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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05463419
Other study ID # YS302
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 3, 2022
Est. completion date April 11, 2024

Study information

Verified date October 2023
Source Yisheng Biopharma (Singapore) Pte. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
PIKA COVID-19 vaccine
SARS-CoV-2 spike subunit protein (Also called "Recombinant SARS-CoV-2 S-trimer protein"), PIKA adjuvant.
Inactivated Covid-19 vaccine
Inactivated SARS-CoV-2 virus

Locations

Country Name City State
Philippines Health Index Multispecialty Clinic -Clinical Research Cavite
Philippines Norzel Medical and Diagnostic Clinical Cebu
Philippines Tropical Disease Foundation Muntinlupa
Philippines St. John Hospital Naga
Philippines UERM Research Center Quezon City
United Arab Emirates Al Kuwait Hospital Dubai

Sponsors (1)

Lead Sponsor Collaborator
Yisheng Biopharma (Singapore) Pte. Ltd.

Countries where clinical trial is conducted

Philippines,  United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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
Primary 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 Immunogenicity at Phase II Study GMT of neutralizing antibody against wild type SARS-CoV-2 virus on Day 7, Day 14, Day 90, Day 180, Day 360.
GMT of neutralizing antibody against Omicron virus on Day 7.
Seroconversion rate of neutralizing antibody against wild type SARS-CoV-2 virus from Day 0 to Day 7.
Seroconversion rate of neutralizing antibody against Omicron virus from Day 0 to Day 7.
Mean geometric titers fold growth of neutralizing antibody against wild type SARS-CoV-2 virus from Day 0 to Day 7.
Mean geometric titers fold growth of neutralizing antibody against Omicron virus from Day 0 to Day 7.
GMT of serum IgG antibody on Day 7.
Seroconversion rate of serum IgG antibody from Day 0 to Day 7.
at day 7, day 14, day 90, day 180, day 360 after booster.
Secondary Efficacy at Phase III Study 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 Day 7 and Day 14.
Seroconversion rate of neutralizing antibody against Omicron virus from Day 0 to Day 7 and Day 14.
Mean geometric titersfold growth of neutralizing antibody against Omicron virus from Day 0 to Day 7 and Day 14.
GMT of serum IgG antibody on Day 7 and Day 14.
Seroconversion rate of serum IgG antibody from Day 0 to Day 7, Day 14
from day 14 to day 360 after booster.
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