Covid-19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: First 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 on d
Sponsors
CinnaGen Company
Eligibility
Sex/Gender
All
Age
5 Years to 40 Years
Inclusion criteria
Inclusion criteria: Chidren, men or women 5 to 40 years Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, and tests Healthy individuals or individuals with stable medical conditions Women eligible to participate in the study who are not pregnant or breastfeeding In children and adolescents aged 5-18, body mass index should be equal percentile or higher, according to WHO child development standards
Exclusion criteria
Exclusion criteria: Subjects with active infection with SARS-COV-2 signs at the screening visit. If subject has history of infection as passed it, involving has no problem 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 (e.g. 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 People who have previously been vaccinated with any type of vaccine against the SARS-CoV-2 virus 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 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 |
|---|---|
| Evaluation of non-inferiority seroconversion for neutralizing antibodies. Timepoint: Two weeks after the second dose. Method of measurement: Conventional virus neutralization test(cVNT) and statistical tests. | — |
Secondary
| 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 1 month after second dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions in individuals aged 5 to 18 years. Timepoint: During 6 months after second dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Comparing GMFR of antibodies against S protein in three groups. Timepoint: 2 weeks after the second dose. Method of measurement: Conventional virus neutralization test(cVNT) and statistical analysis.;Comparing seroconversion of antibodies against S protein in three groups. Timepoint: 2 weeks after the second dose. Method of measurement: ELISA test and statistical analysis.;Comparing GMR of antibodies against S protein. Timepoint: 2 weeks after the second dose. Method of measurement: ELISA test and statistical analysis.;Comparing GMT of neutralizing antibodies in three groups. Timepoint: 2 weeks after the second dose. Method of measurement: cVNT and statistical analysis.;Comparing GMFR of neutralizing antibodies in three groups. Timepoint: 2 weeks after the second dose. Method of measurement: cVNT and statistical analysis.;Comparing GMR of neutralizing antibodies. Timepoint: 2 weeks after the second dose. Method of measurement: cVNT and statistical analysis.;Comparing GMC of antibodies against S protein in three groups. Timepoint: 2 weeks after the second dose. Method of measurement: ELISA test and statistical analysis. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNassim Anjidani
Orchidpharmed
Outcome results
None listed