A Phase I Study to Evaluate Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Individuals

NCT ID: NCT05305300

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2022-09-15

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.

Conditions

COVID-19 Pandemic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm A: Primary Immunization

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.

Group Type: EXPERIMENTAL

PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A

Intervention Type: BIOLOGICAL

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.

Arm B1: Booster Immunization 1

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.

Group Type: EXPERIMENTAL

PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B

Intervention Type: BIOLOGICAL

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.

Arm B2: Booster Immunization 2

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.

Group Type: EXPERIMENTAL

PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B

Intervention Type: BIOLOGICAL

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.

Interventions

PIKA 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.

Intervention Type: BIOLOGICAL

PIKA 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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.

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.

Exclusion Criteria

1. History of COVID-19 of less than 6 months prior to enrollment

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 not less than 14 days prior to study enrollment.

4. 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).

1. History of close contact with a person infected or suspected of COVID-19 not less than 14 days prior to study enrollment.

2. Positive test for SARS-CoV-2 infection, including but not limited to RT-PCR/RAT at screening, before the first dose (Day 0) .

3. Have received three and more doses of COVID-19 vaccine.

4. Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yisheng Biopharma (Singapore) Pte. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuan Liu, Ph.D

Role: STUDY_DIRECTOR

Yisheng Biopharma CO., Ltd.

Locations

Al Kuwait Hospital (Al Baraha Hospital)

Dubai, , United Arab Emirates

Countries

United Arab Emirates

References

Lim RJ, Qiu X, Leong RN, Gutierrez JL, Halima A, Mostafa M, Ghoneim Y, Abdrabo M, Rashad M, Hannawi S, Liu Y, Mojares Z. Safety, tolerability, and immunogenicity of PIKA-adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine in healthy adults: an open-label randomized phase I clinical trial. Clin Exp Vaccine Res. 2024 Oct;13(4):315-328. doi: 10.7774/cevr.2024.13.4.315. Epub 2024 Oct 31.

Reference Type: DERIVED

PMID: 39525677 (View on PubMed)

Other Identifiers

YS-009

Identifier Type: -

Identifier Source: org_study_id