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COVID-19 Vaccine For Indirect Protection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04818736
Recruitment Status : Withdrawn (Vaccine roll out plans increased so timing was no longer feasible)
First Posted : March 26, 2021
Last Update Posted : May 14, 2021
Sponsor:
Collaborators:
University of Alberta
University of Saskatchewan
University of Manitoba
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Vaccine Preventable Disease Biological: COVID-19 Vaccination Other: Usual care Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: COVID Vaccine for Indirect Protection: A Cluster Randomized Controlled Trial in Hutterite Colonies
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COVID-19
mRNA-1273 vaccine
Biological: COVID-19 Vaccination
Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28
Other Name: Moderna mRNA-1273 vaccine

Experimental: Control
Usual care
Other: Usual care
Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.




Primary Outcome Measures :
  1. RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members [ Time Frame: 12 week period starting after first dose ]
    RT-PCR confirmed from nasal swabs


Secondary Outcome Measures :
  1. RT-PCR confirmed COVID-19 among all Hutterite colony members [ Time Frame: 12 week period starting after first dose ]
    RT-PCR confirmed from nasal swabs

  2. RT-PCR confirmed COVID-19 in high-risk participants [ Time Frame: 12 week period starting after first dose ]
    RT-PCR confirmed from nasal swabs

  3. COVID-19 antibody testing [ Time Frame: Baseline and through study completion, estimated at 4 months ]
    Blood spot testing of COVID-19 antibodies

  4. Acute respiratory illness [ Time Frame: 12 week period starting after first dose ]
    Participant self-report

  5. School or work-related absenteeism [ Time Frame: 12 week period starting after first dose ]
    Participant self-report

  6. Physician visits for respiratory illness [ Time Frame: 12 week period starting after first dose ]
    Participant self-report

  7. Signs and symptoms of lower respiratory infection and pneumonia [ Time Frame: 12 week period starting after first dose ]
    Participant self-report

  8. Intensive care admission [ Time Frame: 12 week period starting after first dose ]
    Participant self-report

  9. Mechanical ventilation [ Time Frame: 12 week period starting after first dose ]
    Participant self-report

  10. Death [ Time Frame: 12 week period starting after first dose ]
    Participant self-report



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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT04818736


Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
University of Alberta
University of Saskatchewan
University of Manitoba
Investigators
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Principal Investigator: Mark Loeb McMaster University
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT04818736    
Other Study ID Numbers: 2021-RCT
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 McMaster University:
vaccination
herd immunity
COVID-19
Additional relevant MeSH terms:
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Vaccine-Preventable Diseases
Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs