COVID - 19
Conditions
Brief summary
A Phase 1, Randomized, Double-blind, Dose-Escalation, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Preventive Vaccine 'GC4006A' in Healthy Adults Aged 19 to 64 Years
Interventions
BIOLOGICALGC4006A
administered as a single dose via Intramuscular injection.
DRUGNormal Saline
Matching placebo administered as a single dose via Intramuscular injection.
Sponsors
GC Biopharma Corp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 19-64 with written informed consent * ≥16 weeks since last COVID-19 vaccination
Exclusion criteria
* Positive SARS-CoV-2 test (RT-PCR/Rapid Antigen) at screening or randomization * \<16 weeks since COVID-19 diagnosis * History of serious adverse event, allergy, or hypersensitivity to the vaccines * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited local and systemic AEs | From baseline up to 7 days |
| Acute adverse events | From baseline up to 30 minutes |
| Unsolicited adverse AEs | From baseline up to 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events (SAE), Adverse events of special interest (AESI), Medically Attended Adverse Events (MAAE) | From baseline up to week 52 | — |
| Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations | From baseline up to week 52 | — |
| 6. Immunogenicity response (SRR, GMT, GMFR for neutralizing antibodies; SRR, GMC, GMFR for binding antibodies) | From baseline up to week 52 | SRR (Seroresponse rate), GMT (Geometric mean titer), GMFR (Geometric mean fold rise), GMC (Geometric mean concentration) |
Countries
South Korea
Outcome results
None listed