Mix and Match COVID-19 Vaccines for Coronavirus Safety and Immunity

(MOSAIC Trial)

Not currently recruiting at 9 trial locations

Overseen By Melissa Holmes

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Canadian Immunization Research Network

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Cancer, Bleeding disorder, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of mixing and matching different COVID-19 vaccines for various doses and intervals. It will assess the immune response and safety of vaccines such as Pfizer (BNT162b2), Moderna (mRNA-1273 SARS-CoV-2 vaccine), AstraZeneca (ChAdOx1-S [recombinant]), and Covifenz. Participants who have received some COVID-19 vaccines or are vaccine-naïve are eligible to join. The trial suits individuals in good health or with stable, mild conditions, who have not experienced severe reactions to past vaccines. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant vaccine development.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressant medication or continuous anticoagulants, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the vaccines tested in this trial have been safe in past studies. The Pfizer-BioNTech vaccine, BNT162b2, has been used in trials and real-world settings without major safety issues. Some individuals might experience mild reactions, such as a sore arm or fatigue.

The AstraZeneca vaccine, ChAdOx1-S, is considered safe and effective. It is approved in many countries, with most side effects, like headaches or tiredness, being mild.

The Covifenz vaccine, derived from plants, has demonstrated good safety results in trials. Most reported side effects have been mild and short-lived.

Lastly, the Moderna vaccine, mRNA-1273, has been widely used and has a strong safety record. Most side effects, such as a sore arm or mild fever, are mild and temporary.

Overall, these vaccines have been well-tolerated in previous studies, with most side effects being mild and short-term. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the mix-and-match COVID-19 vaccine approach because it offers potential flexibility and enhanced immunity compared to standard vaccination protocols. Unlike traditional methods that stick to a single vaccine type, this strategy combines different vaccines, like Pfizer/BioNTech's BNT162b2 and Moderna's mRNA-1273, potentially boosting immune response by leveraging varied mechanisms. Additionally, by testing vaccines such as Covifenz, which uses plant-based technology, this trial explores alternatives that could complement existing mRNA vaccines and help address global supply challenges. This innovative approach could lead to more personalized vaccine strategies, enhancing protection against COVID-19 variants.

What evidence suggests that this trial's treatments could be effective for COVID-19?

This trial will explore the effects of different COVID-19 vaccine combinations. Research has shown that the Pfizer-BioNTech vaccine, BNT162b2, is highly effective, with a 95% success rate in preventing COVID-19. Studies have also found that Moderna's mRNA-1273 vaccine is about 94.1% effective in stopping COVID-19, including severe cases. The AstraZeneca vaccine, ChAdOx1-S, is about 60.59% effective after the first dose in reducing the severity of COVID-19. The Covifenz vaccine, which is plant-based, has an effectiveness of 69.5% to 71% against COVID-19. All these vaccines have been shown to lower the risk of severe illness, hospitalization, and death from COVID-19. Participants in this trial will receive different combinations of these vaccines to assess safety and immunity. ^{1 2 6 7 8}

Who Is on the Research Team?

Joanne Langley

Principal Investigator

Dalhousie University/CIRN

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing and able to follow all study procedures for the entire study period.

I have never received a COVID-19 vaccine.

I have received or am scheduled for a COVID-19 vaccine within 55 days before Visit 1.

Exclusion Criteria

I am on a continuous anticoagulant medication.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose 1 and 2 Administration

Participants receive the first and second doses of the COVID-19 vaccine, with intervals of either 28 days or 112 days between doses.

4-16 weeks

2 visits (in-person)

Dose 3 Administration

Participants receive the third dose of the COVID-19 vaccine, anticipated to be administered 6 months after the second dose.

6 months

1 visit (in-person)

Dose 4 Administration

Participants receive the fourth dose of the COVID-19 vaccine, anticipated to be administered 3 months after the third dose.

3 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the vaccination schedule, with assessments of immune response and adverse events.

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• BNT162b2
• ChAdOx1-S [recombinant]
• Covifenz
• mRNA-1273 SARS-CoV-2 vaccine

Trial Overview

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.

How Is the Trial Designed?

Group I: Group 9b Experimental Treatment 1 Intervention

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

Group II: Group 7c Experimental Treatment 1 Intervention

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

Group III: Group 2b Active Control 1 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 8b Active Control 1 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 apart Active Control 3 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 apart Active Control 2 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 7b Active Control 1 Intervention

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

Group VIII: Group 1b Active Control 1 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 apart Active Control 3 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 apart Active Control 3 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 apart Active Control 3 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 apart Active Control 3 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 3b Active Control 1 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 apart Active Control 3 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 apart Active Control 2 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 apart Active Control 3 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 apart Active Control 3 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 4b Active Control 1 Intervention

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

Group XIX: Group 5b Active Control 1 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 6b Active Control 1 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 apart Active Control 2 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 apart Active Control 2 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 1c Active Control 1 Intervention

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

Group XXIV: Group 2c Active Control 1 Intervention

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

Group XXV: Group 3c Active Control 1 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 4c Active Control 1 Intervention

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

Group XXVII: Group 5c Active Control 2 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 6c Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Canadian Immunization Research Network

Lead Sponsor

Trials

12

Recruited

10,600+

Children's Hospital Research Institute of Manitoba

Collaborator

Trials

9

Recruited

3,400+

CHU de Quebec-Universite Laval

Collaborator

Trials

177

Recruited

110,000+

Ottawa Hospital Research Institute

Collaborator

Trials

585

Recruited

3,283,000+

Ontario Agency for Health Protection and Promotion

Collaborator

Trials

11

Recruited

28,800+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Interior Health

Industry Sponsor

Trials

7

Recruited

701,000+

Canadian Center for Vaccinology

Collaborator

Trials

12

Recruited

6,300+

BC Children's Hospital Research Institute

Collaborator

Trials

14

Recruited

2,800+

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