<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/NCT04415749</url>
  </required_header>
  <id_info>
    <org_study_id>ALT-201-102</org_study_id>
    <secondary_id>HHSO100201600008C</secondary_id>
    <nct_id>NCT04415749</nct_id>
  </id_info>
  <brief_title>NasoShield in Healthy Adults to Study Safety and Immunogenicity</brief_title>
  <official_title>A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Immunogenicity of NasoShield Administered as One or Two Doses in Different Dosing Positions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Altimmune, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biomedical Advanced Research and Development Authority</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Altimmune, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety for up to two doses of NasoShield, to&#xD;
      determine if antibodies that protect against anthrax are formed after treatment with&#xD;
      NasoShield, and to determine whether the formation of these antibodies are affected by&#xD;
      different positions of administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed about the study and potential risks, all healthy volunteers that have&#xD;
      given written informed consent will undergo screening to determine eligibility for study&#xD;
      entry. If the healthy volunteer qualifies for the study, they will be randomly assigned to 1&#xD;
      of 3 treatment groups. Within the treatment group, the participant will be randomized in a&#xD;
      double-blind manner in a 5:2 ratio to NasoShield or placebo.&#xD;
&#xD;
      The investigational drug (either NasoShield or placebo) will be administered on Days 1 and 29&#xD;
      after qualifying into the study. The position of administration and the amount of time the&#xD;
      subject will need to stay in the specified position will depend on the group to which the&#xD;
      subject is assigned.&#xD;
&#xD;
      Participants will return to the investigational site for multiple visits through Day 210&#xD;
      (approximately 6 months after the second dose). At each visit, the participant will be asked&#xD;
      about interim medical history and use of any medications, and safety and immunogenicity&#xD;
      assessments will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">March 3, 2021</completion_date>
  <primary_completion_date type="Actual">March 3, 2021</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>3 parallel groups defined by dosing position and number of doses</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double-Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Reactogenicity to evaluate the safety of NasoShield</measure>
    <time_frame>For 7 days after vaccination</time_frame>
    <description>Subjects will record solicited local and systemic events for 7 days after each dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events (AEs) to evaluate the safety of NasoShield</measure>
    <time_frame>From Day 1 to Day 210</time_frame>
    <description>All adverse events from Day 1 to Day 57; serious adverse events (SAE), medically attended adverse events (MAAE), and new-onset chronic illnesses (NCI) from Day 1 to Day 210</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-protective antigen (PA) immunoglobulin G (IgG) to evaluate humoral immunogenicity</measure>
    <time_frame>From Day 1 to Day 210</time_frame>
    <description>Titer measured by enzyme-linked immunosorbent assay (ELISA) in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxin neutralization antibody 50% neutralization factor (TNA-NF50) titer measured in serum by cytotoxic assay to evaluate humoral immunogenicity</measure>
    <time_frame>From Day 1 to Day 210</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-protective antigen (PA) immunoglobulin A (IgA) to evaluate mucosal immune response</measure>
    <time_frame>From Day 1 to Day 57</time_frame>
    <description>Titer measured by enzyme-linked immunosorbent assay (ELISA) in serum</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>NasoShield One Dose in Position 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NasoShield on Day 1 and saline placebo on Day 29 in position 1 (Group 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo in Position 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline placebo on Day 1 and saline placebo on Day 29 in position 1 (Group 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NasoShield Two Doses in Position 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NasoShield on Day 1 and Day 29 in position 2 (Group 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo in Position 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline placebo on Day 1 and Day 29 in position 2 (Group 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NasoShield Two Doses in Position 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NasoShield on Day 1 and Day 29 in position 3 (Group 3)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo in Position 3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline placebo on Day 1 and Day 29 in position 3 (Group 3)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NasoShield</intervention_name>
    <description>NasoShield is an adenovirus-vectored anthrax vaccine</description>
    <arm_group_label>NasoShield One Dose in Position 1</arm_group_label>
    <arm_group_label>NasoShield Two Doses in Position 2</arm_group_label>
    <arm_group_label>NasoShield Two Doses in Position 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline</description>
    <arm_group_label>NasoShield One Dose in Position 1</arm_group_label>
    <arm_group_label>Placebo in Position 1</arm_group_label>
    <arm_group_label>Placebo in Position 2</arm_group_label>
    <arm_group_label>Placebo in Position 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women 18 to 49 years of age, inclusive&#xD;
&#xD;
          2. Good general health status&#xD;
&#xD;
          3. Adequate venous access for repeated phlebotomies&#xD;
&#xD;
          4. Screening laboratory results within institutional normal range or Grade 1 abnormality&#xD;
             if the Investigator documents clinical insignificance. Creatine kinase or bilirubin&#xD;
             may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate&#xD;
             aminotransferase (AST) and the Investigator considers the result not to be clinically&#xD;
             significant due to vigorous exercise or Gilbert's syndrome&#xD;
&#xD;
          5. Negative drug and alcohol screen at Screening and predose on Day 1&#xD;
&#xD;
          6. For women who have not been surgically sterilized or who do not have laboratory&#xD;
             confirmation of postmenopausal status, negative pregnancy test&#xD;
&#xD;
          7. Willingness to practice a highly effective method of contraception that may include,&#xD;
             but is not limited to, abstinence, sex only with persons of the same sex, monogamous&#xD;
             relationship with a postmenopausal partner, monogamous relationship with vasectomized&#xD;
             partner, vasectomy, surgical sterilization (hysterectomy, bilateral tubal ligation,&#xD;
             salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD),&#xD;
             or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28&#xD;
             days after the last IP dose&#xD;
&#xD;
          8. Willingness to participate and comply with all aspects of the study through the entire&#xD;
             study period, including nasopharyngeal swabs and blood and urine samples&#xD;
&#xD;
          9. Provision of written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant, possibly pregnant, or lactating women&#xD;
&#xD;
          2. Body mass index &gt; 35.0 kg/m2&#xD;
&#xD;
          3. Positive result for HIV, hepatitis B virus, or hepatitis C virus at Screening&#xD;
&#xD;
          4. Asthma or other chronic lung disease that is greater than mild in severity.&#xD;
             Specifically excluded are participants with any of the following events in the past&#xD;
             year:&#xD;
&#xD;
               -  Daily symptoms&#xD;
&#xD;
               -  Daily use of short acting beta 2 agonists&#xD;
&#xD;
               -  Use of inhaled steroids or theophylline&#xD;
&#xD;
               -  Use of pulse systemic steroids&#xD;
&#xD;
               -  Emergency care or hospitalization related to asthma or other chronic lung disease&#xD;
&#xD;
               -  Systemic steroids for asthma exacerbation&#xD;
&#xD;
          5. History of diabetes mellitus (gestational diabetes is allowed if treatment was not&#xD;
             required postpartum and serum glucose is currently in the normal range)&#xD;
&#xD;
          6. History of coronary artery disease, arrhythmia, or congestive heart failure&#xD;
&#xD;
          7. Clinically significant ECG abnormality&#xD;
&#xD;
          8. Poorly controlled hypertension (systolic blood pressure &gt; 150 mmHg or diastolic blood&#xD;
             pressure &gt; 95 mmHg) at Screening or predose on Day 1&#xD;
&#xD;
          9. History of anaphylaxis or angioedema&#xD;
&#xD;
         10. Known allergy to any of the ingredients in the vaccine formulation&#xD;
&#xD;
         11. Known allergy or sensitivity to latex&#xD;
&#xD;
         12. History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other&#xD;
             nasal abnormality that might affect vaccine administration&#xD;
&#xD;
         13. Previous nasal surgery or nasal cauterization&#xD;
&#xD;
         14. Any symptoms of upper respiratory infection or temperature &gt; 38°C within 3 days before&#xD;
             Day 1&#xD;
&#xD;
         15. Any symptoms within 24 hours before Day 1 of upper respiratory illness or allergy&#xD;
             flare-up that, in the opinion of the Investigator, presents as nasal congestion or&#xD;
             rhinorrhea that could inhibit the proper administration of the IP&#xD;
&#xD;
         16. Known or suspected malignancy, excluding non-melanoma skin cancers and other early&#xD;
             stage surgically excised malignancies that the Investigator considers to be&#xD;
             exceedingly unlikely to recur&#xD;
&#xD;
         17. Immunocompromised individuals, including those who have used corticosteroids(including&#xD;
             intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating&#xD;
             biologics, or other immunomodulating therapies within 90 days before Day 1 or those&#xD;
             who plan use during the study period&#xD;
&#xD;
         18. History of autoimmune or demyelinating disease&#xD;
&#xD;
         19. Use of statin medication within 30 days before Day 1 (see list in Section 6.7.1)&#xD;
&#xD;
         20. Receipt of intranasal medications (including over-the-counter medications) within 30&#xD;
             days before Day 1&#xD;
&#xD;
         21. Receipt of any IP within 30 days before Day 1&#xD;
&#xD;
         22. Receipt of any vaccine within 30 days before Day 1&#xD;
&#xD;
         23. Receipt of intranasal vaccine within 90 days before Day 1&#xD;
&#xD;
         24. Receipt of any licensed or investigational anthrax vaccine in civilian or military&#xD;
             life&#xD;
&#xD;
         25. Any change in medication for a chronic medical condition within 30 days before Day 1&#xD;
&#xD;
         26. Past regular use or current use of intranasal illicit drugs&#xD;
&#xD;
         27. Any medical, psychiatric, or social condition or occupational or other responsibility&#xD;
             that in the judgment of the Investigator would interfere with or serve as a&#xD;
             contraindication to protocol adherence, assessment of safety (including&#xD;
             reactogenicity), or a subject's ability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>JBR Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 12, 2021</last_update_submitted>
  <last_update_submitted_qc>May 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anthrax</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04415749
org study id: ALT-201-102
secondary id: HHSO100201600008C
nct id: NCT04415749
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety for up to two doses of NasoShield, to
      determine if antibodies that protect against anthrax are formed after treatment with
      NasoShield, and to determine whether the formation of these antibodies are affected by
      different positions of administration.
After being informed about the study and potential risks, all healthy volunteers that have
      given written informed consent will undergo screening to determine eligibility for study
      entry. If the healthy volunteer qualifies for the study, they will be randomly assigned to 1
      of 3 treatment groups. Within the treatment group, the participant will be randomized in a
      double-blind manner in a 5:2 ratio to NasoShield or placebo.

      The investigational drug (either NasoShield or placebo) will be administered on Days 1 and 29
      after qualifying into the study. The position of administration and the amount of time the
      subject will need to stay in the specified position will depend on the group to which the
      subject is assigned.

      Participants will return to the investigational site for multiple visits through Day 210
      (approximately 6 months after the second dose). At each visit, the participant will be asked
      about interim medical history and use of any medications, and safety and immunogenicity
      assessments will be performed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3 parallel groups defined by dosing position and number of doses
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: Double-Blind
measure: Reactogenicity to evaluate the safety of NasoShield
time frame: For 7 days after vaccination
description: Subjects will record solicited local and systemic events for 7 days after each dose
measure: Adverse Events (AEs) to evaluate the safety of NasoShield
time frame: From Day 1 to Day 210
description: All adverse events from Day 1 to Day 57; serious adverse events (SAE), medically attended adverse events (MAAE), and new-onset chronic illnesses (NCI) from Day 1 to Day 210
measure: Anti-protective antigen (PA) immunoglobulin G (IgG) to evaluate humoral immunogenicity
time frame: From Day 1 to Day 210
description: Titer measured by enzyme-linked immunosorbent assay (ELISA) in serum
measure: Toxin neutralization antibody 50% neutralization factor (TNA-NF50) titer measured in serum by cytotoxic assay to evaluate humoral immunogenicity
time frame: From Day 1 to Day 210
measure: Anti-protective antigen (PA) immunoglobulin A (IgA) to evaluate mucosal immune response
time frame: From Day 1 to Day 57
description: Titer measured by enzyme-linked immunosorbent assay (ELISA) in serum
arm group label: NasoShield One Dose in Position 1
arm group type: Experimental
description: NasoShield on Day 1 and saline placebo on Day 29 in position 1 (Group 1)
arm group label: Placebo in Position 1
arm group type: Placebo Comparator
description: Saline placebo on Day 1 and saline placebo on Day 29 in position 1 (Group 1)
arm group label: NasoShield Two Doses in Position 2
arm group type: Experimental
description: NasoShield on Day 1 and Day 29 in position 2 (Group 2)
arm group label: Placebo in Position 2
arm group type: Placebo Comparator
description: Saline placebo on Day 1 and Day 29 in position 2 (Group 2)
arm group label: NasoShield Two Doses in Position 3
arm group type: Experimental
description: NasoShield on Day 1 and Day 29 in position 3 (Group 3)
arm group label: Placebo in Position 3
arm group type: Placebo Comparator
description: Saline placebo on Day 1 and Day 29 in position 3 (Group 3)
intervention type: Biological
intervention name: NasoShield
description: NasoShield is an adenovirus-vectored anthrax vaccine
arm group label: NasoShield One Dose in Position 1
arm group label: NasoShield Two Doses in Position 2
arm group label: NasoShield Two Doses in Position 3
intervention type: Other
intervention name: Placebo
description: Normal saline
arm group label: NasoShield One Dose in Position 1
arm group label: Placebo in Position 1
arm group label: Placebo in Position 2
arm group label: Placebo in Position 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No