<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02196285</url>
  </required_header>
  <id_info>
    <org_study_id>ASCLIN 002/2014</org_study_id>
    <nct_id>NCT02196285</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella</brief_title>
  <acronym>MR</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences&#xD;
      demonstrate the benefit for providing the universal access to vaccines containing measles and&#xD;
      rubella antigens, mainly due to, respectively, mortality in children and malformations in&#xD;
      fetuses. This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability&#xD;
      and imunogenicity of double viral vaccine anti-measles and rubella (MR), which is developed&#xD;
      and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil,&#xD;
      for use in human beings. 30 eligible volunteers, between 18-49 years old, will be vaccinated&#xD;
      and monitored for local and systemic adverse events and titration of antibodies. The study&#xD;
      will last 20 months in total.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability and&#xD;
      imunogenicity of double viral vaccine anti-measles and rubella (MR), which is developed and&#xD;
      produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for&#xD;
      use in human beings. 30 eligible volunteers, between 18-49 years old, will be vaccinated and&#xD;
      monitored for local and systemic adverse events and titration of antibodies. The study will&#xD;
      last 20 months in total.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability analysis of the study vaccine</measure>
    <time_frame>9 months</time_frame>
    <description>To evaluate the occurrence of serious adverse events among the subjects who have received study vaccine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Imunogenicity analysis</measure>
    <time_frame>9 months</time_frame>
    <description>To evaluate imune response between post and pre-vaccination antibodies.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Rubella</condition>
  <condition>Measles</condition>
  <arm_group>
    <arm_group_label>Double viral vaccine (MR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Measles and rubella vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Double viral (MR) vaccine</intervention_name>
    <description>Measles and Rubella vaccine, as single arm</description>
    <arm_group_label>Double viral vaccine (MR)</arm_group_label>
    <other_name>Measles and Rubella vaccine</other_name>
    <other_name>MR Vaccine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Age between 18 and 49 years old;&#xD;
&#xD;
          -  Willing to provide name, address, telephone and other contact information in order to&#xD;
             be contacted, whenever needed (example: in case of missing any scheduled visit,&#xD;
             contact for confirmation of scheduling a visit, urgent safety notifications);&#xD;
&#xD;
          -  Willing to strictly follow the study protocol;&#xD;
&#xD;
          -  Capacity for understanding and signing in the Informed Consent Form;&#xD;
&#xD;
          -  To understand the impossibility of participating in another clinical trial during the&#xD;
             time of participation in the study, until 6 months after its conclusion;&#xD;
&#xD;
          -  Intellectual level which allows to filling in the diaries for registering of symptoms&#xD;
             at home;&#xD;
&#xD;
          -  Willing to undergo to serological testing to HIV, HBV and HCV;&#xD;
&#xD;
          -  Being in good health, with no significant medical history;&#xD;
&#xD;
          -  Physical examination at screening period without clinically significant changes;&#xD;
&#xD;
          -  Lab examination at screening period within the normal ranges, determined by the&#xD;
             laboratory or abnormal values, grading below 1 or 2, according to medical decision.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious adverse reaction to any vaccination, as respiratory difficulty, angioedema and&#xD;
             anaphylaxis;&#xD;
&#xD;
          -  Acute or chronic disease, as diabetes, heart disease, systemic arterial hypertension;&#xD;
&#xD;
          -  Use of anti-allergic with antigen injections in a maximum timeline of 14 days before&#xD;
             the vaccination;&#xD;
&#xD;
          -  Use of immunoglobulin in the past 12 months before the study vaccination;&#xD;
&#xD;
          -  Use of blood products within 12 months before the vaccination;&#xD;
&#xD;
          -  Use of any vaccine type within 30 days before the vaccination of the study;&#xD;
&#xD;
          -  Chronic use of any medication, except homeopathy, and trivial ones, as nasal&#xD;
             physiologic solution and vitamins;&#xD;
&#xD;
          -  Previous immunosuppressive or cytotoxic medication, in the last 6 months. Individuals&#xD;
             who have made use of this kind of medication in non-immunosuppressant doses, as nasal&#xD;
             corticosteroid for allergic rhinitis of topic corticosteroid for non-complicated&#xD;
             dermatitis, for more than 14 days, are allowed to be included in the study.&#xD;
&#xD;
          -  Use of any kind of medication under investigation within one year before the&#xD;
             vaccination.&#xD;
&#xD;
          -  Unstable asthma or which may have required urgent care, hospitalization or intubation&#xD;
             within the last 2 years, or which requires use of oral or intravenous corticosteroid.&#xD;
&#xD;
          -  Coagulopathies diagnosed by a physician or report of capillary fragility (ex: bruises&#xD;
             or bleedings without justifiable cause;&#xD;
&#xD;
          -  Convulsions, except the ones caused by fever, before 2 years old;&#xD;
&#xD;
          -  Psychiatric disease which difficults the adherence to the protocol, such as psychosis,&#xD;
             obsessive-compulsive disorders, bipolar disease under treatment, diseases which&#xD;
             require treatment with lithium and suicidal ideas in the last 5 years from the&#xD;
             inclusion;&#xD;
&#xD;
          -  Active malignant (p.e. any kind of cancer) or treated disease, to which the individual&#xD;
             may relapse during the study;&#xD;
&#xD;
          -  Asplenia (absence of spleen or its removal);&#xD;
&#xD;
          -  Positive HIV in the screening examination of history of any immunosuppressant disease;&#xD;
&#xD;
          -  Positive serology for C hepatitis in the screening evaluation;&#xD;
&#xD;
          -  Positive Antigen HBs in the screening evaluation;&#xD;
&#xD;
          -  Alcoholism (CAGE criteria), used for detection of abusive drinkers or alcoholic,&#xD;
             validated in the Brazilian population with sensibility of 88% and specificity of 83%,&#xD;
             if two or more answers, among four possible, are afirmative(Mansur and Monteiro,&#xD;
             1983), or according to medical decision;&#xD;
&#xD;
          -  Abuse of illicit drugs, according to medical decision;&#xD;
&#xD;
          -  Acquired or congenital immunodeficiency;&#xD;
&#xD;
          -  Allergy to the vaccine compounds, as egg, neomycin and gelatin.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose CerbinoNeto, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unidade de Ensaios Clínicos para Imunobiológicos, Fiocruz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unidade de Ensaios Clínicos para Imunobiológicos</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>21040900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>June 21, 2016</last_update_submitted>
  <last_update_submitted_qc>June 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Double</keyword>
  <keyword>Viral</keyword>
  <keyword>Vaccine</keyword>
  <keyword>Measles</keyword>
  <keyword>Rubella</keyword>
  <keyword>Safety</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Imunogenicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Measles</mesh_term>
    <mesh_term>Rubella</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02196285
org study id: ASCLIN 002/2014
nct id: NCT02196285
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Safety and tolerability analysis of the study vaccine
time frame: 9 months
description: To evaluate the occurrence of serious adverse events among the subjects who have received study vaccine.
measure: Imunogenicity analysis
time frame: 9 months
description: To evaluate imune response between post and pre-vaccination antibodies.
arm group label: Double viral vaccine (MR)
arm group type: Experimental
description: Measles and rubella vaccine
intervention type: Biological
intervention name: Double viral (MR) vaccine
description: Measles and Rubella vaccine, as single arm
arm group label: Double viral vaccine (MR)
other name: Measles and Rubella vaccine
other name: MR Vaccine
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jose CerbinoNeto, PHD
role: Principal Investigator
affiliation: Unidade de Ensaios Clínicos para Imunobiológicos, Fiocruz
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Measles
mesh term: Rubella
mesh term: Vaccines