Trial *
Publication Hannawi S, J Infect, 2022
Dates: 2022-01-18 to 2022-04-05
Funding: Mixed (Beijing Science and Technology Plan Project, National Key Research and Development Program of China, Sinocelltech Ltd.)
Conflict of interest: Yes

Methods
RCT
Location : Single center / UAE
Follow-up duration (months): 1
20 mcg SCTV01C (n=79)
40 mcg SCTV01C (n=80)
Placebo (n=75)
Inclusion criteria
  • Adults 18-59
  • had previously received primary series of BBIBP-CorV 3–24 months earlier
  • no history of infections with SARS-CoV-2.
Exclusion criteria
  • Individuals who were high-risk populations (such as medical workers, close contacts of patients with COVID-19 infection, etc.)
  • with fever
  • a history of severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS) or other coronavirus infection.
Interventions
Intervention
1 IM dose of 20 mcg SCTV01C 3-24 months following completion of the BBIBP-CorV primary series
1 IM dose of 40 mcg SCTV01C 3-24 months following completion of the BBIBP-CorV primary series
Control
1 IM dose of placebo 3-24 months following completion of the BBIBP-CorV primary series
Participants
Randomized
234 participants
Characteristics of participants
Type of participants: Adults
N=234
0 males
Children: 0
Mean age:
Age range: NR
Description of participants
Adults previously vaccinated with primary series of BBIBP-CorV with no history of COVID-19 in a single center in the United Arab Emirates.
Primary outcome
In the register
NR
In the report
1) incidence and severity of adverse reactions (ARs) within 7 days after vaccination, adverse events (AEs) within 7 days, unsolicited AEs within 28 days, laboratory abnormalities related AEs within 14 days, serious adverse events (SAEs), AEs of special interest (AESIs) and medically attended AEs (MAAEs) within 365 days, after vaccination. 2) geometric mean concentration (GMC) of the specific spike binding IgG antibodies against spike protein of wild-type SARS-COV-2 strain on day 28 after vaccination (D28) and GMTs of neutralizing antibodies (live virus neutralization assay) to Delta (B.1.617.2) and Omicron (B.1.1.529) variants on D28, and the fold increase of these GMC and GMT from baseline (before vaccination).
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes, When the trials are complete
Data accessibility: Anonymized participant data will be made available when the trials are complete, upon requests directed to the corresponding author. Corresponding author Liangzhi Xie: LX@sinocelltech.com
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 published article, the supplement was used in data extraction and risk of bias assessment. The protocol, registry and statistical analysis plan were not available. This was a letter to the editor that did not report a registry therefore we cannot determine if the procedures, interventions or outcomes were determined a priori. Preliminary analysis of those with at least 28 days follow-up.