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

• Sponsor: University of Debrecen (Other)
• Overall Status: Completed
• CT.gov ID: NCT05547802
• Collaborator: (none)
• Enrollment: 122
• Location: 1
• Actual Duration (Months): 4.3
• Patients Per Site Per Month: 28.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Basic BBIBP-CorV Vaccination is Not as Effective as BNT162b	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 Design

• Study Type: Observational
• Actual Enrollment: 122 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Evaluation of the Efficacy of BBIBP-CorV Inactivated Vaccine Combined With BNT62b2 mRNA Booster Vaccine
• Actual Study Start Date: Nov 16, 2021
• Actual Primary Completion Date: Jan 6, 2022
• Actual Study Completion Date: Mar 28, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Development of COVID-19 disease [Half year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: -

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Debrecen	Debrecen	Hajdu-Bihar	Hungary	4032

Sponsors and Collaborators

• University of Debrecen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Béla Nagy Jr., MD, PhD, associate professor, University of Debrecen
• ClinicalTrials.gov Identifier: NCT05547802
• Other Study ID Numbers: UDebrecen
• First Posted: Sep 21, 2022
• Last Update Posted: Sep 21, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 21, 2022