COVID-19
Conditions
Keywords
Delta, Omicron, COVID-19
Brief summary
A Phase 1 study to evaluate safety, tolerability, and immunogenicity of SARS-CoV-2 variant mRNA vaccines which are used to prevent COVID-19 caused by SARS-CoV-2 infection. this study is conducted during Indonesian subjects aged 18 years and older who have not received SARS-CoV-2 vaccines.
Interventions
Sponsors
Suzhou Abogen Biosciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-Blind
Intervention model description
60 subjects will be randomized in a 2:2:1 ratio to receive ABO1009-DP, ABO-CoV.617.2, or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Voluntarily sign the ICF approved by the Ethics Committee before any study procedure and agree to participate in the study. 2. Healthy male or female able to provide legal identity certificate and aged 18 years and older when signing the ICF. 3. Have not previously received any SARS-CoV-2 vaccine (marketed or investigational) before screening. 4. Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial. 5. Males or females of childbearing potential voluntarily take effective contraceptive methods from signing ICF to 3 months after the last vaccination, including sexual abstinence or effective contraceptive measures (e.g., intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, intrauterine device \[IUD\], condoms \[male\], diaphragm, and cervical cap).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of solicited adverse events (AEs) | 0 to 7 days after each injection | Solicited adverse events 0 to 7 days after each injection； |
| Incidence of unsolicited AEs | 0 to 28 days after each injection | Unsolicited adverse events 0 to 28 days after each injection ； Adverse reactions/events related to blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after each injection |
| Changes of blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after each injection in comparison to pre-injection | 4 days after each injection in comparison to pre-injection | Adverse reactions/events related to blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after each injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of S-RBD-specific IgG antibody, titer of neutralizing antibodies, and the number of T cells | from the first vaccination to 12 months after 2 injections | Evaluate the immunogenicity of ABO1009-DP and ABO-CoV.617.2 against SARS-CoV-2 (original strain, Delta variant and Omicron variant) |
| Collection of Safety information | through 12 months after 2 injections | Serious adverse events (SAEs), adverse events of special interest (AESIs) and other medically attended adverse events (MAAEs) through 12 months after 2 injections |
Countries
Indonesia
Outcome results
None listed