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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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SARS-CoV2 Infection Coronavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

mRNA- COVID-19

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Prevnar13

Intervention Type DRUG

Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly

Interventions

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mRNA- COVID-19

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

Intervention Type DRUG

Prevnar13

Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly

Intervention Type DRUG

Other Intervention Names

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Pfizer-BioNtech mRNA- COVID-19 Pneumococcal Vaccine

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes