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

NCT05305300 | Completed Phase 1 DMC

• 1 other identifier: YS-009
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (6)

• Solicited local adverse events,

  Incidence of solicited local adverse events (AEs).

  7 days after each vaccination.

• Solicited systemic AEs

  Incidence of solicited systemic AEs.

  7 days after each vaccination.

• Unsolicited AEs

  Incidence of unsolicited AEs.

  28 days after each vaccination.

• Serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs)

  Incidence of serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs).

  through study completion, an average of 6 months.

• Medically Attended AEs (MAAEs)

  Incidence of Medically Attended AEs (MAAEs).

  through study completion, an average of 6 months.

• AEs of special interest (AESIs)

  Incidence of AEs of special interest (AESIs).

  through study completion, an average of 6 months.

Study Arms (3)

Arm A: Primary Immunization

EXPERIMENTAL

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

Arm B1: Booster Immunization 1

EXPERIMENTAL

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

Arm B2: Booster Immunization 2

EXPERIMENTAL

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

Interventions

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

PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B 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 B1: Booster Immunization 1; Arm B2: Booster Immunization 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Yisheng Biopharma (Singapore) Pte. Ltd.: lead

Study Sites (1)

Al Kuwait Hospital (Al Baraha Hospital)

Dubai, United Arab Emirates

Location

Related Publications (1)

• 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.

  PMID: 39525677 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Vitronectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Extracellular Matrix Proteins; Scleroproteins

Study Officials

• Yuan Liu, Ph.D

  Yisheng Biopharma CO., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: March 31, 2022
• Study Start: October 18, 2021
• Primary Completion: May 15, 2022
• Study Completion: September 15, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)