NCT05305300

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Yisheng Biopharma (Singapore) Pte. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	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.
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.

Timeline

• Start date: 2021-10-18
• Primary completion: 2022-05-15
• Completion: 2022-09-15
• First posted: 2022-03-31
• Last updated: 2022-12-22

Locations

1 site across 1 country: United Arab Emirates