COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05175625

Payam Tabarsi, M.D.

Not reported

2022-01-04

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: male or female ≥18 years willing and able to comply with all study requirements, including scheduled visits, interventions, and laboratory tests healthy adults or adults in a stable medical condition, defined as not being hospitalized within 3 months prior to the screening visit subjects who have received two doses of a covid-19 vaccine of any type between 4 to 9 months before the screening visit

subjects with signs of active sars-cov-2 infection at the screening visit or within 72 hours prior to the screening visit subjects who have been diagnosed with a breakthrough infection after receiving two doses of a covid-19 vaccine subjects with epilepsy or a history of febrile seizures subjects who receive immunosuppressive or cytotoxic medications. subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products. subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study. subjects who have received any vaccines within 28 days prior to the screening visit or intend to receive any vaccines up to day 14 of the study. subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular injection. female subjects who are pregnant or breastfeeding or have planned to become pregnant within one month after the study injection. subjects who have received any blood, plasma, or immunoglobulin products from 90 days prior to the screening visit or intend to receive during the study period. subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion. subjects who have donated ≥450 ml of blood or blood products within 28 days prior to the screening visit.

2

Cinnagen

18

100

Iran;Islamic Republic of

Healthy volunteers

N/A

300

Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies

None

Phase 3

[{"arm_notes": "25 \u00b5g SARS-CoV-2 recombinant spike protein+Advax-SM adjuvant 15 mg;1;IM;have received two doses of a COVID-19 vaccine of any type between 4 to 9 months before the screening visit", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1;IM;have received two doses of a COVID-19 vaccine of any type between 4 to 9 months before the screening visit", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]