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

NCT05547802 | Completed

• 1 other identifier: UDebrecen
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Basic BBIBP-CorV Vaccination is Not as Effective as BNT162b

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Development of COVID-19 disease

  Half year

Study Arms (2)

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

Homologous vaccination cohort

Subjects receiving three doses of BNT162b2 vaccine.

Biological: BBIBP-CorV and/or BNT162b2 vaccine

Interventions

BBIBP-CorV and/or BNT162b2 vaccine BIOLOGICAL

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

Heterologous vaccination cohort; Homologous vaccination cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (1)

University of Debrecen

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples were stored prior to laboratory analysis by an immunoassay to measure the level of anti-SARS-CoV-2 total Ig.

Study Officials

• Zoltán Szekanecz, MD, PhD

  University of Debrecen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: November 16, 2021
• Primary Completion: January 6, 2022
• Study Completion: March 28, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)