NCT04818736

COVID-19 Vaccine For Indirect Protection

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Vaccine Preventable Disease

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccination	Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28
OTHER	Usual care	Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.

Timeline

• Start date: 2021-04-15
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2021-03-26
• Last updated: 2021-05-14

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study