Serology After BBIBP-CorV Inactivated Vaccine Combined With BNT62b2 mRNA Booster Vaccine

Study Overview
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Brief Summary
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In this prospective study, SARS-CoV-2 spike protein specific total immunoglobulin (Ig) levels are analyzed before and after BNT162b2 third mRNA booster vaccination in individuals previously administered with two doses of BBIBP-CorV vaccine in comparison to immunized participants with three doses of BNT162b2 vaccination. Questionnaires from recruited participants are reviewed prior to booster vaccination for the occurrence of a previous SARS-CoV-2 infection and hospitalization.

Detailed Description
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Sixty-one volunteers (39 females, 22 males) vaccinated by BBIBP-CorV were included with the mean age of 63.9 years. To serve as a control group, 61 patients (41 females, 20 males) were vaccinated with BNT162b2 at a mean age of 59.9 years. At least four months after the first two-dose vaccination regimens, both groups received the third booster BNT162b2 vaccine based on the recommendations of the Hungarian Public Health Centre. Total Ig levels against SARS-CoV-2 spike protein 1 receptor-binding domain (anti-SARS-CoV-2 S1-RBD) were measured by an immunoassay (Roche Diagnostics) and their calculated ratios after/before booster dose were compared between the two groups. Vaccination efficacy via incidence of infection and hospitalization was monitored during study period. We found that BNT162b2 can successfully booster the effect of two-dose BBIBP-CorV vaccination to enhance humoral immune response against SARS-CoV-2 infection.

Official Title
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Evaluation of the Efficacy of BBIBP-CorV Inactivated Vaccine Combined With BNT62b2 mRNA Booster Vaccine

Conditions
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Basic BBIBP-CorV Vaccination is Not as Effective as BNT162b

Intervention / Treatment
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* Biological: BBIBP-CorV and/or BNT162b2 vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Exclusion Criteria: included age < 18 years, known primary immunodeficiency, malignancy and ongoing immunosuppressive therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heterologous vaccination cohort<br>Subjects with two doses of BBIBP-CorV vaccine and third (second booster) dose of the BNT162b2 vaccine. | Biological: BBIBP-CorV and/or BNT162b2 vaccine<br>* Booster immunization was carried out at least 4 months after the first two doses of basic immunization.<br>|
| Homologous vaccination cohort<br>Subjects receiving three doses of BNT162b2 vaccine. | Biological: BBIBP-CorV and/or BNT162b2 vaccine<br>* Booster immunization was carried out at least 4 months after the first two doses of basic immunization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serology status after booster vaccination | Following the booster dose, serum sample was collected after 30 days to determine induced total level of anti-SARS-CoV-2 spike protein antibodies. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of COVID-19 disease | Vaccination efficacy via incidence of infection and hospitalization was monitored during study period. | Half year |