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

Mark Loeb

Status and phase: Not yet enrolling; Phase 4

Conditions: SARS-CoV2 Infection; Coronavirus Infection

Treatments: Drug: mRNA- COVID-19; Drug: Prevnar13

Study type: Interventional

Funder types: Other

Identifiers

NCT04978038

mRNA-COVID19-D3-2021

Details and patient eligibility

About

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).

Full 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.

Enrollment: 414 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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414 participants in 2 patient groups

Pfizer-BioNtech mRNA- COVID-19

Experimental group

Description:

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

Treatment:

Drug: mRNA- COVID-19

Pneumococcal Prevnar-13

Active Comparator group

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.

Treatment:

Drug: Prevnar13