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COVID-19Early Phase 1FLUMMR-BRANCT05401448

Non-specific Effects of FLU-MMR Vaccines in Adults

A Early Phase 1 study testing Influenza and MMR vaccines in people with COVID-19, run by Radboud University Medical Center at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Various observational studies have reported an association between influenza vaccination and lower rates of infection with SARS-Cov-2 and less COVID-19 disease severity have been reported in large epidemiological studies in US, Brazil and Italy. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Influenza and MMR vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
638 participants
Where
1 siteBrazil
Study dates
1 Jun 2021to 31 Aug 2022
Phase
Early Phase 1
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • To be eligible to participate in this study, the participant must meet the following criteria:
  • Be older than 18 years old. Observation: the elderly is at risk for severe forms of COVID-19, therefore, the evidence in this age group is very relevant. However, they can also be a first priority population to receive a specific vaccine, limiting the time to follow-up on the study. In addition, influenza and MMR vaccines can lead to a lower immune system in the elderly than in young people. Therefore, it is likely that a more rational choice will be to carry out the study in a young population.

Who cannot join

  • Participants will not be included in the study if they present (reported by the research participants):
  • Known allergy to components of influenza and MMR vaccines or serious adverse events to previous administration.
  • Fever (> 38 degrees Celsius) in the last 24 hours.
  • Pregnancy. Note: pregnancy should be avoided for one month after vaccination.
  • Symptoms of active viral or bacterial infection.
  • Documented diagnosis of COVID-19.
Show all 11Show fewer
  • Vaccination in the last 4 weeks against SARS-CoV-2.
  • Immunocompromised participants. This exclusion category includes: a) infection with the human immunodeficiency virus (HIV-1); b) neutropenic participant with less than 500 neutrophils/mm3; c) participant with organ transplantation; d) participants with bone marrow transplantation; e) participants in chemotherapy treatment; f) participants with primary immunodeficiency; g) participants with severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine medication; i) treatment with oral or intravenous steroids, for example, daily doses of prednisone or equivalent for more than 3 months, or probable use of oral or intravenous steroids within next four weeks.
  • Some type of lymphoma or malignancy in the previous two years.
  • Direct involvement in the design or execution of the study.
  • Absence from work for more than 4 weeks within the next 12 weeks after study admission (vacation, maternity leave, retirement, planned surgery, etc.)

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Faculdade da Polícia Militar

    Goiânia, Goiás

Other trials in Brazil

About this study

Official title: Study of the Non-specific Effects of Influenza and MMR Vaccine on Infectious Diseases in Goiânia, Goiás, Brazil

Various observational studies have reported an association between influenza vaccination and lower rates of infection with SARS-Cov-2 and less COVID-19 disease severity have been reported in large epidemiological studies in US, Brazil and Italy. Observational studies from the Netherlands showed also strongly reduced COVID-19 infection rates among influenza-vaccinated healthcare workers, with ORs of 0.61 and 0.49 for the first and second wave of COVID-19, respectively. In addition, in-vitro immunological analyses showed that the quadrivalent inactivated influenza vaccine can induce a trained immunity program against SARS-CoV-2 (2). In-vivo vaccination against influenza was also shown to induce improved interferon responses against SARS-CoV-2, with modulation of hyperinflammatory responses. Trained immunity could be the underlying mechanism for the potential protective effect of influenza vaccine, a mechanism that has also been proven for BCG vaccination, and epidemiological evidence suggests similar non-specific effects of MMR and OPV vaccination. Currently, various clinical trials are being conducted to study the impact of BCG, MMR and OPV vaccination on COVID-19, but prospective clinical data on influenza vaccination are lacking. Although specific COVID-19 vaccines have been developed and are proven effective, there are important reasons for assessing in a controlled randomized trial the effect of influenza and MMR vaccine on COVID19:

  • Specific COVID-19 vaccines are still not yet available for all segments of the population, and especially not for the majority of the population in developing countries.
  • The emergence of new SARS-CoV-2 variants, especially the P1 variant from Brazil, may very well be associated with reduced response to vaccines. An immunomodulatory protective vaccine that protects in an antigen-independent manner would be of great importance.
  • It would also be conceptually important to know whether influenza and the MMR vaccine can induce heterologous protection against another viral infection, in the context of future pandemics.
Conditions
COVID-19
Being tested
Influenza, MMR vaccines, Placebo
Keywords
SARS-CoV-2, Heterologous effects of vaccines, Other viral infections
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfluenzaBiological

    Influenza: 0.5 ml of reconstituted Influenza vaccine will be administered intramuscularly in the left upper arm as recommended by the manufacturer.

  • MMR vaccinesBiological

    MMR: 0.5 ml of reconstituted MMR vaccine will be administered intramuscularly in the left upper arm as recommended by the manufacturer.

  • PlaceboOther

    Placebo: 0.5 ml of 0.9% NaCl will be administered intradermally in the left upper arm.

Study groups in NCT05401448
Study groupRoleWhat they receive
PlaceboPlacebo comparatorsterile 0.9% NaCl
Receives: Other: Placebo
InfluenzaExperimentalInfluenza (tetravalent vaccine)
Receives: Biological: Influenza
MMRExperimentalmeasles, mumps, and rubella vaccine
Receives: Biological: MMR vaccines

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative incidence of SARS-CoV-2 infection during 1 year follow up

    COVID-19 will be defined as meeting the following two criteria:

    1. signs and symptoms compatible with the disease as judged by the adjudication committee based on the most recent knowledge of COVID-19
    2. microbiological or radiological confirmation: meeting any of the following: a. presence of SARS-CoV-2 virus by PCR

    Measured: 3 months after inclusion

  2. Cumulative incidence of SARS-CoV-2 infection

    COVID-19 will be defined as meeting the following two criteria:

    1. signs and symptoms compatible with the disease as judged by the adjudication committee based on the most recent knowledge of COVID-19
    2. microbiological or radiological confirmation: meeting any of the following: a. presence of SARS-CoV-2 virus by PCR

    Measured: 6 months after inclusion

  3. Cumulative incidence of SARS-CoV-2 infection

    COVID-19 will be defined as meeting the following two criteria:

    1. signs and symptoms compatible with the disease as judged by the adjudication committee based on the most recent knowledge of COVID-19
    2. microbiological or radiological confirmation: meeting any of the following: a. presence of SARS-CoV-2 virus by PCR

    Measured: 12 months after inclusion

Secondary outcomes (3)

  1. Severity of SARS-CoV-2 and the incidence of clinically relevant RTI

    Cumulative incidence of hospitalization for COVID-19; Cumulative incidence of ICU admission for COVID-19; Cumulative incidence of death due to COVID-19; All parameters combined, measured as number of days or number of deaths will be used to report COVID19 severity.

    Measured: 3, 6 and 12 months after inclusion

  2. Severity of other respiratory tract infections (RTIs)

    Cumulative incidence of hospitalization for other RTIs; Cumulative incidence of hospitalization for all infections; Cumulative incidence of death due to other infections;

    All parameters combined, measured as number of days or number of deaths will be used to report the severity of the infection.

    Cumulative incidence of hospitalization for all infections

    Measured: 3, 6 and 12 months after inclusion

  3. Incidence and magnitude of plasma/serum antibodies (IgA, M, G) and SARS-Cov-2-specific antibodies at the end of study

    The measurement of the antibodies titers will be used together with the self informed questionnaires in order to confirm the incidence of COVID19 and/or other RTIs.

    Measured: 3, 6 and 12 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start1 Jun 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
638 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05401448
Sponsor's protocol ID
FLUMMR-BRA
Acronym
FLUMMR-BRA
Status last verified
Sep 2024
First submitted
19 May 2022
Last updated
2 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Influenza and MMR vaccines in people with COVID-19, run by Radboud University Medical Center at 1 site in Brazil.

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 2 inclusion and 11 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: finished, as of the sponsor's last update on 2 Oct 2024. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cumulative incidence of SARS-CoV-2 infection during 1 year follow up (time frame: 3 months after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05401448.

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 2 Oct 2024.

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