<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/NCT03760549</url>
  </required_header>
  <id_info>
    <org_study_id>ALT103-201EXT</org_study_id>
    <nct_id>NCT03760549</nct_id>
  </id_info>
  <brief_title>Study of the Safety and Immunogenicity of NasoVAX Extension</brief_title>
  <official_title>Extension Study for Study ALT-103-201: One-year Follow-up for the 1×10(11th) vp NasoVAX Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Altimmune, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Altimmune, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is an extension to Study ALT-103-201, a Phase 2a, randomized, double-blind,&#xD;
      placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy&#xD;
      adults 18 to 49 years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an extension to Study ALT-103-201 to evaluate immunogenicity of NasoVAX&#xD;
      administered by intranasal spray at a single dose of 1×1011 vp at Day 366 (± 60 days). Up to&#xD;
      15 subjects who received NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 will be&#xD;
      screened, and a serum sample will be collected from each eligible subject for evaluation of&#xD;
      influenza HAI assay against influenza A/California/07/2009(H1N1), a strain homologous to the&#xD;
      one used for NasoVAX (monovalent AdcoCA09.HA). Ad5 antibody neutralization assay may also be&#xD;
      performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">February 18, 2019</completion_date>
  <primary_completion_date type="Actual">February 18, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Immune response to NasoVAX when administered by intranasal spray at a single dose of 1×10(11th) vp after approximately 1year</measure>
    <time_frame>Day 366</time_frame>
    <description>Antibody level measured by hemagglutination inhibition titer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Persistence of antivector immune response following NasoVAX administered by intranasal spray at a single 1×10(11th) vp dose after approximately 1year</measure>
    <time_frame>Day 366</time_frame>
    <description>Antibody level measured by Adenovirus serotype 5 neutralization</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">8</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Extension of NasoVAX high dose</arm_group_label>
    <description>A serum sample will be collected from each eligible subject who received NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 for evaluation of influenza hemagglutination assay against influenza A/California/07/2009(H1N1), a strain homologous to the one used for NasoVAX (monovalent AdcoCA09.HA). Ad5 antibody neutralization assay may also be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Subjects were administered NasoVAX high dose</intervention_name>
    <description>NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo</description>
    <arm_group_label>Extension of NasoVAX high dose</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects who were previously randomized to the 1×10(11th) vp NasoVAX group in Study&#xD;
        ALT-103-201&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          1. Receipt of NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201&#xD;
&#xD;
          2. Adequate venous access for phlebotomy&#xD;
&#xD;
          3. Provision of written informed consent&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
        1. Any medical, psychiatric, or social condition or occupational or other responsibility&#xD;
        that in the judgment of the Investigator would interfere with the subject providing an&#xD;
        adequate blood sample or the subject's ability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peta-Gay Jackson-Booth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Optimal Health Research</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>March 4, 2019</last_update_submitted>
  <last_update_submitted_qc>March 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03760549
org study id: ALT103-201EXT
nct id: NCT03760549
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This study is an extension to Study ALT-103-201, a Phase 2a, randomized, double-blind,
      placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy
      adults 18 to 49 years of age.
This study is an extension to Study ALT-103-201 to evaluate immunogenicity of NasoVAX
      administered by intranasal spray at a single dose of 1×1011 vp at Day 366 (± 60 days). Up to
      15 subjects who received NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 will be
      screened, and a serum sample will be collected from each eligible subject for evaluation of
      influenza HAI assay against influenza A/California/07/2009(H1N1), a strain homologous to the
      one used for NasoVAX (monovalent AdcoCA09.HA). Ad5 antibody neutralization assay may also be
      performed.
observational model: Other
time perspective: Other
measure: Immune response to NasoVAX when administered by intranasal spray at a single dose of 1×10(11th) vp after approximately 1year
time frame: Day 366
description: Antibody level measured by hemagglutination inhibition titer
measure: Persistence of antivector immune response following NasoVAX administered by intranasal spray at a single 1×10(11th) vp dose after approximately 1year
time frame: Day 366
description: Antibody level measured by Adenovirus serotype 5 neutralization
arm group label: Extension of NasoVAX high dose
description: A serum sample will be collected from each eligible subject who received NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 for evaluation of influenza hemagglutination assay against influenza A/California/07/2009(H1N1), a strain homologous to the one used for NasoVAX (monovalent AdcoCA09.HA). Ad5 antibody neutralization assay may also be performed.
intervention type: Drug
intervention name: Subjects were administered NasoVAX high dose
description: NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo
arm group label: Extension of NasoVAX high dose
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peta-Gay Jackson-Booth, MD
role: Principal Investigator
affiliation: Study Principal Investigator
facility: 
country: United States
responsible party type: Sponsor