COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05171946

Iman Almansour, Ph.D.

ikalmansour@iau.edu.sa

2021-12-29

Not recruiting

RCT

Randomized

Single group assignment

Blind label

single-center

Prevention

inclusion criteria study participants should meet all the below inclusion criteria to be eligible for the study: male or female participants between the age of 18 to 55 years (inclusive) at the time of enrollment. healthy participants as determined by the medical history, physical examination, clinical verification by the investigator. participant who are committed to comply with planned scheduled visits, vaccination, laboratory tests, and any other procedures. participants who received 2 doses of an approved mrna covid-19 vaccine at least 4 months prior to enrollment. female subjects must have used an acceptable contraceptive method for at least 60 days prior to receiving the first dose of the investigational vaccine and should continue using contraception for at least 1 month after receiving the last dose of the investigational vaccine. male subjects able to father children, and sexually active with a female partner who is able to bear children must be willing to use (or have his female partner use) an acceptable contraceptive method from the time they receive the first dose of the study vaccine until at least 1 month after the last dose of study vaccine. willing to sign the informed consent which includes all the requirements and restrictions listed in the informed consent and the protocol. exclusion criteria study participants should meet none of the exclusion criteria listed below: participant with known infection with hepatitis b virus (hbv), hepatitis c virus (hcv), and human immunodeficiency virus (hiv). individuals with current infection and diagnosis with covid-19 documented by pcr nasal swab test. individuals who received an authorized mrna covid-19 vaccine within the past 4 months of first study drug administration. individuals who received only one dose of a covid-19 vaccine. individuals working in facility with high probability of infection with sars-cov-2 such as health workers in hospitals. history of adverse reaction associated with vaccines and/or severe allergic reaction to any component of the study intervention. individuals under immunosuppressive therapy. individuals receiving treatment or medications that can adherently affect the immune system in the last 90 days, including but not limited to: interferon, immunoglobin, immunomodulators, epinephrine injector, cytotoxic drug. individuals diagnosed any diseases that is/are associated with sever covid-19, including the following factors: diabetes hypertension asthma bmi more than 30 kg/m2 pregnant or lactating women. chronic pulmonary disease chronic liver diseases chronic renal diseases individuals with known or suspected immunological disorders, including, autoimmune disease and diabetes mellitus. individuals with current or previous neurological disorders, such as seizure or gillian-barre syndrome. individuals with psychiatric disorder or cognitive impairment. individuals with bleeding disorder or other conditions associated with prolonged bleeding time. individuals with clinically significant abnormal safety laboratory results at screening in the opinion of the investigator. individuals receiving or planning to receive non-study vaccine 30 days prior to study enrollment. individuals receiving or donating blood or blood components 60 days prior to study enrollment. individuals participating in a clinical trial with an investigational vaccine, treatment, or device 30 days prior to study enrollment. individuals intending to participate in another clinical trial while being enrolled in this study. individuals with history of alcohol or drug addiction. individual with other condition that may interfere with the health or the participants or that interfere with study's primary or secondary objectives. female participants who are pregnant, plan to get pregnant or are breast feeding.

None

3

Iman Almansour

18

55

None

Healthy volunteers

N/A

30

GMT of the serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti-RBD);GMT of the serum SARS-CoV-2 S neutralizing antibodies;Proportion of subjects with four folds increase in serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti- RBD);Proportion of subjects with four folds increase in serum SARS-CoV-2 neutralizing antibodies;The percentage and frequency of study subjects reporting adverse events (AE);The percentage and frequency of study subjects reporting local reaction;The percentage and frequency of study subjects reporting systemic events (SAE);The percentage of study subjects reporting systematic reaction

None

Phase 1

[{"arm_notes": "Low-dose;1mg;3;Days0-21-42;IM", "treatment_id": 2101, "treatment_name": "S.opt.fl covid-19 pdna vaccine", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Mid-dose;2mg;3;Days0-21-42;IM", "treatment_id": 2101, "treatment_name": "S.opt.fl covid-19 pdna vaccine", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "High-dose;4mg;3;Days0-21-42;IM", "treatment_id": 2101, "treatment_name": "S.opt.fl covid-19 pdna vaccine", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}]