Covid-19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: Injecting one dose of 1 ml solution of SpikoGen® vaccine containing recombinant SARS-CoV-2-S protein and Advax™ and CpG adjuvants in the non-dominant arm. Intervent
Sponsors
CinnaGen Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Men or women older than 18 years Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, and tests Individuals who received two doses of the SARS-CoV-2 vaccine with each platform within 4 to 9 months prior to the screening visit Healthy adults or adults with stable medical conditions
Exclusion criteria
Exclusion criteria: Subjects with active infection with SARS-COV-2 signs at the screening visit and 72 hours before the screening visit People with a history of Covid -19 after 2 doses of vaccination People with epilepsy or a history of febrile seizures People who are being treated with immunosuppressive drugs. Among the cytotoxic agents or systemic corticosteroids, for example, for cancer, autoimmune disease or organ transplants or require a specific medical prescription during the study period. Receiving cytotoxic and chemotherapy drugs at any dose will prevent people from entering the study People who have a history of severe allergic reactions (eg anaphylaxis) to any components of the vaccine being studied or other drugs Individuals who have received any other research product within 30 days prior to screening visit or intend to participate in another clinical study at the time of this study Individuals who received other authorized vaccines (such as Influenza vaccine or Gardasil) within 28 days prior to the screening visit in this study or intend to receive each vaccine up to 14 days after the second vaccination People who have a known bleeding disorder and who, according to the researcher, may have problems with the intramuscular injection Pregnant or breast-feeding women or women who plan to become pregnant up to 1 month after the booster dose People who have received or intend to receive any blood / plasma or immunoglobulin products during the 90 days prior to the screening visit People with special circumstances who, in the researcher's view, may increase the risk of participating in the study or interfering with the evaluation of the initial objectives of the study People who have donated more than or equal to 450 ml of blood or blood products in the 28 days before the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of seroconversion for neutralizing antibodies in two groups. Timepoint: two weeks after booster dose. Method of measurement: ELISA and statistical analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of solicited adverse events. Timepoint: Up to 7 days after booster dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Occurrence of unsolicited adverse events. Timepoint: Up to 14 days after booster dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Incidence of Serious Adverse Event and Suspected Unexpected Serious Adverse Reactions. Timepoint: during 6 months after booster dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Comparing GMC of antibodies against S protein. Timepoint: days 14,90,180. Method of measurement: ELISA test and statistical analysis.;Comparing GMFR of antibodies against S protein. Timepoint: two weeks after booster dose. Method of measurement: ELISA test and statistical analysis.;Comparison of seroconversion of antibodies against S1 protein. Timepoint: two weeks after booster dose. Method of measurement: ELISA test and statistical analysis.;Comparison of seroconversion antibodies against RBD protein in two groups. Timepoint: two weeks after booster dose. Method of measurement: ELISA test and statistical analysis.;Comparison of GMC for Antibody against RBD protein in two groups. Timepoint: days 14,90,180. Method of measurement: ELISA test and statistical analysis.;Comparison of GMFR for neutralizing antibodies against RBD in two groups. Timepoint: two weeks after booster dose. Method of measurement: ELISA test and statistical analysis.;Comparison of GMC for neutralizing antibodies against SARS-CoV-2 in two groups. Timepoint: days 14,90,180. Method of measurement: ELISA test and statistical analysis.;Comparison of GMFR for neutralizing antibodies against SARS-CoV-2 in two groups. Timepoint: two weeks after booster dose. Method of measurement: ELISA test and statistical analysis.;Evaluation of cellular immune response and Interfe | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNassim Anjidani
Orchid Pharmed
Outcome results
None listed