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Trial record 1 of 2 for:    COVID | MOSAIC
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Mix and Match of the COVID-19 Vaccine for Safety and Immunogenicity (MOSAIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04894435
Recruitment Status : Active, not recruiting
First Posted : May 20, 2021
Last Update Posted : March 29, 2023
Sponsor:
Collaborators:
Canadian Center for Vaccinology
BC Children's Hospital Research Institute
Children's Hospital Research Institute of Manitoba
CHU de Quebec-Universite Laval
Ottawa Hospital Research Institute
Ontario Agency for Health Protection and Promotion
University of Toronto
Massachusetts General Hospital
Interior Health
McGill University Health Centre/Research Institute of the McGill University Health Centre
Information provided by (Responsible Party):
Canadian Immunization Research Network

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: mRNA-1273 SARS-CoV-2 vaccine Biological: BNT162b2 Biological: ChAdOx1-S [recombinant] Other: 0, 28 day schedule Other: 0, 112 day schedule Biological: Covifenz Phase 2

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 Design
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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 669 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

M=Moderna SpikeVax mRNA; P=Pfizer/BioNTech Comirnaty mRNA; A=AstraZeneca Vaxzervia; C=Medicago Covifenz VLP

MOSAIC 1:

  • Group 1 - M, M - 28 days
  • Group 2 - M, M - 112 days
  • Group 3 - M, P - 28 days
  • Group 4 - M, P - 112 days
  • Group 5 - P, P - 28 days
  • Group 6 - P, P - 112 days
  • Group 7 - P, M - 28 days
  • Group 8 - P, M - 112 days
  • Group 9 - A, M - 28 days
  • Group 10 - A, M - 112 days
  • Group 11 - A, P - 28 days
  • Group 12 - A, P - 112 days

MOSAIC 2:

  • Group 1b - P, P, P
  • Group 2b - P, P, M
  • Group 3b - M, M, M
  • Group 4b - M, M, P
  • Group 5b - P and M in any order, M
  • Group 6b - P and M in any order, P
  • Group 7b - A, P or M, P
  • Group 8b - A, P or M, M
  • Group 9b - Any vaccine in any order, C (open-label)

MOSAIC 3:

  • Group 1c - P, P, P, P
  • Group 2c - P, P, P, C
  • Group 3c - M, M, M, M
  • Group 4c - M, M, M, C
  • Group 5c - Any 3 in any order, P or M
  • Group 6c - Any 3 in any order, C
  • Group 7c - Any 3 in any order, C (open-label)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Participants, laboratory staff, and statistical analysis personnel will be blinded to which vaccine they are receiving for those in randomized arms.

Laboratory staff and statistical analysis personnel will be blinded to which vaccine they are receiving for those in open-label arms.
Primary Purpose: Prevention
Official Title: 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?
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
  • COVID-19 Vaccine Moderna
  • Spikevax

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:
  • COVID-19 Vaccine Moderna
  • Spikevax

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:
  • COVID-19 Vaccine Moderna
  • Spikevax

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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty

Other: 0, 28 day schedule
Second injection administered 28 days post first injection
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:
  • COVID-19 Vaccine Moderna
  • Spikevax

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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty

Other: 0, 112 day schedule
Second injection administered 112 days post first injection
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.

 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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty

Other: 0, 28 day schedule
Second injection administered 28 days post first injection
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.

 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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty

Other: 0, 112 day schedule
Second injection administered 112 days post first injection
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:
  • COVID-19 Vaccine Moderna
  • Spikevax

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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty

Other: 0, 28 day schedule
Second injection administered 28 days post first injection
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:
  • COVID-19 Vaccine Moderna
  • Spikevax

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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty

Other: 0, 112 day schedule
Second injection administered 112 days post first injection
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:
  • COVID-19 Vaccine Moderna
  • Spikevax

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:
  • Astra Zeneca COVID-19 Vaccine
  • COVISHIELD AstraZeneca COVID-19 Vaccine
  • Vaxzevria

Other: 0, 28 day schedule
Second injection administered 28 days post first injection
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:
  • COVID-19 Vaccine Moderna
  • Spikevax

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:
  • Astra Zeneca COVID-19 Vaccine
  • COVISHIELD AstraZeneca COVID-19 Vaccine
  • Vaxzevria

Other: 0, 112 day schedule
Second injection administered 112 days post first injection
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.

 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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty

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:
  • Astra Zeneca COVID-19 Vaccine
  • COVISHIELD AstraZeneca COVID-19 Vaccine
  • Vaxzevria

Other: 0, 28 day schedule
Second injection administered 28 days post first injection
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.

 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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty

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:
  • Astra Zeneca COVID-19 Vaccine
  • COVISHIELD AstraZeneca COVID-19 Vaccine
  • Vaxzevria

Other: 0, 112 day schedule
Second injection administered 112 days post first injection
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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty
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:
  • COVID-19 Vaccine Moderna
  • Spikevax
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:
  • COVID-19 Vaccine Moderna
  • Spikevax
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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty
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:
  • COVID-19 Vaccine Moderna
  • Spikevax
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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty
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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty
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:
  • COVID-19 Vaccine Moderna
  • Spikevax
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 Name: 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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty
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 Name: 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:
  • COVID-19 Vaccine Moderna
  • Spikevax
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 Name: 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:
  • COVID-19 Vaccine Moderna
  • Spikevax

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:
  • Pfizer-BioNTech COVID-19 Vaccine
  • Comirnaty
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 Name: 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 Name: Medicago COVID-19 vaccine


Outcome Measures
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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).

  10. 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).

  11. 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.

  12. 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

  13. 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

  14. 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


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894435


Locations
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Canada, British Columbia
Royal Inland Hospital
Kamloops, British Columbia, Canada
Penticton Regional Hospital
Penticton, British Columbia, Canada
BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada, V5Z 4H4
Canada, Manitoba
Children's Hospital Research Institute of Manitoba
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada
Canada, Ontario
Ottawa Hospital Research Institute, University of Ottawa
Ottawa, Ontario, Canada
Canada, Quebec
McGill University Health Centre Vaccine Study Centre
Montréal, Quebec, Canada, H9H 4Y6
CHU de Québec, Université Laval
Québec City, Quebec, Canada
Sponsors and Collaborators
Canadian Immunization Research Network
Canadian Center for Vaccinology
BC Children's Hospital Research Institute
Children's Hospital Research Institute of Manitoba
CHU de Quebec-Universite Laval
Ottawa Hospital Research Institute
Ontario Agency for Health Protection and Promotion
University of Toronto
Massachusetts General Hospital
Interior Health
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Joanne Langley Dalhousie University/CIRN
More Information
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Responsible Party: Canadian Immunization Research Network
ClinicalTrials.gov Identifier: NCT04894435    
Other Study ID Numbers: CT24
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: March 29, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canadian Immunization Research Network:
SARS-CoV-2
vaccine
clinical trial
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs