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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28
Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.
McMaster University
Hamilton, Ontario, Canada
RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members
RT-PCR confirmed from nasal swabs
Time frame: 12 week period starting after first dose
RT-PCR confirmed COVID-19 among all Hutterite colony members
RT-PCR confirmed from nasal swabs
Time frame: 12 week period starting after first dose
RT-PCR confirmed COVID-19 in high-risk participants
RT-PCR confirmed from nasal swabs
Time frame: 12 week period starting after first dose
COVID-19 antibody testing
Blood spot testing of COVID-19 antibodies
Time frame: Baseline and through study completion, estimated at 4 months
Acute respiratory illness
Participant self-report
Time frame: 12 week period starting after first dose
School or work-related absenteeism
Participant self-report
Time frame: 12 week period starting after first dose
Physician visits for respiratory illness
Participant self-report
Time frame: 12 week period starting after first dose
Signs and symptoms of lower respiratory infection and pneumonia
Participant self-report
Time frame: 12 week period starting after first dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Intensive care admission
Participant self-report
Time frame: 12 week period starting after first dose
Mechanical ventilation
Participant self-report
Time frame: 12 week period starting after first dose
Death
Participant self-report
Time frame: 12 week period starting after first dose