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

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

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.

Study Overview

• Status: Completed
• Conditions: Basic BBIBP-CorV Vaccination is Not as Effective as BNT162b
• Intervention / Treatment: Biological: BBIBP-CorV and/or BNT162b2 vaccine

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• Hungary
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4032
      • University of Debrecen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

As part of the regular clinical practice, all participants received the third vaccine dose at a general practitioner's (GP) office. Following the initial immunization period, a survey was conducted to monitor vaccine efficacy via the incidence of infection and hospitalization by patient questionnaire. Booster immunization was carried out at least 4 months after the first two doses of basic immunization (two doses of BNT162b2 or BBIBP-CorV), and baseline (pre-booster) antibody level was measured on the same day of the administration of booster immunization (first sampling). Following the booster dose with BNT162b2, another serum sample was collected after 30 days in order to determine induced total level of anti-SARS-CoV-2 spike protein antibodies (second sampling).

Description

Inclusion Criteria: -

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Heterologous vaccination cohort; Subjects with two doses of BBIBP-CorV vaccine and third (second booster) dose of the BNT162b2 vaccine.	Biological: BBIBP-CorV and/or BNT162b2 vaccine; 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.	Biological: BBIBP-CorV and/or BNT162b2 vaccine; Booster immunization was carried out at least 4 months after the first two doses of basic immunization.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Debrecen
• Investigators: Study Director: Zoltán Szekanecz, MD, PhD, University of Debrecen

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): January 6, 2022
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: UDebrecen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: These data will be published in a manuscript in a peer-reviewed international journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No