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Trial record 1 of 1 for:    NCT04894435
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Mix and Match of the Second COVID-19 Vaccine Dose for Safety and Immunogenicity (MOSAIC)

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ClinicalTrials.gov Identifier: NCT04894435
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : August 25, 2021
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
Information provided by (Responsible Party):
Canadian Immunization Research Network

Brief Summary:
The main goals of this study are to assess the immune response and safety of two different vaccines for first and second 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 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Group 1 - Moderna mRNA and Moderna mRNA - 28 days apart
  • Group 2 - Moderna mRNA and Moderna mRNA - 16 weeks (112 days) apart
  • Group 3 - Moderna mRNA and Pfizer/BioNTech mRNA - 28 days apart
  • Group 4 - Moderna mRNA and Pfizer/BioNTech mRNA - 16 weeks (112 days) weeks apart
  • Group 5 - Pfizer/BioNTech mRNA and Pfizer/BioNTech mRNA - 28 days apart
  • Group 6 - Pfizer/BioNTech mRNA and Pfizer/BioNTech mRNA - 16 weeks (112 days) apart
  • Group 7 - Pfizer/BioNTech mRNA and Moderna mRNA - 28 days apart
  • Group 8 - Pfizer/BioNTech mRNA and Moderna mRNA - 16 weeks (112 days) apart
  • Group 9 - AZ and Moderna mRNA - 28 days apart
  • Group 10 - AZ and Moderna mRNA - 16 weeks (112 days) apart
  • Group 11 - AZ and Pfizer/BioNTech - 28 days apart
  • Group 12 - AZ and Pfizer/BioNTech - 16 weeks (112 days) apart
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants, laboratory staff, and statistical analysis personnel will be blinded to which vaccine they are receiving.
Primary Purpose: Prevention
Official Title: Immunogenicity and Adverse Events Following Immunization With Alternate Schedules of Authorized COVID-19 Vaccines in Canada: MOSAIC Study (Mix and Match of the Second cOvid-19 Vaccine Dose for SAfety and ImmunogeniCity)
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

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 Name: 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 Name: 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 Name: 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 Name: Pfizer-BioNTech COVID-19 Vaccine

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 Name: 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 Name: Pfizer-BioNTech COVID-19 Vaccine

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 Name: Pfizer-BioNTech COVID-19 Vaccine

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 Name: Pfizer-BioNTech COVID-19 Vaccine

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 Name: 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 Name: Pfizer-BioNTech COVID-19 Vaccine

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 Name: 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 Name: Pfizer-BioNTech COVID-19 Vaccine

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 Name: COVID-19 Vaccine Moderna

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

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 Name: COVID-19 Vaccine Moderna

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

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

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

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




Primary Outcome Measures :
  1. Antibody response to SARS-CoV-2 S protein [ 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 [ 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.


Secondary Outcome Measures :
  1. Durability of antibody response to SARS-CoV-2 S over 12 months [ 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 [ 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. [ 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. Acceptability of vaccines as determined by participant-completed questionnaire. [ 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.



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 second dose of study vaccine (Please refer to the definition section for a description of child-bearing potential and adequate contraception)
  5. Vaccine-exposed subgroups: have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 57 days prior to Visit 1 (documentation of receipt required), OR
  6. Vaccine naïve subgroups: have not received an authorized COVID-19 vaccine at any time

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. History of laboratory-confirmed COVID-19 disease prior to enrolment by participant report

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


Contacts
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Contact: Melissa Holmes 902-470-6854 melissa.holmes@dal.ca
Contact: Jill Mutch, RN 902-470-3860 jill.mutch@iwk.nshealth.ca

Locations
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Canada, Alberta
University of Alberta Withdrawn
Edmonton, Alberta, Canada
Canada, British Columbia
Royal Inland Hospital Not yet recruiting
Kamloops, British Columbia, Canada
Contact: Joyce Okofo Adjei    250-274-2995    joyce.okohoadjei@interiorhealth.ca   
Principal Investigator: Elizabeth Parfitt         
Penticton Regional Hospital Not yet recruiting
Penticton, British Columbia, Canada
Contact: Susan Keast    250-274-2995    susan.keast@interiorhealth.ca   
Principal Investigator: Tom Oliver         
Sub-Investigator: Tiffany Bursey         
BC Children's Hospital Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z 4H4
Contact: Lovelyn Charles    604-875-2187    mosaic.vec@bcchr.ubc   
Principal Investigator: Manish Sadarangani         
Canada, Manitoba
Children's Hospital Research Institute of Manitoba Recruiting
Winnipeg, Manitoba, Canada
Contact: Rachel Keijzer    204-789-3206    rkeijzer2@chrim.ca   
Principal Investigator: Guillaume Poliquin         
Canada, Nova Scotia
Canadian Center for Vaccinology Recruiting
Halifax, Nova Scotia, Canada
Contact: Yasaswini Palukuru    902-470-8141    ccfv@iwk.nshealth.ca   
Principal Investigator: Joanne Langley         
Canada, Ontario
Ottawa Hospital Research Institute, University of Ottawa Recruiting
Ottawa, Ontario, Canada
Contact: Jennifer Dodd    613-737-8899 ext 72310    mosaicstudy@toh.ca   
Principal Investigator: Juthaporn Cowan         
Canada, Quebec
CHU de Québec, Université Laval Recruiting
Québec City, Quebec, Canada
Contact: Jo-Ann Costa    418-666-7000 ext 10269    recherche_vaccination@ssss.gouv.qc.ca   
Principal Investigator: Marc Dionne         
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
Investigators
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Principal Investigator: Joanne Langley Dalhousie University/CIRN
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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: August 25, 2021
Last Verified: August 2021

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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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Vaccines
Immunologic Factors
Physiological Effects of Drugs