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IRCT20200802048266N1 IRCT 2020-09-22 Ahvaz University of Medical Sciences The effect of MMR vaccine in preventing Covid disease 19 Investigating the effectiveness of MMR vaccination The rate of COVID19 in medical staff compared to the control group 2020-11-19 anticipated 323 Complete https://irct.ir/trial/50035 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, block randomization is used and the size of the blocks is randomly selected (for example, blocks of 8, 6, or 10 that contain an equal number of each group in each block).So that the number of samples assigned to each of the study groups is equal. In this method, the blocks are determined based on the personal characteristics of the staff of Ahwaz Health Centers in the face of Covid 19.Within each block, half of the individuals are considered as intervention groups and half as controls. The main goal of this method is to balance the number of participants in each group.In the intervention group, the MMR vaccine will be given to prevent COVID-19 complications, but in the control group, the vaccine will not be used. 3 covid-19. Intervention 1: Intervention group: Health workers exposed to the epidemic virus (COVID-19) who were randomly selected after registering personal information including name, gender, age, weight, place of residence, occupation, presence of underlying diseases And disease characteristics were randomly divided into one of two experimental and control groups based on AB and BA random block design. Is placedIf their antibody level is not safe for measles, mumps or rubella, the vaccine will be injected. It is injected according to the protocol of the Ministry of Health. External substance prescribed: MMR vaccine - Participants in the intervention group will receive a dose of MMR vaccine at the rate of 0.5 cc by subcutaneous method (SC)Then, in three periods of two, six and twelve months, the results of the desired indicators are collected. In addition, all subjects in both groups will be routinely searched for signs and symptoms associated with acute respiratory infection / Covid-19. Also, at baseline and 12 months later, serum interferon gamma levels and antibody titers against measles, rubella, and mumps, and if available, IgG and IgM antibody titers against SARS-CoV-2 swabs for PCR measurement. Is taken. Intervention 2: Control group: Health workers exposed to the epidemic virus (COVID-19) who were randomly selected after registering personal information including name, gender, age, weight, place of residence, occupation, presence of underlying diseases And disease characteristics were randomly divided into one of two experimental and control groups based on AB and BA random block design. Is placed.In this group, the vaccine is not injected to evaluate the efficacy of MMR vaccine in the intervention group.Then, in three periods of two, six and twelve months, the results of the desired indicators are collected. In addition, all subjects in both groups will be routinely searched for signs and symptoms associated with acute respiratory infection / Covid-19. Also, at baseline and 12 months later, serum interferon gamma levels and antibody titers against measles, rubella, and mumps, and if available, IgG and IgM antibody titers against SARS-CoV-2 swabs for PCR measurement. Is taken. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Souri Heidari
Moshfag
Ahvaz Iran (Islamic Republic of) 61347535579 +98 61 3336 0289 Sourihedari@yahoo.com Ahvaz University of Medical Sciences scientific Souri Heidari
Moshfag
Ahvaz Iran (Islamic Republic of) 6134753579 0986133360289 Sourihedari@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Ahvaz health personnel with the age of 25-65 years 25 years 65 years Both People with defective immune systems MMR vaccine susceptibility Taking immunosuppressive drugs such as corticosteroids Pregnant women People who are not allowed to get the MMR vaccine People who have active cancer and are receiving chemotherapy or radiotherapy. People who have had an organ transplant and are receiving immunosuppressive drugs. People with active HIV infection . U07.1 COVID-19, virus identified Prevention Prevention Intervention group: Health workers exposed to the epidemic virus (COVID-19) who were randomly selected after registering personal information including name, gender, age, weight, place of residence, occupation, presence of underlying diseases And disease characteristics were randomly divided into one of two experimental and control groups based on AB and BA random block design. Is placedIf their antibody level is not safe for measles, mumps or rubella, the vaccine will be injected. It is injected according to the protocol of the Ministry of Health. External substance prescribed: MMR vaccine - Participants in the intervention group will receive a dose of MMR vaccine at the rate of 0.5 cc by subcutaneous method (SC)Then, in three periods of two, six and twelve months, the results of the desired indicators are collected. In addition, all subjects in both groups will be routinely searched for signs and symptoms associated with acute respiratory infection / Covid-19. Also, at baseline and 12 months later, serum interferon gamma levels and antibody titers against measles, rubella, and mumps, and if available, IgG and IgM antibody titers against SARS-CoV-2 swabs for PCR measurement. Is taken Control group: Health workers exposed to the epidemic virus (COVID-19) who were randomly selected after registering personal information including name, gender, age, weight, place of residence, occupation, presence of underlying diseases And disease characteristics were randomly divided into one of two experimental and control groups based on AB and BA random block design. Is placed.In this group, the vaccine is not injected to evaluate the efficacy of MMR vaccine in the intervention group.Then, in three periods of two, six and twelve months, the results of the desired indicators are collected. In addition, all subjects in both groups will be routinely searched for signs and symptoms associated with acute respiratory infection / Covid-19. Also, at baseline and 12 months later, serum interferon gamma levels and antibody titers against measles, rubella, and mumps, and if available, IgG and IgM antibody titers against SARS-CoV-2 swabs for PCR measurement. Is taken Weight. Timepoint: The beginning of the study. Method of measurement: kilograms. WBC. Timepoint: At the beginning and end of the study. Method of measurement: Flow cytometry. Lymphocyte count / percentage in CBC. Timepoint: At the beginning and end of the study. Method of measurement: Flow cytometry. Anti measles antibody titer. Timepoint: At the beginning and end of the study. Method of measurement: Eliza test. Anti rubella antibody titer. Timepoint: At the beginning and end of the study. Method of measurement: Eliza test. Anti mumps antibody titer. Timepoint: At the beginning and end of the study. Method of measurement: Eliza test. Anti SARS-CoV-2 IgG & IgM. Timepoint: At the beginning and end of the study. Method of measurement: Eliza test. PCR test. Timepoint: At the beginning and end of the study. Method of measurement: RT-PCR test using nasopharyngeal swabs. Reduce the need for intubation. Timepoint: At the beginning and end of the study. Method of measurement: View. Mortality rate. Timepoint: At the beginning and end of the study. Method of measurement: View. Ahvaz University of Medical Sciences Approved 2020-07-25 Ethics Committee of Ahwaz Jundipur University of Medical Sciences golastan Ahvaz Khouzestan Iran (Islamic Republic of)