COVID-19 Pandemic
Conditions
Brief summary
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 years and above. The study will comprise of two arms. Arm A will include subjects who never been infected with COVID-19 or with a history of COVID-19 infection for not less than 6 months prior to study participation and Arm B will include subjects who will be receiving PIKA vaccine as a booster vaccination dose to COVID-19 primary vaccination of inactivated or mRNA Covid 19 vaccines.
Detailed description
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 years and above. The study will comprise of two arms. Arm A will include subjects who had never been infected with COVID-19 or with a history of COVID-19 infection for not less than 6 months prior to study participation and Arm B will include subjects who will be receiving PIKA vaccine as a booster vaccination dose to COVID-19 primary vaccination of inactivated or mRNA Covid 19 vaccines. Arm A: 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 Arm A. Subjects in Group 1-3 will receive two doses of PIKA COVID-19 vaccine via IM administration on Days 0 and 7. Fifteen eligible subjects in each dose group. Arm B: There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 90 subjects will be enrolled in Arm B which will be divided into Arm B1 (45 subjects) and Arm B2 (45 subjects). Arm B1 will enroll subjects who received Inactivated vaccines and will comprise of 15 subjects per dose (45 subjects). Arm B2 will enroll subjects who received mRNA vaccines and will comprise of 15 subjects per dose (45 subjects). Subjects in Group 1-3 of Arm B1 and Arm B2 will receive one booster dose of PIKA COVID-19 vaccine via IM administration on Days 0.
Interventions
BIOLOGICALPIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A
receive two doses of PIKA COVID-19 vaccine (5 μg S protein/1mg PIKA, 10μg S protein/1mg PIKA and 20μg S protein/1mg PIKA) via IM administration on Days 0 and 7.
BIOLOGICALPIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B
receive one dose of PIKA COVID-19 vaccine (5 μg S protein/1mg PIKA, 10μg S protein/1mg PIKA and 20μg S protein/1mg PIKA) via IM administration on Days 0.
Sponsors
Yisheng Biopharma (Singapore) Pte. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria of Arm A: 1. Male and female healthy volunteers. 2. Age ≥18 years on Study Day 0. 3. Judged by the investigator to be healthy on the basis of medical history, physical examination and vital signs performed at screening. 4. Able to provide informed consent. 5. Able and willing to comply with all study procedures over follow-up period of approximately 6 months. 6. For more inclusion criteria, please contact the investigator or sponsor. Inclusion Criteria of Arm B: Male and female healthy volunteers. 1. Received complete primary series of COVID-19 Inactivated Vaccines not less than 6 months or Received complete primary series of COVID-19 mRNA Vaccines not less than 6 month. 2. Age ≥18 years on Study Day 0. 3. Judged by the investigator to be healthy on the basis of medical history, physical examination and vital signs performed at screening. 4. Able to provide informed consent . 5. Able and willing to comply with all study procedures over follow-up period of approximately 6 months. 6. For more inclusion criteria, please contact the investigator or sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solicited systemic AEs | 7 days after each vaccination. | Incidence of solicited systemic AEs. |
| Unsolicited AEs | 28 days after each vaccination. | Incidence of unsolicited AEs. |
| Solicited local adverse events, | 7 days after each vaccination. | Incidence of solicited local adverse events (AEs). |
| Serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs) | through study completion, an average of 6 months. | Incidence of serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs). |
| Medically Attended AEs (MAAEs) | through study completion, an average of 6 months. | Incidence of Medically Attended AEs (MAAEs). |
| AEs of special interest (AESIs) | through study completion, an average of 6 months. | Incidence of AEs of special interest (AESIs). |
Countries
United Arab Emirates
Outcome results
None listed