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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-16

Study Completion Date

2022-03-28

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.

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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.

Conditions

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Basic BBIBP-CorV Vaccination is Not as Effective as BNT162b

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Heterologous vaccination cohort

Subjects with two doses of BBIBP-CorV vaccine and third (second booster) dose of the BNT162b2 vaccine.

BBIBP-CorV and/or BNT162b2 vaccine

Intervention Type BIOLOGICAL

Booster immunization was carried out at least 4 months after the first two doses of basic immunization.

Homologous vaccination cohort

Subjects receiving three doses of BNT162b2 vaccine.

BBIBP-CorV and/or BNT162b2 vaccine

Intervention Type BIOLOGICAL

Booster immunization was carried out at least 4 months after the first two doses of basic immunization.

Interventions

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BBIBP-CorV and/or BNT162b2 vaccine

Booster immunization was carried out at least 4 months after the first two doses of basic immunization.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: -

Exclusion Criteria: included age \< 18 years, known primary immunodeficiency, malignancy and ongoing immunosuppressive therapy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No