Fourth Dose of mRNA COVID-19 Vaccine in Residents of LTCFs

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fourth Dose of Pfizer mRNA COVID-19 Vaccine in Residents of Long-Term Care Facilities

Conditions
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SARS-CoV2 Infection, Coronavirus Infection

Intervention / Treatment
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* Drug: mRNA- COVID-19
* Drug: Prevnar13


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pfizer-BioNtech mRNA- COVID-19<br>Eligible participants will be vaccinated with the Pfizer-BioNtech mRNA- COVID-19. A 0.3ml dose of the vaccine will be administered intramuscularly. | Drug: mRNA- COVID-19<br>* Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly<br>* Other names: Pfizer-BioNtech mRNA- COVID-19;|
| Active Comparator: Pneumococcal Prevnar-13<br>Eligible participants will be vaccinated with Pfizer Prevar-13 (pneumococcal vaccine) in a blinded manner such that the vaccination with Pfizer-BioNtech mRNA- COVID-19 will be mimicked. That is, a 0.5ml dose of the vaccine will be administered intramuscularly. After completion of the study participants in the control arm will be given a fourth dose of Pfizer-BioNtech mRNA- COVID-19. | Drug: Prevnar13<br>* Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly<br>* Other names: Pneumococcal Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of neutralizing antibodies | The primary outcome of this study will be detectable neutralizing antibody to the Omicron strain of SARS-CoV-2. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total IgG spike response | Secondary Outcome measured using in-house assay for IgG spike protein response | 28 Days | 
| Total IgM spike response | Secondary Outcome measured using in-house assay for IgM spike protein response | 28 Days | 
| IgA spike antibodies titre | Secondary Outcome measured using in-house assay for IgA spike protein titre | 28 Days | 
| Anti-RBD antibody titre | Secondary Outcome measured using in-house assay for Anti-RBD antibody titre | 28 Days | 
| ADCC Response | Secondary Outcome measured using in-house assay for ADCC response | 28 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Immunization, Long-term care