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

Primary Purpose

SARS-CoV2 Infection, Coronavirus Infection

Status
Not yet recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
mRNA- COVID-19
Prevnar13
Sponsored by
Mark Loeb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV2 Infection focused on measuring COVID-19, Immunization, Long-term care

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pfizer-BioNtech mRNA- COVID-19

Pneumococcal Prevnar-13

Arm Description

Eligible participants will be vaccinated with the Pfizer-BioNtech mRNA- COVID-19. A 0.3ml dose of the vaccine will be administered intramuscularly.

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.

Outcomes

Primary Outcome Measures

Detection of neutralizing antibodies
The primary outcome of this study will be detectable neutralizing antibody to the Omicron strain of SARS-CoV-2.

Secondary Outcome Measures

Total IgG spike response
Secondary Outcome measured using in-house assay for IgG spike protein response
Total IgM spike response
Secondary Outcome measured using in-house assay for IgM spike protein response
IgA spike antibodies titre
Secondary Outcome measured using in-house assay for IgA spike protein titre
Anti-RBD antibody titre
Secondary Outcome measured using in-house assay for Anti-RBD antibody titre
ADCC Response
Secondary Outcome measured using in-house assay for ADCC response

Full Information

First Posted
July 20, 2021
Last Updated
June 29, 2022
Sponsor
Mark Loeb
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1. Study Identification

Unique Protocol Identification Number
NCT04978038
Brief Title
Fourth Dose of mRNA COVID-19 Vaccine in Residents of LTCFs
Official Title
Fourth Dose of Pfizer mRNA COVID-19 Vaccine in Residents of Long-Term Care Facilities
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Loeb

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection, Coronavirus Infection
Keywords
COVID-19, Immunization, Long-term care

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
414 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pfizer-BioNtech mRNA- COVID-19
Arm Type
Experimental
Arm Description
Eligible participants will be vaccinated with the Pfizer-BioNtech mRNA- COVID-19. A 0.3ml dose of the vaccine will be administered intramuscularly.
Arm Title
Pneumococcal Prevnar-13
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
mRNA- COVID-19
Other Intervention Name(s)
Pfizer-BioNtech mRNA- COVID-19
Intervention Description
Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly
Intervention Type
Drug
Intervention Name(s)
Prevnar13
Other Intervention Name(s)
Pneumococcal Vaccine
Intervention Description
Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly
Primary Outcome Measure Information:
Title
Detection of neutralizing antibodies
Description
The primary outcome of this study will be detectable neutralizing antibody to the Omicron strain of SARS-CoV-2.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Total IgG spike response
Description
Secondary Outcome measured using in-house assay for IgG spike protein response
Time Frame
28 Days
Title
Total IgM spike response
Description
Secondary Outcome measured using in-house assay for IgM spike protein response
Time Frame
28 Days
Title
IgA spike antibodies titre
Description
Secondary Outcome measured using in-house assay for IgA spike protein titre
Time Frame
28 Days
Title
Anti-RBD antibody titre
Description
Secondary Outcome measured using in-house assay for Anti-RBD antibody titre
Time Frame
28 Days
Title
ADCC Response
Description
Secondary Outcome measured using in-house assay for ADCC response
Time Frame
28 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Loeb, MD
Phone
905-525-9140
Ext
26066
Email
loebm@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Loeb, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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