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mRNA Vaccine

Mix and Match COVID-19 Vaccines for Coronavirus Safety and Immunity (MOSAIC Trial)

Phase 2

Waitlist Available

Led By Joanne Langley

Research Sponsored by Canadian Immunization Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Continuous use of anticoagulants

Inability or unwillingness of participant or legally acceptable representative to give written informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 28, 56, 112, 140, 365

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different vaccines for safety and efficacy.

Who is the study for?

This trial is for adults over 18 who've had at least two COVID-19 vaccine doses ≥6 months ago, or are unvaccinated. They must be in good health or with stable conditions and not planning pregnancy soon. Those previously vaccinated can join if they're scheduled for their first dose within 55 days before the study.

What is being tested?

The study tests immune response and safety of mixing different COVID-19 vaccines (Covifenz, mRNA-1273, BNT162b2, ChAdOx1-S) across four doses and various intervals between initial shots to see how well they work together.

What are the potential side effects?

Possible side effects include typical vaccine reactions like soreness at injection site, fatigue, headache, muscle pain, chills, fever and nausea. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never received a COVID-19 vaccine.

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I have received two COVID-19 vaccine doses over 6 months ago, as required in Canada.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on a continuous anticoagulant medication.

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I am unable or unwilling to give consent for the trial.

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I am currently being treated for cancer, except for skin cancer.

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I am not allergic to any vaccine or its components.

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I haven't received blood products or immunoglobulins in the last 3 months.

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I have a bleeding disorder or have had significant bleeding after injections or blood draws.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 28, 56, 112, 140, 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 28, 56, 112, 140, 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 28, 56, 112, 140, 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Antibody response to SARS-CoV-2 S protein after 2 doses

Antibody response to SARS-CoV-2 S protein after 3 doses

Antibody response to SARS-CoV-2 S protein after 4 doses

Secondary study objectives

Acceptability of vaccines as determined by participant-completed questionnaire after 2 doses

Vaccines

Acceptability of vaccines as determined by participant-completed questionnaire after 4 doses

+11 more

Other study objectives

Exploratory assessment of interval between dose 1 and 2 on immune response after 3 or 4 doses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

28Treatment groups

Experimental Treatment

Active Control

Group I: Group 9bExperimental Treatment1 Intervention

Participants will receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.

Group II: Group 7cExperimental Treatment1 Intervention

Participants will receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.

Group III: Group 2bActive Control1 Intervention

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

Group IV: Group 8bActive Control1 Intervention

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

Group V: Group 7: Pfizer/BioNTech, Moderna - 28 days apartActive Control3 Interventions

Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group VI: Group 5: Pfizer/BioNTech, Pfizer/BioNTech - 28 days apartActive Control2 Interventions

Participants will be blinded and receive two doses (0.3mL each) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle 28 days apart. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group VII: Group 7bActive Control1 Intervention

Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.

Group VIII: Group 1bActive Control1 Intervention

Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.

Group IX: Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apartActive Control3 Interventions

Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S \[recombinant\] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3 mL) of BNT162b2 vaccine after 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group X: Group 12: Astra Zeneca, Pfizer/BioNTech - 112 days apartActive Control3 Interventions

Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S \[recombinant\] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3 mL) of BNT162b2 vaccine after 112 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group XI: Group 9: Astra Zeneca, Moderna - 28 days apartActive Control3 Interventions

Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S \[recombinant\] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group XII: Group 3: Moderna, Pfizer/BioNTech - 28 days apartActive Control3 Interventions

Participants will be blinded and receive one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3mL) of BNT162b2 vaccine after 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group XIII: Group 3bActive Control1 Intervention

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

Group XIV: Group 4: Moderna, Pfizer/BioNTech - 112 days apartActive Control3 Interventions

Participants will be blinded and receive one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3mL) of BNT162b2 vaccine after 112 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group XV: Group 6: Pfizer/BioNTech, Pfizer/BioNTech - 112 days apartActive Control2 Interventions

Participants will be blinded and receive two doses (0.3mL each) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle 112 days apart. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group XVI: Group 8: Pfizer/BioNTech, Moderna - 112 days apartActive Control3 Interventions

Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 112 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group XVII: Group 10: Astra Zeneca, Moderna - 112 days apartActive Control3 Interventions

Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S \[recombinant\] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 112 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group XVIII: Group 4bActive Control1 Intervention

Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.

Group XIX: Group 5bActive Control1 Intervention

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

Group XX: Group 6bActive Control1 Intervention

Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.

Group XXI: Group 1: Moderna, Moderna - 28 Days apartActive Control2 Interventions

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. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group XXII: Group 2: Moderna, Moderna - 112 days apartActive Control2 Interventions

Participants will be blinded and receive two doses (0.20 mg/mL each) of mRNA-1273 SARS-CoV-2 vaccine at 0.20 mg/mL via intramuscular injection in the deltoid muscle 112 days apart. Vaccine-exposed participants will only be blinded to, and receive, the second injection.

Group XXIII: Group 1cActive Control1 Intervention

Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.

Group XXIV: Group 2cActive Control1 Intervention

Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.

Group XXV: Group 3cActive Control1 Intervention

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

Group XXVI: Group 4cActive Control1 Intervention

Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.

Group XXVII: Group 5cActive Control2 Interventions

Participants will be blinded and receive either one dose (0.3mL) of BNT162b2 or one half dose (0.25mL) of mRNA-1273 via intramuscular injection in the deltoid muscle.

Group XXVIII: Group 6cActive Control1 Intervention

Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.

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