COVID-19 Vaccine For Indirect Protection
Primary Purpose
Vaccine Preventable Disease
Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
COVID-19 Vaccination
Usual care
Sponsored by
About this trial
This is an interventional prevention trial for Vaccine Preventable Disease focused on measuring vaccination, herd immunity, COVID-19
Eligibility Criteria
Group A: Anyone other than the adults aged ≥18 years who are vaccinated
Inclusion Criteria:
- Individuals under the age of 18
- Individuals with a contraindication to study vaccines
- Those not willing to be vaccinated but consent to follow up
Exclusion Criteria:
- There are no exclusion criteria for this category of participants:
Group B: Adults aged 18 years or older, who will be vaccinated as part of the intervention.
Exclusion Criteria:
- Anaphylactic reaction to any component of the study vaccine or to a previous dose of the study vaccines
- Pregnancy
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
COVID-19
Control
Arm Description
mRNA-1273 vaccine
Usual care
Outcomes
Primary Outcome Measures
RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members
RT-PCR confirmed from nasal swabs
Secondary Outcome Measures
RT-PCR confirmed COVID-19 among all Hutterite colony members
RT-PCR confirmed from nasal swabs
RT-PCR confirmed COVID-19 in high-risk participants
RT-PCR confirmed from nasal swabs
COVID-19 antibody testing
Blood spot testing of COVID-19 antibodies
Acute respiratory illness
Participant self-report
School or work-related absenteeism
Participant self-report
Physician visits for respiratory illness
Participant self-report
Signs and symptoms of lower respiratory infection and pneumonia
Participant self-report
Intensive care admission
Participant self-report
Mechanical ventilation
Participant self-report
Death
Participant self-report
Full Information
NCT ID
NCT04818736
First Posted
March 24, 2021
Last Updated
May 12, 2021
Sponsor
McMaster University
Collaborators
University of Alberta, University of Saskatchewan, University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT04818736
Brief Title
COVID-19 Vaccine For Indirect Protection
Official Title
COVID Vaccine for Indirect Protection: A Cluster Randomized Controlled Trial in Hutterite Colonies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Vaccine roll out plans increased so timing was no longer feasible
Study Start Date
April 15, 2021 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
University of Alberta, University of Saskatchewan, University of Manitoba
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to test whether vaccinating adults ≥18 years in Hutterite colonies with mRNA-1273 (Moderna COVID-19) vaccine as compared to control (usual care) can prevent RT-PCR confirmed COVID-19 in non-vaccinated Hutterite members.
Detailed Description
Despite the efficacy that has been demonstrated in Phase III randomized controls trials of mRNA COVID-19 vaccines, a critical question that remains unanswered is whether mRNA vaccines lead to herd immunity. The rationale for conducting this study is to learn whether vaccinating adults with a COVID-19 vaccine will prevent COVID-19 infections in non-vaccinated community members. Hutterite communities are unique since they are isolated from towns and cities and also share a number of communal activities, such as eating meals and attending church. Because of their location and practices, the Hutterite colonies give an opportunity to see whether vaccinating some Hutterite members with the COVID vaccine provides protection to the whole group. If the study shows that immunizing some of the population reduces the level of COVID-19 infection for other members of the population, this may be very important in stopping the COVID-19 pandemic and future pandemics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine Preventable Disease
Keywords
vaccination, herd immunity, COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID-19
Arm Type
Experimental
Arm Description
mRNA-1273 vaccine
Arm Title
Control
Arm Type
Experimental
Arm Description
Usual care
Intervention Type
Biological
Intervention Name(s)
COVID-19 Vaccination
Other Intervention Name(s)
Moderna mRNA-1273 vaccine
Intervention Description
Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.
Primary Outcome Measure Information:
Title
RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members
Description
RT-PCR confirmed from nasal swabs
Time Frame
12 week period starting after first dose
Secondary Outcome Measure Information:
Title
RT-PCR confirmed COVID-19 among all Hutterite colony members
Description
RT-PCR confirmed from nasal swabs
Time Frame
12 week period starting after first dose
Title
RT-PCR confirmed COVID-19 in high-risk participants
Description
RT-PCR confirmed from nasal swabs
Time Frame
12 week period starting after first dose
Title
COVID-19 antibody testing
Description
Blood spot testing of COVID-19 antibodies
Time Frame
Baseline and through study completion, estimated at 4 months
Title
Acute respiratory illness
Description
Participant self-report
Time Frame
12 week period starting after first dose
Title
School or work-related absenteeism
Description
Participant self-report
Time Frame
12 week period starting after first dose
Title
Physician visits for respiratory illness
Description
Participant self-report
Time Frame
12 week period starting after first dose
Title
Signs and symptoms of lower respiratory infection and pneumonia
Description
Participant self-report
Time Frame
12 week period starting after first dose
Title
Intensive care admission
Description
Participant self-report
Time Frame
12 week period starting after first dose
Title
Mechanical ventilation
Description
Participant self-report
Time Frame
12 week period starting after first dose
Title
Death
Description
Participant self-report
Time Frame
12 week period starting after first dose
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Group A: Anyone other than the adults aged ≥18 years who are vaccinated
Inclusion Criteria:
Individuals under the age of 18
Individuals with a contraindication to study vaccines
Those not willing to be vaccinated but consent to follow up
Exclusion Criteria:
- There are no exclusion criteria for this category of participants:
Group B: Adults aged 18 years or older, who will be vaccinated as part of the intervention.
Exclusion Criteria:
Anaphylactic reaction to any component of the study vaccine or to a previous dose of the study vaccines
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Loeb
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVID-19 Vaccine For Indirect Protection
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