Publication Amplify, Unpublished, 2023
Funding: Not reported/unclear
Conflict of interest: *
Multicenter / USA |
Follow-up duration (months): 4.5
|1x10^10 vp Ad26.COV2.S (n = 106)
2.5x10^10 vp Ad26.COV2.S (n = 329)
5x10^10 vp Ad26.COV2.S (n = 329)
1 IM dose of 1x10^10 vp Ad26.COV2.S (booster), at least 6 months after prime vaccination with 2 doses of BNT162b2.
1 IM dose of 2.5x10^10 vp Ad26.COV2.S (booster), at least 6 months after prime vaccination with 2 doses of BNT162b2.
1 IM dose of 5x10^10 vp Ad26.COV2.S (booster), at least 6 months after prime vaccination with 2 doses of BNT162b2.
|Characteristics of participants|
Type of participants: Adults including elderly and stable co-morbidities
Age range: NR
|Description of participants|
Adults including elderly and stable co-morbidities with no history of COVID-19 in 21 centres in USA.
|In the register|
1. Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2 [ Time Frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15) ]: Percentage of participants with serological response against SARS-CoV-2 original strain, 14 days after Ad26.COV2.S booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer
|In the report|
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|General comment||Unpublished results posted on the trial registry. In addition to the study registry, the protocol and statistical analysis plan were used in data extraction and risk of bias assessment. Preliminary analysis, follow-up visits were scheduled up to day 235 after booster; longest follow-up was for SAEs and results are reported up to data cut-off (15 December 2021), which was up to 4.5 months. The target sample size specified in the registry was achieved. Only the primary outcomes in the registry were available, and these were reported; some outcomes were not reported. There is no change from the trial registration in the intervention and control treatments.|