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Trial record 1 of 1 for:    NCT04978038
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Third Dose of COVID-19 Vaccine in LTCF Residents

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ClinicalTrials.gov Identifier: NCT04978038
Recruitment Status : Not yet recruiting
First Posted : July 27, 2021
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Mark Loeb, McMaster University

Brief Summary:
This study is a multi-centre, blinded, randomized controlled trial. LTCF residents ≥65 years who have had two doses of mRNA-1273 vaccine will be randomized to vaccination with a third dose of mRNA-1273 vaccine or to vaccination with a control (Prevnar-13 vaccine).

Condition or disease Intervention/treatment Phase
SARS-CoV2 Infection Coronavirus Infection Drug: MRNA-1273 Drug: Prevnar13 Phase 4

Detailed Description:
The primary objective of this study is to test whether vaccinating LTCF residents ≥65 years with a third dose of mRNA-1273 (Moderna COVID-19) vaccine as compared to control (Prevnar-13) lead to increase in detectable neutralizing antibody. Participants will be randomized to receive either the Moderna 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 offered a third dose of mRNA-1273 if our data show that a third dose is effective in boosting the immune response.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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.
Primary Purpose: Prevention
Official Title: Third Dose of Moderna mRNA-1273 COVID-19 Vaccine in Residents of Long-Term Care Facilities
Estimated Study Start Date : September 15, 2021
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : April 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mRNA-1273 Vaccine
Eligible participants will be vaccinated with the mRNA-1273 (Moderna COVID-19 Vaccine). A .5ml dose of the vaccine will be administered intramuscularly.
Drug: MRNA-1273
Moderna COVID-19 Vaccine (mRNA-1273) .5ml dose administered intramuscularly
Other Name: Moderna COVID-19 Vaccine

Active Comparator: Pneumococcal Prevnar-13
Eligible participants will be vaccinated with Pfizer Prevar-13 (pneumococcal vaccine) in a blinded manner such that the vaccination with mRNA-1273 will be mimicked. That is, a .5ml dose of the vaccine will be administered intramuscularly. After completion of the study participants in the control arm will be offered a third dose of mRNA-1273 if our data shows that a third dose is effective in boosting the immune response.
Drug: Prevnar13
Pfizer Prevnar-13 pneumococcal vaccine .5ml dose administered intramuscularly
Other Name: Pneumococcal Vaccine




Primary Outcome Measures :
  1. Detection of neutralizing antibody to the vaccine strain. [ Time Frame: 28 Days ]
    The primary outcome of this study will be detectable neutralizing antibody to the vaccine strain at 4 weeks following the third dose of mRNA-1273 vaccine. The trial will be blocked and stratified by LTCFs. Participants will be asked to obtain a third blood draw at a 6-month time interval for longer-term assessment of the immune response following the third dose.

  2. Detection of neutralizing antibody to the vaccine strain. [ Time Frame: 6 months ]
    The primary outcome of this study will be detectable neutralizing antibody to the vaccine strain at 4 weeks following the third dose of mRNA-1273 vaccine. The trial will be blocked and stratified by LTCFs. Participants will be asked to obtain a third blood draw at a 6-month time interval for longer-term assessment of the immune response following the third dose.


Secondary Outcome Measures :
  1. Total IgG spike response [ Time Frame: 28 Days ]
    Secondary Outcome measured using in-house assay for IgG spike protein response

  2. Total IgG spike response [ Time Frame: 6 months ]
    Secondary Outcome measured using in-house assay for IgG spike protein response

  3. Total IgM spike response [ Time Frame: 28 Days ]
    Secondary Outcome measured using in-house assay for IgM spike protein response

  4. Total IgM spike response [ Time Frame: 6 months ]
    Secondary Outcome measured using in-house assay for IgM spike protein response

  5. IgA spike antibodies titre [ Time Frame: 28 Days ]
    Secondary Outcome measured using in-house assay for IgA spike protein titre

  6. IgA spike antibodies titre [ Time Frame: 6 Months ]
    Secondary Outcome measured using in-house assay for IgA spike protein titre

  7. Anti-RBD antibody titre [ Time Frame: 28 Days ]
    Secondary Outcome measured using in-house assay for Anti-RBD antibody titre

  8. Anti-RBD antibody titre [ Time Frame: 6 Months ]
    Secondary Outcome measured using in-house assay for Anti-RBD antibody titre

  9. ADCC Response [ Time Frame: 28 Days ]
    Secondary Outcome measured using in-house assay for ADCC response

  10. ADCC Response [ Time Frame: 6 Months ]
    Secondary Outcome measured using in-house assay for ADCC response



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A LTCF resident will be eligible if they are ≥ 65 years and have received two doses of mRNA-1273 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-1273 or pneumococcal Prevnar-13 vaccine
  • Having received pneumococcal polysaccharide vaccine within 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04978038


Contacts
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Contact: Mark Loeb, MD 905-525-9140 ext 26066 loebm@mcmaster.ca

Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
Mark Loeb
Investigators
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Principal Investigator: Mark Loeb, MD McMaster University
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Responsible Party: Mark Loeb, M.D., MSc, Professor, Pathology and Molecular Medicine, and Clinical Epidemiology and Biostatistics, McMaster University
ClinicalTrials.gov Identifier: NCT04978038    
Other Study ID Numbers: mRNA-1273-D3-2021
First Posted: July 27, 2021    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mark Loeb, McMaster University:
COVID-19
Immunization
Long-term care
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs