A Phase II/III Study of PIKA Recombinant SARS-CoV-2 Vaccine as a Booster Dose.

NCT05463419 | Completed Phase 2

• 1 other identifier: YS302
• Study Type: interventional
• Target: 5,860
• Locations: 2 countries
• Sites: 6

Brief Summary

This is a Phase II/III, randomized, double-blinded study in adults ≥ 18 years old who received 2 or more doses of inactivated COVID-19 vaccine to evaluate the efficacy, safety and immunogenicity of a booster dose of PIKA COVID-19 vaccine compared to the comparator inactivated COVID-19 vaccine. Phase II/III will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.

Conditions

Covid-19 Vaccine

Outcome Measures

Primary Outcomes (3)

• Immunogenicity at Phase II Study

  Geometric mean titer (GMT) of neutralizing antibody against Omicron virus on D14 after the booster dose

  at day 14 after booster.

• Efficacy at Phase III Study

  Incidence of first occurrence of Rt-PCR positive symptomatic illness after D14 of booster dose

  up to 360 days after booster

• Safety at Phase II and Phase III

  Incidence of AE, MAAE, SAE, SUSAR and AESI after booster dose

  up to 360 days after booster.

Secondary Outcomes (2)

• Immunogenicity at Phase II Study

  at day 7, day 14, day 90, day 180, day 360 after booster.

• Efficacy at Phase III Study

  from day 14 to day 360 after booster.

Study Arms (2)

PIKA COVID-19 vaccine

EXPERIMENTAL

One dose of the experimental vaccine should be administered on Study Day 0 in the deltoid muscle.

Biological: PIKA COVID-19 vaccine

Inactivated Covid-19 vaccine

ACTIVE COMPARATOR

One dose of the control vaccine should be administered on Study Day 0 in the deltoid muscle.

Biological: Inactivated Covid-19 vaccine

Interventions

PIKA COVID-19 vaccine BIOLOGICAL

SARS-CoV-2 spike subunit protein (Also called "Recombinant SARS-CoV-2 S-trimer protein"), PIKA adjuvant.

PIKA COVID-19 vaccine

Inactivated Covid-19 vaccine BIOLOGICAL

Inactivated SARS-CoV-2 virus

Inactivated Covid-19 vaccine

Eligibility Criteria

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

You may qualify if:

• Subject who met all of the following criteria may be enrolled.
• Age more than or equal 18 years on Screening.
• Judged by the investigator to be healthy based on 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 12 months.
• Received 2 or more doses of inactivated COVID-19 vaccine as primary series with their last dose at least 3 months prior to enrollment.
• Axillary body temperature ≤37.5℃.
• SARS-COV-2 test was negative for nasopharyngeal swabs by RT PCR.
• Non-pregnant and not lactating women.
• 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.
• 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.
• Men must be willing to refrain from sperm donation, starting after screening until 60 days after receiving the last vaccination.

You may not qualify if:

• Subject who met any of the following criteria may not be enrolled.
• Abnormal vital signs or laboratory test results prior to D0 judged as clinically significant by investigator.
• Known allergy, hypersensitivity, or intolerance to the test vaccine (including any excipients and the antibiotics kanamycin and aminoglycosides).
• 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.
• 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.
• History or family history of convulsions, seizures, encephalopathy, and mental illness.
• History of narcolepsy.
• Known substance abuse and addiction within the past 2 years.
• Uninterrupted use of systemic immunosuppressants or other immunomodulators within 30 days prior to D0.
• Use of blood or blood-related products (e.g., blood transfusion, human albumin, human immunoglobulin, etc.) within 30 days prior to D0.
• 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.
• Use of nonsteroidal anti-inflammatory drugs and/or antiallergic drugs within 3 days prior to D0
• Have symptoms of COVID-19, such as respiratory symptoms, fever, cough, shortness of breath and dyspnea.
• Surgical removal of whole or part of spleen for any reason
• 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.

Sponsors & Collaborators

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

Study Sites (6)

Health Index Multispecialty Clinic -Clinical Research

Cavite, 4104, Philippines

Location

Norzel Medical and Diagnostic Clinical

Cebu, Philippines

Location

Tropical Disease Foundation

City of Muntinlupa, Philippines

Location

St. John Hospital

Naga, Philippines

Location

UERM Research Center

Quezon City, Philippines

Location

Al Kuwait Hospital

Dubai, United Arab Emirates

Location

Related Publications (1)

• Lim RJ, Qiu X, Alberto E, Capeding MR, Carlos J, Leong RN, Gutierrez JL, Trillana M, Liu Y, Mojares Z. Safety and immunogenicity of PIKA-adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine as a booster against SARS-CoV-2: a phase II, open-label, randomized, double-blinded study. Clin Exp Vaccine Res. 2024 Oct;13(4):329-337. doi: 10.7774/cevr.2024.13.4.329. Epub 2024 Oct 31.

  PMID: 39525672 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blind
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 19, 2022
• Study Start: October 3, 2022
• Primary Completion: December 28, 2023
• Study Completion: April 11, 2024
• Last Updated: July 23, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1); PH (5)