Safety and Immunogenicity of an Inactivated Vaccine Against COVID-19 in Medical Workers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Immunogenicity of an Inactivated Vaccine Against COVID-19 in Medical Workers

Conditions
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SARS-CoV-2 Infection, Covid19

Intervention / Treatment
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* Biological: SARS-CoV-2 Vaccine(Vero Cell), Inactivated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent according to ICH/GCP regulations prior to any trial specific procedures. Male or female aged 18-59 years. Exclusion Criteria: NA

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccination Group<br>Participants vaccinated with inactivated SARS-CoV-2 vaccine are studied for safety and antibody response. | Biological: SARS-CoV-2 Vaccine(Vero Cell), Inactivated<br>* The subjects of Vaccination Group will receive two doses, 21 days apart of inactivated SARS-CoV-2 vaccine (4 μg of BBIBP-CorV)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels | at 12 months after dose 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inactivated vaccine, SARS-CoV-2, Covid19