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OpenTrials
Completed

NCT Number: NCT05547802

Serology After 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.

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Key information

Conditions

Basic BBIBP-CorV Vaccination is Not as Effective as BNT162b

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Debrecen

Debrecen, Hajdú-Bihar, 4032, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

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

Treatment and study plan

BBIBP-CorV and/or BNT162b2 vaccine

Biological

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

Primary outcomes

  1. Serology status after booster vaccination

    Time frame: 30 days

    Following the booster dose, serum sample was collected after 30 days to determine induced total level of anti-SARS-CoV-2 spike protein antibodies.

Secondary outcomes

  1. Development of COVID-19 disease

    Time frame: Half year

    Vaccination efficacy via incidence of infection and hospitalization was monitored during study period.

Sponsors and collaborators

Lead sponsor

University of Debrecen

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.