COVID-19 Vaccine For Indirect Protection

NCT04818736 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 2021-RCT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccine Preventable Disease

Keywords

vaccination; herd immunity; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• RT-PCR confirmed COVID-19 among all Hutterite colony members

  12 week period starting after first dose

• RT-PCR confirmed COVID-19 in high-risk participants

  12 week period starting after first dose

• COVID-19 antibody testing

  Baseline and through study completion, estimated at 4 months

• Acute respiratory illness

  12 week period starting after first dose

• School or work-related absenteeism

  12 week period starting after first dose

Study Arms (2)

COVID-19

EXPERIMENTAL

mRNA-1273 vaccine

Biological: COVID-19 Vaccination

Control

EXPERIMENTAL

Usual care

Other: Usual care

Interventions

COVID-19 Vaccination BIOLOGICAL

Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28

Also known as: Moderna mRNA-1273 vaccine

COVID-19

Usual care OTHER

Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals under the age of 18
• Individuals with a contraindication to study vaccines
• Those not willing to be vaccinated but consent to follow up

You may not qualify if:

• Group B: Adults aged 18 years or older, who will be vaccinated as part of the intervention.
• Anaphylactic reaction to any component of the study vaccine or to a previous dose of the study vaccines
• Pregnancy

Sponsors & Collaborators

• McMaster University: lead
• University of Alberta: collaborator
• University of Saskatchewan: collaborator
• University of Manitoba: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Vaccine-Preventable Diseases; COVID-19

Interventions

heterologous prime boost COVID-19 vaccination; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Mark Loeb

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: April 15, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)