Publication Fadlyana E, Lancet Infect Dis, 2023
Dates: 2021-11-26 to 2021-12-16
Funding: Public/non profit (Ministry of Health, Indonesia)
Conflict of interest: no COI
Multicenter / Indonesia |
Follow-up duration (months): 1
|CoronaVac + boost 0.5mL ChAdOx1 (n=193)
CoronaVac + boost 0.25mL ChAdOx1 (n=192)
CoronaVac + boost 30 mcg BNT162b2 (n=193)
CoronaVac + boost 15 mcg BNT162b2 (n=190)
CoronaVac + boost 0.5mL CoronaVac (n=192)
1 IM dose of BNT162b2 (30 mcg in 0.3 mL), 6-9 months after CoronaVac primary schedule.
1 IM dose of BNT162b2 (15 mcg in 0.15 mL), 6-9 months after CoronaVac primary schedule.
1 IM dose of ChAdOx1-S (>2·5 × 108 IU in 0.5 mL), 6-9 months after CoronaVac primary schedule.
1 IM dose of ChAdOx1-S (>1·25 × 108 IU in 0.25 mL), 6-9 months after CoronaVac primary schedule.
1 IM dose of BNT162b2 Coronavac (3 mcg in 0·5 mL), 6-9 months after CoronaVac primary schedule.
|Characteristics of participants|
Type of participants: Healthy adults
Immunocompromized patients: 0
Age range: NR
|Description of participants|
Healthy adults without a history of laboratory confirmed COVID-19 within one month prior recruitment in 5 centres in Indonesia
|In the register|
To evaluate the antibody titres before and one month (+7 days) after booster dose with full and half booster dose of ChAdOx1-S, Comirnaty®, or CoronaVac®.
|In the report|
Evaluate the seropositive, seroconversion rate and geometric mean titres of IgG anti-S-RBD and neutralising antibodies 28 days after booster dose vaccination.
Yes. In English
Yes, Anonymous participant data that underlie the results reported in this Article will be available on completion of the clinical trial.
|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 published article, the study registry, protocol and supplementary appendix were used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. The article reports results of booster vaccinations in participants who received a CoronaVac primary schedule; recruitment was ongoing for participants who received a ChAdOx1-S primary schedule. The primary outcome in the article reflects that in the registry. The trial (n = 960) did not achieve the target sample size in the report (n = 1000).|