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

Phase 4

• Conditions: Coronavirus Infection; SARS-CoV2 Infection
• Interventions: Drug: mRNA- COVID-19; Drug: Prevnar13

• Registration Number: NCT04978038
• Lead Sponsor: Mark Loeb

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.

Study Timeline

• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-23
• Study First Posted: 2021-07-27
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30
• Study Start: 2022-08-01
• Primary Completion: 2022-11-15
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 414

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pfizer-BioNtech mRNA- COVID-19	mRNA- COVID-19	Eligible participants will be vaccinated with the Pfizer-BioNtech mRNA- COVID-19. A 0.3ml dose of the vaccine will be administered intramuscularly.
Pneumococcal Prevnar-13	Prevnar13	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Anti-RBD antibody titre	28 Days	Secondary Outcome measured using in-house assay for Anti-RBD antibody titre
IgA spike antibodies titre	28 Days	Secondary Outcome measured using in-house assay for IgA spike protein titre
ADCC Response	28 Days	Secondary Outcome measured using in-house assay for ADCC response
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

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada