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

Primary Purpose

COVID-19

Status

Active

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

mRNA-1273 SARS-CoV-2 vaccine

BNT162b2

ChAdOx1-S [recombinant]

0, 28 day schedule

0, 112 day schedule

Covifenz

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring SARS-CoV-2, vaccine, clinical trial

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participant is willing and able to give written informed consent to participate in the study
Age 18 years of age or older in good health or with mild or moderate stable co-morbidities at the time of enrolment
Able and willing to complete all the scheduled study procedures during the whole study follow-up period
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)
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)
MOSAIC -1 Vaccine naïve subgroups: have not received an authorized COVID-19 vaccine at any time
MOSAIC-2 participants have received two doses of COVID-19 vaccines authorized in Canada ≥6 months prior to study vaccine administration (documentation of receipt required)

Exclusion Criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm 25

Arm 26

Arm 27

Arm 28

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Group 1: Moderna, Moderna - 28 Days apart

Group 2: Moderna, Moderna - 112 days apart

Group 3: Moderna, Pfizer/BioNTech - 28 days apart

Group 4: Moderna, Pfizer/BioNTech - 112 days apart

Group 5: Pfizer/BioNTech, Pfizer/BioNTech - 28 days apart

Group 6: Pfizer/BioNTech, Pfizer/BioNTech - 112 days apart

Group 7: Pfizer/BioNTech, Moderna - 28 days apart

Group 8: Pfizer/BioNTech, Moderna - 112 days apart

Group 9: Astra Zeneca, Moderna - 28 days apart

Group 10: Astra Zeneca, Moderna - 112 days apart

Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart

Group 12: Astra Zeneca, Pfizer/BioNTech - 112 days apart

Group 1b

Group 2b

Group 3b

Group 4b

Group 5b

Group 6b

Group 7b

Group 8b

Group 9b

Group 1c

Group 2c

Group 3c

Group 4c

Group 5c

Group 6c

Group 7c

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

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

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

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

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

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

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

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

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

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

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.

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

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

Outcomes

Primary Outcome Measures

Antibody response to SARS-CoV-2 S protein after 2 doses

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.

Antibody response to SARS-CoV-2 S protein after 2 doses

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.

Antibody response to SARS-CoV-2 S protein after 3 doses

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.

Antibody response to SARS-CoV-2 S protein after 4 doses

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

Durability of antibody response to SARS-CoV-2 S over 12 months after 2 doses

Assess durability of immune responses in each study group over 12 months based on anti-spike antibody titers and pseudoneutralization assay.

Pseudoneutralization assay, T cell testing, Antibody dependent cellular cytotoxicity (ADCC), Antibody avidity, RNA seq after 2 doses

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.

Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 2 doses

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).

Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 3 doses

Acceptability of vaccines as determined by participant-completed questionnaire after 2 doses

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.

Acceptability of vaccines as determined by participant-completed questionnaire after 3 doses

Antibody to SARS-CoV-2 S and N, RBD after 3 doses

Assess durability of the immune responses in each study group over 12 months after the study vaccine.

Pseudoneutralization assay, T cell testing, Antibody dependent cellular cytotoxicity after 3 doses

Further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365

Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 4 doses

Acceptability of vaccines as determined by participant-completed questionnaire after 4 doses

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).

Antibody to SARS-CoV-2 S and N, RBD after 4 doses

Assess durability of the immune responses in each study group over 12 months after the study vaccine.

Antibody dependent cellular cytotoxicity after 4 doses

Further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365

Pseudoneutralization assay after 4 doses

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

T cell testing after 4 doses

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

Full Information

NCT ID

NCT04894435

First Posted

May 18, 2021

Last Updated

July 13, 2023

Sponsor

Canadian Immunization Research Network

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

1. Study Identification

Unique Protocol Identification Number

NCT04894435

Brief Title

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

Acronym

MOSAIC

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?

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 20, 2021 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Canadian Immunization Research Network

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

SARS-CoV-2, vaccine, clinical trial

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

669 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Moderna, Moderna - 28 Days apart

Arm Type

Active Comparator

Arm Description

Arm Title

Group 2: Moderna, Moderna - 112 days apart

Arm Type

Active Comparator

Arm Description

Arm Title

Group 3: Moderna, Pfizer/BioNTech - 28 days apart

Arm Type

Active Comparator

Arm Description

Arm Title

Group 4: Moderna, Pfizer/BioNTech - 112 days apart

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group 5: Pfizer/BioNTech, Pfizer/BioNTech - 28 days apart

Arm Type

Active Comparator

Arm Description

Arm Title

Group 6: Pfizer/BioNTech, Pfizer/BioNTech - 112 days apart

Arm Type

Active Comparator

Arm Description

Arm Title

Group 7: Pfizer/BioNTech, Moderna - 28 days apart

Arm Type

Active Comparator

Arm Description

Arm Title

Group 8: Pfizer/BioNTech, Moderna - 112 days apart

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group 9: Astra Zeneca, Moderna - 28 days apart

Arm Type

Active Comparator

Arm Description

Arm Title

Group 10: Astra Zeneca, Moderna - 112 days apart

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart

Arm Type

Active Comparator

Arm Description

Arm Title

Group 12: Astra Zeneca, Pfizer/BioNTech - 112 days apart

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group 1b

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 2b

Arm Type

Active Comparator

Arm Description

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

Arm Title

Group 3b

Arm Type

Active Comparator

Arm Description

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

Arm Title

Group 4b

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 5b

Arm Type

Active Comparator

Arm Description

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

Arm Title

Group 6b

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 7b

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 8b

Arm Type

Active Comparator

Arm Description

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

Arm Title

Group 9b

Arm Type

Experimental

Arm Description

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

Arm Title

Group 1c

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 2c

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 3c

Arm Type

Active Comparator

Arm Description

Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.

Arm Title

Group 4c

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 5c

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group 6c

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 7c

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

mRNA-1273 SARS-CoV-2 vaccine

Other Intervention Name(s)

COVID-19 Vaccine Moderna, Spikevax

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

BNT162b2

Other Intervention Name(s)

Pfizer-BioNTech COVID-19 Vaccine, Comirnaty

Intervention Description

A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.

Intervention Type

Biological

Intervention Name(s)

ChAdOx1-S [recombinant]

Other Intervention Name(s)

Astra Zeneca COVID-19 Vaccine, COVISHIELD AstraZeneca COVID-19 Vaccine, Vaxzevria

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

0, 28 day schedule

Intervention Description

Second injection administered 28 days post first injection

Intervention Type

Other

Intervention Name(s)

0, 112 day schedule

Intervention Description

Second injection administered 112 days post first injection

Intervention Type

Biological

Intervention Name(s)

Covifenz

Other Intervention Name(s)

Medicago COVID-19 vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

Antibody response to SARS-CoV-2 S protein after 2 doses

Description

Time Frame

Day 56

Title

Antibody response to SARS-CoV-2 S protein after 2 doses

Description

Time Frame

Day 140

Title

Antibody response to SARS-CoV-2 S protein after 3 doses

Description

Time Frame

Day 28

Title

Antibody response to SARS-CoV-2 S protein after 4 doses

Description

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

Durability of antibody response to SARS-CoV-2 S over 12 months after 2 doses

Description

Assess durability of immune responses in each study group over 12 months based on anti-spike antibody titers and pseudoneutralization assay.

Time Frame

Baseline and Days 28, 56, 112, 140, 365

Title

Pseudoneutralization assay, T cell testing, Antibody dependent cellular cytotoxicity (ADCC), Antibody avidity, RNA seq after 2 doses

Description

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.

Time Frame

Days 28, 56, 112, 140, 365

Title

Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 2 doses

Description

Time Frame

From time of first study injection through Day 365.

Title

Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 3 doses

Description

Time Frame

From time of first study injection through Day 365.

Title

Acceptability of vaccines as determined by participant-completed questionnaire after 2 doses

Description

Time Frame

Days 56, 140, and 365

Title

Acceptability of vaccines as determined by participant-completed questionnaire after 3 doses

Description

Time Frame

Days 28, 180

Title

Antibody to SARS-CoV-2 S and N, RBD after 3 doses

Description

Assess durability of the immune responses in each study group over 12 months after the study vaccine.

Time Frame

Days 180 and 365

Title

Pseudoneutralization assay, T cell testing, Antibody dependent cellular cytotoxicity after 3 doses

Description

Further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365

Time Frame

Day 365

Title

Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 4 doses

Description

Time Frame

From time of first study injection through Day 365.

Title

Acceptability of vaccines as determined by participant-completed questionnaire after 4 doses

Description

Time Frame

Days 28, 180

Title

Antibody to SARS-CoV-2 S and N, RBD after 4 doses

Description

Assess durability of the immune responses in each study group over 12 months after the study vaccine.

Time Frame

Days 180 and 365

Title

Antibody dependent cellular cytotoxicity after 4 doses

Description

Further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365

Time Frame

Day 365

Title

Pseudoneutralization assay after 4 doses

Description

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

Time Frame

Day 365

Title

T cell testing after 4 doses

Description

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

Time Frame

Day 365

Other Pre-specified Outcome Measures:

Title

Exploratory assessment of interval between dose 1 and 2 on immune response after 3 or 4 doses

Description

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.

Time Frame

From time of first study injection through Day 365.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant is willing and able to give written informed consent to participate in the study Age 18 years of age or older in good health or with mild or moderate stable co-morbidities at the time of enrolment Able and willing to complete all the scheduled study procedures during the whole study follow-up period 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) 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) MOSAIC -1 Vaccine naïve subgroups: have not received an authorized COVID-19 vaccine at any time MOSAIC-2 participants have received two doses of COVID-19 vaccines authorized in Canada ≥6 months prior to study vaccine administration (documentation of receipt required) 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: Inability or unwillingness of participant or legally acceptable representative to give written informed consent 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 Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin) 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 Allergy to any study vaccine or any active substance in a study vaccine Bleeding disorder or history of significant bleeding following IM injections or venipuncture Continuous use of anticoagulants A history of anaphylaxis to a previous vaccine Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine MOSAIC-1: History of laboratory-confirmed COVID-19 disease prior to enrolment by participant report Administration of a live virus vaccine within 4 weeks prior to study vaccine receipt.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joanne Langley

Organizational Affiliation

Dalhousie University/CIRN

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Inland Hospital

City

Kamloops

State/Province

British Columbia

Country

Canada

Facility Name

Penticton Regional Hospital

City

Penticton

State/Province

British Columbia

Country

Canada

Facility Name

BC Children's Hospital Research Institute

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4H4

Country

Canada

Facility Name

Children's Hospital Research Institute of Manitoba

City

Winnipeg

State/Province

Manitoba

Country

Canada

Facility Name

Canadian Center for Vaccinology

City

Halifax

State/Province

Nova Scotia

Country

Canada

Facility Name

Ottawa Hospital Research Institute, University of Ottawa

City

Ottawa

State/Province

Ontario

Country

Canada

Facility Name

McGill University Health Centre Vaccine Study Centre

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H9H 4Y6

Country

Canada

Facility Name

CHU de Québec, Université Laval

City

Québec City

State/Province

Quebec

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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

COVID-19

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm 25

Arm 26

Arm 27

Arm 28

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial