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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04967742 |
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Full text link
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
hope.liu@ubiasia.com.tw |
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Registration date
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
2021-07-20 |
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Recruitment status
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria male or non-pregnant female who previously participated in and completed two vaccinations in the v-122 study. women of childbearing potential and men must agree to practice medically effective contraception during study period. able to understand the content and possible risks of informed consent and willing to sign the informed consent form (icf). able to understand and agrees to comply with all study procedures and be available for all study visits. ear temperature ≤ 38.0°c. at screening visit, at least 6 months after first vaccination in the v-122 study. exclusion criteria female who is pregnant or positive in pregnancy test at screening visit. female who is breast-feeding or plans to breastfeed within 90 days after booster vaccination. any acute illness, as determined by the study investigator 3 days before booster vaccination. prior administration of attenuated, nucleic acid (mrna or dna) or vectored vaccines in last 1 month before booster vaccination or expectation of such vaccines in the month after booster vaccination. prior administration of subunit vaccine or inactivated vaccine in last 14 days before booster vaccination or expectation of receipt of such vaccines in the 14 days after booster vaccination. any medical disease or condition that, in the opinion of the study investigator, may confound the results of the study or pose an additional risk to the subjects by their participation in the study. previous exposure to sars-cov-2 or receipt of an investigational or eua vaccine product for the prevention of covid-19, mers or sars except ub-612. subjects who take part in another clinical study, other than v-122 study, within 12 weeks prior to the day of informed consent. prior administration of immunoglobulins and/or any blood products in last 4 months before booster vaccination. prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination. |
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Exclusion criteria
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
None |
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Number of arms
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
United Biomedical Inc., Asia |
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Inclusion age min
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
20 |
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Inclusion age max
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
55 |
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Countries
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Taiwan |
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Type of patients
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
50 |
|
primary outcome
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2;Geometric mean fold increase of neutralizing antibody against SARS-CoV-2;GMT of neutralizing antibody against SARS-CoV-2;GMT of neutralizing antibody against SARS-CoV-2;GMT of neutralizing antibody against SARS-CoV-2;Occurrence of adverse reactions and the percentage of subjects with ≥ Grade 3 adverse events |
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Notes
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Phase 1 |
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Arms
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "100 \u03bcg;1 (1 booster dose for subjects at UB-612 vaccine 10 \u03bcg in V-122 study)", "treatment_id": 1325, "treatment_name": "Ub-612", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "100 \u03bcg;1 (1 booster dose for subjects at UB-612 vaccine 30 \u03bcg in V-122 study.)", "treatment_id": 1325, "treatment_name": "Ub-612", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "100 \u03bcg;1 (1 booster dose for subjects at UB-612 vaccine 100 \u03bcg in V-122 study.)", "treatment_id": 1325, "treatment_name": "Ub-612", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}] |