COVID-19 trials registries data warehouse

http://en.irct.ir/trial/60375

Dr. Haleh Hamedifar

cinnagen@cinnagen.com

2021-12-12

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

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

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

2

CinnaGen Company

18

100

Iran

Healthy volunteers

N/A

300

Comparison of seroconversion for neutralizing antibodies in two groups

Phase 3

[{"arm_notes": "25 \u00b5g subunit vaccine with Advax-CpG adjuvant (1 mL), 1, day 0, IM ", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]