Serology After BBIBP-CorV Inactivated Vaccine Combined With BNT62b2 mRNA Booster Vaccine
- Conditions
- Basic BBIBP-CorV Vaccination is Not as Effective as BNT162b
- Interventions
- Biological: BBIBP-CorV and/or BNT162b2 vaccine
- Registration Number
- NCT05547802
- Lead Sponsor
- University of Debrecen
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
included age < 18 years, known primary immunodeficiency, malignancy and ongoing immunosuppressive therapy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Heterologous vaccination cohort BBIBP-CorV and/or BNT162b2 vaccine Subjects with two doses of BBIBP-CorV vaccine and third (second booster) dose of the BNT162b2 vaccine. Homologous vaccination cohort BBIBP-CorV and/or BNT162b2 vaccine Subjects receiving three doses of BNT162b2 vaccine.
- Primary Outcome Measures
Name Time Method Serology status after booster vaccination 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 Outcome Measures
Name Time Method Development of COVID-19 disease Half year Vaccination efficacy via incidence of infection and hospitalization was monitored during study period.
Trial Locations
- Locations (1)
University of Debrecen
ðŸ‡ðŸ‡ºDebrecen, Hajdu-Bihar, Hungary