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastrointestinal, hepato-biliary, blood dyscrasia, uncontrolled hypertension and diabetes, clinically significant chronic pulmonary disease, asthma (with the exception of history of resolved childhood asthma), immunological and autoimmune diseases or any condition which in the opinion of the Investigator might interfere with the evaluation of the study objectives 6. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g. healthcare worker in direct care of COVID-19 patients, front line workers in COVID-19 hotspots/outbreak areas) 7. Pregnant or lactating women or willingness/intention to become pregnant during the study 8. Men and Women (of child-bearing potential) not agreeing to use adequate contraception during the study 9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection 10. Severely immunocompromised subjects. This exclusion category comprises a) subjects with solid organ transplantation; b) subjects with bone marrow transplantation; c) subjects under chemotherapy/radiotherapy; d) subjects with primary immunodeficiency; e) treatment with any anticytokine therapies. f) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisolone or equivalent for longer than 3 months from the time of screening, or probable use of oral or intravenous steroids in the following four weeks 11. History of solid or non-solid malignancy or lymphoma (except basal cell carcinoma of the skin and cervical carcinoma in situ) 12. Known allergy to any component of the RBD SARS-CoV-2 HBsAg VLP Vaccine, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema. 13. A history of anaphylaxis to a vaccine, food, drug, toxin or other exposure. 14. Known hypersensitivity reactions to yeast. 15. Positive test result at screening for human immunodeficiency virus (Types 1 or 2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody. 16. Clinical laboratory tests of blood and urine not within the normal range and show clinically relevant deviations as judged by the Investigator 17. History of demyelinating disease or Guillain Barre syndrome 18. Eczema or other significant skin lesion or infection at the site of vaccination 19. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination 20. Positive screen for drugs of abuse#or alcohol (breath test) at screening and randomization (Day 0). 21. Participants who currently smoke 10 cigarettes or equivalent per day 22. Subjects not willing to/unable to comply with study procedures 23. Participating in any other study and have received any other investigational medication or device within 30 days prior to randomization or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study. 24. Receipt of blood/blood products/immunoglobulins or donation of blood/ blood products 8 weeks prior to vaccination or planned receipt or donation during the study period 25. Any other medical condition which in the opinion of the Investigator may affect the subject’s safety or study participation and conduct
Outcome results
None listed