Trial CTRI/2022/04/042017
Publication Kulkarni P , Research Square, 2023
Dates: 2022-05-01 to 2022-12-31
Funding: Private (Serum Institute of India Pvt Ltd )
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / India
Follow-up duration (months): 6
BBV152/Boost SII-NVX-CoV2373 = (n=92)BBV152/BoostBBV152 = (n=94)
Inclusion criteria
  • Healthy adults aged 18 years or older
  • Give written informed consent
  • Have completed primary COVID-19 immunization schedule with either BBV152 (2 doses) at least 6 months ago
  • Clinically wellcontrolled comorbidities were allowed.
Exclusion criteria
  • Participants with a history of laboratory confirmed COVID-19
  • History of allergic reactions after previous vaccinations
  • Hypersensitivity to any component of study vaccines
  • Any condition with impaired/altered function of immune system
  • Any clinically signicant systemic disorder were excluded.
Interventions
Intervention
1 dose of SII-NVX-CoV2373 at least 6 after prime vaccination with BBV152
Control
1 dose of BBV152 at least 6 after prime vaccination with BBV152
Participants
Randomized
186 participants
Characteristics of participants
Type of participants: Adults
N=186
120 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Adults including elderly and controlled co-morbidities, primed with viral vector and inactivated vaccines, with no history of COVID-19 in 8 centres in India.
Primary outcome
In the register
Anti-S IgG and Neutralizing antibodies 28 days after vaccination
In the report
Anti-S IgG and neutralizing antibodies (nAbs)
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: No
Data accessibility: Prasad Kulkarni drompsk@seruminstitute.c

Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the preprint, the study registry was used in data extraction and risk of bias assessment. The target sample size specified in the registry was achieved (n=186).The article presented interim analyses (6 months) for a study with ongoing follow-up. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes.