| Trial registration number
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KCT0006670 |
Full text link
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=20444
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First author
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Sung-Han Kim
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Contact
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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shkimmd@amc.seoul.kr
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Registration date
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-10-15
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Recruitment status
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. provide written informed consent before the first study-specific procedure
- 19~54 years, Male and Female (Step 1 (Phase I))
- 19~85 years, Male and Female (Step 2 (Phase IIa))
2. Participants must have a body mass index (BMI) between =18.5 and =30.0 kg/m2 at screening
3. Must agree to use highly effective, medically accepted double-barrier contraception (both male and female partners) from screening until study completion (until 3 months after second vaccination) as specified below in this criterion
4. Must agree not to donate blood or transfusion (including whole blood, plasma, and platelet components)
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Exclusion criteria
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Participant with the evidence of COVID-19 infection because of one or more of the following:
1) Positive for COVID-19 when performing RT-PCR with upper respiratory tract samples, (oropharyngeal/nasopharyngeal swab)
(However, if symptoms of cough or sputum are present, additional RT-PCR is performed using a lower respiratory tract sample (sputum), and registration is possible if all are negative)
2) History of COVID-19,
3) Positive test for COVID-19 (lgM or IgG) antibody at screening,
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Number of arms
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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3
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Funding
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Eyegene
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Inclusion age min
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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19
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Inclusion age max
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Democratic People's Republic of Korea
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Type of patients
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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45
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primary outcome
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Solicited Adverse Events recorded up to 1st and 2nd vaccination;SRR; GMT; GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point
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Notes
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 1/Phase 2
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Arms
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "0.25mL(mRNA 50 \u03bcg)", "treatment_id": 2048, "treatment_name": "Eg-covid", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.50mL(mRNA 100 \u03bcg)", "treatment_id": 2048, "treatment_name": "Eg-covid", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.50mL(mRNA 200 \u03bcg)", "treatment_id": 2048, "treatment_name": "Eg-covid", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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