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To evaluate the safety and immunogenicity of COVID-19 mRNA vaccine in people aged 18 years and older, 300 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group (150 people) will be divided into 2 age groups (75 each):18 to 59 years old and ≥ 60 years old. The subjects will be randomized into vaccine group or placebo group in a ratio of 2:1. Subjects will complete 2 doses of vaccination on Day 0 and Day 21, in which the low-dose group will received 0.3 ml of the study vaccine or placebo, and the high dose group received 0.5 ml of the study vaccine or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine Group, low dose, 18-59 year-old | Experimental | 2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21 |
|
| Vaccine Group, low dose, 60 year-old and above | Experimental | 2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21 |
|
| Vaccine Group, high dose, 18-59 year-old | Experimental | 2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21 |
|
| Vaccine Group, high dose, 60 year-old and above | Experimental | 2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21 |
|
| Placebo Group, low dose, 18-59 year-old | Placebo Comparator | 2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21 |
|
| Placebo Group, low dose, 60 year-old and above |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 mRNA vaccine | Biological | 2 doses of vaccine on Day 0 and Day 21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of wild type neutralizing antibodies | GMT of wild type neutralizing antibodies | 28 days after complete immunization |
| Immunogenicity of wild type neutralizing antibodies | Sero-conversation rate of wild type neutralizing antibodies | 28 days after complete immunization |
| The incidence of adverse reactions (AR) | To evaluate the incidence of adverse reactions (AR) in all subjects | Within 14 days of each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse reactions (AR) | To evaluate the incidence of adverse reactions (AR) in all subjects | Within 28 days of complete immunization |
| The incidence of adverse reactions (AR) | To evaluate the incidence of adverse reactions (AR) in all subjects |
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Inclusion Criteria:
Exclusion Criteria:
Criteria for exclusion of the first dose
Second dose exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruihua Dong | Beijing Friendship Hospital | Principal Investigator |
| Kexin Zhao | Hebei Petro China Center Hospital | Principal Investigator |
| Tao Huang | Hunan Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Beijing | Beijing Municipality | China | |||
| Hebei Petro China Center Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41267026 | Derived | Jin Z, Wu J, Huang T, Zhao K, Zhang M, Liu J, Song J, Yin H, Wu X, Liu J, Zhu T, Huang H, Li J, Wang H, Gou J, Dong R. Safety, immunogenicity, persistence and dose evaluation of the CS-2034 mRNA COVID-19 vaccine: a phase II randomized controlled trial in healthy Chinese adults. BMC Infect Dis. 2025 Nov 20;25(1):1625. doi: 10.1186/s12879-025-12053-4. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722934 | CVnCoV COVID-19 vaccine |
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2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21 |
|
| Placebo Group, high dose, 18-59 year-old | Placebo Comparator | 2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21 |
|
| Placebo Group, high dose, 60 year-old and above | Placebo Comparator | 2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21 |
|
| Placebo | Biological | 2 doses of placebo on Day 0 and Day 21 |
|
| Within 60 minutes of each vaccination |
| The incidence of SAE, MAE and AESI | To evaluation the incidence of SAE, MAE, and AESI in all subjects | 12 months after complete vaccination |
| Immunogenicity of wild type neutralizing antibodies | Sero-conversation rate of wild type neutralizing antibodies | Before the 1st dose, 14 days after the 2nd dose, and 3, 6, 12 months after the 2nd dose |
| Immunogenicity of wild type neutralizing antibodies | GMT of wild type neutralizing antibodies | Before the 1st dose, 14 days after the 2nd dose, and 3, 6, 12 months after the 2nd dose |
| Immunogenicity of wild type neutralizing antibodies | GMI of wild type neutralizing antibodies | Before the 1st dose, 14 days after the 2nd dose, and 3, 6, 12 months after the 2nd dose |
| Immunogenicity of wild type neutralizing antibodies | GMI of wild type neutralizing antibodies | 28 days after complete immunization |
| Immunogenicity of anti-S-RBD Ig G antibodies | Sero-conversation rate of anti-S-RBD Ig G antibodies | Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination |
| Immunogenicity of anti-S-RBD Ig G antibodies | GMC of anti-S-RBD Ig G antibodies | before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination |
| Immunogenicity of anti-S-RBD Ig G antibodies | GMI of anti-S-RBD Ig G antibodies | before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination |
| Cellular immunity | The response levels and positive rates of IL-2 produced by S protein RBD by ICS in the first 15 subjects in each group | Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination |
| Cellular immunity | The response levels and positive rates of IL-4 produced by S protein RBD by ICS in the first 15 subjects in each group | Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination |
| Cellular immunity | The response levels and positive rates of IL-5 produced by S protein RBD by ICS in the first 15 subjects in each group | Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination |
| Cellular immunity | The response levels and positive rates of IL-17 produced by S protein RBD by ICS in the first 15 subjects in each group | Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination |
| Cellular immunity | The response levels and positive rates of IFN-γ produced by S protein RBD by ICS in the first 15 subjects in each group | Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination |
| Changes in laboratory indicators | Changes in white blood cell count | Before 1st dose and 28 days after second dose |
| Changes in laboratory indicators | Changes in neutrophils | Before 1st dose and 28 days after second dose |
| Changes in laboratory indicators | Changes in lymphocyte count | Before 1st dose and 28 days after second dose |
| Changes in laboratory indicators | Changes in platelet count | Before 1st dose and 28 days after second dose |
| VOC/VOI serum cross neutralization | To evaluated the level of VOC/VOI serum cross neutralization results in all subjects. | 28 days after complete immunization |
| Langfang |
| Hebei |
| China |
| Hunan Provincial Center for Disease Control and Prevention | Changsha | Hunan | China |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |