Clinical trial NCT04818736: COVID-19 Vaccine For Indirect Protection
Official title: COVID Vaccine for Indirect Protection: A Cluster Randomized Controlled Trial in Hutterite Colonies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Vaccine Preventable Disease
Keywords: vaccination
herd immunity
COVID-19
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: University of Saskatchewan
name: University of Manitoba
First posted: 2021-03-26
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members
timeFrame: 12 week period starting after first dose
Secondary outcomes:
measure: RT-PCR confirmed COVID-19 among all Hutterite colony members
timeFrame: 12 week period starting after first dose
measure: RT-PCR confirmed COVID-19 in high-risk participants
timeFrame: 12 week period starting after first dose
measure: COVID-19 antibody testing
timeFrame: Baseline and through study completion, estimated at 4 months
measure: Acute respiratory illness
timeFrame: 12 week period starting after first dose
measure: School or work-related absenteeism
timeFrame: 12 week period starting after first dose
measure: Physician visits for respiratory illness
timeFrame: 12 week period starting after first dose
measure: Signs and symptoms of lower respiratory infection and pneumonia
timeFrame: 12 week period starting after first dose
measure: Intensive care admission
timeFrame: 12 week period starting after first dose
measure: Mechanical ventilation
timeFrame: 12 week period starting after first dose
measure: Death
timeFrame: 12 week period starting after first dose
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Mark Loeb
role: PRINCIPAL_INVESTIGATOR
References: