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

• Sponsor: Mark Loeb (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04978038
• Collaborator: (none)
• Enrollment: 414
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 82.9

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV2 Infection; Coronavirus Infection	Drug: mRNA- COVID-19; Drug: Prevnar13	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 414 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Controlled TrialRandomized Controlled Trial
• Masking: Triple (Participant, 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.
• Primary Purpose: Prevention
• Official Title: Fourth Dose of Pfizer mRNA COVID-19 Vaccine in Residents of Long-Term Care Facilities
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Nov 15, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Total IgG spike response [28 Days]

   Secondary Outcome measured using in-house assay for IgG spike protein response

2. Total IgM spike response [28 Days]

   Secondary Outcome measured using in-house assay for IgM spike protein response

3. IgA spike antibodies titre [28 Days]

   Secondary Outcome measured using in-house assay for IgA spike protein titre

4. Anti-RBD antibody titre [28 Days]

   Secondary Outcome measured using in-house assay for Anti-RBD antibody titre

5. ADCC Response [28 Days]

   Secondary Outcome measured using in-house assay for ADCC response

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster University	Hamilton	Ontario	Canada	L8S 4K1

Sponsors and Collaborators

• Mark Loeb

Investigators

• Principal Investigator: Mark Loeb, MD, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Loeb, M.D., MSc, Professor, Pathology and Molecular Medicine, and Clinical Epidemiology and Biostatistics, McMaster University
• ClinicalTrials.gov Identifier: NCT04978038
• Other Study ID Numbers: mRNA-COVID19-D3-2021
• First Posted: Jul 27, 2021
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Mark Loeb, M.D., MSc, Professor, Pathology and Molecular Medicine, and Clinical Epidemiology and Biostatistics, McMaster University: COVID-19; Immunization; Long-term care
• Additional relevant MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

No Results Posted as of Jun 30, 2022