COVID-19 Vaccine For Indirect Protection

• ClinicalTrials.gov Identifier: NCT04818736
• Recruitment Status: Withdrawn
• First Posted: March 26, 2021
• Last Update Posted: May 14, 2021
• Sponsor: McMaster University
• Collaborators: University of Alberta; University of Saskatchewan; University of Manitoba
• Information provided by (Responsible Party): McMaster University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vaccine Preventable Disease	Biological: COVID-19 Vaccination; Other: Usual care	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Controlled Trial
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: COVID Vaccine for Indirect Protection: A Cluster Randomized Controlled Trial in Hutterite Colonies
• Estimated Study Start Date: April 15, 2021
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members [ Time Frame: 12 week period starting after first dose ]
   RT-PCR confirmed from nasal swabs

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 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

Contacts and Locations

Locations

Canada, Ontario

McMaster University

Hamilton, Ontario, Canada, L8S 4K1

Sponsors and Collaborators

McMaster University

University of Alberta

University of Saskatchewan

University of Manitoba

Investigators

• Principal Investigator: Mark Loeb; McMaster University

More Information

• Responsible Party: McMaster University
• ClinicalTrials.gov Identifier: NCT04818736
• Other Study ID Numbers: 2021-RCT
• First Posted: March 26, 2021
• Last Update Posted: May 14, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by McMaster University:

vaccination; herd immunity; COVID-19

Additional relevant MeSH terms:

Vaccine-Preventable Diseases; Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs