None listed
Conditions
Brief summary
This is the first-in-human study of PIKA-adjuvanted PIKA covid-19 vaccine. This is a Phase I, open label dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety, tolerability, and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged 18-65 years. There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 45 subjects will be enrolled in this study. Subjects in Group 1-3 will receive two doses of PIKA COVID-19 vaccine via IM administration on Days 1 and 8. Solicited and unsolicited adverse events (AEs) will be recorded for 7 days and 28 days, respectively, following each study injection. 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.
Interventions
This is a Phase I, open label, dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety, tolerability, and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged 18-65 years. The study will be conducted in New Zealand at the New Zealand Clinical Research site located in the city of Christchurch.
There will be 3 dose groups, 1 to 3 with esca
This is a Phase I, open label, dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety, tolerability, and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged 18-65 years. The study will be conducted in New Zealand at the New Zealand Clinical Research site located in the city of Christchurch. There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 45 subjects will be enrolled in this study. Subjects in Group 1-3 will receive two doses of PIKA COVID-19 vaccine via IM administration on Days 1 and 8. The medical monitor and principal investigator will review the safety experience of all subjects enrolled in Group 1 through Study Day 8. Fifteen eligible subjects in each dose group will receive the study vaccine on Study Days 1 and 8 via intramuscular injection in alternative deltoid muscles. Subjects will be sequentially assigned to a dose group based on the timing of completion of screening. Enrollment of each dose cohort will start with 3 sentinel subjects, at least one male and one female. The remaining subjects will be enrolled at least 48 hours later after the 3 sentinel subjects complete the first dose administration with no safety concerns as assessed by the Principal Investigator. The Medical Monitor and Principal Investigator will review the safety data of all subjects enrolled in Group 1 through Study Day 8. If no pausing rules have been met, Group 2 will be enrolled following the enrollment practice in Group 1. Accordingly, Group 3 can be enrolled when no pausing rules are met after all subjects in Group 2 completed Day 8 visit, as assessed by the Principal Investigator and local Medical Monitor. The enrollment of Group 3 will also follow the same enrollment practice as Groups 1 and 2. The duration of the entire study is anticipated to be 8 months from the start of screening to last subject visit. The duration of each individual subject is approximately 7 months from the consent to last visit Dosage Form: Liquid Composition: vaccine will be formulated pending on the dose cohort. Each vaccine will have varying amount S protein. • 5 ug S protein/1mg PIKA • 10 ug S protein /1mg PIKA • 20 ug S protein /1mg PIKA Route: Intramuscular injection into the deltoid muscle, the first dose to right arm and second dose on left arm.
Sponsors
Yisheng Biopharma (Singapore) Pte Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 enrolled or could interfere with evaluation of the study vaccine or has interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting)
Outcome results
None listed