Covid-19 Living Data

Trial NCT04510207
Publication Al Kaabi N, Vaccines, 2023

Funding: Private (Wuhan Institute of Biological Products Co., Ltd. (No. CNBG-WH-043), and the Beijing Institute of Biological Products Co., Ltd. (No. CNBG-BIBP-021))
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / United Arab Emirates Follow-up duration (months): *
	Boost BBIBP-CorV = (3172) Boost WIBP-CorV = (3097) Boost placebo = (3101
Inclusion criteria	Healthy people aged 18+ years old General good health as established by medical history and physical examination Women of childbearing age are not pregnant (negative urine pregnancy test), are not breastfeeding, do not have pregnancy plan within the three months after enrollment, and have already taken effective contraceptive measures two weeks before enrollment Participants are able and willing to complete the whole research procedure Participants have the ability to understand the research procedures, to sign the informed consent voluntarily after explanation, and can comply with the requirements of the clinical research program.
Exclusion criteria	Confirmed acute cases of SARS-CoV-2 infection With a medical history of SARS, MERS virus infection (self-report, on-site inquiry) Fever (axillary temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea within 14 days before vaccination (Tympanic temperature / Temporal artery temperature > 37.5 ℃) Positive urine pregnancy test result Body temperature axillary ≥ 37.0 ℃ before vaccination（Tympanic temperature / Temporal artery temperature≥ 37.5 ℃) With previous severe allergic reactions (such as acute allergic reactions, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of the inactivated SARS-CoV-2 vaccine With a medical history or family history of convulsion, epilepsy, encephalopathy or mental illness With congenital malformation or developmental disorder, genetic defects, severe malnutrition, etc. With known or suspected diseases include acute respiratory diseases (e.g. influenza like illness, acute cough, sore throat), severe cardiovascular diseases, severe liver diseases, severe kidney diseases, uncontrollable hypertension (systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases. Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases With a history of coagulation dysfunction (such as coagulation factor deficiency, coagulation disease). － Receiving anti-TB therapy Receiving immune enhancement or inhibitor therapy within 3 months (continuous oral or IV administration for more than 14 days) Vaccinated live attenuated vaccine within 1 month before vaccination and other vaccines within 14 days before vaccination Received blood products within 3 months before vaccination Received other investigational drugs within 6 months before vaccination Other circumstances judged by investigators that were not suitable for participating in this clinical trial.
Interventions
	Intervention 1 IM dose of WIBP-CorV at least 6 months after the last doses of WIBP-CorV as part of the prime series 1 IM dose of BBIBP-CorV at least 6 months after the last doses of BBIBP-CorV as part of the prime series
	Control 1 IM dose of adjuvant at least 6 months after the last doses of adjuvant as part of the prime series
Participants
	Randomized 9370 participants
	Characteristics of participants Type of participants: Healthy volunteers N=9370 7902 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Healthy volunteers with no history of SARS-CoV-2 in a single center in United Arab Emirates
Primary outcome
	In the register 1.The incidence of COVID-19 cases after two-doses of vaccination [ Time Frame: From14 days after the second dose to 6 month after the second dose ] 2.The incidence of COVID-19 cases after the booster dose of immunization [ Time Frame: From 14 days after the booster dose ]
	In the report Laboratory-confirmed symptomatic COVID-19 case that occurred at least 14 days after the booster vaccine.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes, Individual participant data will be available beginning 3 months and ending 1 year after publication. Supporting clinical documentation, including study protocol, statistical analysis plan, and informed consent, will be available for at least 1 year immediately after publication. Data accessibility: Researchers providing scientifically sound advice will be given access to individual participant data. Please send proposals to moc.mrahponis@gnimoaixgnay. These proposals will be reviewed and approved by funders, investigators, and collaborators according to scientific merit. To gain access, data requesters will need to sign a data access agreement.
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 supplementary materials and study registry were used in data extraction and risk of bias assessment. Participants were recruited in an earlier phase 3 trial of two doses and maintained the blind state to receive a booster dose of vaccine or placebo. The first registry update referring to the booster vaccines is from 2022-01-22, although it is unclear when recruitment for the booster part of the trial started. Assuming this date was after January 2022, then there were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. The trial follow-up is ongoing.