Trial ChiCTR2100041705, ChiCTR2100041706
Publication Feng Y, Infect. Dis. Poverty, 2021
Dates: 2021-01-01 to 2021-05-30
Funding: Public/non profit (Shanxi Province Coronavirus disease Financial Support Project and Shanxi Provincial Laboratory for Major Infectious Disease Prevention, Control, Diagnosis and Treatment)
Conflict of interest: no COI

Methods
RCT
Location : Single center / China
Follow-up duration (months): 1.9
Sinopharm BBIBP-CorV D0/14 (n=270)
Sinopharm BBIBP-CorV D0/21 (n=270)
Sinopharm BBIBP-CorV D0/28 (n=269)
Inclusion criteria
  • Occupational high-risk population
  • aged 18-59 years
  • signed the informed consent form
  • participated voluntarily
Exclusion criteria
  • History or family history of allergy, convulsion, epilepsy, encephalopathy or psychosis
  • any intolerance or allergy to any component of the vaccine
  • known or suspected diseases including severe respiratory disease, severe cardiovascular disease, severe liver or kidney disease, medically uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg), complications of diabetes mellitus, malignancy, various acute diseases or acute episodes of chronic disease
  • various infectious, suppurative and allergic skin diseases
  • congenital or acquired immunodeficiency, other vaccination history within 14 days before vaccination, a history of coagulation dysfunction, a history of non-specific immunoglobulin injection within 1 month prior to enrollment, acute illness with fever (body temperature > 37.0°C)
  • and being pregnant or breastfeeding
Interventions
Intervention
2 IM doses of 4 mcg, 14 days apart
2 IM doses of 4 mcg, 21 days apart
Control
2 IM doses of 4 mcg, 28 days apart
Participants
Randomized
809 participants
Characteristics of participants
Type of participants: Healthy adults
N=809
592 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Healthy adults from high-risk occupational population at a single center in China
Primary outcome
In the register
1. Serum neutralizing antibodies, IgG antibodies, and IgM antibodies of SARS-CoV-2 28 days after the last dose of vaccination; 2. Serious adverse events (SAE) during the entire study period (6 months after the full vaccination; 3. Serum neutralizing antibodies, IgG antibodies, and IgM antibodies of SARS-CoV-2 at months 3, 6, and 12 after the last dose of vaccination
In the report
1. Seroconversion rates (geometric mean titer (GMT) ≥ 16) and GMT of neutralizing antibody to live SARS-CoV-2 at day 28 after the last dose; 2. Occurrence of adverse reactions within 7 days after the first and second vaccinations
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes, Following manuscript publication, following the provision of ethics approval.
Data accessibility: corresponding author Professor Suping Wang, supingwang@sxmu.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 pre-print article, the trial registries were used in data extraction and assessment of risk of bias. The article reports on vaccine immunogenicity and safety in airport ground staff and public security officers, considered to be at high risk of exposure; the two populations were registered separately, but analyzed combined. Neither protocol nor statistical analysis plan was available. The primary outcomes in the article (seroconversion and GMTs of neutralizing antibodies and adverse reactions) differed from those in the registry (neutralizing antibodies, IgG antibodies, and IgM antibodies). Reactogenicity safety outcomes described in the report as primary outcomes but in the registries as secondary. The trial (n = 809) achieved its target sample size (n = 720). This trial was updated on Mars 9th, 2022 after publication of the study report.