A Phase I Study to Evaluate Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Individuals
COVID-19 Pandemic
About this trial
This is an interventional prevention trial for COVID-19 Pandemic
Eligibility Criteria
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.
Sites / Locations
- Al Kuwait Hospital (Al Baraha Hospital)
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm A: Primary Immunization
Arm B1: Booster Immunization 1
Arm B2: Booster Immunization 2
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.
There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. Arm B1 will enroll subjects who received Inactivated vaccines and will comprise of 15 subjects per dose. In arm B1, fifteen eligible subjects in each dose group will receive the study vaccine on Study Days 0 via intramuscular injection in alternative deltoid muscles.
There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. Arm B2 will enroll subjects who received mRNA vaccines and will comprise of 15 subjects per dose. In arm B2, fifteen eligible subjects in each dose group will receive the study vaccine on Study Days 0 via intramuscular injection in alternative deltoid muscles.