COVID-19. COVID-19, virus identified
Conditions
Sponsors
CinnaGen Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Men or women =18 years Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations and tests Healthy adults or adults with stable medical conditions. Women eligible to participate in the study who are not pregnant or breastfeeding.
Exclusion criteria
Exclusion criteria: Subjects with active infection with SARS-COV-2 signs at the screening visit. Subjects with body temperature equal or more than 38 degrees centigrade, during 72 hours before screening visit or at the visit. Subjects with any progressive or severe neurological disorder, seizures, or a history of Guillain-Barre syndrome. Subjects who receive immunosuppressive or cytotoxic medications. Pregnant women, or breastfeeding mothers, or women who plan to become pregnant during the study. Subjects who have a history of severe allergic reactions (e.g. anaphylaxis) to the study vaccine or any components of the vaccine or any other drugs. Subjects who have received any other investigational product within 30 days prior to the screening visit or intend to participate in other clinical studies during this trial. Subjects who have been vaccinated with other vaccines against the SARS-CoV-2 virus. Subjects who received other authorized vaccines within 28 days prior to the screening visit in this study or intend to receive any vaccines up to 14 days after the second vaccination. Subjects who have any known bleeding disorder or may have problems with the intramuscular injection according to the researcher's opinion. Subjects who have received or intend to receive any blood / plasma or immunoglobulin products 90 days prior to the screening visit. Subjects with special circumstances who, may increase the risk of participating in the study or interfering with the evaluation of the primary endpoints of the study according to researcher's opinion. Subjects who have donated =450 ml of blood or blood products 28 days prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of solicited adverse events. Timepoint: Up to 7 days after each dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Occurrence of unsolicited adverse events. Timepoint: Up to 28 days after each dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Evaluation of seroconversion for IgG against S protein. Timepoint: On days 21 and 35. Method of measurement: ELISA and statistical analysis.;GMC measurement for IgG-binding antibody (bAb) against protein S. Timepoint: On days 0, 21 and 35. Method of measurement: ELISA and statistical analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of seroconversion for nAb against SARS-CoV-2. Timepoint: Days 21 and 35. Method of measurement: sVNT (by ELISA) and statistical analysis.;Evaluation of seroconversion for IgA against RBD. Timepoint: Days 21, 35. Method of measurement: ELISA test and statistical analysis.;Evaluation of seroconversion for IgA against S protein. Timepoint: Days 21, 35. Method of measurement: ELISA test and statistical analysis.;Evaluation of seroconversion for IgG against RBD. Timepoint: Days 21, 35. Method of measurement: ELISA test and statistical analysis.;Evaluating GMC of bAb (IgG) against RBD. Timepoint: Days 0, 21, 35. Method of measurement: ELISA test and statistical analysis.;Evaluating GMFR of bAb (IgG) against S protein. Timepoint: Days 21, 35. Method of measurement: ELISA test and statistical analysis.;Evaluating GMFR of bAb IgG against RBD. Timepoint: Days 21, 35. Method of measurement: ELISA test and statistical analysis.;Evaluating GMC of nAb against SARS-COV-2. Timepoint: Days 0, 21, 35. Method of measurement: ELISA test and statistical analysis.;Evaluating GMFR of nAb against SARS-COV-2. Timepoint: Days 21, 35. Method of measurement: ELISA test and statistical analysis.;Evaluating cellular immune response by measuring proliferation percentage of CD4/CD8 lymphocytes. Timepoint: Days 0, 21, 35. Method of measurement: Flow cytometry.;Incidence of SAEs and SUSARs. Timepoint: During 6 months after second dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;?Evaluation of cell proliferation (percentage of CD4 and CD8 cells) producing interferon-gamma after exposure to specific antigen, 25% of sample size (100 patients). Timepoint: On days 0, 21, 35. Method of measurement: Intracellular Cytokine Staining and Flow cytometry.;NAb titer measurement against SARS-CoV-2. Timepoint: Days 21 and 35. Method of measurement: cVNT and statistical analysis.;Evaluating GMC of IgA against S protein. Timepoint: Da | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNassim Anjidani
Orchid Pharmed
Outcome results
None listed