COVID-19 Vaccine For Indirect Protection

Phase 4

Withdrawn

• Conditions: Vaccine Preventable Disease
• Interventions: Biological: COVID-19 Vaccination; Other: Usual care

• Registration Number: NCT04818736
• Lead Sponsor: McMaster University

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.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Study Start: 2021-04-15
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-14
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVID-19	COVID-19 Vaccination	mRNA-1273 vaccine
Control	Usual care	Usual care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
School or work-related absenteeism	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
RT-PCR confirmed COVID-19 among all Hutterite colony members	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
RT-PCR confirmed COVID-19 in high-risk participants	12 week period starting after first dose	RT-PCR confirmed from nasal swabs
Intensive care admission	12 week period starting after first dose	Participant self-report
Mechanical ventilation	12 week period starting after first dose	Participant self-report
Acute respiratory illness	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
Death	12 week period starting after first dose	Participant self-report

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada