COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12621001009808.aspx

Dr Chris Wynne

chris@ccst.co.nz

2021-08-02

Not recruiting

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

1. Is age greater than equal to 18 and less than equal to 65 years on Study Day 1 2. Male and female healthy volunteers: 3. Judged by the investigator to be healthy on the basis of medical history, physical examination, vital signs, and no significant ECG abnormalities performed at screening 4. Able to provide informed consent form 5. Able and willing to comply with all study procedures over follow-up period of approximately 6 months 6. Body mass index of 18-32kg/square meter, inclusive, at screening 7. For female subjects with childbearing potential: must agree to avoid pregnancy from 21 days prior to study Day 1 until at least 90 days after last study vaccination. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm. 8. Men must be willing to refrain from sperm donation, starting after screening until 90 days after receiving the last study vaccination. Male and female subjects must use a barrier method of contraception, from 21 days prior to study Day 1 until at least 90 days after last study vaccination. Barrier methods of contraception include: • Male condoms • Female condoms • Female diaphragm (‘cap’)

1. History of COVID-19 2. Received partial or complete course of any type of COVID-19 vaccine. 3. History of close contact with a person infected or suspected of COVID-19 within 6 months prior to screening. 4. Positive test for SARS-CoV-2 infection, including but not limited to RT-PCR at screening 5. Positive rapid serological test (IgM or IgG against SARS-CoV-2) at screening or prior to first vaccination if available 6. Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial 7. Currently working in an occupation with a high risk of exposure to SARS-CoV-2 (eg. Healthcare worker, emergency response personnel having direct interactions with or providing direct care to patients) 8. History of infection of Middle East Respiratory Syndrome (MERS), or Severe Acute Respiratory Syndrome (SARS) 9. Positive serology test results for hepatitis C virus antibody, HIV antibody, and/or hepatitis B virus surface antigen at Screening 10. Currently taking marketed, investigational, off-label product for the prevention of MERS, SARS, or COVID-19 11. Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 1 12. Fever (tympanic temperature greater than 37.5 degree C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath or dyspnea within 14 days before administration 13. Subjects with abnormal indicators, such as blood biochemistry, blood routine and urine routine deemed clinically significant by the investigator, or the value is beyond grade 1 per toxicity grading scale 14. History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of PIKA COVID-19 vaccine 15. History of convulsion, epilepsy, encephalopathy or severe mental illness 16. Diagnosed with congenital malformations or developmental disorders, genetic defects, severe malnutrition 17. Diagnosed with severe liver and kidney diseases, uncontrollable hypertension (systolic pressure greater than 140 mmHg, diastolic pressure greater than 90 mmHg), diabetic complications, malignant tumors, acute viral or bacterial infections or acute onset of chronic disease 18. Diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases 19. History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease) 20. Vaccinated with live attenuated vaccine within 1 month, or other vaccine within 14 days before vaccination 21. Receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days) 22. Received systemic immunosuppressants within 4 months prior to vaccination, or anticipating the need for immunosuppressant at any time during participation in the study. Topical or inhaled treatment is allowed if not used within 14 days prior to vaccination. 23. Receiving blood products within 3 months before administration 24. History of alcohol or drug abuse within 3 years before first vaccination 25. Has donated 450ml or greater of blood within 28 days prior to vaccination 26. History of anaphylaxis or angioedema including but not limited to history of anaphylaxis after any vaccine. 27. Any condition that, in the opinion of the investigator, would pose a health risk to the subject if e

3

Yisheng Biopharma (Singapore) Pte Ltd

18

65

New Zealand

Healthy volunteers

N/A

45

To assess the safety and tolerability of the PIKA COVID-19 vaccine. Safety will be assessed by monitoring the solicited adverse events (AEs) for example Injection site reactions (pain; swelling; and erythema); fever; fatigue; nausea; headache and myalgia. Solicited adverse events will be recorded by diary card. [Solicited Adverse Events will be recorded on Day 1; Day 8; Day 15 post dose and during early termination if it is terminated before D15. ];Safety assessment will be done by monitoring unsolicited adverse events (AEs). Serious adverse events (SAEs); including suspected and unexpected serious reaction (SUSAR); adverse events of special interest (AESIs); and medically attended adverse events (MAAEs) will be recorded for the entire duration of the study. Unsolicited AEs will be recorded for 7 days and 28 days; respectively; following each vaccine. These will be recorded by the participant in the participant diary and reviewed when the participant attends their visits at the site. [Unsolicited adverse events (AEs) will be recorded on Day 1; Day 8; Day 15; Day 36 post dose and at early termination if it is terminated before D36];Safety will be assessed via clinical laboratory tests including hematology; biochemistry; coagulation[Blood samples will be collected at screening visit; Day 8; Day 15 post dose and at early termination. Should the participant withdraw prior to their Day 15 visit; they will come in for an additional Early Termination visit which includes the collection of samples for haematology; chemistry; coagulation; urinalysis; Neutralizing antibodies; Serum IgG and cellular immunity. Should they withdraw after their Day 15 visit; they will come in for an additional Early Termination visit which will include sample collection for Neutralizing antibodies; Serum IgG and cellular immunity. ]

Phase 1

[{"arm_notes": "5 ug S protein/1mg PIKA;2;days1-8;IM", "treatment_id": 2037, "treatment_name": "Pika covid-19 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "10 ug S protein /1mg PIKA;2;days1-8;IM", "treatment_id": 2037, "treatment_name": "Pika covid-19 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "20 ug S protein /1mg PIKA;2;days1-8;IM", "treatment_id": 2037, "treatment_name": "Pika covid-19 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]