<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/NCT01696422</url>
  </required_header>
  <id_info>
    <org_study_id>DEN-01-IB</org_study_id>
    <secondary_id>U1111-1135-4553</secondary_id>
    <nct_id>NCT01696422</nct_id>
  </id_info>
  <brief_title>Phase II Trial to Evaluate Safety and Immunogenicity of a Dengue 1,2,3,4 (Attenuated) Vaccine</brief_title>
  <official_title>Phase II, Step-wise, Randomized, Double-blind, Controlled Clinical Trial for Safety and Immunogenicity Evaluation of a Lyophilized Formulation of Dengue 1,2,3,4 (Attenuated) Vaccine in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Butantan Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Banco Nacional de Desenvolvimento Economico e Social</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Butantan Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Butantan Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase II step-wise, randomized, multicenter, double-blind and controlled clinical&#xD;
      trial to evaluate the safety and immunogenicity of a attenuated tetravalent lyophilized&#xD;
      dengue vaccine manufactured by Butantan Institute. Three Clinical Sites at University of Sao&#xD;
      Paulo - Brazil will participate in the study. A total of 300 volunteers will be recruited and&#xD;
      divided into two steps: Step A (with no previous exposure to dengue) and Step B (with and&#xD;
      without previous exposure to dengue). In step A the participants will be assigned to receive&#xD;
      either the lyophilized vaccine, or the liquid vaccine(developed at NIH and produced and&#xD;
      formulated at Butantan according to the NIH-Protocol), or the placebo. In Step B participants&#xD;
      will be assigned to receive either the lyophilized vaccine, or the placebo. Both vaccine&#xD;
      formulations (lyophilized and liquid) are composed of the same attenuated viruses: rDEN1∆30,&#xD;
      rDEN2/4∆30(ME), rDEN3∆30/31, and rDEN4∆30. At the end of the study, 20 volunteers will have&#xD;
      received the liquid formulation (NIH), 210 the lyophilized formulation (Butantan), and 70&#xD;
      will have received the placebo. All participants included in both steps will be followed by a&#xD;
      period of five years after their inclusion in the study. The study hypothesis is that the&#xD;
      investigational lyophilized dengue vaccine manufactured by Butantan Institute is safe and&#xD;
      confers balanced immune response, after one dose of 1000PFU, to all for vaccine viruses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase II step-wise, randomized, multicenter, double-blind and controlled clinical&#xD;
      trial to evaluate the safety and immunogenicity of an attenuated tetravalent lyophilized&#xD;
      dengue vaccine manufactured by Butantan Institute. A total of 300 volunteers will be&#xD;
      recruited including men and no pregnant/breastfeeding women between 18 and 59 years of age&#xD;
      complete, with and without previous exposure to dengue that will be randomized into Step A&#xD;
      and Step B. Step A will include 50 volunteers with no previous exposure and they will be&#xD;
      randomly assigned to receive one dose of either the lyophilized formulation (Butantan), or&#xD;
      the liquid formulation (TetraVax-DV Vaccine - Admixture TV003 developed by NIH/NIAID and&#xD;
      produced and formulated at Butantan according the NIH-Protocol), or the placebo. A second&#xD;
      dose will be administered six months after the first vaccination as part of an exploratory&#xD;
      assessment. Step B will include 250 participants(50 without previous exposure to dengue,and&#xD;
      200 with previous exposure to dengue) who will be randomly assigned to receive one dose of&#xD;
      either the lyophilized formulation (Butantan),or the placebo. All participants included in&#xD;
      both steps will be followed by a period of five years after their inclusion in the study. The&#xD;
      vaccines will be administered at dose of 1000 PFU (for each of the vaccine viruses),and both&#xD;
      vaccines and the placebo will be administered subcutaneously.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>Up to day 21 after vaccination</time_frame>
    <description>Frequency of solicited and unsolicited local and systemic adverse reactions up to Day 21 after vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>Up to day 91 after vaccination</time_frame>
    <description>Seroconversion rate for each of the four vaccine viruses defined by PRNT50 ≥1:10 for each vaccine virus serotype on Days 28, 56 or 91.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>up to Day 182 after the first vaccination</time_frame>
    <description>Unsolicited adverse events after Day 21 and up to Day 182 after the first vaccination;&#xD;
Viremia for each of the four vaccine virus on Days 3, 6, 9, 12, 15 and 21 after the first vaccination of all volunteers in Step A of study and 40 volunteers with previous exposure to Dengue of Step B. For other volunteers from Step B, viremia only is measured on Day 12.&#xD;
Cases of suspected and confirmed dengue in five years after the first vaccination;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>Annualy up to five years</time_frame>
    <description>Response rates of monovalent, bivalent, trivalent or tetravalent, at Day 28, 56 and 91 and annually after vaccination, as measured by PRNT50 for each one of the four vaccine viruses;&#xD;
The difference between the geometric means, pre and post vaccination, serum level of neutralizing antibodies measured by PRNT50 for each of the four vaccine viruses evaluated until five years after the first vaccination.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory</measure>
    <time_frame>Up to Day 182 after the second vaccination</time_frame>
    <description>The seroconversion rate for each one of the four vaccine according to previous exposure to other flaviviruses;&#xD;
The solicited and unsolicited local and systemic adverse reactions, until Day 21 after the second vaccination;&#xD;
Unsolicited adverse events after Day 21 and Day 182 after the second vaccination for participants from Step A;&#xD;
The differences in pre and post vaccination cellular immune response after the first and second vaccination and annually for five years for participants in Step A;&#xD;
Viremia for each one of the four vaccine viruses on Days 3, 6, 9, 12, 15 and 21 after a second vaccination for participants in Step A;&#xD;
The difference in rates of seroconversion for each of the four types vaccination after the second vaccination for participants in Step A;&#xD;
The differences in cellular immune response pre and post vaccination after the first vaccination and annually for five years for 40 participants from Step B with previous exposure to dengue.</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Dengue</condition>
  <arm_group>
    <arm_group_label>Step A: dengue lyophilized vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dengue 1,2,3,4 (attenuated) vaccine Two doses with a six-months interval, SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Step A:dengue liquid vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TetraVax-DV Vaccine - Admixture TV003 Two doses with a six-months interval, SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Step A: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo comparator Two doses with a six-months interval, SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Step B: dengue lyophilized vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dengue 1,2,3,4 (attenuated) vaccine Single dose, SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Step B: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo comparator Single dose, SC</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Dengue 1,2,3,4 (attenuated) vaccine</intervention_name>
    <description>Dose 1000 PFU per virus (1,2,3,4) Route:subcutaneous</description>
    <arm_group_label>Step A: dengue lyophilized vaccine</arm_group_label>
    <arm_group_label>Step B: dengue lyophilized vaccine</arm_group_label>
    <other_name>Butantan DV</other_name>
    <other_name>Dengue Tetravalent Vaccine - Lyophilized formulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TetraVax-DV Vaccine - Admixture TV003</intervention_name>
    <description>Dose 1000 PFU per virus (1,2,3,4) Route: subcutaneous</description>
    <arm_group_label>Step A:dengue liquid vaccine</arm_group_label>
    <other_name>Dengue Tetravalent Vaccine - Liquid formulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Route:subcutaneous</description>
    <arm_group_label>Step A: Placebo</arm_group_label>
    <arm_group_label>Step B: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults (men and non-pregnant women), from 18 to 59 years old;&#xD;
&#xD;
          -  Willingness to participate throughout the study period (approximately five years);&#xD;
&#xD;
          -  Willingness to participate documented by the signature of ICF;&#xD;
&#xD;
          -  Females with childbearing potential must be willing to avoid pregnancies up to three&#xD;
             weeks after the last vaccine dose. All female volunteers will be considered with&#xD;
             childbearing potential unless they have documented history of hysterectomy, tubal&#xD;
             ligation or are postmenopausal (12 months of amenorrhea after the last menstrual&#xD;
             period).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy (confirmed by positive beta-hCG test) or breastfeeding;&#xD;
&#xD;
          -  Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as&#xD;
             clinical history, physical examination and/or laboratory results;&#xD;
&#xD;
          -  Compromised immune system diseases including: diabetes mellitus, cancer (except basal&#xD;
             cell carcinoma) and autoimmune diseases;&#xD;
&#xD;
          -  Behavioral, cognitive or psychiatric disease that in the opinion of the principal&#xD;
             investigator or his representative physician, affects the participant ability to&#xD;
             understand and cooperate with all study protocol requirements;&#xD;
&#xD;
          -  Values of absolute neutrophil, alanine aminotransferase (ALT) or serum creatinine&#xD;
             count greater than or equal to Grade 1, as defined in the protocol;&#xD;
&#xD;
          -  Abusive usage of alcohol or drugs in the past 12 months that has caused medical,&#xD;
             professional or family problems, indicated by clinical history;&#xD;
&#xD;
          -  History of severe allergic reactions or anaphylaxis;&#xD;
&#xD;
          -  Diagnosis of asthma with a history of hospitalization in the last six months due to&#xD;
             illness;&#xD;
&#xD;
          -  Fever or suspect fever within 72 hours prior to vaccination or axillary temperature&#xD;
             greater than 37,8°C on the day of vaccination;&#xD;
&#xD;
          -  Positive result of HIV-1 serology by screening or confirmed tests;&#xD;
&#xD;
          -  Screening or confirmed positive test for hepatitis C virus (HCV);&#xD;
&#xD;
          -  Positive test of hepatitis B virus antigen surface (AgHBs) alone or against hepatitis&#xD;
             B &quot;core&quot; antigen antibody (anti-HBc);&#xD;
&#xD;
          -  Use of corticosteroids (except topical or nasal) or other immunosuppressive drugs&#xD;
             within 42 days before study initiation/baseline. It will be considered&#xD;
             immunosuppressive dose of corticosteroids the equivalent to a dose ≥10 mg of&#xD;
             prednisone per day for over 14 days;&#xD;
&#xD;
          -  Use of anticoagulant medication;&#xD;
&#xD;
          -  Have received live virus vaccine within 28 days or killed virus vaccine in the last 14&#xD;
             days prior to vaccination, or have a scheduled immunization during the first 42 days&#xD;
             after receiving the investigational product;&#xD;
&#xD;
          -  History of asplenia;&#xD;
&#xD;
          -  Have received blood products in the past six months, including transfusions or&#xD;
             immunoglobulin, or scheduled administration of blood products or immunoglobulin for&#xD;
             the first 42 days after vaccination;&#xD;
&#xD;
          -  Use of any investigational product within 42 days before or after receiving this study&#xD;
             vaccination;&#xD;
&#xD;
          -  Has participated in another clinical trial six months prior to vaccination;&#xD;
&#xD;
          -  Denies permission for biological material storage for future research as defined in&#xD;
             ICF;&#xD;
&#xD;
          -  Any other condition that might put in risk the safety/rights of a potential&#xD;
             participant or hurdle his/her compliance with this protocol in investigator's opinion&#xD;
             or his representative physician.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander R Precioso, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Instituto Butantan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da USP</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246- 903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.</citation>
    <PMID>16553547</PMID>
  </reference>
  <reference>
    <citation>Durbin AP, Kirkpatrick BD, Pierce KK, Schmidt AC, Whitehead SS. Development and clinical evaluation of multiple investigational monovalent DENV vaccines to identify components for inclusion in a live attenuated tetravalent DENV vaccine. Vaccine. 2011 Sep 23;29(42):7242-50. doi: 10.1016/j.vaccine.2011.07.023. Epub 2011 Jul 21.</citation>
    <PMID>21781997</PMID>
  </reference>
  <reference>
    <citation>Durbin AP, Kirkpatrick BD, Pierce KK, Elwood D, Larsson CJ, Lindow JC, Tibery C, Sabundayo BP, Shaffer D, Talaat KR, Hynes NA, Wanionek K, Carmolli MP, Luke CJ, Murphy BR, Subbarao K, Whitehead SS. A single dose of any of four different live attenuated tetravalent dengue vaccines is safe and immunogenic in flavivirus-naive adults: a randomized, double-blind clinical trial. J Infect Dis. 2013 Mar 15;207(6):957-65. doi: 10.1093/infdis/jis936. Epub 2013 Jan 17.</citation>
    <PMID>23329850</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dengue</keyword>
  <keyword>tetravalent attenuated Vaccine</keyword>
  <keyword>Healthy adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dengue</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/NCT01696422
org study id: DEN-01-IB
secondary id: U1111-1135-4553
nct id: NCT01696422
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This is a phase II step-wise, randomized, multicenter, double-blind and controlled clinical
      trial to evaluate the safety and immunogenicity of a attenuated tetravalent lyophilized
      dengue vaccine manufactured by Butantan Institute. Three Clinical Sites at University of Sao
      Paulo - Brazil will participate in the study. A total of 300 volunteers will be recruited and
      divided into two steps: Step A (with no previous exposure to dengue) and Step B (with and
      without previous exposure to dengue). In step A the participants will be assigned to receive
      either the lyophilized vaccine, or the liquid vaccine(developed at NIH and produced and
      formulated at Butantan according to the NIH-Protocol), or the placebo. In Step B participants
      will be assigned to receive either the lyophilized vaccine, or the placebo. Both vaccine
      formulations (lyophilized and liquid) are composed of the same attenuated viruses: rDEN1∆30,
      rDEN2/4∆30(ME), rDEN3∆30/31, and rDEN4∆30. At the end of the study, 20 volunteers will have
      received the liquid formulation (NIH), 210 the lyophilized formulation (Butantan), and 70
      will have received the placebo. All participants included in both steps will be followed by a
      period of five years after their inclusion in the study. The study hypothesis is that the
      investigational lyophilized dengue vaccine manufactured by Butantan Institute is safe and
      confers balanced immune response, after one dose of 1000PFU, to all for vaccine viruses.
This is a phase II step-wise, randomized, multicenter, double-blind and controlled clinical
      trial to evaluate the safety and immunogenicity of an attenuated tetravalent lyophilized
      dengue vaccine manufactured by Butantan Institute. A total of 300 volunteers will be
      recruited including men and no pregnant/breastfeeding women between 18 and 59 years of age
      complete, with and without previous exposure to dengue that will be randomized into Step A
      and Step B. Step A will include 50 volunteers with no previous exposure and they will be
      randomly assigned to receive one dose of either the lyophilized formulation (Butantan), or
      the liquid formulation (TetraVax-DV Vaccine - Admixture TV003 developed by NIH/NIAID and
      produced and formulated at Butantan according the NIH-Protocol), or the placebo. A second
      dose will be administered six months after the first vaccination as part of an exploratory
      assessment. Step B will include 250 participants(50 without previous exposure to dengue,and
      200 with previous exposure to dengue) who will be randomly assigned to receive one dose of
      either the lyophilized formulation (Butantan),or the placebo. All participants included in
      both steps will be followed by a period of five years after their inclusion in the study. The
      vaccines will be administered at dose of 1000 PFU (for each of the vaccine viruses),and both
      vaccines and the placebo will be administered subcutaneously.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Safety
time frame: Up to day 21 after vaccination
description: Frequency of solicited and unsolicited local and systemic adverse reactions up to Day 21 after vaccination.
measure: Immunogenicity
time frame: Up to day 91 after vaccination
description: Seroconversion rate for each of the four vaccine viruses defined by PRNT50 ≥1:10 for each vaccine virus serotype on Days 28, 56 or 91.
measure: Safety
time frame: up to Day 182 after the first vaccination
description: Unsolicited adverse events after Day 21 and up to Day 182 after the first vaccination;
Viremia for each of the four vaccine virus on Days 3, 6, 9, 12, 15 and 21 after the first vaccination of all volunteers in Step A of study and 40 volunteers with previous exposure to Dengue of Step B. For other volunteers from Step B, viremia only is measured on Day 12.
Cases of suspected and confirmed dengue in five years after the first vaccination;
measure: Immunogenicity
time frame: Annualy up to five years
description: Response rates of monovalent, bivalent, trivalent or tetravalent, at Day 28, 56 and 91 and annually after vaccination, as measured by PRNT50 for each one of the four vaccine viruses;
The difference between the geometric means, pre and post vaccination, serum level of neutralizing antibodies measured by PRNT50 for each of the four vaccine viruses evaluated until five years after the first vaccination.
measure: Exploratory
time frame: Up to Day 182 after the second vaccination
description: The seroconversion rate for each one of the four vaccine according to previous exposure to other flaviviruses;
The solicited and unsolicited local and systemic adverse reactions, until Day 21 after the second vaccination;
Unsolicited adverse events after Day 21 and Day 182 after the second vaccination for participants from Step A;
The differences in pre and post vaccination cellular immune response after the first and second vaccination and annually for five years for participants in Step A;
Viremia for each one of the four vaccine viruses on Days 3, 6, 9, 12, 15 and 21 after a second vaccination for participants in Step A;
The difference in rates of seroconversion for each of the four types vaccination after the second vaccination for participants in Step A;
The differences in cellular immune response pre and post vaccination after the first vaccination and annually for five years for 40 participants from Step B with previous exposure to dengue.
arm group label: Step A: dengue lyophilized vaccine
arm group type: Experimental
description: Dengue 1,2,3,4 (attenuated) vaccine Two doses with a six-months interval, SC
arm group label: Step A:dengue liquid vaccine
arm group type: Active Comparator
description: TetraVax-DV Vaccine - Admixture TV003 Two doses with a six-months interval, SC
arm group label: Step A: Placebo
arm group type: Placebo Comparator
description: Placebo comparator Two doses with a six-months interval, SC
arm group label: Step B: dengue lyophilized vaccine
arm group type: Experimental
description: Dengue 1,2,3,4 (attenuated) vaccine Single dose, SC
arm group label: Step B: Placebo
arm group type: Placebo Comparator
description: Placebo comparator Single dose, SC
intervention type: Biological
intervention name: Dengue 1,2,3,4 (attenuated) vaccine
description: Dose 1000 PFU per virus (1,2,3,4) Route:subcutaneous
arm group label: Step A: dengue lyophilized vaccine
arm group label: Step B: dengue lyophilized vaccine
other name: Butantan DV
other name: Dengue Tetravalent Vaccine - Lyophilized formulation
intervention type: Biological
intervention name: TetraVax-DV Vaccine - Admixture TV003
description: Dose 1000 PFU per virus (1,2,3,4) Route: subcutaneous
arm group label: Step A:dengue liquid vaccine
other name: Dengue Tetravalent Vaccine - Liquid formulation
intervention type: Other
intervention name: Placebo
description: Route:subcutaneous
arm group label: Step A: Placebo
arm group label: Step B: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexander R Precioso, MD, PhD
role: Study Director
affiliation: Instituto Butantan
facility: 
facility: 
country: Brazil
citation: Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.
PMID: 16553547
citation: Durbin AP, Kirkpatrick BD, Pierce KK, Schmidt AC, Whitehead SS. Development and clinical evaluation of multiple investigational monovalent DENV vaccines to identify components for inclusion in a live attenuated tetravalent DENV vaccine. Vaccine. 2011 Sep 23;29(42):7242-50. doi: 10.1016/j.vaccine.2011.07.023. Epub 2011 Jul 21.
PMID: 21781997
citation: Durbin AP, Kirkpatrick BD, Pierce KK, Elwood D, Larsson CJ, Lindow JC, Tibery C, Sabundayo BP, Shaffer D, Talaat KR, Hynes NA, Wanionek K, Carmolli MP, Luke CJ, Murphy BR, Subbarao K, Whitehead SS. A single dose of any of four different live attenuated tetravalent dengue vaccines is safe and immunogenic in flavivirus-naive adults: a randomized, double-blind clinical trial. J Infect Dis. 2013 Mar 15;207(6):957-65. doi: 10.1093/infdis/jis936. Epub 2013 Jan 17.
PMID: 23329850
responsible party type: Sponsor
mesh term: Dengue
mesh term: Vaccines