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:
1. to evaluate the safety profile of the AdimrSC-2f vaccine, and
2. to assess the immunogenicity of the AdimrSC-2f vaccine.
Biological: AdimrSC-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.
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 exclusion criteria will be excluded.
1. Subject with a body mass index (BMI) < 18.5 kg/m2 (underweight) or ≥ 35 kg/m2
(greater than Class I obesity) at the Screening Visit.
2. Subject with history of cancer (except localized skin cancer without metastases)
within 5 years prior to the Screening visit.
3. Subject has ongoing or medical history of hypertension or diabetes mellitus.
4. Subject has ongoing use of tobacco or nicotine-containing products (nicotine
patch included) or e-cigarette devices or with history of using
nicotine-containing product as documented in medical chart or by verbal
confirmation at screening.
5. Subject with documented history of substance or alcohol abuse in the medical
chart or by verbal confirmation within 6 months (approximately 180 days) prior to
the Screening visit.
6. Subject who received any vaccine (live, inactivated, or bacterial) within 1 month
(approximately 30 days) prior to the Screening visit.
7. Subject with hypersensitivity to the ingredients of AdimrSC-2f (including
aluminum).
8. Subject with personal or family history of Guillain-Barré Syndrome.
9. Subject who has travelled abroad within 3 months (approximately 90 days) prior to
the Screening visit.
10. Subject with influenza-like illness as defined by any of the following symptoms
at Screening visit: fever (tympanic temperature ≥ 38℃), dry cough, headache,
fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of
breath, muscle and joint pain, or sore throat.
11. Female subject who is pregnant or lactating at screening or plans to be pregnant
during the study period.
12. Subject who treated with an investigational drug or device or have participated
in a clinical study within 3 months (approximately 90 days) prior to the
Screening visit.
13. Subject with clinically significant abnormal ECG at the Screening visit or with
history of clinically significant cardiovascular disease such as arrhythmia,
coronary artery disease or heart failure, as judged by the investigator.
14. Subject with any confirmed or suspected abnormal immune function,
immunosuppressive, or immunodeficiency or received any immunosuppressants or
immunomodulators within 6 months (approximately 180 days) prior to the Screening
visit.
15. Subject with history of wheezing, asthma, chronic obstructive pulmonary disease,
or have used bronchodilator within 3 months (approximately 90 days) prior to the
Screening visit.
16. Subject who had blood donation within 2 weeks prior to the Screening visit.
17. Subject who received any blood products, including immunoglobulin within 3 months
(approximately 90 days) prior to the Screening visit.
18. Subject who is not suitable to participate in this study as judged by the
investigator.
19. Subject with chronic illness.
National Taiwan University Hospital
Taipei, Taiwan