SARS-CoV2 Infection
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy, safety and immunogenicity of GX-19N in healthy individuals who have received one of COVID-19 vaccine authorized for emergency use.
Interventions
BIOLOGICALGX-19N
DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen
OTHERPlacebo
GX-19N formulation buffer
Sponsors
PT Kalbe Farma Tbk
Genexine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adult males or females aged 18 years and above at the time of consent 2. Healthy subjects in normal medical condition as determined by medical history, physical examination, and investigator's discretion 3. Have previously received homologous full-dose of COVID-19 vaccine authorized for emergency use, and at least 3 months post second vaccination prior to Day 1 4. Negative results for SARS-COV-2 rapid antigen test at the screening period 5. Able to comply with all study procedures and requirements 6. Agree for blood and nasal swab samples could be collected throughout the study period, including surveillance visit
Exclusion criteria
1. Unable to follow clinical and follow-up procedures 2. Acute fever with temperature above 38℃, coughing, breathing difficulty, chills, muscle ache, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to the vaccination 3. History of SARS-CoV-2 infection or have experienced prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine 4. History of a malignant disease within the past 5 years 5. Immune dysfunction, including immunodeficiency disorder, or family history of such conditions (Except stable/well-controlled HIV-positive participants) 6. Have received immunoglobulin or blood-derived products within 3 months prior to the vaccination or are scheduled to receive them during the study period 7. Have been dependent on antipsychotic drugs and narcotic analgesics within 6 months prior to the vaccination 8. History or are suspected of alcohol or drug dependency 9. History of hypersensitivity or allergic reactions including anaphylaxis 10. A current or history of clinically significant chronic cardiovascular, endocrine, gastrointestinal, hepatic (including hepatitis B and C), renal, neurological, respiratory, psychiatric or other medical disorders not excluded by other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs and Serious AEs (SAEs) after each vaccination | Up to 1 month after each vaccination | Percentage of subjects reporting AEs and SAEs after each vaccination |
| First occurrence of COVID-19 at least 14 days after the second vaccination | Up to 1 year after first vaccination | Symptomatic, virologically confirmed COVID-19 as described in the study |
| Incidence of severe solicited adverse events (AEs) | Up to 7 days after each vaccination | Percentage of subjects reporting grade 3 or higher AEs after each vaccination |
| Incidence of SAE, and Adverse events of special interest (AESIs), which relevant to COVID-19 including possible vaccine-enhanced disease | Up to 1 year after first vaccination | SAE and AESIs reported in all subjects at any time after the first vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First occurrence of severe COVID-19 at least 14 days after the second vaccination | Up to 1 year after first vaccination | Symptomatic, virologically confirmed severe COVID-19 as described in the study |
| Cell-mediated immune responses after vaccination | Up to 1 year after first vaccination | Antigen-specific T cell response in a subset of Phase 2/3 |
| Antibody responses after vaccination | Up to 1 year after first vaccination | Analysis of binding antibodies and neutralizing antibodies in a subset of Phase 2/3 |
Other
| Measure | Time frame | Description |
|---|---|---|
| First occurrence of COVID-19 at least 14 days after the first vaccination | Up to 1 year after first vaccination | Symptomatic, virologically confirmed COVID-19 as described in the study |
| First occurrence of asymptomatic, virologically confirmed COVID-19 at least 14 days after the last vaccination in subjects | Up to 1 year after first vaccination | Without symptom, but virologically confirmed COVID-19 as described in the study |
Outcome results
None listed