COVID-19 Vaccine For Indirect Protection

Vaccine Preventable Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04818736
• Other study ID #: 2021-RCT
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 15, 2021
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Vaccine Preventable Disease

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	University of Alberta, University of Manitoba, University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

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