Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ningbo Rongan Biological Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This trial is a phase II clinical trial of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). The trial was randomized, blinded, placebo controlled. To evaluate the safety and immunogenicity of the study vaccine in participants aged 18 years and older who have received SARS-CoV-2 Vaccine.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2 Bivalent mRNA Vaccine | Experimental | 100 μg /1.0 mL/dose, One booster dose 1.0mL IM injection of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). |
|
| Saline | Placebo Comparator | One booster dose 1.0mL IM injection of saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 Bivalent mRNA Vaccine | Biological | 100 μg /1.0 mL/dose, slightly milky white and clear liquid, intramuscular injection into the lateral deltoid muscle of the upper arm. |
| Measure | Description | Time Frame |
|---|---|---|
| GMT and SCR of live virus neutralizing antibodys against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains). | GMT and SCR of live virus neutralizing antibodys against SARS-CoV-2 ( Delta strain, Omicron BA.5, XBB strains and current major circulating strains) on day 14 after vaccination. | 14 day after booster vaccination. |
| Incidence of solicited and unsolicited adverse events | Incidence of solicited and unsolicited adverse events within 0-28 days after booster vaccination. | 0-28 days after booster vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs). | Incidence of SAEs and AESIs through 12 months after booster vaccination in all subjects. | 12 months after booster vaccination |
| GMI of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains). |
| Measure | Description | Time Frame |
|---|---|---|
| Specific T cell responses after booster vaccination. | Specific T cell responses secreting IL-2, IL-4, IL-13, IFN-γ cytokines (ELISpot) on days 7, 14, and 28 after booster vaccination in cellular immune subgroups. | 7, 14, 28 days after booster vaccination. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fan Zhang | AIM Vaccine Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuanmiao Liu | Bengbu | Anhui | China |
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Saline | Other | 100 μg /1.0 mL/dose, intramuscular injection into the lateral deltoid muscle of the upper arm. |
|
GMI of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains) on day 14 after booster vaccination. |
| 14 day after booster vaccination. |
| GMT, SCR, GMI of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains). | GMT, SCR, GMI of live virus neutralizing antibodies against SARS-CoV-2 ( Delta strain, Omicron BA.5, XBB strains and current major circulating strains) on days 7 and 28 after booster vaccination. | 7, 28 days after booster vaccination. |
| GMT of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains). | GMT of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains) at 3, 6, 12 months after booster vaccination. | 3, 6, 12 months after booster vaccination. |
| GMC, SCR, GMI of IgG antibodies against S proteins of SARS-CoV-2 ( Delta strain, Omicron BA.5) | GMC, SCR, GMI of IgG antibodies against S proteins of SARS-CoV-2 ( Delta strain, Omicron BA.5) on days 7, 14, and 28 after booster vaccination. | 7, 14, 28 days after booster vaccination. |
| GMC of antibodies against S proteins of SARS-CoV-2 (Delta strain, Omicron BA.5) | GMC of antibodies against S proteins of SARS-CoV-2 (Delta strain, Omicron BA.5) at 3 months, 6 months and 12 months after booster vaccination. | 3, 6, 12 months after booster vaccination. |
| D017670 |
| Sodium Compounds |