Trial NCT05096832
Publication Wang X-Y, Emerg Microbes Infec, 2022
Dates: 2021-11-03 to 2022-01-27
Funding: Private (Livzon Mabpharm Inc.)
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / Pakistan, Malaysia
Follow-up duration (months): 2.87
Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) (n = 5121); Placebo (adjuvant) (n = 5120)
Inclusion criteria
  • Adults aged 18 years of age or older
  • healthy or had stable chronic medical conditions in the previous 3-month
  • completed two doses inactivated vaccine primary regimen (either BBIBP-CorV produced by China National Biotec Group Company Limited or CoronaVac manufactured by Sinovac Life Sciences) 3-6 months ago.
Exclusion criteria
  • Medical history of Covid-19, SARS and MERS
  • a positive SARS-CoV-2 PCR test at baseline
  • an immunocompromising condition
  • having received COVID-19 vaccines other than BBIBP-CorV and CornaVac
  • and pregnant or breastfeeding women
Interventions
Intervention
1 IM dose of 10 mcg V-01, 3-6 months after primary inactivated virus schedule
Control
1 IM dose of placebo (adjuvant), 3-6 months after primary inactivated virus schedule
Participants
Randomized
10,241 participants
Characteristics of participants
Type of participants: Healthy adults
N=10,241
7073 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 18-82
Description of participants
Healthy adults or those with stable chronic conditions, with no previous history of COVID-19, at 15 centers in Pakistan and Malaysia.
Primary outcome
In the register
1. The relative efficacy of recombinant SARS-CoV-2 fusion protein vaccine (V-01) as a booster to prevent symptomatic and RT-PCR positive COVID-19 (mild or above severity) [ Time Frame: From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization ] To evaluate the relative efficacy of recombinant SARS-CoV-2 fusion protein vaccine (V-01) as a booster to prevent symptomatic and reverse transcription polymerase chain reaction (RT-PCR) positive COVID-19 (mild or above severity) compared with the placebo control group; 2. The incidence of adverse events (AEs) [ Time Frame: Within 28 days after the booster vaccination ] To evaluate the incidence of adverse events (AEs) within 28 days after the booster vaccination.
In the report
1) Confirmed symptomatic SARS-CoV- 2 infection with onset at least 14 days after the administration of study-agents, and secondary endpoint was protection of severe or critical COVID-19; 2) Local or systemic adverse events occurred within 28 days after the receipt of study-agent.
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: NR
Data accessibility: Xuan-Yi Wang, M.D., Ph.D. - Email: xywang@shmu.edu.cn

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 and pre-print article, the prospective trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary and secondary outcomes in the article reflect those in the registry. The trial (n = 10,241) has not reached its target sample size (n = 10,722). The article reports an event-driven interim and preliminary analysis triggered by the identification of a pre-specified number of symptomatic COVID-19 events. Recruitment and follow-up continues.