Vaccine Preventable Disease
Conditions
Keywords
vaccination, herd immunity, COVID-19
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.
Interventions
BIOLOGICALCOVID-19 Vaccination
Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28
OTHERUsual care
Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.
Sponsors
University of Alberta
University of Saskatchewan
University of Manitoba
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members | 12 week period starting after first dose | RT-PCR confirmed from nasal swabs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 12 week period starting after first dose | Participant self-report |
| RT-PCR confirmed COVID-19 among all Hutterite colony members | 12 week period starting after first dose | RT-PCR confirmed from nasal swabs |
| RT-PCR confirmed COVID-19 in high-risk participants | 12 week period starting after first dose | RT-PCR confirmed from nasal swabs |
| COVID-19 antibody testing | Baseline and through study completion, estimated at 4 months | Blood spot testing of COVID-19 antibodies |
| Mechanical ventilation | 12 week period starting after first dose | Participant self-report |
| School or work-related absenteeism | 12 week period starting after first dose | Participant self-report |
| Physician visits for respiratory illness | 12 week period starting after first dose | Participant self-report |
| Signs and symptoms of lower respiratory infection and pneumonia | 12 week period starting after first dose | Participant self-report |
| Intensive care admission | 12 week period starting after first dose | Participant self-report |
| Acute respiratory illness | 12 week period starting after first dose | Participant self-report |
Countries
Canada
Outcome results
None listed