Vaccine Preventable DiseasePhase 4NCT04818736
COVID-19 Vaccine For Indirect Protection
A Phase 4 study testing COVID-19 Vaccination in people with Vaccine Preventable Disease, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccine Preventable Disease
- What is being tested?
- COVID-19 Vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2021to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals under the age of 18
- Individuals with a contraindication to study vaccines
- Those not willing to be vaccinated but consent to follow up
Who cannot join
- 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.
- Anaphylactic reaction to any component of the study vaccine or to a previous dose of the study vaccines
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID Vaccine for Indirect Protection: A Cluster Randomized Controlled Trial in Hutterite Colonies
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.
Read the 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.
- Conditions
- Vaccine Preventable Disease
- Being tested
- COVID-19 Vaccination, Usual care
- Keywords
- vaccination, herd immunity, COVID-19
- Medical subject headings
- Vaccine-Preventable Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccinationBiological
Also called Moderna mRNA-1273 vaccine
Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28
Usual careOther
Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Experimental | mRNA-1273 vaccine Receives: Biological: COVID-19 Vaccination |
| Control | Experimental | Usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members
RT-PCR confirmed from nasal swabs
Measured: 12 week period starting after first dose
Secondary outcomes (10)
RT-PCR confirmed COVID-19 among all Hutterite colony members
RT-PCR confirmed from nasal swabs
Measured: 12 week period starting after first dose
RT-PCR confirmed COVID-19 in high-risk participants
RT-PCR confirmed from nasal swabs
Measured: 12 week period starting after first dose
COVID-19 antibody testing
Blood spot testing of COVID-19 antibodies
Measured: Baseline and through study completion, estimated at 4 months
Acute respiratory illness
Participant self-report
Measured: 12 week period starting after first dose
School or work-related absenteeism
Participant self-report
Measured: 12 week period starting after first dose
Physician visits for respiratory illness
Participant self-report
Measured: 12 week period starting after first dose
Signs and symptoms of lower respiratory infection and pneumonia
Participant self-report
Measured: 12 week period starting after first dose
Intensive care admission
Participant self-report
Measured: 12 week period starting after first dose
Mechanical ventilation
Participant self-report
Measured: 12 week period starting after first dose
Death
Participant self-report
Measured: 12 week period starting after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start15 Apr 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Vaccine roll out plans increased so timing was no longer feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Preventable DiseaseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, University of Saskatchewan, University of Manitoba
- Responsible party
- Sponsor
- Investigators
- Mark Loeb, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818736
- Sponsor's protocol ID
- 2021-RCT
- Status last verified
- Feb 2021
- First submitted
- 24 Mar 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID Vaccine for Indirect Protection: A Cluster Randomized Controlled Trial in Hutterite Colonies
- ClinicalTrials.gov ID
- NCT04818736
- Acronym / sponsor ID
- 2021-RCT
- Conditions
- Vaccine Preventable Disease
- Keywords
- vaccination, herd immunity, COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Vaccine roll out plans increased so timing was no longer feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- University of Alberta, University of Saskatchewan, University of Manitoba
- Study start
- 15 Apr 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | Experimental | Biological: COVID-19 VaccinationmRNA-1273 vaccine |
| Control | Experimental | Other: Usual careUsual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals under the age of 18
- Individuals with a contraindication to study vaccines
- Those not willing to be vaccinated but consent to follow up
Key exclusion criteria (4 listed)
- 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.
- Anaphylactic reaction to any component of the study vaccine or to a previous dose of the study vaccines
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 VaccinationAlso: Moderna mRNA-1273 vaccineDose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28 | Biological | COVID-19 |
| Usual careParticipants can receive the COVID-19 whenever they are eligible according to local provincial guidelines. | Other | Control |
Primary outcome
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
10 secondary outcomes
RT-PCR confirmed COVID-19 among all Hutterite colony members
Time frame: 12 week period starting after first dose
RT-PCR confirmed COVID-19 in high-risk participants
Time frame: 12 week period starting after first dose
COVID-19 antibody testing
Time frame: Baseline and through study completion, estimated at 4 months
Acute respiratory illness
Time frame: 12 week period starting after first dose
School or work-related absenteeism
Time frame: 12 week period starting after first dose
Physician visits for respiratory illness
Time frame: 12 week period starting after first dose
Signs and symptoms of lower respiratory infection and pneumonia
Time frame: 12 week period starting after first dose
Intensive care admission
Time frame: 12 week period starting after first dose
Mechanical ventilation
Time frame: 12 week period starting after first dose
Death
Time frame: 12 week period starting after first dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: No
Related trials for Vaccine Preventable Disease
Recruiting
The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort
Hepatitis B, Vaccination; Infection
Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
Active, not recruitingPhase 1/2
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over
Shingles, Herpes Zoster
RecruitingPhase 4
Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania
HPV Infection, Vaccine Preventable Disease
Active, not recruitingObservational study
Herpes Virus Infections in Kidney Transplant Patients
Kidney Transplant; Complications, Varicella Zoster Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Loeb principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COVID-19 Vaccination in people with Vaccine Preventable Disease, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members (time frame: 12 week period starting after first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.