Back to resultsA Phase I Study to Evaluate Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Individuals
Primary Purpose
COVID-19 Pandemic
Status
Completed
Phase
Phase 1
Locations
United Arab Emirates
Study Type
Interventional
Intervention
PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A
PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B
Sponsored by
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
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm A: Primary Immunization
Arm B1: Booster Immunization 1
Arm B2: Booster Immunization 2
Arm Description
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.
Outcomes
Primary Outcome Measures
Solicited local adverse events,
Incidence of solicited local adverse events (AEs).
Solicited systemic AEs
Incidence of solicited systemic AEs.
Unsolicited AEs
Incidence of unsolicited AEs.
Serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs)
Incidence of serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs).
Medically Attended AEs (MAAEs)
Incidence of Medically Attended AEs (MAAEs).
AEs of special interest (AESIs)
Incidence of AEs of special interest (AESIs).
Secondary Outcome Measures
Full Information
NCT ID
NCT05305300
First Posted
March 20, 2022
Last Updated
December 20, 2022
Sponsor
Yisheng Biopharma (Singapore) Pte. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05305300
Brief Title
A Phase I Study to Evaluate Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Individuals
Official Title
A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Adults Who is COVID-19 naïve or Had Previous COVID-19 Infection or Completed Inactivated or mRNA COVID-19 Vaccination.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yisheng Biopharma (Singapore) Pte. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Primary Immunization
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B1: Booster Immunization 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B2: Booster Immunization 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B
Intervention Description
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.
Primary Outcome Measure Information:
Title
Solicited local adverse events,
Description
Incidence of solicited local adverse events (AEs).
Time Frame
7 days after each vaccination.
Title
Solicited systemic AEs
Description
Incidence of solicited systemic AEs.
Time Frame
7 days after each vaccination.
Title
Unsolicited AEs
Description
Incidence of unsolicited AEs.
Time Frame
28 days after each vaccination.
Title
Serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs)
Description
Incidence of serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs).
Time Frame
through study completion, an average of 6 months.
Title
Medically Attended AEs (MAAEs)
Description
Incidence of Medically Attended AEs (MAAEs).
Time Frame
through study completion, an average of 6 months.
Title
AEs of special interest (AESIs)
Description
Incidence of AEs of special interest (AESIs).
Time Frame
through study completion, an average of 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Liu, Ph.D
Organizational Affiliation
Yisheng Biopharma CO., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Al Kuwait Hospital (Al Baraha Hospital)
City
Dubai
Country
United Arab Emirates
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase I Study to Evaluate Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Individuals
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