Covid-19 Living Data

Trial NCT04952727
Publication Jin P, medRxiv, 2022
Dates: 2021-08-26 to 2021-11-13
Funding: Mixed (National Natural Science Foundation of China; Jiangsu Science Fund for Distinguished Young Scholars Program; Jiangsu Provincial Key Research and Development Program ; Jinbo Gou, Tao Zhu, Haitao Huang, Xue Wang, Peng Wan are employees of CanSino Biologics. )
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / China Follow-up duration (months): 6
	1 dose CoronaVac (3 mcg per 0.5mL), 1 dose Ad5-nCOV (5×10^10 vp in 0.5mL Ad5-CoV-2) (n = 50) 2 doses CoronaVac (3 mcg per 0.5mL) (n = 50)
Inclusion criteria	Healthy subjects aged 60 and above, who have received one dose of inactive SARS-CoV-2 vaccine in the past 1-3 months can provide informed consent and sign informed consent form (ICF) able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study Axillary temperature ≤ 37.0’C in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization
Exclusion criteria	Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months acute febrile diseases and infectious diseases severe chronic diseases or condition in progress cannot be controlled congenital or acquired angioedema / neuroedema history of urticaria 1 year before receiving the investigational vaccine asplenia or functional asplenia thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection) needle sickness history of immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy or inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months received blood products within 4 months before injection of investigational vaccines under anti-tuberculosis treatment not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social or other conditions.
Interventions
	Intervention 1 IM dose CoronaVac (3 mcg per 0.5mL) and 1 IM dose Ad5-nCOV (5x10^10 vp in 0.5 mL), 30-90 days apart
	Control 2 IM doses CoronaVac (3 mcg per 0.5mL), 30-90 days apart
Participants
	Randomized 100 participants
	Characteristics of participants Type of participants: Elderly N=100 51 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Adults aged ≥60 years without severe or unstable comorbidities or confirmed history of COVID-19 or SARS-CoV-2 infection at a single center in China.
Primary outcome
	In the register 1)Incidence of adverse reactions within 28 days after the booster dose. [ Time Frame: Within 28 days after the booster dose ] 2) GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose. [ Time Frame: On day 14 after the booster dose ]
	In the report GMT of neutralizing antibodies to wild-type SARS-CoV-2 at day 14 after vaccination.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes Data accessibility: Researchers who provide a scientifically sound proposal are allowed to access to the de-identified individual participant data. Individual participant data can be obtained with a request to jingxin42102209@126.com (Jingxin Li) or jszfc@vip.sina.com (Fengcai Zhu, MSc).
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 protocol, statistical analysis plan, supplementary material and study registry were used in data extraction and risk of bias assessment. The registry had an additional primary outcome that was reported as a secondary outcome in the paper. The trial included two other randomized arms assessing booster vaccinations that are extracted separately. The homologeous/heterologeous primary series arms (n = 100) achieved their target sample size (n = 100).