Clinical trial (phase 1) of RAZI- MMR vaccine in 18-49 years old volunteers

In open label phase I clinical trial of this study,we are going to vaccinate 40 volunteers, who are 18-49 year-old. Informed consent will be obtained from all of the participants. Inclusion criteria for recruiting participants are: negative history of any contact with patients infected by Measles, Rubella or Mumps viruses during the last two months; not being under Immunocompromising treatment; not being pregnant and no plan for pregnancy within the next three months; not being under radiotherapy.Exclusion criteria for recruiting participants are: Positive history of Immunodeficiency؛Positive history of Congenital disorders; Positive history of Genetic disease; positive history of Liver disease;positive history of Kidney disease; Temperature > 38.0 °C at the time of the first visit; presence of an acute febrile disease at the time of the first visit; Positive history of blood transfusion during the last three months; Positive history of receiving intramascular immunogluboline during the last three months; Positive history of severe adverse effect after previous MMR Vaccine injection; Positive history of egg hypersensitivity ;positive history of thrombocytopenia. Each volunteer will receive one dose of S12 MMR vaccine and we will withdraw 2 blood samples (one sample just before vaccination and one sample two weeks after) for hematology and biochemistry tests. In this study, all volunteers will be under close observation for one hour after vaccination and then they will be followed daily for two weeks, and weekly for four weeks to assess the possible side effects of vaccination.

Razi Vaccine and Serum Research Institute