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

NCT04978038 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: mRNA-COVID19-D3-2021
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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).

Conditions

SARS-CoV2 Infection; Coronavirus Infection

Keywords

COVID-19; Immunization; Long-term care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total IgG spike response

  28 Days

• Total IgM spike response

  28 Days

• IgA spike antibodies titre

  28 Days

• Anti-RBD antibody titre

  28 Days

• ADCC Response

  28 Days

Study Arms (2)

Pfizer-BioNtech mRNA- COVID-19

EXPERIMENTAL

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

Pneumococcal Prevnar-13

ACTIVE COMPARATOR

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

Interventions

mRNA- COVID-19 DRUG

Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly

Also known as: Pfizer-BioNtech mRNA- COVID-19

Pfizer-BioNtech mRNA- COVID-19

Prevnar13 DRUG

Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly

Also known as: Pneumococcal Vaccine

Pneumococcal Prevnar-13

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• LTCF residents ≥ 65 years who have received three doses of mRNA vaccine.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mark Loeb: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

2019-nCoV Vaccine mRNA-1273; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors; Streptococcal Vaccines; Bacterial Vaccines

Study Officials

• Mark Loeb, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Loeb, MD

CONTACT

905-525-9140; loebm@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., MSc, Professor, Pathology and Molecular Medicine, and Clinical Epidemiology and Biostatistics

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 27, 2021
• Study Start: August 1, 2022
• Primary Completion: November 15, 2022
• Study Completion: December 31, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)