COVID-19 Vaccine For Indirect Protection

McMaster University

Status and phase: Withdrawn; Phase 4

Conditions: Vaccine Preventable Disease

Treatments: Biological: COVID-19 Vaccination; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04818736

2021-RCT

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

COVID-19

Experimental group

Description:

mRNA-1273 vaccine

Treatment:

Biological: COVID-19 Vaccination

Control

Experimental group

Description:

Usual care

Treatment:

Other: Usual care