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mRNA Vaccine

mRNA- COVID-19 for COVID-19

Phase 4
Waitlist Available
Led By Mark Loeb, MD
Research Sponsored by Mark Loeb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
LTCF residents ≥ 65 years who have received three doses of mRNA vaccine.
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is testing whether a fourth dose of the Pfizer vaccine is more effective than a control vaccine in people 65 and older who have already received three doses of the Pfizer vaccine.

Eligible Conditions
  • COVID-19
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antibodies, Blocking
Secondary outcome measures
ADCC Response
Anti-RBD antibody titre
IgA spike antibodies titre
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pfizer-BioNtech mRNA- COVID-19Experimental Treatment1 Intervention
Eligible participants will be vaccinated with the Pfizer-BioNtech mRNA- COVID-19. A 0.3ml dose of the vaccine will be administered intramuscularly.
Group II: Pneumococcal Prevnar-13Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Mark LoebLead Sponsor
Mark Loeb, MDPrincipal InvestigatorMcMaster University
8 Previous Clinical Trials
6,421 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA signed off on MRNA-1273?

"Our team assesses the safety of MRNA-1273 as a 3 because it has already cleared Phase 4 trials, signifying its approval."

Answered by AI

How many individuals are involved in this experiment?

"This clinical trial is not presently recruiting. It was initially posted on August 1st, 2022 and its latest update occurred on June 29th of the same year. If you are in search for other research studies, there are 1750 trials actively searching for patients with infections as well as 25 studies that are seeking participants to assess the efficacy of MRNA-1273."

Answered by AI

What key aims are being sought after from this research endeavor?

"The main goal of this 28-day clinical trial is to detect neutralizing antibodies against the vaccine strain. Secondary objectives include monitoring total IgM and IgG spike response, as well as Anti-RBD antibody titre, all measured using in-house assays."

Answered by AI

Has this particular research been conducted before?

"Currently, there are 25 active clinical trials of MRNA-1273 spanning 218 cities and 22 nations. The first ever trial of this drug was conducted by ModernaTX, Inc in 2020 with a sample size of 30 thousand participants running through the Phase 3 approval stage. Since then, 13 more have been finalized."

Answered by AI

Has research been conducted with MRNA-1273 prior to this?

"Currently, 25 trials of MRNA-1273 are ongoing, 11 of these reaching the final phase. Although some studies take place in Liverpool and New york City, there are a sum total of 596 clinical trial sites worldwide testing this drug."

Answered by AI

Is the enrollment phase of this trial still open?

"Unfortunately, this investigation is currently not accepting applications. It was initially posted on August 1st 2022 and edited for the last time at the end of June that same year. If you are on the hunt for other studies, there are presently 1750 trials searching for individuals with infections and 25 active recruitment efforts for MRNA-1273 patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fourth Dose of mRNA COVID-19 Vaccine in Residents of LTCFs
Mark Loeb 2022. "Fourth Dose of mRNA COVID-19 Vaccine in Residents of LTCFs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04978038.
~155 spots leftby Apr 2025
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