This study is a multi-centre, blinded, randomized controlled trial. LTCF residents ≥ 65years who have received three doses of mRNA vaccine will be randomized to vaccinationwith a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine or to vaccination with acontrol (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.
Drug: mRNA- COVID-19
Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly
Other Name: Pfizer-BioNtech mRNA- COVID-19
Drug: Prevnar13
Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly
Other Name: Pneumococcal Vaccine
Inclusion Criteria:
- LTCF residents ≥ 65 years who have received three doses of mRNA vaccine.
Exclusion Criteria:
- Immunocompromised individuals due to known or suspected immunodeficiency or due to
receipt of immunosuppressive medication (e.g., steroids, biologics).
- Having had a severe adverse reaction (e.g., anaphylactic allergy) to mRNA or
pneumococcal vaccine.
- Having received pneumococcal polysaccharide vaccine within 12 months.
- LTCF residents who have an interval less than 3 months from their third mRNA COVID
vaccine dose.
McMaster University
Hamilton, Ontario, Canada
Mark Loeb, MD
905-525-9140 - 26066
loebm@mcmaster.ca
Mark Loeb, MD, Principal Investigator
McMaster University