<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/NCT02239172</url>
  </required_header>
  <id_info>
    <org_study_id>FhCMB rPA83-001</org_study_id>
    <nct_id>NCT02239172</nct_id>
  </id_info>
  <brief_title>PA83-FhCMB Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine</brief_title>
  <official_title>A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fraunhofer, Center for Molecular Biotechnology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fraunhofer, Center for Molecular Biotechnology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes of this study is to evaluate and compare the safety, reactogenicity, and&#xD;
      tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Up to 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in antibody titer after three immunizations</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Anthrax</condition>
  <arm_group>
    <arm_group_label>12.5 µg + Alhydrogel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>25 µg + Alhydrogel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>50 µg + Alhydrogel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 µg + Alhydrogel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PA83-FhCMB</intervention_name>
    <arm_group_label>100 µg + Alhydrogel</arm_group_label>
    <arm_group_label>12.5 µg + Alhydrogel</arm_group_label>
    <arm_group_label>25 µg + Alhydrogel</arm_group_label>
    <arm_group_label>50 µg + Alhydrogel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Citizen or permanent resident of the US&#xD;
&#xD;
          -  Male or female aged 18 to 49 years inclusive&#xD;
&#xD;
          -  Able to give written informed consent&#xD;
&#xD;
          -  Healthy, as determined by medical history, physical examination, vital signs, and&#xD;
             clinical safety laboratory examinations at baseline&#xD;
&#xD;
          -  Females should fulfill one of the following criteria:&#xD;
&#xD;
               1. At least one year post-menopausal&#xD;
&#xD;
               2. Surgically sterile&#xD;
&#xD;
               3. Willing to use a medically approved form of contraception (eg, oral, implantable,&#xD;
                  transdermal, or injectable hormonal contraceptive; intrauterine device; barrier&#xD;
                  protection to include female condom, diaphragm, cervical cap, or male condoms in&#xD;
                  conjunction with spermicide) for 30 days prior to first vaccination and through&#xD;
                  the end of the study&#xD;
&#xD;
               4. Willing to abstain from sexual intercourse for 30 days prior to first vaccination&#xD;
                  and through the end of the study&#xD;
&#xD;
          -  Women of childbearing potential must have a negative urine pregnancy test within 24&#xD;
             hours preceding receipt of each dose&#xD;
&#xD;
          -  Comprehension of the study requirements&#xD;
&#xD;
          -  Expressed availability for the required study period&#xD;
&#xD;
          -  Ability to attend scheduled visits and to be contacted by telephone throughout the&#xD;
             follow-up period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of anthrax disease or receipt of anthrax vaccine&#xD;
&#xD;
          -  Presence of significant uncontrolled medical or psychiatric illness (acute or chronic)&#xD;
             including institution of new medical or surgical treatment or a significant dose&#xD;
             alteration for uncontrolled symptoms or drug toxicity within 3 months of screening&#xD;
&#xD;
          -  Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Cancer or treatment for cancer, within the previous 3 years, excluding basal cell&#xD;
             carcinoma&#xD;
&#xD;
          -  Presence of any medical condition that may be associated with impaired immune&#xD;
             responsiveness, including diabetes mellitus, per the investigator's discretion&#xD;
&#xD;
          -  Presently receiving or history of receiving, during the preceding 3-month period, any&#xD;
             medications or other treatments that may adversely affect the immune system&#xD;
&#xD;
               1. This includes allergy injections, immune globulin, interferon, immunomodulators,&#xD;
                  cytotoxic drugs, or systemic corticosteroids (oral or injectable; 20 mg/day x 14&#xD;
                  days or longer)&#xD;
&#xD;
               2. Radiation therapy&#xD;
&#xD;
               3. Intranasal and topical corticosteroids will be allowed&#xD;
&#xD;
          -  Receipt or planned administration of a non study vaccine within 14 days prior to&#xD;
             vaccination and throughout the study period (30 days for live vaccines) Immunization&#xD;
             on an emergency basis with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) or&#xD;
             influenza vaccine up to 14 days before or at least 14 days after a dose of study&#xD;
             vaccine will be allowed&#xD;
&#xD;
          -  History of anaphylactic type reaction to injected vaccines&#xD;
&#xD;
          -  History of drug or chemical abuse in the year before the study&#xD;
&#xD;
          -  Receipt of any investigational product or nonregistered drug within 30 days prior to&#xD;
             vaccination or currently enrolled in any investigational drug study or intends to&#xD;
             enroll in such a study within the ensuing study period&#xD;
&#xD;
          -  Receipt of blood or blood products 8 weeks prior to vaccination or planned&#xD;
             administration during the study period&#xD;
&#xD;
          -  Donation of blood or blood products within 8 weeks prior to vaccination or at any time&#xD;
             during the study&#xD;
&#xD;
          -  Acute disease within 72 hours prior to vaccination&#xD;
&#xD;
               1. Acute disease is defined as the presence of a moderate or severe illness (as&#xD;
                  determined by the Investigator through medical history and physical examination)&#xD;
                  with or without fever (≥38°C; 100.4°F), or an oral temperature of ≥38°C orally&#xD;
&#xD;
               2. Study vaccine can be administered to persons with a minor illness&#xD;
&#xD;
          -  History of immunodeficiency, chronic illness requiring continuous or frequent medical&#xD;
             intervention, autoimmune disease, use of immunosuppressive medications, or ongoing&#xD;
             therapy with systemic corticosteroids within 3 months prior to any planned vaccine&#xD;
             dose. Inhaled and topical steroids are permitted. &quot;Burst&quot; therapy of steroids is&#xD;
             permitted except within 2 weeks prior to vaccination.&#xD;
&#xD;
          -  Evidence of psychiatric, medical and/or substance abuse problems during the past 6&#xD;
             months that the investigator believes would adversely affect the subject's ability to&#xD;
             participate in the trial&#xD;
&#xD;
          -  Occupational or other responsibilities that would prevent completion of participation&#xD;
             in the trial, including:&#xD;
&#xD;
               1. US military or reservists who may receive the licensed anthrax vaccine (BioThrax)&#xD;
                  or served during the Persian Gulf War between January and May, 1991. Such&#xD;
                  individuals may be enrolled only if they provide their medical records, which can&#xD;
                  then show proof that they have not received the licensed anthrax vaccine.&#xD;
&#xD;
               2. Postal and other workers who may be exposed to anthrax or may have to take&#xD;
                  BioThrax&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, might interfere with&#xD;
             interpretation of data supporting the primary study objectives&#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>Walter Reed Army Institute of Research, Clinical Trials Center</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>May 10, 2016</last_update_submitted>
  <last_update_submitted_qc>May 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anthrax</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02239172
org study id: FhCMB rPA83-001
nct id: NCT02239172
lead sponsor: 
has dmc: No
The purposes of this study is to evaluate and compare the safety, reactogenicity, and
      tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Number of Participants with Adverse Events
time frame: Up to 3 months
measure: Change from Baseline in antibody titer after three immunizations
time frame: Up to 6 months
arm group label: 12.5 µg + Alhydrogel
arm group type: Experimental
description: vaccine
arm group label: 25 µg + Alhydrogel
arm group type: Experimental
description: vaccine
arm group label: 50 µg + Alhydrogel
arm group type: Experimental
description: vaccine
arm group label: 100 µg + Alhydrogel
arm group type: Experimental
description: vaccine
intervention type: Biological
intervention name: PA83-FhCMB
arm group label: 100 µg + Alhydrogel
arm group label: 12.5 µg + Alhydrogel
arm group label: 25 µg + Alhydrogel
arm group label: 50 µg + Alhydrogel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anthrax
sharing ipd: Undecided