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

C

Canadian Immunization Research Network

Status and phase

Active, not recruiting
Phase 2

Conditions

COVID-19

Treatments

Biological: Covifenz
Other: 0, 28 day schedule
Biological: mRNA-1273 SARS-CoV-2 vaccine
Other: 0, 112 day schedule
Biological: ChAdOx1-S [recombinant]
Biological: BNT162b2

Study type

Interventional

Funder types

Other
NETWORK
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

669 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

669 participants in 28 patient groups

Group 1: Moderna, Moderna - 28 Days apart
Active Comparator group
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.
Treatment:
Other: 0, 28 day schedule
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 2: Moderna, Moderna - 112 days apart
Active Comparator group
Description:
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.
Treatment:
Other: 0, 112 day schedule
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 3: Moderna, Pfizer/BioNTech - 28 days apart
Active Comparator group
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 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.
Treatment:
Biological: BNT162b2
Other: 0, 28 day schedule
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 4: Moderna, Pfizer/BioNTech - 112 days apart
Active Comparator group
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.
Treatment:
Biological: BNT162b2
Other: 0, 112 day schedule
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 5: Pfizer/BioNTech, Pfizer/BioNTech - 28 days apart
Active Comparator group
Description:
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.
Treatment:
Biological: BNT162b2
Other: 0, 28 day schedule
Group 6: Pfizer/BioNTech, Pfizer/BioNTech - 112 days apart
Active Comparator group
Description:
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.
Treatment:
Biological: BNT162b2
Other: 0, 112 day schedule
Group 7: Pfizer/BioNTech, Moderna - 28 days apart
Active Comparator group
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 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.
Treatment:
Biological: BNT162b2
Other: 0, 28 day schedule
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 8: Pfizer/BioNTech, Moderna - 112 days apart
Active Comparator group
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.
Treatment:
Biological: BNT162b2
Other: 0, 112 day schedule
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 9: Astra Zeneca, Moderna - 28 days apart
Active Comparator group
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 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.
Treatment:
Biological: ChAdOx1-S [recombinant]
Other: 0, 28 day schedule
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 10: Astra Zeneca, Moderna - 112 days apart
Active Comparator group
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.
Treatment:
Biological: ChAdOx1-S [recombinant]
Other: 0, 112 day schedule
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart
Active Comparator group
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 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection.
Treatment:
Biological: BNT162b2
Biological: ChAdOx1-S [recombinant]
Other: 0, 28 day schedule
Group 12: Astra Zeneca, Pfizer/BioNTech - 112 days apart
Active Comparator group
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.
Treatment:
Biological: BNT162b2
Biological: ChAdOx1-S [recombinant]
Other: 0, 112 day schedule
Group 1b
Active Comparator group
Description:
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: BNT162b2
Group 2b
Active Comparator group
Description:
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 3b
Active Comparator group
Description:
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 4b
Active Comparator group
Description:
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: BNT162b2
Group 5b
Active Comparator group
Description:
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 6b
Active Comparator group
Description:
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: BNT162b2
Group 7b
Active Comparator group
Description:
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: BNT162b2
Group 8b
Active Comparator group
Description:
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 9b
Experimental group
Description:
Participants will receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: Covifenz
Group 1c
Active Comparator group
Description:
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: BNT162b2
Group 2c
Active Comparator group
Description:
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: Covifenz
Group 3c
Active Comparator group
Description:
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 4c
Active Comparator group
Description:
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: Covifenz
Group 5c
Active Comparator group
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.
Treatment:
Biological: BNT162b2
Biological: mRNA-1273 SARS-CoV-2 vaccine
Group 6c
Active Comparator group
Description:
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: Covifenz
Group 7c
Experimental group
Description:
Participants will receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Treatment:
Biological: Covifenz

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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