COVID-19
Conditions
Brief summary
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.
Detailed description
The objectives of this phase I study are: 1. to evaluate the safety profile of the AdimrSC-2f vaccine, and 2. to assess the immunogenicity of the AdimrSC-2f vaccine.
Interventions
BIOLOGICALAdimrSC-2f
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.
Sponsors
Adimmune Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who meet ALL inclusion criteria will be included. 1. Male or non-pregnant female, aged 20 to 60 years old (inclusive). 2. Subject who is physically and mentally capable of participating the study and are willing to adhere to study procedures. 3. 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. 4. Subject with negative test result in SARS-CoV-2 antibody (IgG and IgM) rapid test at the Screening visit. 5. Subject with negative serology test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C antibody at the Screening visit. 6. Subjects' clinical laboratory test results are in the normal range or with abnormal values without clinical significance as judged by the investigator. 7. Female subject with childbearing potential must have negative result in urine pregnancy test at the Screening visit. 8. Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period. Effective birth control includes: 1. Intrauterine device plus one barrier method 2. Oral, implantable, or injectable contraceptives plus one barrier method; or 3. Two barrier methods Effective barrier methods are male or female condoms, diaphragms, or spermicides (creams or gels that contain a chemical to kill sperm). Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥ 1 year. 9. Male subject who agrees to use an adequate method of contraception during the study period \[e.g., barrier contraceptives (male condom)\]. 10. Subject who provides informed consent after receiving a detailed explanation of study procedures.
Exclusion criteria
* Subjects who meet ANY
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The solicited adverse events (SoAEs) | The 7 days following each vaccination | Determining the solicited adverse events (SoAEs) (the percentage, severity, and relationship to the AdimrSC-2f vaccine) during 7 days following each vaccination. |
| Incidence of abnormal laboratory tests results | Day 7 after vaccination | Determining the clinically significant changes in hematology, biochemistry, and coagulation results from baseline at Visit 2 and Visit 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of AdimrSC-2f vaccine: AE | Day 0 to Day 182 | 1. Determining the SoAEs and unsolicited AES (the percentage, severity, and relationship to AdimrSC-2f vaccine) during the study period. 2. Overall AEs and serious adverse events (SAEs) during the study period. |
| Immunogenicity | Day 7,21,28,and 42 | Determining the changes of antibody titers between baseline and the subsequent scheduled visits |
Countries
Taiwan
Outcome results
None listed