xml: <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/NCT05997264</url>
    </required_header>
    <id_info>
      <org_study_id>ABST001</org_study_id>
      <nct_id>NCT05997264</nct_id>
    </id_info>
    <brief_title>Anthrax AV7909 Boost Evaluation Study</brief_title>
    <acronym>ABESt</acronym>
    <official_title>A Randomized, Double-blinded, Multicenter Study in Healthy Adults to Evaluate Safety and Immunogenicity of AV7909 Administered at Two Dose Levels on Two Vaccination Schedules, Including a Primary Series and Booster Doses</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Biomedical Advanced Research and Development Authority</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Rho Federal Systems Division, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>ICON plc</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Biomedical Advanced Research and Development Authority</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This randomized, phase 2, double-blinded, multicenter study is designed to assess the safety&#xD;
        and immune response kinetics of AV7909 administered on 2 primary series vaccination schedules&#xD;
        followed by 6- and 12-month boosters.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This trial is a randomized, double-blinded, multicenter study designed to evaluate safety and&#xD;
        immune response kinetics of full and half doses of AV7909 administered on 2 primary series&#xD;
        vaccination schedules followed by 6- and 12-month boosters. Healthy adult male and female&#xD;
        subjects aged 18 through 65 years, inclusive, will be screened for baseline health status to&#xD;
        ensure trial eligibility. Subjects meeting all the inclusion and none of the exclusion&#xD;
        criteria will be randomized to receive either half or full doses of AV7909 on 1 of 2&#xD;
        vaccination schedules. Randomization will be stratified by sex. Subjects will be randomized&#xD;
        1:1:1:1 within stratum across 4 treatment groups (approximately 55 subjects per group).&#xD;
        Subjects will receive a total of 5 intramuscular (IM) injections. Primary series IP doses&#xD;
        will be administered on Days 1, 15, and 29, and booster IP doses will be administered on Days&#xD;
        181 and 366. On each IP administration day, each subject will receive an IM injection of&#xD;
        full-dose AV7909 (0.5 mL), half-dose AV7909 (0.25 mL), or placebo (0.5 mL or 0.25 mL sodium&#xD;
        chloride for injection), based on their assigned treatment group.&#xD;
  &#xD;
        Safety assessments will be based on solicited adverse events (AEs; local and systemic&#xD;
        reactogenicity symptoms) with onset within 7 days after each IP administration; unsolicited&#xD;
        treatment-emergent adverse events (TEAEs) with onset within 30 days after each IP&#xD;
        administration; and treatment-emergent serious adverse events (SAEs), potentially&#xD;
        immune-mediated medical conditions (PIMMCs), and medically attended adverse events (MAAEs)&#xD;
        occurring during study participation (ie, up to 1 year after the last IP administration). For&#xD;
        this study, a PIMMC is considered to be unexpected and will be treated as a serious and&#xD;
        unexpected suspected adverse reaction (SUSAR) per 21 CFR 312.32.&#xD;
  &#xD;
        Immunogenicity assessments will include geometric mean titer (GMT), seroprotection rate, and&#xD;
        seroconversion rate by toxin-neutralizing antibody (TNA) 50% neutralization factor (NF50) and&#xD;
        enzyme-linked immunosorbent assay (ELISA) anti-protective antigen (PA) Immunoglobulin G&#xD;
        (IgG).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>All solicited local and systemic reactogenicity symptoms with onset within 7 days after each IP administration day.</measure>
      <time_frame>Within 7 days after each IP administration.</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Geometric mean titer (GMT) as measured by toxin-neutralizing antibody (TNA) 50% neutralization</measure>
      <time_frame>Day 64</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Unsolicited treatment-emergent adverse events (TEAEs) with onset within 30 days after each IP administration day.</measure>
      <time_frame>Within 30 days after each IP administration.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment-emergent serious adverse events (SAEs) up to 1 year after the last IP administration day.</measure>
      <time_frame>Within 1 year after the last IP administration.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment-emergent potentially immune-mediated medical conditions (PIMMCs) up to 1 year after the last IP administration day.</measure>
      <time_frame>Within 1 year after the last IP administration.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment-emergent medically attended adverse events (MAAEs) up to 1 year after the last IP administration day.</measure>
      <time_frame>Within 1 year after the last IP administration.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric mean titer (GMT) as measured by toxin-neutralizing antibody (TNA) 50% neutralization factor (NF50) at Day 15, Day 29, Day 36, Day 43, Day 50, Day 85, Day 181, Day 211, Day 366, Day 396, Day 546, and Day 731.</measure>
      <time_frame>Day 15 through 731.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Seroprotection rate as measured by toxin-neutralizing antibody (TNA) 50% neutralization factor (NF50) at Day 15, Day 29, Day 36, Day 43, Day 50, Day 64, Day 85, Day 181, Day 211, Day 366, Day 396, Day 546, and Day 731.</measure>
      <time_frame>Day 15 through 731.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric mean titer (GMT) as measured by ELISA anti-PA IgG at Day 15, Day 29, Day 36, Day 43, Day 50, Day 64, Day 85, Day 181, Day 211, Day 366, Day 396, Day 546, and Day 731.</measure>
      <time_frame>Day 15 through 731.</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">220</enrollment>
    <condition>Anthrax</condition>
    <arm_group>
      <arm_group_label>Full Dose Schedule 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This study group will receive full dose AV7909 (0.5mL) at study days 1, 15, 181 and 366. A placebo full dose (0.5 mL) will be administered between the second and third dose of AV7909 at study day 29.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Full Dose Schedule 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This study group will receive of AV7909 full dose (0.5 mL) at study days 1, 29, 181 and 366. A placebo full dose (0.5 mL) will be administered between the first and second dose of AV7909 at study day 15.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Half Dose Schedule 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This study group will receive of AV7909 half dose (0.25 mL) at study days 1, 15, 181 and 366. A placebo half dose (0.25 mL) will be administered between the second and third dose of AV7909 at study day 29.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Half Dose Schedule 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This study group will receive of AV7909 half dose (0.25 mL) at study days 1, 29, 181 and 366. A placebo full dose (0.25 mL) will be administered between the first and second dose of AV7909 at study day 15.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>AV7909 Full Dose (0.5 mL)</intervention_name>
      <description>AV7909 Anthrax Vaccine is being developed by Emergent Product Development Gaithersburg Inc. (Emergent) for PEP of disease in persons 18 through 65 years of age following suspected or confirmed B. anthracis exposure when administered in conjunction with the recommended antibacterial regimen. AV7909 is a combination product containing BioThrax and CPG 7909, a synthetic immunostimulatory oligodeoxynucleotide that has been shown to be a potent vaccine adjuvant. CPG 7909 is a Toll-like receptor 9 agonist designed to induce both an enhanced antigen-specific antibody response and a natural killer T-cell immune response when used in combination with prophylactic (preventative) or therapeutic vaccines.</description>
      <arm_group_label>Full Dose Schedule 1</arm_group_label>
      <arm_group_label>Full Dose Schedule 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>AV7909 Half Dose (0.25 mL)</intervention_name>
      <description>AV7909 Anthrax Vaccine is being developed by Emergent Product Development Gaithersburg Inc. (Emergent) for PEP of disease in persons 18 through 65 years of age following suspected or confirmed B. anthracis exposure when administered in conjunction with the recommended antibacterial regimen. AV7909 is a combination product containing BioThrax and CPG 7909, a synthetic immunostimulatory oligodeoxynucleotide that has been shown to be a potent vaccine adjuvant. CPG 7909 is a Toll-like receptor 9 agonist designed to induce both an enhanced antigen-specific antibody response and a natural killer T-cell immune response when used in combination with prophylactic (preventative) or therapeutic vaccines.</description>
      <arm_group_label>Half Dose Schedule 1</arm_group_label>
      <arm_group_label>Half Dose Schedule 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or non-pregnant females, 18 through 65 years of age, inclusive.&#xD;
  &#xD;
            2. Willing and able to provide written informed consent prior to initiation of study&#xD;
               procedures.&#xD;
  &#xD;
            3. In relatively stable health, as determined by medical history and physical&#xD;
               examination. Any chronic medical diagnoses or conditions should be stable and well&#xD;
               managed, with no significant changes expected during the study period, and in the&#xD;
               opinion of the site investigator, will not impact the ability to assess safety and/or&#xD;
               immunogenicity per the study design.&#xD;
  &#xD;
            4. If a female of childbearing potential who is sexually active, agrees to use an&#xD;
               acceptable method of birth control from Screening to Day 396 and has used a reliable&#xD;
               birth control method for at least 2 months prior to Screening.&#xD;
  &#xD;
                 1. Female of childbearing potential is defined as post onset menarche and&#xD;
                    pre-menopausal person capable of becoming pregnant. This does not include females&#xD;
                    who meet any of the following conditions: a) menopausal &gt;2 years; b) tubal&#xD;
                    ligation &gt;1 year; c) bilateral salpingo-oophorectomy; or d) hysterectomy.&#xD;
  &#xD;
                 2. Adequate contraception is defined as a contraceptive method with a failure rate&#xD;
                    of less than 1% per year when used consistently and correctly and when&#xD;
                    applicable, in accordance with the product label, for example: oral&#xD;
                    contraceptives, either combined or progestogen alone; injectable progestogen;&#xD;
                    implants of etenogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous&#xD;
                    contraceptive patches; intrauterine device or intrauterine system; the female&#xD;
                    subject has exclusively female sexual partners; partner is sterile or otherwise&#xD;
                    unable to produce sperm (information on the person's sterility can come from the&#xD;
                    site personnel's review of the subject's medical records or interview with the&#xD;
                    subject regarding her medical history); male condom combined with a vaginal&#xD;
                    spermicide (foam, gel, film, cream, or suppository); or male condom combined with&#xD;
                    a female diaphragm, either with or without a vaginal spermicide (foam, gel, film,&#xD;
                    cream, or suppository).&#xD;
  &#xD;
            5. Available for all study visits, willing to participate in all study procedures, and&#xD;
               not planning to relocate from the area for the duration of the study.&#xD;
  &#xD;
            6. Has a body mass index (BMI) greater than 18.0 and less than 35.0 kg/m2, inclusive&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Has an acute illness, as determined by the site investigator, within 72 hours prior to&#xD;
               study IP administration.&#xD;
  &#xD;
                 -  An acute illness that is nearly resolved, with only minor residual symptoms&#xD;
                    remaining, is allowable if, in the opinion of the site investigator, the residual&#xD;
                    symptoms will not interfere with the ability of study staff to assess safety&#xD;
                    parameters as required by the protocol.&#xD;
  &#xD;
                 -  If the subject's temperature is above 100.4°F, indicating illness, the subject&#xD;
                    may be re-assessed for eligibility a minimum of 24 hours later.&#xD;
  &#xD;
            2. Has a history of severe reactions to components of AV7909.&#xD;
  &#xD;
            3. Has a history of anthrax disease, suspected exposure to anthrax, or previous&#xD;
               vaccination with any anthrax vaccine.&#xD;
  &#xD;
            4. Has recently diagnosed or poorly controlled human immunodeficiency virus (HIV).&#xD;
  &#xD;
            5. Has an acute or chronic hepatitis B or hepatitis C infection, as identified through&#xD;
               laboratory testing.&#xD;
  &#xD;
               - A subject who has been effectively treated for hepatitis C, as evidenced by a&#xD;
               negative hepatitis C ribonucleic acid (RNA) confirmation test, and who no longer&#xD;
               requires antiviral therapy is not excluded.&#xD;
  &#xD;
            6. Is suffering from or has a history of neuralgia, paresthesia, neuritis, convulsions,&#xD;
               or encephalomyelitis within 90 days prior to Screening, or a family history of&#xD;
               Guillain-Barré syndrome.&#xD;
  &#xD;
            7. Has a history of alcohol or drug abuse within 5 years prior to Screening.&#xD;
  &#xD;
            8. Has any diagnosis, current or past, of schizophrenia, bipolar disease, or any other&#xD;
               psychiatric diagnosis that may, in the opinion of the site investigator, interfere&#xD;
               with subject compliance or safety evaluations.&#xD;
  &#xD;
            9. Is taking herbal medicines/preparations that are known to have a direct or indirect&#xD;
               effect on the immune system.&#xD;
  &#xD;
           10. Presence of tattoos on both upper arms that would cover or partially cover all&#xD;
               potential vaccination sites.&#xD;
  &#xD;
           11. Clinically relevant signs of pathology or conduction disturbances documented by&#xD;
               electrocardiogram (EKG).&#xD;
  &#xD;
           12. Has taken corticosteroids as follows within 30 days prior to Screening.&#xD;
  &#xD;
                 -  Oral or parenteral corticosteroids at a dose of ≥20 mg daily and/or&#xD;
  &#xD;
                 -  High-dose (&gt;800 mcg/day of beclomethasone di-iso-propionate chlorofluorocarbon&#xD;
                    [CFC] or equivalent) inhaled corticosteroids.&#xD;
  &#xD;
           13. Female of childbearing potential who has a positive urine pregnancy test or who is&#xD;
               currently breastfeeding.&#xD;
  &#xD;
           14. Has had any vaccination (licensed or under Emergency Use Authorization [EUA]; any&#xD;
               type) within the 30 days prior to the planned first study IP administration.&#xD;
  &#xD;
           15. Is immunosuppressed due to an underlying disease or medication, use of anticancer&#xD;
               chemotherapy (cytotoxic), or radiation therapy.&#xD;
  &#xD;
           16. With the exception of basal or squamous cell skin cancer, has known active neoplastic&#xD;
               disease, including hematologic malignancy.&#xD;
  &#xD;
           17. Has received an investigational agent within 30 days prior to the planned first study&#xD;
               IP administration.&#xD;
  &#xD;
           18. Has any laboratory test result or clinical findings (including vital signs) that&#xD;
               singly or in combination are likely to unfavorably alter the risks of subject&#xD;
               participation or to confound study safety or immunogenicity results, in the opinion of&#xD;
               the site investigator. Additionally, the following are exclusionary:&#xD;
  &#xD;
                 1. Has any clinically significant Grade 3 laboratory or vital sign result, or any&#xD;
                    Grade 4 laboratory or vital sign result (regardless of assessed significance) at&#xD;
                    Screening.&#xD;
  &#xD;
                 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;2 times the&#xD;
                    upper limit of normal (ULN), or bilirubin &gt;1.5 times the ULN unless isolated&#xD;
                    Gilbert's syndrome.&#xD;
  &#xD;
                 3. Creatinine &gt;1.5 times ULN for age and sex.&#xD;
  &#xD;
                 4. White blood cell count &lt;3,000/µL or &gt;12,500/µL; absolute neutrophil count&#xD;
                    &lt;1,200/µL; absolute lymphocyte count &lt;750/µL; hemoglobin &lt;10 g/dL females, or&#xD;
                    &lt;11.5 g/dL males; platelet count &lt;75,000/µL.&#xD;
  &#xD;
                 5. Hemoglobin A1c (HbA1c) &gt;7.0% at Screening.&#xD;
  &#xD;
           19. Has any disease or medical condition that, in the opinion of the site investigator,&#xD;
               might confound interpretation of safety or immunogenicity.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Derek Eisnor, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Biomedical Advanced Research and Development Authority</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bryant Moore</last_name>
      <phone>8153294258</phone>
      <email>bryant.moore@iconplc.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Stacey Duckett</last_name>
      <email>stacey.duckett@iconplc.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Accellacare of Hickory</name>
        <address>
          <city>Hickory</city>
          <state>North Carolina</state>
          <zip>28601</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joe Moran, MD</last_name>
        <phone>704-924-2105</phone>
        <email>joe.moran@piedmonthealthcare.com</email>
      </contact>
      <contact_backup>
        <last_name>Kelli Hedger</last_name>
        <phone>704-924-2105</phone>
        <email>Kelli.Hedger@accellacare.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Accellacare of Salisbury</name>
        <address>
          <city>Salisbury</city>
          <state>North Carolina</state>
          <zip>28144</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joe Moran, MD</last_name>
        <phone>704-924-2105</phone>
        <email>joe.moran@piedmonthealthcare.com</email>
      </contact>
      <contact_backup>
        <last_name>Kelli Hedger</last_name>
        <phone>704-924-2105</phone>
        <email>Kelli.Hedger@accellacare.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Accellacare of Piredmont</name>
        <address>
          <city>Statesville</city>
          <state>North Carolina</state>
          <zip>28625</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joe Moran, MD</last_name>
        <phone>704-924-2105</phone>
        <email>Joe.Moran@piedmonthealthcare.com</email>
      </contact>
      <contact_backup>
        <last_name>Kelli Hedger</last_name>
        <phone>704-924-2105</phone>
        <email>Kelli.Hedger@accellacare.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Accellacare of Winston-Salem</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27103</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joe Moran, MD</last_name>
        <phone>704-924-2105</phone>
      </contact>
      <contact_backup>
        <last_name>Kelli Hedger</last_name>
        <phone>704-924-2105</phone>
        <email>Kelli.Hedger@accellacare.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Accellacare Knoxville</name>
        <address>
          <city>Jefferson City</city>
          <state>Tennessee</state>
          <zip>37760</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Paul Wakefield, MD</last_name>
        <phone>865-244-4276</phone>
        <email>pwakefield@summithealthcare.com</email>
      </contact>
      <contact_backup>
        <last_name>Alex Manis</last_name>
        <phone>865-244-4276</phone>
        <email>Alex.Manis@accellacare.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Accellacare Knoxville</name>
        <address>
          <city>Knoxville</city>
          <state>Tennessee</state>
          <zip>37912</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Accellacare Knoxville</name>
        <address>
          <city>Knoxville</city>
          <state>Tennessee</state>
          <zip>37938</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Paul Wakefield, MD</last_name>
        <phone>865-244-4276</phone>
        <email>pwakefield@summithealthcare.com</email>
      </contact>
      <contact_backup>
        <last_name>Alex Manis</last_name>
        <phone>865-244-4276</phone>
        <email>Alex.Manis@accellacare.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997264
  org study id: ABST001
  nct id: NCT05997264
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This randomized, phase 2, double-blinded, multicenter study is designed to assess the safety
        and immune response kinetics of AV7909 administered on 2 primary series vaccination schedules
        followed by 6- and 12-month boosters.
  This trial is a randomized, double-blinded, multicenter study designed to evaluate safety and
        immune response kinetics of full and half doses of AV7909 administered on 2 primary series
        vaccination schedules followed by 6- and 12-month boosters. Healthy adult male and female
        subjects aged 18 through 65 years, inclusive, will be screened for baseline health status to
        ensure trial eligibility. Subjects meeting all the inclusion and none of the exclusion
        criteria will be randomized to receive either half or full doses of AV7909 on 1 of 2
        vaccination schedules. Randomization will be stratified by sex. Subjects will be randomized
        1:1:1:1 within stratum across 4 treatment groups (approximately 55 subjects per group).
        Subjects will receive a total of 5 intramuscular (IM) injections. Primary series IP doses
        will be administered on Days 1, 15, and 29, and booster IP doses will be administered on Days
        181 and 366. On each IP administration day, each subject will receive an IM injection of
        full-dose AV7909 (0.5 mL), half-dose AV7909 (0.25 mL), or placebo (0.5 mL or 0.25 mL sodium
        chloride for injection), based on their assigned treatment group.
  
        Safety assessments will be based on solicited adverse events (AEs; local and systemic
        reactogenicity symptoms) with onset within 7 days after each IP administration; unsolicited
        treatment-emergent adverse events (TEAEs) with onset within 30 days after each IP
        administration; and treatment-emergent serious adverse events (SAEs), potentially
        immune-mediated medical conditions (PIMMCs), and medically attended adverse events (MAAEs)
        occurring during study participation (ie, up to 1 year after the last IP administration). For
        this study, a PIMMC is considered to be unexpected and will be treated as a serious and
        unexpected suspected adverse reaction (SUSAR) per 21 CFR 312.32.
  
        Immunogenicity assessments will include geometric mean titer (GMT), seroprotection rate, and
        seroconversion rate by toxin-neutralizing antibody (TNA) 50% neutralization factor (NF50) and
        enzyme-linked immunosorbent assay (ELISA) anti-protective antigen (PA) Immunoglobulin G
        (IgG).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: All solicited local and systemic reactogenicity symptoms with onset within 7 days after each IP administration day.
  time frame: Within 7 days after each IP administration.
  measure: Geometric mean titer (GMT) as measured by toxin-neutralizing antibody (TNA) 50% neutralization
  time frame: Day 64
  measure: Unsolicited treatment-emergent adverse events (TEAEs) with onset within 30 days after each IP administration day.
  time frame: Within 30 days after each IP administration.
  measure: Treatment-emergent serious adverse events (SAEs) up to 1 year after the last IP administration day.
  time frame: Within 1 year after the last IP administration.
  measure: Treatment-emergent potentially immune-mediated medical conditions (PIMMCs) up to 1 year after the last IP administration day.
  time frame: Within 1 year after the last IP administration.
  measure: Treatment-emergent medically attended adverse events (MAAEs) up to 1 year after the last IP administration day.
  time frame: Within 1 year after the last IP administration.
  measure: Geometric mean titer (GMT) as measured by toxin-neutralizing antibody (TNA) 50% neutralization factor (NF50) at Day 15, Day 29, Day 36, Day 43, Day 50, Day 85, Day 181, Day 211, Day 366, Day 396, Day 546, and Day 731.
  time frame: Day 15 through 731.
  measure: Seroprotection rate as measured by toxin-neutralizing antibody (TNA) 50% neutralization factor (NF50) at Day 15, Day 29, Day 36, Day 43, Day 50, Day 64, Day 85, Day 181, Day 211, Day 366, Day 396, Day 546, and Day 731.
  time frame: Day 15 through 731.
  measure: Geometric mean titer (GMT) as measured by ELISA anti-PA IgG at Day 15, Day 29, Day 36, Day 43, Day 50, Day 64, Day 85, Day 181, Day 211, Day 366, Day 396, Day 546, and Day 731.
  time frame: Day 15 through 731.
  arm group label: Full Dose Schedule 1
  arm group type: Experimental
  description: This study group will receive full dose AV7909 (0.5mL) at study days 1, 15, 181 and 366. A placebo full dose (0.5 mL) will be administered between the second and third dose of AV7909 at study day 29.
  arm group label: Full Dose Schedule 2
  arm group type: Experimental
  description: This study group will receive of AV7909 full dose (0.5 mL) at study days 1, 29, 181 and 366. A placebo full dose (0.5 mL) will be administered between the first and second dose of AV7909 at study day 15.
  arm group label: Half Dose Schedule 1
  arm group type: Experimental
  description: This study group will receive of AV7909 half dose (0.25 mL) at study days 1, 15, 181 and 366. A placebo half dose (0.25 mL) will be administered between the second and third dose of AV7909 at study day 29.
  arm group label: Half Dose Schedule 2
  arm group type: Experimental
  description: This study group will receive of AV7909 half dose (0.25 mL) at study days 1, 29, 181 and 366. A placebo full dose (0.25 mL) will be administered between the first and second dose of AV7909 at study day 15.
  intervention type: Biological
  intervention name: AV7909 Full Dose (0.5 mL)
  description: AV7909 Anthrax Vaccine is being developed by Emergent Product Development Gaithersburg Inc. (Emergent) for PEP of disease in persons 18 through 65 years of age following suspected or confirmed B. anthracis exposure when administered in conjunction with the recommended antibacterial regimen. AV7909 is a combination product containing BioThrax and CPG 7909, a synthetic immunostimulatory oligodeoxynucleotide that has been shown to be a potent vaccine adjuvant. CPG 7909 is a Toll-like receptor 9 agonist designed to induce both an enhanced antigen-specific antibody response and a natural killer T-cell immune response when used in combination with prophylactic (preventative) or therapeutic vaccines.
  arm group label: Full Dose Schedule 1
  arm group label: Full Dose Schedule 2
  intervention type: Biological
  intervention name: AV7909 Half Dose (0.25 mL)
  description: AV7909 Anthrax Vaccine is being developed by Emergent Product Development Gaithersburg Inc. (Emergent) for PEP of disease in persons 18 through 65 years of age following suspected or confirmed B. anthracis exposure when administered in conjunction with the recommended antibacterial regimen. AV7909 is a combination product containing BioThrax and CPG 7909, a synthetic immunostimulatory oligodeoxynucleotide that has been shown to be a potent vaccine adjuvant. CPG 7909 is a Toll-like receptor 9 agonist designed to induce both an enhanced antigen-specific antibody response and a natural killer T-cell immune response when used in combination with prophylactic (preventative) or therapeutic vaccines.
  arm group label: Half Dose Schedule 1
  arm group label: Half Dose Schedule 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Derek Eisnor, MD
  role: Study Chair
  affiliation: Biomedical Advanced Research and Development Authority
  last name: Bryant Moore
  phone: 8153294258
  email: bryant.moore@iconplc.com
  last name: Stacey Duckett
  email: stacey.duckett@iconplc.com
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  country: United States
  responsible party type: Sponsor
  mesh term: Anthrax