Fourth Dose of mRNA COVID-19 Vaccine in Residents of LTCFs | NCT04978038

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

NCT04978038

Sponsor

Mark Loeb

Status

Unknown status

Last Update Posted

Jun 30, 2022Actual

Enrollment

414Estimated

Phase

Phase 4

Conditions

SARS-CoV2 Infection
Coronavirus Infection

Interventions

mRNA- COVID-19
Prevnar13

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Estimated

Primary Completion Date

Nov 15, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Jul 20, 2021

First Submission Date that Met QC Criteria

Jul 23, 2021

First Posted Date

Jul 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2022

Last Update Posted Date

Jun 30, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mark Loeb, M.D., MSc, Professor, Pathology and Molecular Medicine, and Clinical Epidemiology and Biostatistics, McMaster UniversitySponsor-Investigator

Lead Sponsor

Mark LoebOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

414Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
mRNA- COVID-19	Drug	Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly	Pfizer-BioNtech mRNA- COVID-19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Total IgG spike response	Secondary Outcome measured using in-house assay for IgG spike protein response	28 Days
Total IgM spike response	Secondary Outcome measured using in-house assay for IgM spike protein response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mark Loeb, MD	Contact	905-525-9140	26066	loebm@mcmaster.ca

Overall Officials

Name	Affiliation	Role
Mark Loeb, MD	McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McMaster University		Hamilton	Ontario	L8S 4K1	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Personal identification information removed and assigned a number. Information linked ID to identifying information stored securely at McMaster. Only vaccine administration will have access to identifying information. No personal identification will be published.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000090983	2019-nCoV Vaccine mRNA-1273
D022242	Pneumococcal Vaccines

Ancestor Terms

ID	Term
D000087503	mRNA Vaccines
D000087504	Nucleic Acid-Based Vaccines
D014614	Vaccines, Synthetic
D011994	Recombinant Proteins

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Triple

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.

Who Masked

ParticipantInvestigatorOutcomes Assessor