Clinical trial NCT02196285: Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella
Official title: A Phase I, Open, Uncontrolled Study, to Evaluate the Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rubella
Measles
Keywords: Double
Viral
Vaccine
Measles
Rubella
Safety
Efficacy
Imunogenicity
Lead sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2014-07-22
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences demonstrate the benefit for providing the universal access to vaccines containing measles and rubella antigens, mainly due to, respectively, mortality in children and malformations in fetuses. 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability analysis of the study vaccine
timeFrame: 9 months
Secondary outcomes:
measure: Imunogenicity analysis
timeFrame: 9 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Unidade de Ensaios Clínicos para Imunobiológicos
state: RJ
Study officials:
affiliation: Unidade de Ensaios Clínicos para Imunobiológicos, Fiocruz
name: Jose CerbinoNeto, PHD
role: PRINCIPAL_INVESTIGATOR
References: