This study is a multi-centre, blinded, randomized controlled trial. LTCF residents ≥ 65 years who have received three doses of mRNA vaccine will be randomized to vaccination with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine or to vaccination with a control (Prevnar-13 vaccine).
The primary objective of this study is to test whether vaccinating LTCF residents ≥65 years with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine as compared to control (PCV13) leads to an increase in detectable neutralizing antibodies. Participants will be randomized to receive either the Pfizer COVID-19 vaccine or the Pnemoccocal Prevnar-13 vaccine at baseline after bloodwork is drawn. Another blood sample will be taken 28 days later. After completion of the study, participants in the control group (pneumococcal Prevnar-13 vaccine) will be given a fourth dose of mRNA COVID-19 vaccine and will have their blood drawn 28 days post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
414
Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly
Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly
McMaster University
Hamilton, Ontario, Canada
Detection of neutralizing antibodies
The primary outcome of this study will be detectable neutralizing antibody to the Omicron strain of SARS-CoV-2.
Time frame: 28 days
Total IgG spike response
Secondary Outcome measured using in-house assay for IgG spike protein response
Time frame: 28 Days
Total IgM spike response
Secondary Outcome measured using in-house assay for IgM spike protein response
Time frame: 28 Days
IgA spike antibodies titre
Secondary Outcome measured using in-house assay for IgA spike protein titre
Time frame: 28 Days
Anti-RBD antibody titre
Secondary Outcome measured using in-house assay for Anti-RBD antibody titre
Time frame: 28 Days
ADCC Response
Secondary Outcome measured using in-house assay for ADCC response
Time frame: 28 Days
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