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This study aims to evaluate the safety and immunogenicity of the preventative vaccine, AdimrSC-2f, in healthy volunteers aged from 20 to 60 years old.
The objectives of this phase I study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AdimrSC-2f Group 1 | Experimental | low dose mcg |
|
| AdimrSC-2f Group 2 | Experimental | low dose mcg+AL |
|
| AdimrSC-2f Group 3 | Experimental | medium dose mcg |
|
| AdimrSC-2f Group 4 | Experimental | high dose mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdimrSC-2f | Biological | AdimrSC-2f is a candidate vaccine against COVID-19 developed by Adimmune Corporation (Adimmune). Using the baculovirus-insect cells expression system, the recombinant receptor binding domain (RBD) of SARS-CoV-2 spike (S) protein is amplified and purified. AdimrSC-2f is formulated in the different dosages of Spike (S) protein without/with aluminum content as adjuvant. |
| Measure | Description | Time Frame |
|---|---|---|
| The solicited adverse events (SoAEs) | Determining the solicited adverse events (SoAEs) (the percentage, severity, and relationship to the AdimrSC-2f vaccine) during 7 days following each vaccination. | The 7 days following each vaccination |
| Incidence of abnormal laboratory tests results | Determining the clinically significant changes in hematology, biochemistry, and coagulation results from baseline at Visit 2 and Visit 4. | Day 7 after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of AdimrSC-2f vaccine: AE |
| Day 0 to Day 182 |
| Immunogenicity |
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Inclusion Criteria:
Subjects who meet ALL inclusion criteria will be included.
Male or non-pregnant female, aged 20 to 60 years old (inclusive).
Subject who is physically and mentally capable of participating the study and are willing to adhere to study procedures.
Subject with no clinically significant abnormal findings in medical history, physical examination, vital signs, or clinical laboratory results at the Screening visit based on the investigator's judgment.
Subject with negative test result in SARS-CoV-2 antibody (IgG and IgM) rapid test at the Screening visit.
Subject with negative serology test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C antibody at the Screening visit.
Subjects' clinical laboratory test results are in the normal range or with abnormal values without clinical significance as judged by the investigator.
Female subject with childbearing potential must have negative result in urine pregnancy test at the Screening visit.
Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period. Effective birth control includes:
Male subject who agrees to use an adequate method of contraception during the study period [e.g., barrier contraceptives (male condom)].
Subject who provides informed consent after receiving a detailed explanation of study procedures.
Exclusion Criteria:
Subjects who meet ANY exclusion criteria will be excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
Determining the changes of antibody titers between baseline and the subsequent scheduled visits |
| Day 7,21,28,and 42 |
| Immunogenicity | Determining the geometric mean increase (GMI) | Day 21 and 42 |
| Immunogenicity | Determining the seroconversion rate (SCR) | Day 21 and 42 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |