COVID-19 Vaccine For Indirect Protection

Study Overview
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Brief Summary
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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
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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.

Official Title
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COVID Vaccine for Indirect Protection: A Cluster Randomized Controlled Trial in Hutterite Colonies

Conditions
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Vaccine Preventable Disease

Intervention / Treatment
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* Biological: COVID-19 Vaccination
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID-19<br>mRNA-1273 vaccine | Biological: COVID-19 Vaccination<br>* Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28<br>* Other names: Moderna mRNA-1273 vaccine;|
| Experimental: Control<br>Usual care | Other: Usual care<br>* Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members | RT-PCR confirmed from nasal swabs | 12 week period starting after first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RT-PCR confirmed COVID-19 among all Hutterite colony members | RT-PCR confirmed from nasal swabs | 12 week period starting after first dose | 
| RT-PCR confirmed COVID-19 in high-risk participants | RT-PCR confirmed from nasal swabs | 12 week period starting after first dose | 
| COVID-19 antibody testing | Blood spot testing of COVID-19 antibodies | Baseline and through study completion, estimated at 4 months | 
| Acute respiratory illness | Participant self-report | 12 week period starting after first dose | 
| School or work-related absenteeism | Participant self-report | 12 week period starting after first dose | 
| Physician visits for respiratory illness | Participant self-report | 12 week period starting after first dose | 
| Signs and symptoms of lower respiratory infection and pneumonia | Participant self-report | 12 week period starting after first dose | 
| Intensive care admission | Participant self-report | 12 week period starting after first dose | 
| Mechanical ventilation | Participant self-report | 12 week period starting after first dose | 
| Death | Participant self-report | 12 week period starting after first dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccination, herd immunity, COVID-19