Covid-19 Living Data

Trial NCT05011526
Publication Torales J, Vaccine, 2022

Funding: Private (Medigen Vaccine Biologics)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / Paraguay Follow-up duration (months): 1.4
	MCV-COV1901 (n = 520) ChAdOx1 (n = 510)
Inclusion criteria	Male or female participant aged 18 years and above at randomization Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before enrollment and expected to remain stable for the duration of the study Female participants: A female participant is eligible is the participant is a woman of non-childbearing potential, ie, surgically sterilized or one year post-menopausal If the participant is a woman of childbearing potential, she must agree to practice sexual abstinence or agree to use medically effective contraception from 14 days before screening to 30 days following the last administration of study intervention Have a negative pregnancy test Participant is willing and able to comply with all required study visits and follow-up required by this protocol Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent.
Exclusion criteria	Pregnant or breast feeding or have plan to become pregnant within 30 days after the last administration of study intervention Employees at the investigator's site, of the Sponsor or delegate who are directly involved in the conduct of the study Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the first dose of study intervention Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention Currently receiving or anticipate to receive concomitant immunosuppressive or immune-modifying therapy within 12 weeks prior to the first dose of study intervention Currently receiving or anticipate to receive treatment with tumor necrosis factor (TNF)-α inhibitors within 12 weeks prior to the first dose of study intervention Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention Has received any other investigational or approved COVID-19 vaccine Immunosuppressive illness or immunodeficient state A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer Bleeding disorder considered a contraindication to IM injection or phlebotomy Known SARS-CoV-2 infection in the 3 months prior to the first dose of study intervention A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome Participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint A history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the MVC-COV1901 or AZD1222 Body (oral, rectal, or ear) temperature ≥ 38.0°C or acute illness within 2 days before the first dose of study intervention.
Interventions
	Intervention 2 IM doses of 15 mcg MVC-COV1901, 28 days apart
	Control 2 IM doses of 15 mcg 5x10^10 VP AZD1222, 28 days apart
Participants
	Randomized 1030 participants
	Characteristics of participants Type of participants: Adults N=1030 619 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 18-91
	Description of participants Healthy adults or adults with pre-existing medical conditions who are in stable condition and with no known SARS-CoV-2 infection in the 3 months prior at 2 centers in Paraguay.
Primary outcome
	In the register 1) Immunogenicity of neutralizing antibody (GMT ratio) [ Time Frame: Day 1 to Day 43 ]; 2) Incidence of Adverse Event within 28 days post the second study intervention [ Time Frame: Day 1 to Day 57 ]
	In the report 1) Immediate adverse events, solicited local and systemic adverse events (evaluated up to 7 days after each dose of the study intervention), and unsolicited adverse events (assessed up to 28 days after each dose of the study intervention); 2) Wild-type anti-SARS-CoV-2 virus-neutralizing antibody GMTs, GMT ratio between MVC-COV1901 and AZD1222, geometric mean fold rise (GMFR) from baseline antibody levels, and seroconversion rates (SCR) at day 14 after the second dose of the vaccine.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: No Data accessibility: Corresponding author : Chia-En Lien, MD, DrPH. email: 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 the preprint article, the trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The article presented interim analyses for a study with ongoing follow-up. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. The trial (n = 1030) achieved its target sample size (n = 1020). This trial was updated on December 12th 2022, after publication of the study report.