To Evaluate the Safety, Tolerability, and Immunogenicity of a PIKA-Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine in Healthy Individuals

Phase 1

• Conditions: COVID 19 or SARS-CoV-2 Infection; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12621001009808
• Lead Sponsor: Yisheng Biopharma (Singapore) Pte Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-02
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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’)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified