COVID-19 Vaccine For Indirect Protection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Vaccine Preventable Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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COVID-19

mRNA-1273 vaccine

Group Type EXPERIMENTAL

COVID-19 Vaccination

Intervention Type BIOLOGICAL

Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28

Control

Usual care

Group Type EXPERIMENTAL

Usual care

Intervention Type OTHER

Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.

Interventions

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COVID-19 Vaccination

Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28

Intervention Type BIOLOGICAL

Usual care

Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.

Intervention Type OTHER

Other Intervention Names

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Moderna mRNA-1273 vaccine

Eligibility Criteria

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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

Group B: Adults aged 18 years or older, who will be vaccinated as part of the intervention.

* Anaphylactic reaction to any component of the study vaccine or to a previous dose of the study vaccines
* Pregnancy

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes