COVID-19 trials registries data warehouse

http://en.irct.ir/trial/56287

Dr. Haleh Hamedifar

cinnagen@cinnagen.com

2021-05-24

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

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.

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.

2

CinnaGen Company

18

100

Iran

Healthy volunteers

N/A

400

Occurrence of solicited adverse events Occurrence of unsolicited adverse events. Evaluation of seroconversion for IgG against S protein GMC measurement for IgG-binding antibody (bAb) against protein S

Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "25\u00b5g;2;Days0-21;IM", "treatment_id": 2232, "treatment_name": "Advax-cpg adjuvant+sars-cov-2 spike (s) protein subunit vaccine", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}]