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Primary:Objectives :SafetyTo describe the safetyprofile of all participants in each group up to 6months post-dose.Immunogenicity:To demonstrate the superiorityof neutralizing antibodyresponse in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine28 days post dose. Secondary:Immunogenicity
Efficacy:To describe the occurrence of virologically-confirmed COVID-19 like illness and serologically confirmed SARS-CoV-2 infection.
Endpoints:Safety Endpoints- Occurrence of unsolicited systemic AEs reported in the 30 minutes after each injection.
Occurrence of solicited injection site reactions and systemicreactions occurring up to 7 days post-dose.
Occurrence of unsolicited non-serious AEs reported up to 28 dayspost-dose. Occurrence of SAEs and AESIs up to 6 months throughout the study. Immunogenicity Endpoints:GMT of neutralizing antibody will be measured with the neutralization assayon D01,D29.
Binding antibody titers to full length SARS-CoV-2 Spike (S) protein will be measured for each study intervention group with the ELISA method
Virologically-confirmed COVID 19 like illness as defined by specified clinical symptoms and signs and confirmed by a positive result for SARS-CoV-2 nucleic acid viral detection assay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SW-BIC-213 | Experimental | Intervention Name :COVID-19 mRNA vaccine Type :Investigational Vaccine Dose :Formulation mRNA Unit Dose Strength(s) :0.5ml; Dosage Level(s) :0.25ml; Route of Administration: injection Intramuscular |
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| SARS-Cov-2 Vaccina(Vero Cell ) Inactivated | Active Comparator | Intervention Name: COVID-19 Inactivated Vaccine Type : Control Vaccine Dose :Inactive Unit Dose Strength(s) : 0.5ml; Route of Administration Intramuscular : injection Intramuscular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SW-BIC-213 | Biological | The patient will take a single 25 μg dose mRNA vaccine SW-BIC-213. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | To describe the safety profile of all participants in each group up to 6 months post-dose. | 6 months post-dose |
| Immunogenicity of 28 days post dose | To demonstrate the superiority of neutralizing antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine 28 days post dose. | 28 days post dose |
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Inclusion Criteria:
24 weeks with the completed the 2-dose Series as the primary vaccination according to the product label.
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yang li, doctor | Contact | +856 02095779465 | yang.li@stemirna.com | |
| bin luo, bachelor | Contact | +856 02095779465 | bin.luo@stemirna.com |
| Name | Affiliation | Role |
|---|---|---|
| Mayfong Mayxay, doctor | National Ethics Committee for Health Research(NECHR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Savannakhét Provincial hospital | Recruiting | Savannakhet | Sava | Laos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38169790 | Derived | Fang Y, Li JX, Duangdany D, Li Y, Guo XL, Phamisith C, Yu B, Shen MY, Luo B, Wang YZ, Liu SJ, Zhao FF, Xu CC, Qiu XH, Yan R, Gui YZ, Pei RJ, Wang J, Shen H, Guan WX, Li HW, Mayxay M. Safety, immunogenicity, and efficacy of a modified COVID-19 mRNA vaccine, SW-BIC-213, in healthy people aged 18 years and above: a phase 3 double-blinded, randomized, parallel controlled clinical trial in Lao PDR (Laos). EClinicalMedicine. 2023 Dec 13;67:102372. doi: 10.1016/j.eclinm.2023.102372. eCollection 2024 Jan. |
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a randomized observer-blinded parallel controlled trial:Experimental group(mRNA vaccine) and positive control group(inactive vaccine)
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This study uses a double blinded design, and the investigators and participants will all remain blinded before unblinding and do not know which group the participant belongs to.
| SARS-Cov-2 Vaccina(Vero Cell ) Inactivated |
| Biological |
The patient will take a third dose of COVID-19 Inactivated vaccine. |
|