Adaptive Phase I Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From SARS-CoV-2, in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies

Tahapan Penelitian : Rekrut
Sponsor:
Mitra Pelaksana:
Aivita Biomedical, Inc.; PT AIVITA Biomedika Indonesia; National Institute of Health Research and Development, Ministry of Health Republic of Indonesia; RSUP Dr. Kariadi Semarang indonesia; Faculty of Medicine University of Diponegoro, Indonesia
No Registry
INA-XSPZF53
Tanggal Input Registry : 28-12-2020

07-12-2020
1. Frequency of solicited local and systemic reactogenicity adverse events (AEs) Percentage of participants with solicited AEs (local, systemic) for 7 days following vaccination by severity score,duration, and peak intensity. 2. Safety Laboratory Values (Serum Chemistry) Safety laboratory values (Serum Chemistry) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination. 3. Safety Laboratory Values (Hematology) Safety laboratory values (Hematology) 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) 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), dan other serious important medical events 5. Frequency of any new-onset chronic medical conditions (NOCMCs) NOCMCs will be documented from the time of study vaccination through approximately 1 year after study vaccination 6. Frequency of medically attended adverse events (MAAEs) Percentage of participants with MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner,through Day 365 by MedDRA classification, severity score, and relatedness. 7. Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs) Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all MAAEs) or AESIs (potential immune-mediated medical conditions or AEs relevant to COVID-19) through the first 90 days by MedDRA classification, severity score, and relatedness.
1. Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs) Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs through Day 28. 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 through Day 28. 3. Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs) Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs through Day 28. SCR is the proportion of participants with ≥4-fold rises in ELISA units. 4. Neutralizing Antibody Activity Expressed as GMTs Neutralizing antibody activity as detected by microneutralization assay (MN) expressed as GMTs at multiple time points through Day 28. 5.Neutralizing antibody activity as detected by MN expressed as GMFRs at multiple time points through Day 28. 6. Neutralizing antibody activity as detected by MN expressed as SCRs at multiple time points through Day 28. 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) through Day 28. 8. Optimal dose of SARS-CoV2 antigen and GM-CSF, Measurement of IgG in subject blood after one month 9. Duration of detection IgG and neutralizing antibody againts SARS-CoV-2in blood after vaccination Measurement of IgG and neutralizing antibody in subject blood after 12 months
 
Adaptive Phase I Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From SARS-CoV-2, in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies
Dendritic Cell Vaccine to Prevent COVID-19
Observasional
This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.
27
 

Inclusion Criteria:

1. 18 years or older, 2. in relatively good health with adequate physical and mental function 3. including factors associated with in increased risk for medical complications associated with COVID-19 infection or increased risk for exposure to SARS-CoV-2

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
 
No. 06/XI/KEPK/2020
On process
No. RG.01.06.1.3.12.20.27
CL-COV-P02-ID
Dr. Muhammad Karyana, M.Kes