Covid-19 Living Data

Trial NCT05197153
Publication Estephan L, Vaccine, 2023
Dates: 2022-01-22 to 2022-04-28
Funding: Mixed (Medigen Vaccine Biologics Corporation (MVC) and Coalition for Epidemic Preparedness Innovations (CEPI) )
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / Taiwan Follow-up duration (months): 5.16
	1/2 MVC-COV190 = (n=81) MVC-COV190 = (n=79) ChAdOx1 = (n=81) mRNA-1273 = (n=82)
Inclusion criteria	Male or female healthy adults 18 years at randomization Have received two homologous doses of AZD1222, mRNA-1273, or MVC-COV1901 vaccine, with the latest dose between 84 and 365 days prior to randomization and an interval between the two homologous doses of at least 25 days
Exclusion criteria	Have received any investigational intervention or other COVID-19 vaccine, blood product or intravenous immunoglobulin, immunosuppressive or immune-modifying therapy, treatment with tumor necrosis factor (TNF)-a, major surgery or any radiation therapy within the pre- specified period Presenting immunosuppressive illness, history of malignancy, bleeding disorder, uncontrolled human immunodeficiency virus (HIV) infection, SARS-CoV-1 or 2 virus infections Allergy to any vaccine component Fever and any other acute or serious medical conditions, which would interfere with adherence to study requirements Pregnant or breast-feeding women
Interventions
	Intervention One IM dose of MVC-COV1901 between 84 to 365 days after ChadOx1 prime vaccination Half IM dose of mRNA-1273 between 84 to 365 days after ChadOx1 prime vaccination Half IM dose of MVC-COV1901 between 84 to 365 days after ChAdOx1 prime vaccination
	Control One IM dose of ChAdOx1 between 84 to 365 days after ChadOx1 prime vaccination
Participants
	Randomized 323 participants
	Characteristics of participants Type of participants: Adults N=323 175 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Adults who received ChAdOx1, mRNA-1273, or MVC-COV1901 as prime vaccination with no history of COVID-19 , in 4 centers in Taiwan
Primary outcome
	In the register Incidence of Adverse Events from Day 1 to 28 [ Time Frame: Day1 to 28 days after vaccination ];Primary Immunogenicity-1 [ Time Frame: Day1 to Day 29 ] Anti-SARS-CoV-2 neutralizing antibody GMT; Primary Immunogenicity-2 [ Time Frame: Day1 to Day 29 ] Seroconversion rate (SCR); Primary Immunogenicity-3 [ Time Frame: Day1 to Day 29 ] Anti-SARS-CoV-2 neutralizing antibody GMR; Primary Immunogenicity-4 [ Time Frame: Day1 to Day 29 ] Anti-SARS-CoV-2 neutralizing antibody serum response rate
	In the report The assessment of the safety, tolerability, and immunogenicity of heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes Data accessibility: allenlien@medigenvac.com
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 all available versions of the published article, the study registry and supplementary material were used in data extraction and risk of bias assessment.The target sample size specified in the registry was not achieved (960 vs 804 participants).The article presented interim analyses for a study with ongoing follow-up.There were no important differences between registry and published report in population, procedures, interventions or outcomes.