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

Coronavirus Infection Clinical Trial

Official title:

Fourth Dose of Pfizer mRNA COVID-19 Vaccine in Residents of Long-Term Care Facilities

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04978038
• Other study ID #: mRNA-COVID19-D3-2021
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: McMaster University
• Contact: Mark Loeb, MD
• Phone: 905-525-9140
• Email: loebm[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 414
• Est. completion date: December 31, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Infections
• SARS-CoV2 Infection

Intervention

Drug:
• mRNA- COVID-19
Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly
• Prevnar13
Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mark Loeb

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total IgG spike response	Secondary Outcome measured using in-house assay for IgG spike protein response	28 Days
Secondary	Total IgM spike response	Secondary Outcome measured using in-house assay for IgM spike protein response	28 Days
Secondary	IgA spike antibodies titre	Secondary Outcome measured using in-house assay for IgA spike protein titre	28 Days
Secondary	Anti-RBD antibody titre	Secondary Outcome measured using in-house assay for Anti-RBD antibody titre	28 Days
Secondary	ADCC Response	Secondary Outcome measured using in-house assay for ADCC response	28 Days