COVID-19 (SARS-CoV-2 infection) vaccine Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
Participants are randomly allocated to receive AV-COVID-19 in 9 arms:
1. 0.1 mg antigen, 0 mcg GMCSF
2. 0.33 mg antigen, 0 mcg GMCSF
3. 1.0 mg antigen,
Sponsors
Ministry of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years or older 2. In relatively good health with adequate physical and mental function 3. Increased risk for medical complications associated with COVID-19 infection or increased risk for exposure to SARS-CoV-2
Exclusion criteria
Exclusion criteria: 1. Active COVID-19 infection by PCR testing 2. Pre-existing IgG or IgM SARS-CoV-2 antibodies 3. Pregnant, Known hypersensitivity to GM-CSF 4. Known active immune deficiency disease or active HIV 5. HBV, HCV, On active treatment with corticosteroids or other immunosuppressive agent 6. Participated in previous COVID-19 vaccine study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Each of the following will be measured from the daily log and patient report: 1. Frequency of solicited local and systemic reactogenicity adverse events (AEs) measured as the percentage of participants with solicited AEs (local, systemic) by severity score, duration, and peak intensity measured at 7 days after each vaccination 2. Safety Laboratory Values (Serum Chemistry) measured by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination 3. Safety Laboratory Values (Hematology) measured by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination 4. Frequency of any serious adverse events (SAEs) measured as the percentage of participants with serious undesirable effect associated with the use of a medical product in a patient, which consist of death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), and other serious important medical events between baseline and 1 year 5. Frequency of any new-onset chronic medical conditions (NOCMCs) documented between the time of study vaccination and 1 year 6. Frequency of medically attended adverse events (MAAEs) defined as the percentage of participants with MAAEs (AEs that lead to an unscheduled visit to a healthcare practitioner) by MedDRA classification, severity score, and relatedness between baseline and 1 year 7. Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs) defined as the percentage of participants with unsolicited AEs (treatment-emergent, serious, suspected unexpected serious, those of special interest, and all MAAEs) or AESIs (potential immune-mediated medical conditions, or AEs relevant to COVID-19) by MedDRA classification, severity score, and relatedness be | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) expressed as Geometric Mean Fold Rises (GMFRs) as detected by ELISA expressed as GMFRs at 28 days 2. Serum Immunoglobulin G (IgG) antibody levels expressed as Geometric Mean Titers (GMTs). Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs at 28 days 3. Serum IgG Antibody Levels specific for the SARS-CoV-2 rS protein antigen(s) expressed as Seroconversion Rates (SCRs) as detected by ELISA expressed as SCRs at 28 days. SCR is the proportion of participants with =4-fold rises in ELISA units. 4. Neutralizing antibody activity expressed as GMTs as detected by microneutralization assay (MN) expressed as GMTs at multiple time points at 28 days 5. Neutralizing antibody activity expressed as GMFRs as detected by MN expressed as GMFRs at multiple time points at 28 days 6. Neutralizing antibody activity expressed as SCRs as detected by MN expressed as SCRs at multiple time points at 28 days 7. Assessment of Cell-Mediated (T helper 1 [Th1]/T helper 2 [Th2]) Pathways. Cell-mediated (Th1/Th2) pathways as measured by whole blood (flow cytometry) and/or in vitro peripheral blood mononuclear cell (PBMC) stimulation (eg, enzyme-linked immunospot [ELISpot], cytokine staining) with SARS-CoV-2 rS protein(s) at 28 days 8. Optimal dose of SARS-CoV2 antigen and GM-CSF through measurement of IgG in subject blood at 1 month 9. Duration of detection IgG and neutralizing antibody against SARS-CoV-2in blood after vaccination through measurement of IgG and neutralizing antibody in subject blood at 12 months | — |
Countries
Indonesia
Contacts
Public ContactMuhammad Karyana
Outcome results
None listed