A Phase II/III, Randomized, Double-blinded Study to Evaluate the Efficacy, Safety and Immunogenicity of a Booster Dose of PIKA-Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine in Adults ≥ 18 Years Old Who Received 2 or more doses of Inactivated Covid-19 Vaccine

PHRR220912-004985

YS-302

2022-CT0690

A Phase II/III, Randomized, Double-blinded Study to Evaluate the Efficacy, Safety and Immunogenicity of a Booster Dose of PIKA-Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine in Adults ≥ 18 Years Old Who Received 2 or more doses of Inactivated Covid-19 Vaccine

This is a Phase II/III, Randomized, Double-blinded Study which aims to Evaluate the Efficacy, Safety and Immunogenicity of a Booster Dose of PIKA-Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine in Adults ≥ 18 Years Old Who Received 2 or more doses of Inactivated Covid-19 Vaccine

Start Date Duration in Months Target Completion Date Actual Completion Date
2022-09-26 13 2023-10-26 0000-00-00

Ongoing

Institution Classification Region LTO #
Yisheng Biopharma (Singapore) PTE. LTD. Private Business Singapore
Institution Classification Region LTO #
Novotech (Australia) Pty. Ltd. - Philippine Branch Private Business NCR 3000006702080
Institution Region
Yisheng Biopharma (Singapore) PTE. LTD. Singapore
Name E-Mail Institution and Institution Address
Jennifer Olive Arellano jenny.arellano@novotech-Cro.com Novotech (Australia) Pty Ltd Philippine Branch - 27th Floor Podium West Tower, The Podium ADB Avenue, Wack Wack, Greenhills East, Mandaluyong City Metro Manila 1550 Philippines
Name E-Mail Institution and Institution Address
Marilyn Bi marilyn.bi@yishengbio.com Yisheng Biopharma (Singapore) PTE. LTD. - 8 Jurong Town Hall Road, #28-03, The JTC Summit, Singapore 609434
Name Expertise Affiliation
Edison Reyes Alberto, MD Pediatrics Health Index Multispecialty Clinic (Bacoor Cavite)
Jose Manuel T. Ranola, MD Infectious Disease St. John Hospital Inc.
Josefina B. Cadorna-Carlos, MD Pediatrics and Infectious Disease University of the East Ramon Magsaysay Memorial Medical Center, Inc. (UERMMMCI)
Maria Rosario Z. Capeding, MD Pediatrics and Infectious Disease Tropical Disease Foundation, Inc.
Norman Cornelio De Asis, MD Internal Medicine Norzel Medical and Diagnostic Clinic
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
Health Index Multispecialty Clinic (Bacoor Cavite) Bacoor, Cavite UERMMMC Research Institute for the Health Sciences Ethics Review Committee Edison Reyes Alberto, MD Pediatrics
St. John Hospital Inc. Naga City, Camarines Sur Bicol Regional Training and Teaching Hospital Institutional Review Board Jose Manuel T. Ranola, MD Infectious Disease
University of the East Ramon Magsaysay Memorial Medical Center, Inc. (UERMMMCI) Los Banos, Laguna UERMMMC Research Institute for the Health Sciences Ethics Review Committee Josefina B. Cadorna-Carlos, MD Pediatrics and Infectious Disease
Tropical Disease Foundation, Inc. Putatan, Muntinlupa Makati Medical Center Institutional Review Board Maria Rosario Z. Capeding, MD Pediatrics and Infectious Disease
Norzel Medical and Diagnostic Clinic San Nicolas, Cebu City Chong Hua Hospital Institutional Review Board Norman Cornelio De Asis, MD Internal Medicine
Project Location Institutional Ethics Review Board
Health Index Multispecialty Clinic (Bacoor Cavite) UERMMMC Research Institute for the Health Sciences Ethics Review Committee
St. John Hospital Inc. Bicol Regional Training and Teaching Hospital Institutional Review Board
University of the East Ramon Magsaysay Memorial Medical Center, Inc. (UERMMMCI) UERMMMC Research Institute for the Health Sciences Ethics Review Committee
Tropical Disease Foundation, Inc. Makati Medical Center Institutional Review Board
Norzel Medical and Diagnostic Clinic Chong Hua Hospital Institutional Review Board

Clinical Trial

Unspecified

 COVID-19

 Primary endpoints of Phase II:
• GMT of neutralizing antibody against Omicron virus on D14 after the booster dose.
• Incidence of solicited local and systemic AEs for 7 days after the booster dose.
• Incidence of unsolicited AEs for 28 days after the booster dose.
• Incidence of MAAEs for 28 days after the booster dose.
• Incidence of SAE for 360 days after the booster dose.
• Incidence of SUSARs for 360 days after the booster dose.
• Incidence of AESIs for 360 days after the booster dose.

Primary endpoints of Phase III:
• Incidence of the first occurrence of SARS-CoV-2 RT-PCR-positive symptomatic illness starting ≥14 Days after the booster dose.
• Incidence of solicited AEs for 7 days after the booster dose.
• Incidence of unsolicited AEs for 28 days after the booster dose.
• Incidence of MAAEs for 28 days after the booster dose.
• Incidence of SAEs for 360 days after the booster dose.
• Incidence of SUSARs for 360 days after the booster dose.
• Incidence of AESIs for 360 days after the booster dose.

Secondary endpoints of Phase II (long term immunogenicity subset):
• GMT of neutralizing antibody against wild type SARS-CoV-2 virus on D14, D90, D180, D360.
• GMT of neutralizing antibody against Omicron virus on D90, D180, D360.
• Seroconversion rate of neutralizing antibody against wild type SARS-CoV-2 virus from D0 to D14, D90, D180, D360.
• Seroconversion rate of neutralizing antibody against Omicron virus from D0 to D14, D90, D180, D360.
• Mean geometric titers fold growth of neutralizing antibody against wild type SARS- CoV-2 virus from D0 to D14, D90, D180, D360.
• Mean geometric titers fold growth of neutralizing antibody against Omicron virus from D0 to D14, D90, D180, D360.
• GMT of serum IgG antibody against SARS-CoV-2 by ELISA on D14, D90, D180, D360.
• Seroconversion rate of serum IgG antibody from D0 to D14, D90, D180, D360.

Secondary endpoints of Phase II (Early immunogenicity analysis subgroup):
• GMT of neutralizing antibody against wild type SARS-CoV-2 virus on D7.
• GMT of neutralizing antibody against Omicron virus on D7.
• Seroconversion rate of neutralizing antibody against wild type SARS-CoV-2 virus from D0 to D7.
• Seroconversion rate of neutralizing antibody against Omicron virus from D0 to D7.
• Mean geometric titers fold growth of neutralizing antibody against wild type SARS-CoV-2 virus from D0 to D7.
• Mean geometric titers fold growth of neutralizing antibody against Omicron virus from D0 to D7.
• GMT of serum IgG antibody on D7.
• Seroconversion rate of serum IgG antibody from D0 to D7.

Secondary endpoints of Phase III:
• Incidence of the first occurrence of either COVID-19 or SARS-CoV-2 infection regardless of symptomatology or severity starting 14 days after the booster dose.
For immunogenicity subset (6% of Phase III):
• GMT of neutralizing antibody against Omicron virus on D7 and D14.
• Seroconversion rate of neutralizing antibody against Omicron virus from D0 to D7 and D14.
• Mean geometric titers fold growth of neutralizing antibody against Omicron virus from D0 to D7 and D14.
• GMT of serum IgG antibody on D7 and D14.
• Seroconversion rate of serum IgG antibody from D0 to D7 and D14.

Exploratory Endpoint:
Future immunologic information on the sensitivity of PIKA COVID 19 vaccine against new SARS-COV-2 variants that may emerge and circulate

Pending

  • Philippines
  • United Arab Emirates

YS-302

Unspecified

2022-09-01

0000-00-00

Protocol Code Number YS-302
Protocol Version Unspecified
Date of Protocol Version Unspecified

7000

Unspecified

Unspecified

Unspecified

0000-00-00

Subjects are eligible to be included in the study only if all of the following criteria apply:
1. Age ≥18 years on Screening
2. Judged by the investigator to be healthy based on medical history, physical examination and vital signs performed at screening.
3. Able to provide informed consent.
4. Able and willing to comply with all study procedures over follow-up period of approximately 12 months.
5. Received 2 or more doses of inactive COVID-19 vaccine as primary series with their last dose at least 3 months prior to enrollment.
6. Body temperature ≤ 37.5℃.
7. SARS-COV-2 test was negative for nasopharyngeal swabs by RT-PCR.
8. Non-pregnancy and not lactating.
9. For female subjects of childbearing potential: must agree to avoid pregnancy from Study Day 0 to Study Day 60 during the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide.
10. Male subjects who are sexually active with a woman of childbearing potential and have not had vasectomy must agree to practice a highly effective form of contraception with their female partners of childbearing potential during the trial, starting after screening until 60 days after receiving the last vaccination.
11. Men must be willing to refrain from sperm donation, starting after screening until 60 days after receiving the last vaccination.

Subjects are excluded from the study if any of the following criteria apply:
1. Abnormal vital signs or laboratory test results prior to D0 judged as clinically significant by investigator.
2. Known allergy, hypersensitivity, or intolerance to the test vaccine (including any excipients and the antibiotics kanamycin and aminoglycosides).
3. History of severe allergies to any drugs, foods or vaccines, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.
4. Diagnosed with any serious disease, or congenital malformation, or uncontrolled chronic disease that may influence the compliance with the study including but not limited to respiratory disease such as asthma or chronic bronchitis, serious cardiovascular disease, kidney disease, autoimmune disease, thalassemia, malignant tumor, hereditary allergy, etc.
5. History or family history of convulsions, seizures, encephalopathy, and mental illness.
6. History of narcolepsy.
7. Known substance abuse and addiction within the past 2 years.
8. Uninterrupted use of systemic immunosuppressants or other immunomodulators within 30 days prior to D0.
9. Use of blood or blood-related products (e.g., blood transfusion, human albumin, human immunoglobulin, etc.) within 30 days prior to D0.
10. Blood loss >400 mL within 28 days prior to D0 (e.g., donated blood or blood products or injury), or planned to donate blood or plasma before D28 of the study.
11. Use of nonsteroidal anti-inflammatory drugs and/or antiallergic drugs within 3 days prior to D0.
12. Have symptoms of COVID-19, such as respiratory symptoms, fever, cough, shortness of breath and dyspnea.
13. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator’s judgment.
14. Surgical removal of whole or part of spleen for any reason
15. Received any vaccines within 28 days prior to D0 or disagree to avoid receiving any vaccines before D28 of the study except the emergent vaccination such as rabies vaccine, tetanus vaccine.
16. Participating in or planning to participate in other clinical trials (drugs or vaccines) during the study period.
17. Any other conditions not eligible for participating in the study at investigator's discretion.

Interventional

PIKA Recombinant Protein COVID-19 Vaccine (PIKA COVID-19 vaccine)

The PIKA Recombinant Protein COVID-19 Vaccine (PIKA COVID-19 vaccine) is a combination of the SARS-CoV-2 spike (S) subunit protein and the PIKA adjuvant. The final formulation of PIKA COVID-19 vaccine is a clear colorless solution. The volume for a standard vial is 1ml.

None

Method of Allocation

Randomized

Masking or Blinding

Double Blind

Masking Details

Blinding Assignment of subjects to the PIKA COVID-19 vaccine or inactivated COVID-19 vaccine arms will be blinded. Subjects, investigator and sponsor or sponsor’s authorized contract research organization (CRO) staff who are involved in the vaccination, clinical evaluation and monitoring of the subjects will be unaware of the investigational vaccine received. Since the container closure of PIKA COVID-19 vaccine is different from that of inactivated COVID-19 vaccine, investigational vaccine will be handled and prepared to use by unblinded pharmacist (or designee in accordance with local and institutional regulations) at the study site. After drawn into syringes for administration, PIKA COVID-19 vaccine and inactivated COVID-19 vaccine are not visually distinct from each other. The study pharmacist (and/or designee) will be unblinded to manage study vaccine inventory. The other unblinded personnel on the study are the study monitor(s) responsible for monitoring investigational vaccines. All unblinded personnel must take care to not reveal individual subject treatment regimen assignments to any other member of the study team. The study Pharmacist (or designee) must be a designated study team member, who is not an employee of Yisheng Biopharma and who will have no other clinical or regulatory responsibilities associated with the conduct of the study during the entire study period. Unblinded study personnel must not participate in the evaluation of adverse events. A Delegation of Authority Log will be maintained by the site and will identify the individual(s) authorized to function as the study vaccine manager, i.e., individuals with access to study blinding information. The randomization code should not be broken except in medical emergencies when the appropriate management of the subject requires knowledge of the randomization. The investigator documents and reports the action to the Sponsor, without revealing the vaccine given to subject to the Yisheng team. Yisheng Biopharma retains the right to break the code for SAEs that are unexpected and are suspected to be causally related to an investigational vaccine and that potentially require expedited reporting to regulatory authorities. Randomization codes will not be broken for the planned analyses of data until all decisions on the evaluability of the data from each individual subject have been made and documented.

Control

Unspecified

Assignment

Single

Phase

Phase II/III

Purpose of the Study

The purpose of this study is to evaluate the efficacy, safety, and immunogenicity of a booster dose of PIKA COVID-19 vaccine in adults ≥18 years old who received 2 or more doses of inactivated COVID-19 vaccine as primary series. Given the current crisis caused by SARS-CoV-2 infection and potential annual outbreak of SARS-CoV-2 and variants, more safe and effective vaccines will be needed to combat the ongoing and future pandemic/endemic.

Detailed purpose of the study

Unspecified

Plan to Share IPD

Unspecified

IPD Description

Unspecified

Date of posting of result summaries

Unspecified

Date of the first journal publication of results

Unspecified

URL hyperlinks related to results and publications

Unspecified

URL link to protocol files(s) with version and data

Unspecified

Baseline Characteristics

Unspecified

Participant Flow

Unspecified

Adverse Events

Unspecified

Outcome Measures

Unspecified

Brief Summary

Unspecified

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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