SARS-CoV2 Infection, Coronavirus Infection
Conditions
Keywords
COVID-19, Immunization, Long-term care
Brief summary
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).
Detailed description
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.
Interventions
DRUGmRNA- COVID-19
Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly
DRUGPrevnar13
Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly
Sponsors
Mark Loeb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, investigators, laboratory staff, safety monitoring committee and research assistants will be blinded. To maintain blinding of the participants, those allocated to the control will receive .5ml Prevnar-13 vaccine to mimic mRNA vaccine. Study vaccine will be administered by unblinded nurses.
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of neutralizing antibodies | 28 days | The primary outcome of this study will be detectable neutralizing antibody to the Omicron strain of SARS-CoV-2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total IgG spike response | 28 Days | Secondary Outcome measured using in-house assay for IgG spike protein response |
| Total IgM spike response | 28 Days | Secondary Outcome measured using in-house assay for IgM spike protein response |
| IgA spike antibodies titre | 28 Days | Secondary Outcome measured using in-house assay for IgA spike protein titre |
| Anti-RBD antibody titre | 28 Days | Secondary Outcome measured using in-house assay for Anti-RBD antibody titre |
| ADCC Response | 28 Days | Secondary Outcome measured using in-house assay for ADCC response |
Countries
Canada
Contacts
Primary ContactMark Loeb, MD
Outcome results
None listed