COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620001308987.aspx

Terry Nolan

t.nolan@unimelb.edu.au

2020-12-04

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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 presence at screening 5. Capable and willing to provide written informed consent prior to the performance of any study-specific procedures

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 taki

5

Accelagen Pty Ltd

18

79

Australia

Healthy volunteers

N/A

255

Phase I: To assess the composite endpoints of vaccine safety and reactogenicity of RBD SARS-CoV-2 HBsAg VLP vaccine containing different adjuvant combinations as compared with placebo in healthy adults aged 18 - 45 years as determined through participant reported (solicited and unsolicited) and clinically identified local and systemic adverse events (e.g. blood tests; vital signs; physical examination).[Participant reported events recorded daily for 7 days post-vaccination and then on occurrence up to 180 days post-vaccination];Phase II; To assess the immune response of two dose strengths and two adjuvant types contained within RBD SARS-CoV-2 HBsAg VLP vaccine as compared with placebo in healthy adults aged 18 - 79 years as determined through assessment of antibody titre and cellular immunity 56 days from first dose. Immune response will be measured through analysis of blood samples.[Increase in neutralising antibody titres and anti-SARS-CoV-2 IgG antibodies as measured at Days 0; 28 and 56 from first vaccine administration];Phase II; To assess the composite endpoints of safety and reactogenicity of RBD SARS-CoV-2 HBsAg VLP vaccine administration as compared with placebo in healthy adults aged 18 - 79 years as determined through participant reported and clinically identified local and systemic adverse events. This will include safety blood assessment and the recording of solicited and unsolicited local and systemic adverse events by participants via an electronic diary or by the clinical staff as part of scheduled clinic visits[Participant reported events reported daily for 7 days post-vaccination and then on occurrence up to 180 days post-vaccination]

Phase 1/Phase 2

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