Publication Rose W, Lancet Reg Health Southeast Asia, 2023
Dates: 2021-08-30 to 2022-01-19
Funding: Public/non profit (Azim Premji Foundation and Bill and Melinda Gates Foundation)
Conflict of interest: no COI
Single center / India |
Follow-up duration (months): 3
|ChAdOx1/BBV152 boost (n = 99)
ChAdOx1/ChAdOx1 boost (n = 101)
BBV152/BBV152 boost (n = 103)
BBV152/ChAdOx1 boost (n = 102)
1 IM booster dose of 0.5 mL BBV152, 12-36 weeks after ChAdOx1 primary schedule.
1 IM booster dose of 0.5 mL ChAdOx1, 12-36 weeks after BBV152 primary schedule.
1 IM booster dose of 0.5 mL ChAdOx1, 12-36 weeks after ChAdOx1 primary schedule.1 IM booster dose of 0.5 mL BBV152, 12-36 weeks after BBV152 primary schedule.
|Characteristics of participants|
Type of participants: Adults
Pregnant women: 0
Immunocompromized patients: 0
Age range: NR
|Description of participants|
Adults that were SARS-CoV-2 infection-free in a single centre in India
|In the register|
Immunogenicity measured by anti spike immunoglobulins for SARS CoV 2 Timepoint: boost Only - Day 28 after the booster dose ; Prime/boost - Day 28 after the second dose of the 2 primary vaccine doses
|In the report|
1)Seropositivity on day 28 post booster.; 2)Incidence of related adverse events, serious adverse events following vaccination and any clinically significant change in the physical examination parameters and laboratory values.
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the preprint article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. Supplementary materials referred to in the article were not available via the pre-print host website at time of extraction. The trial was planned as open label in the registry but was reported as double-blind. The methods of randomization and masking in the report differ from those in the registry. The co-primary immunogenicity and safety outcomes in the article reflect include the immunogenicity primary outcome in the registry. It seems likely that the trial (n = 404) achieved its target sample size as the report included only four of twelve groups included in the registry, with a total target sample size of 1100. This trial was updated on April 24th 2023, after publication of the study report.|