Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella

This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability and imunogenicity of double viral vaccine anti-measles and rubella (MR), which is developed and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 30 eligible volunteers, between 18-49 years old, will be vaccinated and monitored for local and systemic adverse events and titration of antibodies. The study will last 20 months in total.

Inclusion criteria

• Male
• Age between 18 and 49 years old;
• Willing to provide name, address, telephone and other contact information in order to be contacted, whenever needed (example: in case of missing any scheduled visit, contact for confirmation of scheduling a visit, urgent safety notifications);
• Willing to strictly follow the study protocol;
• Capacity for understanding and signing in the Informed Consent Form;
• To understand the impossibility of participating in another clinical trial during the time of participation in the study, until 6 months after its conclusion;
• Intellectual level which allows to filling in the diaries for registering of symptoms at home;
• Willing to undergo to serological testing to HIV, HBV and HCV;
• Being in good health, with no significant medical history;
• Physical examination at screening period without clinically significant changes;
• Lab examination at screening period within the normal ranges, determined by the laboratory or abnormal values, grading below 1 or 2, according to medical decision.

Exclusion criteria

• Serious adverse reaction to any vaccination, as respiratory difficulty, angioedema and anaphylaxis;
• Acute or chronic disease, as diabetes, heart disease, systemic arterial hypertension;
• Use of anti-allergic with antigen injections in a maximum timeline of 14 days before the vaccination;
• Use of immunoglobulin in the past 12 months before the study vaccination;
• Use of blood products within 12 months before the vaccination;
• Use of any vaccine type within 30 days before the vaccination of the study;
• Chronic use of any medication, except homeopathy, and trivial ones, as nasal physiologic solution and vitamins;
• Previous immunosuppressive or cytotoxic medication, in the last 6 months. Individuals who have made use of this kind of medication in non-immunosuppressant doses, as nasal corticosteroid for allergic rhinitis of topic corticosteroid for non-complicated dermatitis, for more than 14 days, are allowed to be included in the study.
• Use of any kind of medication under investigation within one year before the vaccination.
• Unstable asthma or which may have required urgent care, hospitalization or intubation within the last 2 years, or which requires use of oral or intravenous corticosteroid.
• Coagulopathies diagnosed by a physician or report of capillary fragility (ex: bruises or bleedings without justifiable cause;
• Convulsions, except the ones caused by fever, before 2 years old;
• Psychiatric disease which difficults the adherence to the protocol, such as psychosis, obsessive-compulsive disorders, bipolar disease under treatment, diseases which require treatment with lithium and suicidal ideas in the last 5 years from the inclusion;
• Active malignant (p.e. any kind of cancer) or treated disease, to which the individual may relapse during the study;
• Asplenia (absence of spleen or its removal);
• Positive HIV in the screening examination of history of any immunosuppressant disease;
• Positive serology for C hepatitis in the screening evaluation;
• Positive Antigen HBs in the screening evaluation;
• Alcoholism (CAGE criteria), used for detection of abusive drinkers or alcoholic, validated in the Brazilian population with sensibility of 88% and specificity of 83%, if two or more answers, among four possible, are afirmative(Mansur and Monteiro, 1983), or according to medical decision;
• Abuse of illicit drugs, according to medical decision;
• Acquired or congenital immunodeficiency;
• Allergy to the vaccine compounds, as egg, neomycin and gelatin.