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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Coronavirus Infection; SARS-CoV2 Infection
• Intervention / Treatment: Drug: mRNA- COVID-19; Drug: Prevnar13

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 Type: Interventional
• Enrollment (Anticipated): 414
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mark Loeb, MD; Phone Number: 26066 905-525-9140; Email: loebm@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pfizer-BioNtech 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.	Drug: mRNA- COVID-19; Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly; Other Names: Pfizer-BioNtech mRNA- COVID-19
Active Comparator: Pneumococcal Prevnar-13; 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; Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly; Other Names: Pneumococcal Vaccine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mark Loeb
• Investigators: Principal Investigator: Mark Loeb, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): November 15, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Immunization; Long-term care
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Coronavirus Infections; Infections; Communicable Diseases; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: mRNA-COVID19-D3-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Personal identification information removed and assigned a number. Information linked ID to identifying information stored securely at McMaster. Only vaccine administration will have access to identifying information. No personal identification will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes