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

(MOSAIC Trial)

Not currently recruiting at 9 trial locations
JM
MH
Overseen ByMelissa Holmes
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Canadian Immunization Research Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.12678

Who Is on the Research Team?

JL

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.
See 5 more

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.
See 8 more

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?
28Treatment groups
Experimental Treatment
Active Control
Group I: Group 9bExperimental Treatment1 Intervention
Group II: Group 7cExperimental Treatment1 Intervention
Group III: Group 2bActive Control1 Intervention
Group IV: Group 8bActive Control1 Intervention
Group V: Group 7: Pfizer/BioNTech, Moderna - 28 days apartActive Control3 Interventions
Group VI: Group 5: Pfizer/BioNTech, Pfizer/BioNTech - 28 days apartActive Control2 Interventions
Group VII: Group 7bActive Control1 Intervention
Group VIII: Group 1bActive Control1 Intervention
Group IX: Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apartActive Control3 Interventions
Group X: Group 12: Astra Zeneca, Pfizer/BioNTech - 112 days apartActive Control3 Interventions
Group XI: Group 9: Astra Zeneca, Moderna - 28 days apartActive Control3 Interventions
Group XII: Group 3: Moderna, Pfizer/BioNTech - 28 days apartActive Control3 Interventions
Group XIII: Group 3bActive Control1 Intervention
Group XIV: Group 4: Moderna, Pfizer/BioNTech - 112 days apartActive Control3 Interventions
Group XV: Group 6: Pfizer/BioNTech, Pfizer/BioNTech - 112 days apartActive Control2 Interventions
Group XVI: Group 8: Pfizer/BioNTech, Moderna - 112 days apartActive Control3 Interventions
Group XVII: Group 10: Astra Zeneca, Moderna - 112 days apartActive Control3 Interventions
Group XVIII: Group 4bActive Control1 Intervention
Group XIX: Group 5bActive Control1 Intervention
Group XX: Group 6bActive Control1 Intervention
Group XXI: Group 1: Moderna, Moderna - 28 Days apartActive Control2 Interventions
Group XXII: Group 2: Moderna, Moderna - 112 days apartActive Control2 Interventions
Group XXIII: Group 1cActive Control1 Intervention
Group XXIV: Group 2cActive Control1 Intervention
Group XXV: Group 3cActive Control1 Intervention
Group XXVI: Group 4cActive Control1 Intervention
Group XXVII: Group 5cActive Control2 Interventions
Group XXVIII: Group 6cActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Safety and Efficacy of the BNT162b2 mRNA Covid-19 ...A two-dose regimen of BNT162b2 (30 μg per dose, given 21 days apart) was found to be safe and 95% effective against Covid-19. The vaccine met ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/35239634/
Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 ...The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and ...
Pfizer Shares Available Analyses of Myocarditis and ...Comirnaty, the mRNA vaccine developed by Pfizer-BioNTech, demonstrated very high effectiveness (around 95%) against SARS-CoV-2 infection in ...
Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 ...The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included ...
Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to ...In a pivotal randomised controlled trial, the BNT162b2 mRNA vaccine (tozinameran, Pfizer–BioNTech) showed 95% or greater efficacy against ...
Safety of COVID-19 Pfizer-BioNtech (BNT162b2) mRNA ...We reviewed the safety profile of the BNT162b2 COVID-19 vaccine in adolescents using mostly real-world data to assist decision-making.
Real-world safety data for the Pfizer BNT162b2 SARS-CoV ...The Pfizer BNT162b2 vaccine showed a reassuring safety profile in clinical trials, but real-world data are scarce.
Coronavirus Disease 2019 (COVID-19) Vaccine SafetyEveryone who gets a COVID-19 vaccine may be monitored onsite for at least 15 minutes after vaccination (people who experience or have experienced non-severe ...
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