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

Sponsor
Yisheng Biopharma (Singapore) Pte. Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05305300
Collaborator
(none)
135
1
3
12.9
10.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A
  • Biological: PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
135 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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.
Actual Study Start Date :
Oct 18, 2021
Anticipated Primary Completion Date :
May 15, 2022
Anticipated Study Completion Date :
Nov 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Experimental: 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.

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.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Solicited local adverse events, [7 days after each vaccination.]

    Incidence of solicited local adverse events (AEs).

  2. Solicited systemic AEs [7 days after each vaccination.]

    Incidence of solicited systemic AEs.

  3. Unsolicited AEs [28 days after each vaccination.]

    Incidence of unsolicited AEs.

  4. 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).

  5. Medically Attended AEs (MAAEs) [through study completion, an average of 6 months.]

    Incidence of Medically Attended AEs (MAAEs).

  6. AEs of special interest (AESIs) [through study completion, an average of 6 months.]

    Incidence of AEs of special interest (AESIs).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria

Inclusion Criteria of Arm A:
  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.

  6. For more inclusion criteria, please contact the investigator or sponsor.

Inclusion Criteria of Arm B:

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.

  6. For more inclusion criteria, please contact the investigator or sponsor.

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Al Kuwait Hospital (Al Baraha Hospital) Dubai United Arab Emirates

Sponsors and Collaborators

  • Yisheng Biopharma (Singapore) Pte. Ltd.

Investigators

  • Study Director: Yuan Liu, Ph.D, Yisheng Biopharma CO., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yisheng Biopharma (Singapore) Pte. Ltd.
ClinicalTrials.gov Identifier:
NCT05305300
Other Study ID Numbers:
  • YS-009
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022