Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A, PIKA COVID-19 Vaccine, Arm A
PIKA COVID-19 Vaccine · 2 trials · 2 indications
Geometric mean titer (GMT) of neutralizing antibody against Omicron virus on D14 after the booster dose
Incidence of first occurrence of Rt-PCR positive symptomatic illness after D14 of booster dose
Incidence of AE, MAAE, SAE, SUSAR and AESI after booster dose
Incidence of solicited local adverse events (AEs).
Incidence of solicited systemic AEs.
Incidence of unsolicited AEs.
Incidence of serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs).
Incidence of Medically Attended AEs (MAAEs).
Incidence of AEs of special interest (AESIs).
| Arm | Type | Description |
|---|---|---|
| PIKA COVID-19 vaccine | EXPERIMENTAL | One dose of the experimental vaccine should be administered on Study Day 0 in the deltoid muscle. |
| Inactivated Covid-19 vaccine | ACTIVE_COMPARATOR | One dose of the control vaccine should be administered on Study Day 0 in the deltoid muscle. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| PIKA COVID-19 vaccine | BIOLOGICAL | SARS-CoV-2 spike subunit protein (Also called "Recombinant SARS-CoV-2 S-trimer protein"), PIKA adjuvant. |
| Inactivated Covid-19 vaccine | BIOLOGICAL | Inactivated SARS-CoV-2 virus |
| 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. |
| 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. |
Inclusion Criteria: Subject who met all of the following criteria may be enrolled. 1. Age more than or equal 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...
PIKA COVID-19 Vaccine, Arm A is an investigational vaccine being studied for use against COVID-19, including as a booster dose. It is developed by LakeShore Biopharma Co., Ltd (ticker: LSB) and is currently in clinical development, with trials completed for both primary vaccination and booster indications.
PIKA COVID-19 Vaccine, Arm A is developed by LakeShore Biopharma Co., Ltd, a company listed on the stock exchange under the ticker LSB. The vaccine is being studied for the prevention of COVID-19 and as a booster dose against the disease.
PIKA COVID-19 Vaccine, Arm A is in Phase 1 clinical development. It is an investigational vaccine, not yet approved by regulatory authorities, and has completed early-stage trials to evaluate its safety, tolerability, and immunogenicity in healthy individuals.
PIKA COVID-19 Vaccine, Arm A has been studied in two completed trials. NCT05305300 was a Phase 1 study in healthy individuals in the United Arab Emirates, and NCT05463419 was a Phase II/III study of the vaccine as a booster dose, conducted in the Philippines and the United Arab Emirates.
PIKA COVID-19 Vaccine, Arm A is associated with the PIKA Recombinant SARS-CoV-2 Vaccine, which was evaluated in a Phase II/III booster dose trial. The vaccine is being developed by LakeShore Biopharma Co., Ltd and is intended for use against COVID-19.