Covid-19 Living Data

Trial NCT05585567
Publication He Q, J. Clin. Med., 2022
Dates: 2022-08-15 to 2022-09-16
Funding: Mixed (The Emergency Key Program of Guangzhou Laboratory; Livzon Pharmaceutical Group Inc)
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / China Follow-up duration (months): 1
	BV-01-B5 =(n=24) V-01=(n=12)
Inclusion criteria	Adults aged 18 -59 years old at time of consent, male or female Normal body temperature Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating and has no birth plan and agree to take effective contraception in 7 months after enrollment and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment Be able and willing to complete the study during the entire study and follow-up period Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.
Exclusion criteria	Serious chronic diseases or uncontrolled diseases Uncontrolled neurological disorders, epilepsy Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks Patients with congenital or acquired immunodeficiency History of severe allergy or be allergic to any components of the test vaccines History of hereditary hemorrhagic tendency or coagulation dysfunction Patients with malignant tumors and other patients have a life expectancy less than 1 year Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol History of previous COVID-19 infection Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials Those considered by the investigator as inappropriate to participate in the study.
Interventions
	Intervention 1 dose of 20 mcg bivalent BV-01-B5 7-9 months after a third dose of an inactivated virus vaccine.
	Control 1 dose of 10 mcg V-01 7-9 months after a third dose of an inactivated virus vaccine.
Participants
	Randomized 36 participants
	Characteristics of participants Type of participants: Healthy adults N=36 19 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 20-55
	Description of participants Healthy adults, aged 18 -59 years old, with no previous COVID-19 infection that had received three doses of ICV (CoronaVac) in one center in China
Primary outcome
	In the register Adverse Event (AE) [ Time Frame: 30 minutes after vaccination ] Observe the AEs occurs at different time point after vaccination AEs [ Time Frame: 0-7 days after vaccination ] Observe the AEs occurs at different time point after vaccination AEs [ Time Frame: 0-28 days after vaccination ] Observe the AEs occurs at different time point after vaccination Serious adverse event (SAE) and adverse event of special interest (AESI) [ Time Frame: Within 12 months after vaccination ] Observe the SAE and AESI after vaccination Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5 [ Time Frame: 28 days after vaccination ] Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)
	In the report The primary objective was to evaluate the safety and immuno- genicity of BV-01-B5 boosters compared to V-01
Documents available	Protocol NR Statistical plan * Data-sharing stated: Unclear Data accessibility: NR
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 retrospective registry was used in data extraction and risk of bias assessment. The target sample size specified in the registry was not achieved. The article present preliminary results for a pilot trial with on-going follow-up. There were no important differences between registry and published report in population, procedures, interventions or outcomes.