COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04818281

Ihsan GURSEL

not reported

2021-03-26

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: to be eligible for the study, each participant must satisfy all the following criteria: healthy participants between 18-59 years of age, sign an informed consent document, negative immunoglobulin g (igg) and immunoglobulin m (igm) antibody for covid-19, negative quantitative polymerase chain reaction (qpcr) sars-cov-2 results of nasopharyngeal/sputum samples, able to comply with the study protocol during the study period, negative tests for human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv), body temperature <37.2 c, body mass index 18-35 kg/m2, normal laboratory levels of whole blood count, alanine transaminase (alt), aspartate transaminase (ast), total bilirubin, urea, creatinine, and fasting blood glucose, good general health (no known disease in the history and physical examination within 14 days prior to the enrolment), female participants who are not pregnant or who will be able to have appropriate contraception methods within 30 days prior to vaccine injection and within 6 months after vaccination, male participants who will be able to have appropriate contraception methods for 6 months after vaccination,

participants with any of the following criteria will be excluded: history of seizure, encephalopathy or psychosis, history of allergic reactions to any known vaccine or to any component of the study vaccine, pregnant, breastfeeding or positive pregnancy test or planning to conceive within 6 months, active infection signs or body temperature >37.2 c, history of sars-cov-2 infection, severe cardiovascular disorders (arrhythmia, conduction disorders, history of myocardial infarction, uncontrolled hypertension), severe chronic disorders (asthma, diabetes mellitus, thyroid disorders…etc), congenital or acquired angioedema, diagnosis of immunodeficiency, diagnosis of bleeding diathesis, use of immunosuppressive treatment, anti-allergic treatment, cytotoxic treatment, inhaler corticosteroids (allergic rhinitis or topical steroid ointments are excluded), those who received blood and blood product transfusions in the last 6 months, those on any vaccine program or experimental medication within 1 month prior to the study, history of any live vaccine administration within 1 month prior to the study, history of any inactive vaccine administration within 1 month prior to the study, use of active tuberculosis treatment, according to the investigator's evaluation, those who have any condition (medical, psychological, social, etc.) that may impair the patient's compliance with the study will be excluded from the study.

3

Ihsan GURSEL, PhD, Prof.

18

59

Turkey

Healthy volunteers

N/A

38

Acute adverse events (AEs);Solicited local and systemic adverse events (AEs);Unsolicited local and systemic adverse events (AEs)

None

Phase 1

[{"arm_notes": "3.75 \u00b5g;2", "treatment_id": 1169, "treatment_name": "Sars-cov-2 vlp vaccine", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "15 \u00b5g;2", "treatment_id": 1169, "treatment_name": "Sars-cov-2 vlp vaccine", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]