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

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.

Conditions

• COVID-19

Interventions

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.

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.

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

0, 28 day schedule

Second injection administered 28 days post first injection

OTHER

0, 112 day schedule

Second injection administered 112 days post first injection

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

Sponsors & Collaborators

• Canadian Center for Vaccinology

  collaborator OTHER

• BC Children's Hospital Research Institute

  collaborator OTHER

• Children's Hospital Research Institute of Manitoba

  collaborator OTHER

• CHU de Quebec-Universite Laval

  collaborator OTHER

• Ottawa Hospital Research Institute

  collaborator OTHER

• Ontario Agency for Health Protection and Promotion

  collaborator OTHER_GOV

• University of Toronto

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Interior Health

  collaborator INDUSTRY

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• Canadian Immunization Research Network

  lead NETWORK

Principal Investigators

• Joanne Langley · Dalhousie University/CIRN

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-20

Primary Completion

2024-11-15

Completion

2025-08-01

Countries

• Canada

Study Locations