Clinical trial NCT04795414: Safety and Immunogenicity of an Inactivated Vaccine Against COVID-19 in Medical Workers
Official title: Safety and Immunogenicity of an Inactivated Vaccine Against COVID-19 in Medical Workers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2 Infection
Covid19
Keywords: SARS-CoV-2
Covid19
Inactivated vaccine
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 1370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical workers in Ruijin Hospital who are willing to receive two dose of SARS-CoV-2 inactivated vaccine via intramuscular injection in the arm

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants reporting local reactions
timeFrame: within 7days post each vaccination
measure: Percentage of participants reporting systemic events
timeFrame: within 7days post each vaccination
measure: Percentage of participants reporting adverse events
timeFrame: From Dose 1 through 1 month after Dose 2
measure: Percentage of participants reporting serious adverse events
timeFrame: From Dose 1 through 1 month after Dose 2
measure: Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres
timeFrame: at 1 month after dose 2
Secondary outcomes:
measure: Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres
timeFrame: at 6 months after dose 2
measure: Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres
timeFrame: at 12 months after dose 2
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Erzhen Chen
role: STUDY_DIRECTOR
affiliation: Ruijin Hospital
name: Xinxin Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.