Mix and Match of the COVID-19 Vaccine for Safety and Immunogenicity (MOSAIC)

February 22, 2024 updated by: Canadian Immunization Research Network

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?

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

669

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Kamloops, British Columbia, Canada
        • Royal Inland Hospital
      • Penticton, British Columbia, Canada
        • Penticton Regional Hospital
      • Vancouver, British Columbia, Canada, V5Z 4H4
        • BC Children's Hospital Research Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Children's Hospital Research Institute of Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Canadian Center for Vaccinology
    • Ontario
      • Ottawa, Ontario, Canada
        • Ottawa Hospital Research Institute, University of Ottawa
    • Quebec
      • Montréal, Quebec, Canada, H9H 4Y6
        • McGill University Health Centre Vaccine Study Centre
      • Québec City, Quebec, Canada
        • CHU de Québec, Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participant is willing and able to give written informed consent to participate in the study
  2. Age 18 years of age or older in good health or with mild or moderate stable co-morbidities at the time of enrolment
  3. Able and willing to complete all the scheduled study procedures during the whole study follow-up period
  4. 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)
  5. 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)
  6. MOSAIC -1 Vaccine naïve subgroups: have not received an authorized COVID-19 vaccine at any time
  7. 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)
  8. 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)

Exclusion Criteria:

  1. Inability or unwillingness of participant or legally acceptable representative to give written informed consent
  2. 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
  3. Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
  4. 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
  5. Allergy to any study vaccine or any active substance in a study vaccine
  6. Bleeding disorder or history of significant bleeding following IM injections or venipuncture
  7. Continuous use of anticoagulants
  8. A history of anaphylaxis to a previous vaccine
  9. Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine
  10. MOSAIC-1: History of laboratory-confirmed COVID-19 disease prior to enrolment by participant report
  11. Administration of a live virus vaccine within 4 weeks prior to study vaccine receipt.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: Moderna, Moderna - 28 Days apart

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.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Other: 0, 28 day schedule
Second injection administered 28 days post first injection
Active Comparator: Group 2: Moderna, Moderna - 112 days apart

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.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Other: 0, 112 day schedule
Second injection administered 112 days post first injection
Active Comparator: Group 3: Moderna, Pfizer/BioNTech - 28 days apart

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.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Other: 0, 28 day schedule
Second injection administered 28 days post first injection
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 4: Moderna, Pfizer/BioNTech - 112 days apart

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.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Other: 0, 112 day schedule
Second injection administered 112 days post first injection
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 5: Pfizer/BioNTech, Pfizer/BioNTech - 28 days apart

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.
Other: 0, 28 day schedule
Second injection administered 28 days post first injection
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 6: Pfizer/BioNTech, Pfizer/BioNTech - 112 days apart

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.
Other: 0, 112 day schedule
Second injection administered 112 days post first injection
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 7: Pfizer/BioNTech, Moderna - 28 days apart

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.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Other: 0, 28 day schedule
Second injection administered 28 days post first injection
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 8: Pfizer/BioNTech, Moderna - 112 days apart

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.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Other: 0, 112 day schedule
Second injection administered 112 days post first injection
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 9: Astra Zeneca, Moderna - 28 days apart

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.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Other: 0, 28 day schedule
Second injection administered 28 days post first injection
Biological: ChAdOx1-S [recombinant]
A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
Other Names:
  • Vaxzevria
  • Astra Zeneca COVID-19 Vaccine
  • COVISHIELD AstraZeneca COVID-19 Vaccine
Active Comparator: Group 10: Astra Zeneca, Moderna - 112 days apart

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.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Other: 0, 112 day schedule
Second injection administered 112 days post first injection
Biological: ChAdOx1-S [recombinant]
A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
Other Names:
  • Vaxzevria
  • Astra Zeneca COVID-19 Vaccine
  • COVISHIELD AstraZeneca COVID-19 Vaccine
Active Comparator: Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart

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.
Other: 0, 28 day schedule
Second injection administered 28 days post first injection
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Biological: ChAdOx1-S [recombinant]
A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
Other Names:
  • Vaxzevria
  • Astra Zeneca COVID-19 Vaccine
  • COVISHIELD AstraZeneca COVID-19 Vaccine
Active Comparator: Group 12: Astra Zeneca, Pfizer/BioNTech - 112 days apart

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.
Other: 0, 112 day schedule
Second injection administered 112 days post first injection
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Biological: ChAdOx1-S [recombinant]
A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
Other Names:
  • Vaxzevria
  • Astra Zeneca COVID-19 Vaccine
  • COVISHIELD AstraZeneca COVID-19 Vaccine
Active Comparator: Group 1b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 2b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Active Comparator: Group 3b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Active Comparator: Group 4b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 5b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Active Comparator: Group 6b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 7b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 8b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Experimental: Group 9b
Participants will receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Biological: Covifenz
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Other Names:
  • Medicago COVID-19 vaccine
Active Comparator: Group 1c
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 2c
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Biological: Covifenz
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Other Names:
  • Medicago COVID-19 vaccine
Active Comparator: Group 3c
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Active Comparator: Group 4c
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Biological: Covifenz
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Other Names:
  • Medicago COVID-19 vaccine
Active Comparator: Group 5c
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.
Biological: mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Other Names:
  • Spikevax
  • COVID-19 Vaccine Moderna
Biological: BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Other Names:
  • Comirnaty
  • Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Group 6c
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Biological: Covifenz
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Other Names:
  • Medicago COVID-19 vaccine
Experimental: Group 7c
Participants will receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Biological: Covifenz
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Other Names:
  • Medicago COVID-19 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody response to SARS-CoV-2 S protein after 2 doses
Time Frame: Day 56
The co-primary outcome for the non-inferiority comparison of 0, 28-day schedules with heterologous second dose is the immune response to SARS-CoV-2 at day 56 (28 days after the second dose of vaccine) based on anti-spike antibody titers.
Day 56
Antibody response to SARS-CoV-2 S protein after 2 doses
Time Frame: Day 140
The co-primary outcome for the non-inferiority comparison of schedules in which the timing of the second dose of vaccine is different (0, 28 days v 0, 112 days) is the immune response to SARS-CoV-2 at day 140 (28 days after the last dose in the 0, 112 day schedule) based on anti-spike antibody titers.
Day 140
Antibody response to SARS-CoV-2 S protein after 3 doses
Time Frame: Day 28
To determine if a vaccination schedule with a heterologous third dose of a COVID-19 vaccine induces a non-inferior serum immune response to SARS-CoV-2, compared to a third dose/booster with a homologous vaccine.
Day 28
Antibody response to SARS-CoV-2 S protein after 4 doses
Time Frame: Day 28
To determine if a vaccination schedule with a heterologous fourth dose of a COVID-19 vaccine induces a non-inferior serum immune response to SARS-CoV-2, compared to a third dose/booster with a homologous vaccine.
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Durability of antibody response to SARS-CoV-2 S over 12 months after 2 doses
Time Frame: Baseline and Days 28, 56, 112, 140, 365
Assess durability of immune responses in each study group over 12 months based on anti-spike antibody titers and pseudoneutralization assay.
Baseline and Days 28, 56, 112, 140, 365
Pseudoneutralization assay, T cell testing, Antibody dependent cellular cytotoxicity (ADCC), Antibody avidity, RNA seq after 2 doses
Time Frame: Days 28, 56, 112, 140, 365
Characterization of the immune response to COVID-19 vaccines in schedules with 0, 28 days versus 0, 112 days dosing and heterologous schedules to day 365.
Days 28, 56, 112, 140, 365
Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 2 doses
Time Frame: From time of first study injection through Day 365.
Description of safety outcomes over 12 months post-vaccination including SAEs (serious adverse events), provincially reportable AEFIs (adverse events following immunization), MAAEs (medically attended adverse events), AESIs (adverse events of special interest).
From time of first study injection through Day 365.
Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 3 doses
Time Frame: From time of first study injection through Day 365.
Description of safety outcomes over 12 months post-vaccination including SAEs (serious adverse events), provincially reportable AEFIs (adverse events following immunization), MAAEs (medically attended adverse events), AESIs (adverse events of special interest).
From time of first study injection through Day 365.
Acceptability of vaccines as determined by participant-completed questionnaire after 2 doses
Time Frame: Days 56, 140, and 365
Four 5 point likert scale type questions asking whether they would want to receive the vaccine again, recommend it to a friend, whether they were anxious about receiving it, and whether they would prefer a more painful injection if it conferred better protection.
Days 56, 140, and 365
Antibody to SARS-CoV-2 S and N, RBD after 3 doses
Time Frame: Days 180 and 365
Assess durability of the immune responses in each study group over 12 months after the study vaccine.
Days 180 and 365
Pseudoneutralization assay, T cell testing, Antibody dependent cellular cytotoxicity after 3 doses
Time Frame: Day 365
Further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365
Day 365
Acceptability of vaccines as determined by participant-completed questionnaire after 3 doses
Time Frame: Days 28, 180
Four 5 point likert scale type questions asking whether they would want to receive the vaccine again, recommend it to a friend, whether they were anxious about receiving it, and whether they would prefer a more painful injection if it conferred better protection.
Days 28, 180
Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 4 doses
Time Frame: From time of first study injection through Day 365.
Description of safety outcomes over 12 months post-vaccination including SAEs (serious adverse events), provincially reportable AEFIs (adverse events following immunization), MAAEs (medically attended adverse events), AESIs (adverse events of special interest).
From time of first study injection through Day 365.
Antibody to SARS-CoV-2 S and N, RBD after 4 doses
Time Frame: Days 180 and 365
Assess durability of the immune responses in each study group over 12 months after the study vaccine.
Days 180 and 365
Acceptability of vaccines as determined by participant-completed questionnaire after 4 doses
Time Frame: Days 28, 180
Four 5 point likert scale type questions asking whether they would want to receive the vaccine again(Yes, definitely; Yes, probably; I don't know; No, probably not; No, definitely not), recommend it to a friend(Yes, definitely; Yes, probably; I don't know; No, probably not; No, definitely not), whether they were anxious about receiving it(Not at all; A little; Moderately; Very; Extremely), and whether they would prefer a more painful injection if it conferred better protection(Vaccine A; Vaccine B; No preference; Unsure/don't know).
Days 28, 180
Antibody dependent cellular cytotoxicity after 4 doses
Time Frame: Day 365
Further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365
Day 365
Pseudoneutralization assay after 4 doses
Time Frame: Day 365
Measuring the 50% Neutralization Titer to further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365
Day 365
T cell testing after 4 doses
Time Frame: Day 365
Measuring the number of T cells to further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365
Day 365

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory assessment of interval between dose 1 and 2 on immune response after 3 or 4 doses
Time Frame: From time of first study injection through Day 365.
Assess the role of intervals between first and second doses of the primary immunization schedule, and between 2nd and 3rd doses, on immune responses after the third dose over the study period.
From time of first study injection through Day 365.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Immunization Research Network

Collaborators

Massachusetts General Hospital
CHU de Quebec-Universite Laval
McGill University Health Centre/Research Institute of the McGill University Health Centre
University of Toronto
Ottawa Hospital Research Institute
Canadian Center for Vaccinology
Interior Health
Ontario Agency for Health Protection and Promotion
BC Children's Hospital Research Institute
Children's Hospital Research Institute of Manitoba

Investigators

  • Principal Investigator: Joanne Langley, Dalhousie University/CIRN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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