Status:
COMPLETED
Non-specific Effects of FLU-MMR Vaccines in Adults
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Faculdade da Polícia Militar, Goiânia, GO - Brazil
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 epi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.)
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
638 Patients enrolled
Trial Details
Trial ID
NCT05401448
Start Date
June 1 2021
End Date
August 31 2022
Last Update
October 2 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Faculdade da Polícia Militar
Goiânia, Goiás, Brazil