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With the unprecedented morbidity of the COVID-19 pandemic, the vaccine effectiveness needs to be assessed across diverse populations. The purpose of this study is to evaluate the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in medical workers.
1370 participants who were negative for serum-specific antibodies against SARS-CoV-2 at the time of screening were enrolled and were receive a two-dose schedule, 21 days apart, with 4 μg BBIBP-CorV inactivated SARS-CoV-2 vaccine. The primary safety outcome includes solicited local and systemic reactions prompted by and recorded in an electronic diary within 7 days post each injection, unsolicited adverse events and serious adverse events assessed from the receipt of each dose, and clinical laboratory abnormalities from dose 1 through 1month after dose 2. Laboratory tests included measurement of alanine aminotransferase, aspartate aminotransferase, serum total bilirubin, serum albumin, creatinine, blood urea nitrogen, and blood routine examination. Immunogenicity was assessed as the serum anti-SARS-CoV-2 specific antibody responses and neutralizing activity at 4 weeks after the second vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccination Group | Participants vaccinated with inactivated SARS-CoV-2 vaccine are studied for safety and antibody response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 Vaccine(Vero Cell), Inactivated | Biological | The subjects of Vaccination Group will receive two doses, 21 days apart of inactivated SARS-CoV-2 vaccine (4 μg of BBIBP-CorV) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting local reactions | Pain at the injection site, swelling, itch, and redness | within 7days post each vaccination |
| Percentage of participants reporting systemic events | Fever, headache, fatigue, nausea, vomiting, diarrhea, constipation, myalgia, arthralgia | within 7days post each vaccination |
| Percentage of participants reporting adverse events | verified by investigators | From Dose 1 through 1 month after Dose 2 |
| Percentage of participants reporting serious adverse events | verified by investigators | From Dose 1 through 1 month after Dose 2 |
| Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres | determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels | at 1 month after dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres | determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels | at 6 months after dose 2 |
| Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres |
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Inclusion Criteria:
Exclusion Criteria:
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Medical workers in Ruijin Hospital who are willing to receive two dose of SARS-CoV-2 inactivated vaccine via intramuscular injection in the arm
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZhiTao Yang | Contact | +8613611965436 | yangzhitao@hotmail.fr | |
| Xiaoqi Yu | Contact | +8613817390935 | yuxiaoqi_03@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Erzhen Chen | Ruijin Hospital | Study Director |
| Xinxin Zhang | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35379815 | Derived | Yu X, Wei D, Xu W, Liu C, Guo W, Li X, Tan W, Liu L, Zhang X, Qu J, Yang Z, Chen E. Neutralizing activity of BBIBP-CorV vaccine-elicited sera against Beta, Delta and other SARS-CoV-2 variants of concern. Nat Commun. 2022 Apr 4;13(1):1788. doi: 10.1038/s41467-022-29477-0. |
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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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Blood sample, including plasma, serum and blood cell
determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels |
| at 12 months after dose 2 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |