COVID-19 Vaccine For Indirect Protection

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Vaccine Preventable Disease
• Intervention / Treatment: Biological: COVID-19 Vaccination; Other: Usual care

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVID-19; mRNA-1273 vaccine	Biological: COVID-19 Vaccination; Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28; Other Names: Moderna mRNA-1273 vaccine
Experimental: Control; Usual care	Other: Usual care; Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members	RT-PCR confirmed from nasal swabs	12 week period starting after first dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RT-PCR confirmed COVID-19 among all Hutterite colony members	RT-PCR confirmed from nasal swabs	12 week period starting after first dose
RT-PCR confirmed COVID-19 in high-risk participants	RT-PCR confirmed from nasal swabs	12 week period starting after first dose
COVID-19 antibody testing	Blood spot testing of COVID-19 antibodies	Baseline and through study completion, estimated at 4 months
Acute respiratory illness	Participant self-report	12 week period starting after first dose
School or work-related absenteeism	Participant self-report	12 week period starting after first dose
Physician visits for respiratory illness	Participant self-report	12 week period starting after first dose
Signs and symptoms of lower respiratory infection and pneumonia	Participant self-report	12 week period starting after first dose
Intensive care admission	Participant self-report	12 week period starting after first dose
Mechanical ventilation	Participant self-report	12 week period starting after first dose
Death	Participant self-report	12 week period starting after first dose

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: University of Manitoba; University of Alberta; University of Saskatchewan
• Investigators: Principal Investigator: Mark Loeb, McMaster University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; vaccination; herd immunity
• Additional Relevant MeSH Terms: Infections; Vaccine-Preventable Diseases; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2021-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes