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To evaluate the safety and immunogenicity of the COVID-19 mRNA vaccine in people aged 18 years and older, 80 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group will be divided into 2 age groups (20 people each):18 to 59 years old and ≥ 60 years old. Subjects will be randomized into vaccine group or placebo group in a ratio of 3:1. Subjects will receive 2 doses of either vaccine or placebo 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 will receive 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 |
|---|---|---|
| The incidence of adverse reactions (AR) | To evaluate the incidence of adverse reactions (AR) within 14 days of immunization in all subjects | within 14 days of immunization |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse reactions (AR) | To evaluate the incidence of adverse reactions (AR) within 28 days of immunization in all subjects | within 28 days of immunization |
| The incidence of SAE, MAE and AESI |
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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 |
|---|---|---|---|
| 37898410 | Derived | Jin Z, Wu J, Wang Y, Huang T, Zhao K, Liu J, Wang H, Zhu T, Gou J, Huang H, Wu X, Yin H, Song J, Li R, Zhang J, Li L, Chen J, Li X, Zhang M, Li J, Hou M, Song Y, Wang B, Gao Q, Wu L, Kong Y, Dong R. Safety and immunogenicity of the COVID-19 mRNA vaccine CS-2034: A randomized, double-blind, dose-exploration, placebo-controlled multicenter Phase I clinical trial in healthy Chinese adults. J Infect. 2023 Dec;87(6):556-570. doi: 10.1016/j.jinf.2023.10.012. Epub 2023 Oct 28. |
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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 |
|
To evaluation the incidence of SAE, MAE, and AESI within 12 months of full immunization in all subjects
| From vaccination to post of 12 months vaccination |
| The incidence of adverse reactions (AR) | To evaluate the incidence of adverse reactions (AR) within 60 minutes of each vaccination in all subjects | Within 60 minutes of each vaccination |
| Changes in laboratory indicators | Changes in white blood cell count | Day 4 and Day 7 post each vaccination |
| Changes in laboratory indicators | Changes in neutrophils | Day 4 and Day 7 post each vaccination |
| Changes in laboratory indicators | Changes in lymphocyte count; | Day 4 and Day 7 post each vaccination |
| Changes in laboratory indicators | Changes in platelet count; | Day 4 and Day 7 post each vaccination |
| Immunogenicity of wild type neutralizing antibodies | Sero-conversation rate of anti-wild type neutralizing antibodies | Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose |
| Immunogenicity of wild type neutralizing antibodies | Geometric mean titer (GMT) of wild type neutralizing antibodies | Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose |
| Immunogenicity of wild type neutralizing antibodies | GMI of wild type neutralizing antibodies | Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose |
| Immunogenicity of anti-S-RBD Ig G antibodies | Sero-conversation rate of anti-S-RBD Ig G antibodies | Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose |
| Immunogenicity of anti-S-RBD Ig G antibodies | GMC of anti-S-RBD Ig G antibodies | Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose |
| Immunogenicity of anti-S-RBD Ig G antibodies | GMI of anti-S-RBD Ig G antibodies | Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose |
| Changes in vital signs | The incidence of outliers detected on vital signs | Day 1 to 4 , Day 7 after the first dose, and the day of second dose, Day 4 after the second dose, and day 7 after the second dose |
| Immuno-persistency of wild type neutralizing antibodies | Sero-conversation rate of anti-wild type virus neutralizing antibodies | Month 3,6 and 12 post second vaccination |
| Immuno-persistency of wild type neutralizing antibodies | GMT of wild type neutralizing antibodies | Month 3,6 and 12 post second vaccination |
| Immuno-persistency of wild type neutralizing antibodies | GMI of wild type neutralizing antibodies | Month 3,6 and 12 post second vaccination |
| 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 |