Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05305300 | A Phase I Study to Evaluate Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Individuals | PHASE1 | COMPLETED | 135 | — | — | Oct 18, 2021 | Sep 15, 2022 | Dec 22, 2022 | 1 | United Arab Emirates |
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 |
|---|---|---|
| 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 (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 Inclusion Criteria of Arm A: 1. Male and female healthy volunteers. 2. Age ≥18 years on Study Day 0. 3. Judged by the investigator to be healthy on the basis of medical history, physical examination and vital signs performed at screening. 4. Able to provide informed consent. 5. ...