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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 28, 56, 112, 140, 365
Awards & highlights
MOSAIC Trial 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.Check my eligibility
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.See study design
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.
MOSAIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never received a COVID-19 vaccine.
Select...
I have received two COVID-19 vaccine doses over 6 months ago, as required in Canada.
MOSAIC Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreOther outcome measures
Exploratory assessment of interval between dose 1 and 2 on immune response after 3 or 4 doses
MOSAIC 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 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 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 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 VII: 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 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 7bActive Control1 Intervention
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
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.
Find a Location
Who is running the clinical trial?
Children's Hospital Research Institute of ManitobaOTHER
6 Previous Clinical Trials
2,144 Total Patients Enrolled
CHU de Quebec-Universite LavalOTHER
167 Previous Clinical Trials
106,488 Total Patients Enrolled
3 Trials studying COVID-19
1,130 Patients Enrolled for COVID-19
Ottawa Hospital Research InstituteOTHER
561 Previous Clinical Trials
2,785,022 Total Patients Enrolled
10 Trials studying COVID-19
1,667 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a continuous anticoagulant medication.I am willing and able to follow all study procedures for the entire study period.I have never received a COVID-19 vaccine.I am unable or unwilling to give consent for the trial.I have received or am scheduled for a COVID-19 vaccine within 55 days before Visit 1.I am 18 or older and in good health or have stable health conditions.I am currently being treated for cancer, except for skin cancer.I have received three doses of a COVID-19 vaccine authorized in Canada at least 3 months ago.I am not allergic to any vaccine or its components.I have received two COVID-19 vaccine doses over 6 months ago, as required in Canada.You had a severe allergic reaction to a vaccine in the past.I have not received a live virus vaccine in the last 4 weeks.I haven't received blood products or immunoglobulins in the last 3 months.I have a bleeding disorder or have had significant bleeding after injections or blood draws.I am a woman who can have children, used birth control for 30 days, tested negative for pregnancy, and will continue birth control for 3 months after the last vaccine dose.I have not taken immunosuppressant drugs in the last 6 months, except for short-term or topical steroids.You have had a confirmed case of COVID-19 before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 5: Pfizer/BioNTech, Pfizer/BioNTech - 28 days apart
- Group 2: Group 8b
- Group 3: Group 7: Pfizer/BioNTech, Moderna - 28 days apart
- Group 4: Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart
- Group 5: Group 2b
- Group 6: Group 1b
- Group 7: Group 7b
- Group 8: Group 12: Astra Zeneca, Pfizer/BioNTech - 112 days apart
- Group 9: Group 9: Astra Zeneca, Moderna - 28 days apart
- Group 10: Group 3: Moderna, Pfizer/BioNTech - 28 days apart
- Group 11: Group 3b
- Group 12: Group 4: Moderna, Pfizer/BioNTech - 112 days apart
- Group 13: Group 6: Pfizer/BioNTech, Pfizer/BioNTech - 112 days apart
- Group 14: Group 9b
- Group 15: Group 8: Pfizer/BioNTech, Moderna - 112 days apart
- Group 16: Group 10: Astra Zeneca, Moderna - 112 days apart
- Group 17: Group 4b
- Group 18: Group 5b
- Group 19: Group 6b
- Group 20: Group 1: Moderna, Moderna - 28 Days apart
- Group 21: Group 2: Moderna, Moderna - 112 days apart
- Group 22: Group 1c
- Group 23: Group 2c
- Group 24: Group 3c
- Group 25: Group 4c
- Group 26: Group 5c
- Group 27: Group 6c
- Group 28: Group 7c
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other ongoing clinical trials using a similar treatment protocol as Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart?
"As of now, there are 56 ongoing trials studying the effects of Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart. Out of those, 19 are in Phase 3. Even though most of the trials for this group are located in Liverpool and New york, there are a total of 1458 sites running studies on this topic."
Answered by AI
Is there still room for more patients in this trial?
"Yes, this study is still looking for participants. The clinicaltrials.gov website shows that the most recent update was on March 7th, 2021 and that the study was originally posted on May 20th, 2020."
Answered by AI
Does this research include elderly individuals as test subjects?
"To be eligible for this study, patients must be between 18 to 99 years old. There are a total of 157 studies for patients that are under the age of 18 and 1026 for those who are over 65."
Answered by AI
Are there any Canadian sites that are participating in this trial?
"This clinical trial is taking place at Canadian Center for Vaccinology in Halifax, Nova Scotia, Children's Hospital Research Institute of Manitoba in Winnipeg, Manitoba, and Penticton Regional Hospital in Penticton, British Columbia; among 7 other locations."
Answered by AI
FDA approval for Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart
"This Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart treatment received a score of 2 for safety. This is due to the lack of efficacy data, as this is only a Phase 2 trial."
Answered by AI
Does this research have any predecessors?
"As of right now, there are 56 active trials for Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart in 358 cities and 45 countries. The earliest one was held in 2020 and it completed its Phase 1 drug approval stage that year. ModernaTX, Inc. sponsored the trial which only involved 120 participants. Out of the 32 total trials like this one, phase 1 is the most advanced with 20 having completed thus far."
Answered by AI
How many people have signed up to test this new medication?
"In order to properly conduct this clinical trial, 1060 patients that fit the specified inclusion criteria must enroll. Some of the locations where patients can participate in this study include Canadian Center for Vaccinology in Halifax, Nova Scotia and Children's Hospital Research Institute of Manitoba in Winnipeg, Manitoba."
Answered by AI
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