Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
The PIKA COVID-19 Vaccine is an investigational vaccine developed by LakeShore Biopharma Co., Ltd for protection against COVID-19. It is a vaccine candidate studied both as a primary immunization and as a booster dose in healthy adults aged 18 years and older. It remains in clinical development.
The PIKA COVID-19 Vaccine is being developed for the prevention of COVID-19 and for use during the COVID-19 pandemic. Clinical studies have evaluated it as a booster dose against SARS-CoV-2 in healthy adult volunteers. It is not an approved product and is still under investigation.
The PIKA COVID-19 Vaccine is developed by LakeShore Biopharma Co., Ltd, which trades under the ticker LSB. The company sponsored the clinical studies of the vaccine candidate in the Philippines and the United Arab Emirates.
The PIKA COVID-19 Vaccine is in Phase 1 development. A Phase 1 study of the vaccine has been completed, and a Phase II/III booster study has also been completed. The vaccine is investigational and has not been approved by the FDA.
The PIKA COVID-19 Vaccine has been studied in two completed trials. NCT05305300 was a Phase 1 study of safety, tolerability, and immunogenicity in healthy individuals in the United Arab Emirates. NCT05463419 was a Phase II/III booster dose study conducted in the Philippines and the United Arab Emirates.
Yes. PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A is an alternative name for the PIKA COVID-19 Vaccine. Searches using that longer designation refer to the same LakeShore Biopharma vaccine candidate studied in the completed Phase 1 and Phase II/III trials.