Covid-19 Living Data

Trial NCT04951388
Publication Liu LTC, medRxiv, 2022
Dates: 2021-07-21 to 2021-12-22
Funding: Mixed (Medigen Vaccine Biologics Corporation; Taiwan Centers for Disease Control (CDC), Ministry of Health and Welfare.)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / Taiwan Follow-up duration (months): 2
	MVC-COV1901 (n = 341) placebo (n = 58)
Inclusion criteria	Aged 12 (inclusive) to 17 (not eligible if the participant turned 18 years old) at the time of randomization body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) at the screening visit lack of travel within 14 days of screening and lack of any oversea travelling throughout the study period written informed consent females only - negative pregnancy test, non-childbearing potential or, if with childbearing potential, abstinence or agreement to use medically effective contraception from 14 days before screening to 30 days following the last injection of study intervention.
Exclusion criteria	Pregnant or breast feeding or have plan to become pregnant in 30 days after last administration of study intervention Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention Participant previously received a coronavirus vaccine 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 (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) 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, e.g. infliximab, adalimumab, etanercept 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 Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia Personal or family (linear or collateral relatives by blood within two generations) history of Guillain-Barré syndrome A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator) Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy Participant with ongoing acute diseases or serious medical conditions which will interfere with adherence to study requirements, or the evaluation of any study endpoint. Acute diseases or serious medical conditions include cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, psychiatric condition (e.g. alcoholism, drug abuse, anorexia or severe depression), current severe infections, autoimmune disease, medical history, physical findings, or laboratory abnormality that in the investigators' opinion are not in stable condition and participating in the study could adversely affect the safety of the participant Participant with previous known SARS-CoV-1 or 2 infection Participant with 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 Body (oral, rectal, or ear) temperature ≥ 38.0°C or acute illness (not including minor illnesses such as diarrhea or mild upper respiratory tract infection at the discretion of the investigator) 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 placebo (0.5mL saline), 28 days apart
Participants
	Randomized 399 participants
	Characteristics of participants Type of participants: Adolescents N=399 214 males Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 12-17
	Description of participants Adolescents aged 12 to 17 years with no serious medical conditions and no previous SARS-CoV-1 infection or vaccination at 5 centers in Taiwan.
Primary outcome
	In the register 1) Incidence of Adverse Events(AEs) [Safety and Tolerability] [ Time Frame: Day 1 to 28 days after the second vaccination ] Solicited local AEs (up to 7 days after each dose of study intervention) Solicited systemic AEs (up to 7 days after each dose of study intervention) Unsolicited AEs (up to 28 days after each dose of study intervention) AE of Special Interest (AESI) Vaccine-Associated Enhanced Disease(VAED) Serious adverse events (SAEs); 2) Immunogenicity of MVC-COV1901-1 [ Time Frame: Day 1 to 28 days after the second vaccination ] nAb GMT, nAb seroconversion rate, GMT ratio
	In the report 1) occurrence rate of solicited (local and systemic) AEs, unsolicited AEs, AESI, VAED, and SAE from Visit 2 (Day 1) to Visit 6 (28 days after second dose of study intervention); 2) neutralizing antibody titers and seroconversion rate (SCR) against live SARS-CoV-2 virus of MVC-COV1901 in adolescents as compared to young adult vaccinees at Visit 6 (Day 57).
Documents available	Protocol NR Statistical plan * Data-sharing stated: Unclear Data accessibility: All data produced in the present work are contained in the manuscript Co-corresponding authors: Li-Min Huang: lmhuang@ha.mc.ntu.edu.tw; Charles Chen: charles@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 pre-print article, the prospective registry and supplementary appendices were used in data extraction and assessment of risk of bias. The primary outcomes in the article reflect those in the registry. Neither protocol nor statistical analysis plan was available. The trial (n = 399) achieved the target sample size in the registry (n = 385).