Immunogenicity and Adverse Events Following Immunization (AEFI) With Alternate Schedules of COVID-19 Vaccines in Canada: is "Mix and Match" of the Second Dose (MOSAIC-1;CT24a) and Additional Doses (MOSAIC-2 and MOSAIC-3;CT24b and CT24c) Safe and Immunogenic?

Canadian Immunization Research Network8 个研究点分布在 1 个国家目标入组 669 人开始时间: 2021年5月20日最近更新: 2025年3月18日

适应症

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方: Canadian Immunization Research Network
入组人数: 669
试验地点: 8
主要终点: Antibody response to SARS-CoV-2 S protein after 3 doses

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main goals of this study are to assess the immune response and safety of two different vaccines for first, second, third and fourth doses as well as for differing intervals between the first and second dose of two-dose vaccines.

详细描述

For dose 1 and 2, the currently available mRNA vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) are two dose vaccines which were studied in schedules of either 0 and 21 days or 0 and 28 days, respectively. The ChAdOx1 nCOV-19 (Astra-Zeneca) adenovirus-vectored vaccine is authorized to be given in two doses one month to 12 weeks apart. We will compare the interval 0, 28 days to a 0, 112 days (16 weeks) schedule, and assess the immunogenicity of both heterogeneous and heterologous second doses using the Canadian schedule.

For dose 3, the currently available mRNA vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) and plant-based virus-like particle (Medicago Covifenz) are anticipated to be administered 6 months apart. We will assess the immunogenicity of both heterogeneous and heterologous third doses using the Canadian schedule.

For dose 4, the currently available mRNA vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) and plant-based virus-like particle (Medicago Covifenz) are anticipated to be administered 3 months apart. We will assess the immunogenicity of both heterogeneous and heterologous third doses using the Canadian schedule.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants, laboratory staff, and statistical analysis personnel will be blinded to which vaccine they are receiving for those in randomized arms.

Laboratory staff and statistical analysis personnel will be blinded to which vaccine they are receiving for those in open-label arms.

入排标准

年龄范围: 18 Years 至 99 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Participant is willing and able to give written informed consent to participate in the study
•Age 18 years of age or older in good health or with mild or moderate stable co-morbidities at the time of enrolment
•Able and willing to complete all the scheduled study procedures during the whole study follow-up period
•If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the final dose of study vaccine (Please refer to the definition section for a description of child-bearing potential and adequate contraception)
•MOSAIC-1 Vaccine-exposed subgroups: have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1 (documentation of receipt required)
•MOSAIC -1 Vaccine naïve subgroups: have not received an authorized COVID-19 vaccine at any time
•MOSAIC-2 participants have received two doses of COVID-19 vaccines authorized in Canada ≥6 months prior to study vaccine administration (documentation of receipt required)
•MOSAIC-3 participants have received three doses of COVID-19 vaccines authorized in Canada ≥3 months prior to study vaccine administration (documentation of receipt required)

排除标准

•Inability or unwillingness of participant or legally acceptable representative to give written informed consent
•Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
•Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
•Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine and for one month after the last dose of study vaccine
•Allergy to any study vaccine or any active substance in a study vaccine
•Bleeding disorder or history of significant bleeding following IM injections or venipuncture
•Continuous use of anticoagulants
•A history of anaphylaxis to a previous vaccine
•Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine
•MOSAIC-1: History of laboratory-confirmed COVID-19 disease prior to enrolment by participant report
•Administration of a live virus vaccine within 4 weeks prior to study vaccine receipt.

研究组 & 干预措施

Group 1: Moderna, Moderna - 28 Days apart

Active Comparator

Participants will be blinded and receive two doses (0.20 mg/mL each) of mRNA-1273 SARS-CoV-2 vaccine via intramuscular injection in the deltoid muscle 28 days apart.