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

Phase 1

Completed

• Conditions: COVID-19 Pandemic
• Interventions: Biological: PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A; Biological: PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B

• Registration Number: NCT05305300
• Lead Sponsor: Yisheng Biopharma (Singapore) Pte. Ltd.

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.

Study Timeline

• Study Start: 2021-10-18
• Status Verified: 2022-03
• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-03-31
• Primary Completion: 2022-05-15
• Study Completion: 2022-09-15
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

Exclusion Criteria of Arm A:

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).
5. For more exclusion criteria, please contact the investigator or sponsor.

Exclusion Criteria of Arm B:

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.
5. For more exclusion criteria, please contact the investigator or sponsor.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm A: Primary Immunization	PIKA COVID-19 Vaccine (CHO cell, S-protein), 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.
Arm B1: Booster Immunization 1	PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B	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 B2: Booster Immunization 2	PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B	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.

Primary Outcome Measures

Name	Time	Method
Solicited local adverse events,	7 days after each vaccination.	Incidence of solicited local adverse events (AEs).
Unsolicited AEs	28 days after each vaccination.	Incidence of unsolicited AEs.
Serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs)	through study completion, an average of 6 months.	Incidence of serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs).
Medically Attended AEs (MAAEs)	through study completion, an average of 6 months.	Incidence of Medically Attended AEs (MAAEs).
Solicited systemic AEs	7 days after each vaccination.	Incidence of solicited systemic AEs.
AEs of special interest (AESIs)	through study completion, an average of 6 months.	Incidence of AEs of special interest (AESIs).

Trial Locations

Locations (1)

Al Kuwait Hospital (Al Baraha Hospital); 🇦🇪 Dubai, United Arab Emirates