Status:
COMPLETED
A Phase I Study to Evaluate Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Individuals
Lead Sponsor:
Yisheng Biopharma (Singapore) Pte. Ltd.
Conditions:
COVID-19 Pandemic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Inclusion Criteria of Arm A:
- Male and female healthy volunteers.
- Age ≥18 years on Study Day 0.
- Judged by the investigator to be healthy on the basis of medical history, physical examination and vital signs performed at screening.
- Able to provide informed consent.
- Able and willing to comply with all study procedures over follow-up period of approximately 6 months.
- For more inclusion criteria, please contact the investigator or sponsor.
- Inclusion Criteria of Arm B:
- Male and female healthy volunteers.
- 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.
- Age ≥18 years on Study Day 0.
- Judged by the investigator to be healthy on the basis of medical history, physical examination and vital signs performed at screening.
- Able to provide informed consent .
- Able and willing to comply with all study procedures over follow-up period of approximately 6 months.
- For more inclusion criteria, please contact the investigator or sponsor.
- Exclusion Criteria:
- Exclusion Criteria of Arm A:
- History of COVID-19 of less than 6 months prior to enrollment
- Received partial or complete course of any type of COVID-19 vaccine.
- History of close contact with a person infected or suspected of COVID-19 not less than 14 days prior to study enrollment.
- Positive test for SARS-CoV-2 infection, including but not limited to RT-PCR /Rapid Antigen Test at screening, before the first dose (Day 0) and before the second dose (Day 7).
- For more exclusion criteria, please contact the investigator or sponsor.
- Exclusion Criteria of Arm B:
- History of close contact with a person infected or suspected of COVID-19 not less than 14 days prior to study enrollment.
- Positive test for SARS-CoV-2 infection, including but not limited to RT-PCR/RAT at screening, before the first dose (Day 0) .
- Have received three and more doses of COVID-19 vaccine.
- Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial.
- For more exclusion criteria, please contact the investigator or sponsor.
Exclusion
Key Trial Info
Start Date :
October 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2022
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT05305300
Start Date
October 18 2021
End Date
September 15 2022
Last Update
December 22 2022
Active Locations (1)
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1
Al Kuwait Hospital (Al Baraha Hospital)
Dubai, United Arab Emirates