<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/NCT01717950</url>
  </required_header>
  <id_info>
    <org_study_id>SVI-12-01</org_study_id>
    <nct_id>NCT01717950</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults</brief_title>
  <official_title>Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic&#xD;
      cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has&#xD;
      protected animals from infection in challenge studies. This study will evaluate the safety&#xD;
      and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers when&#xD;
      co-administered with different concentrations of the immunostimulant GLA-AF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open-label, dose-escalation phase 1 clinical trial in healthy, hookworm-naïve adults:&#xD;
&#xD;
        -  Study site: George Washington Medical Faculty Associates, Washington, DC&#xD;
&#xD;
        -  Number of participants: 40 in 2 cohorts of 20.&#xD;
&#xD;
      In Cohort 1 five (5) volunteers will receive 30 µg Na-APR-1 (M74) /Alhydrogel®, five (5) will&#xD;
      receive 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF, and ten (10) will receive 30 µg&#xD;
      Na-APR-1 (M74) /Alhydrogel® plus 5 µg GLA-AF. In Cohort 2 five (5) volunteers will receive&#xD;
      100 µg Na-APR-1 (M74)/Alhydrogel®, five (5) will receive 100 µg Na-APR-1 (M74) /Alhydrogel®&#xD;
      plus 2.5 µg GLA-AF, and ten (10) will receive 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5 µg&#xD;
      GLA-AF.&#xD;
&#xD;
      The cohorts will be enrolled in a staggered fashion with safety data assessed prior to the&#xD;
      Na-APR-1 dose escalation from 30 to 100 µg. In addition, within each cohort, vaccinations&#xD;
      will be staggered such that formulations containing 0, 2.5, and 5 µg GLA-AF will be tested&#xD;
      sequentially: for example, those receiving Na-APR-1 (M74)/Alhydrogel® in combination with 2.5&#xD;
      µg GLA-AF will be vaccinated no sooner than 3 days after the last volunteer is vaccinated&#xD;
      with the formulation containing no GLA-AF, whereas those vaccinated with Na-APR-1&#xD;
      (M74)/Alhydrogel® plus 5 µg GLA-AF will be vaccinated no sooner than 7 days after the last&#xD;
      one receives the 2.5 µg GLA-AF formulation.&#xD;
&#xD;
        -  Immunization schedule: Study days 0, 56 and 112.&#xD;
&#xD;
        -  Route: IM in the deltoid muscle.&#xD;
&#xD;
        -  Doses of Na-APR-1 (M74) to be tested: 30 and 100 µg.&#xD;
&#xD;
        -  Doses of Alhydrogel®: 240 and 800 µg for the 30 and 100 µg doses of Na-APR-1 (M74),&#xD;
           respectively.&#xD;
&#xD;
        -  Doses of GLA-AF to be tested: 2.5 µg and 5 µg.&#xD;
&#xD;
        -  Study duration: 44 weeks (10 months) per study participant; total duration of the study&#xD;
           estimated at approximately 13 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">June 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vaccine-related Adverse Events</measure>
    <time_frame>Day 290</time_frame>
    <description>The frequency of immediate, systemic, and local injection site adverse events will be summarized. Adverse events will be assessed by study team members at 1 hour post-vaccination as well as 3, 7, 14, and 28 days following each vaccination. In addition, study participants will be asked to complete symptom diaries for the 7 days after each vaccination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IgG antibody response to Na-APR-1</measure>
    <time_frame>14 days after final vaccination</time_frame>
    <description>Dose and formulation of Na-APR-1 that generates the highest IgG antibody response at Day 126 (14 days after final vaccination), as determined by an indirect enzyme-linked immunosorbent assay (ELISA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B cell response to Na-APR-1</measure>
    <time_frame>Study Days 14, 70, 126, 140 and 290</time_frame>
    <description>Dose and formulation of the Na-APR-1 (M74) vaccine that results in the highest production of Na-APR-1 (M74) specific B cells and subtypes (memory or plasma).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploratory cellular immune response to Na-APR-1</measure>
    <time_frame>Study Days 14, 70, 126, 140 and 290</time_frame>
    <description>Exploratory studies of the cellular immune responses to the Na APR-1 (M74) antigen both before and after immunization.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hookworm Infection</condition>
  <condition>Hookworm Disease</condition>
  <arm_group>
    <arm_group_label>30 µg Na-APR-1 (M74)/Alhydrogel®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>30 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>100 µg Na-APR-1 (M74)/Alhydrogel®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>100 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>100 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Na-APR-1 (M74)/Alhydrogel®</intervention_name>
    <description>The Na-APR-1 (M74) candidate vaccine contains the recombinant Na-APR-1 (M74) protein expressed by Nicotiana plants. Purified Na-APR-1 (M74) was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10 mM imidazole, 150 mM sodium chloride and 0.3% Empigen BB, with pH 7.4 ± 0.1. The final concentration of Na-APR-1 (M74) in the drug product is 0.1 mg/ml, whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-APR-1 (M74) will be delivered by injecting different volumes of the 0.1 mg/ml Na-APR-1 (M74) preparation.</description>
    <arm_group_label>100 µg Na-APR-1 (M74)/Alhydrogel®</arm_group_label>
    <arm_group_label>100 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF</arm_group_label>
    <arm_group_label>100 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF</arm_group_label>
    <arm_group_label>30 µg Na-APR-1 (M74)/Alhydrogel®</arm_group_label>
    <arm_group_label>30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF</arm_group_label>
    <arm_group_label>30 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF</arm_group_label>
    <other_name>Na-APR-1</other_name>
    <other_name>Necator americanus Aspartic Protease-1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Gluco-Pyranosylphospho-Lipid A Aqueous Formulation</intervention_name>
    <description>GLA-AF contains a synthetic monophosphoryl lipid A (MPL) molecule that has Toll-Like Receptor-4 agonist activity. MPL is itself derived from the lipopolysaccharide (LPS) of Salmonella minnesota, a natural TLR4 agonist that is pyrogenic and can induce toxic shock. LPS, and more specifically, its lipid A component, has long been known for its strong adjuvant effects; however, its high toxicity has precluded its use in a vaccine formulation.</description>
    <arm_group_label>100 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF</arm_group_label>
    <arm_group_label>100 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF</arm_group_label>
    <arm_group_label>30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF</arm_group_label>
    <arm_group_label>30 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF</arm_group_label>
    <other_name>GLA-AF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females between 18 and 50 years, inclusive.&#xD;
&#xD;
          -  Good general health as determined by means of the screening procedure.&#xD;
&#xD;
          -  Available for the duration of the trial (44 weeks).&#xD;
&#xD;
          -  Willingness to participate in the study as evidenced by signing the informed consent&#xD;
             document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if&#xD;
             female).&#xD;
&#xD;
          -  Participant unwilling to use reliable contraception methods up until one month&#xD;
             following the third immunization (if female and not surgically sterile, abstinent or&#xD;
             at least 2 years post-menopausal).&#xD;
&#xD;
          -  Currently lactating and breast-feeding (if female).&#xD;
&#xD;
          -  Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic,&#xD;
             rheumatologic, autoimmune, diabetes, or renal disease by history, physical&#xD;
             examination, and/or laboratory studies.&#xD;
&#xD;
          -  Known or suspected immunodeficiency.&#xD;
&#xD;
          -  Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than&#xD;
             1.25-times the upper reference limit).&#xD;
&#xD;
          -  Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the&#xD;
             upper reference limit, or more than trace protein or blood on urine dipstick testing).&#xD;
&#xD;
          -  Laboratory evidence of hematologic disease (hemoglobin &lt;11.5 g/dl [females] or &lt;12.5&#xD;
             g/dl [males]; absolute leukocyte count &lt;3600/mm3 or &gt;10.7 x 103/mm3; absolute&#xD;
             neutrophil count [ANC] &lt;1700/ mm3; absolute lymphocyte count &lt;700/mm3; or platelet&#xD;
             count &lt;140,000/mm3).&#xD;
&#xD;
          -  Laboratory evidence of a coagulopathy (PTT or PT INR greater than 1.1-times the upper&#xD;
             reference limit).&#xD;
&#xD;
          -  Serum glucose (random) greater than 1.2-times the upper reference limit.&#xD;
&#xD;
          -  Other condition that in the opinion of the investigator would jeopardize the safety or&#xD;
             rights of a volunteer participating in the trial or would render the subject unable to&#xD;
             comply with the protocol.&#xD;
&#xD;
          -  Participation in another investigational vaccine or drug trial within 30 days of&#xD;
             starting this study.&#xD;
&#xD;
          -  Volunteer has had medical, occupational, or family problems as a result of alcohol or&#xD;
             illicit drug use during the past 12 months.&#xD;
&#xD;
          -  History of a severe allergic reaction or anaphylaxis.&#xD;
&#xD;
          -  Severe asthma as defined by the need for daily use of inhalers or emergency clinic&#xD;
             visit or hospitalization within 6 months of the volunteer's expected first vaccination&#xD;
             in the study.&#xD;
&#xD;
          -  Positive ELISA for hepatitis B surface antigen (HBsAg).&#xD;
&#xD;
          -  Positive confirmatory test for HIV infection.&#xD;
&#xD;
          -  Positive confirmatory test for hepatitis C virus (HCV) infection.&#xD;
&#xD;
          -  Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within&#xD;
             30 days of the volunteer's expected first vaccination in this study.&#xD;
&#xD;
          -  Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to&#xD;
             the volunteer's expected first vaccination in the study.&#xD;
&#xD;
          -  History of a surgical splenectomy.&#xD;
&#xD;
          -  Receipt of blood products within the past 6 months.&#xD;
&#xD;
          -  History of previous infection with hookworm or residence for more than 6 months in a&#xD;
             hookworm-endemic area.&#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>David J Diemert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>George Washington University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>George Washington University Medical Faculty Associates</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>July 29, 2019</last_update_submitted>
  <last_update_submitted_qc>July 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Maria Elena Bottazzi PhD</investigator_full_name>
    <investigator_title>Sponsor</investigator_title>
  </responsible_party>
  <keyword>Human Hookworm</keyword>
  <keyword>Necator americanus</keyword>
  <keyword>Hookworm</keyword>
  <keyword>Hookworm Disease</keyword>
  <keyword>Iron-deficiency anemia</keyword>
  <keyword>Soil-transmitted helminth infection</keyword>
  <keyword>Neglected Tropical Disease</keyword>
  <keyword>Na-APR-1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hookworm Infections</mesh_term>
    <mesh_term>Ancylostomiasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aluminum Hydroxide</mesh_term>
  </intervention_browse>
  <study_docs>
    <study_doc>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://smhs.gwu.edu/mitm-crg/</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT01717950
org study id: SVI-12-01
nct id: NCT01717950
lead sponsor: 
collaborator: 
has dmc: Yes
Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic
      cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has
      protected animals from infection in challenge studies. This study will evaluate the safety
      and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers when
      co-administered with different concentrations of the immunostimulant GLA-AF.
Open-label, dose-escalation phase 1 clinical trial in healthy, hookworm-naïve adults:

        -  Study site: George Washington Medical Faculty Associates, Washington, DC

        -  Number of participants: 40 in 2 cohorts of 20.

      In Cohort 1 five (5) volunteers will receive 30 µg Na-APR-1 (M74) /Alhydrogel®, five (5) will
      receive 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF, and ten (10) will receive 30 µg
      Na-APR-1 (M74) /Alhydrogel® plus 5 µg GLA-AF. In Cohort 2 five (5) volunteers will receive
      100 µg Na-APR-1 (M74)/Alhydrogel®, five (5) will receive 100 µg Na-APR-1 (M74) /Alhydrogel®
      plus 2.5 µg GLA-AF, and ten (10) will receive 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5 µg
      GLA-AF.

      The cohorts will be enrolled in a staggered fashion with safety data assessed prior to the
      Na-APR-1 dose escalation from 30 to 100 µg. In addition, within each cohort, vaccinations
      will be staggered such that formulations containing 0, 2.5, and 5 µg GLA-AF will be tested
      sequentially: for example, those receiving Na-APR-1 (M74)/Alhydrogel® in combination with 2.5
      µg GLA-AF will be vaccinated no sooner than 3 days after the last volunteer is vaccinated
      with the formulation containing no GLA-AF, whereas those vaccinated with Na-APR-1
      (M74)/Alhydrogel® plus 5 µg GLA-AF will be vaccinated no sooner than 7 days after the last
      one receives the 2.5 µg GLA-AF formulation.

        -  Immunization schedule: Study days 0, 56 and 112.

        -  Route: IM in the deltoid muscle.

        -  Doses of Na-APR-1 (M74) to be tested: 30 and 100 µg.

        -  Doses of Alhydrogel®: 240 and 800 µg for the 30 and 100 µg doses of Na-APR-1 (M74),
           respectively.

        -  Doses of GLA-AF to be tested: 2.5 µg and 5 µg.

        -  Study duration: 44 weeks (10 months) per study participant; total duration of the study
           estimated at approximately 13 months.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Vaccine-related Adverse Events
time frame: Day 290
description: The frequency of immediate, systemic, and local injection site adverse events will be summarized. Adverse events will be assessed by study team members at 1 hour post-vaccination as well as 3, 7, 14, and 28 days following each vaccination. In addition, study participants will be asked to complete symptom diaries for the 7 days after each vaccination.
measure: IgG antibody response to Na-APR-1
time frame: 14 days after final vaccination
description: Dose and formulation of Na-APR-1 that generates the highest IgG antibody response at Day 126 (14 days after final vaccination), as determined by an indirect enzyme-linked immunosorbent assay (ELISA).
measure: B cell response to Na-APR-1
time frame: Study Days 14, 70, 126, 140 and 290
description: Dose and formulation of the Na-APR-1 (M74) vaccine that results in the highest production of Na-APR-1 (M74) specific B cells and subtypes (memory or plasma).
measure: Exploratory cellular immune response to Na-APR-1
time frame: Study Days 14, 70, 126, 140 and 290
description: Exploratory studies of the cellular immune responses to the Na APR-1 (M74) antigen both before and after immunization.
arm group label: 30 µg Na-APR-1 (M74)/Alhydrogel®
arm group type: Experimental
arm group label: 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF
arm group type: Experimental
arm group label: 30 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF
arm group type: Experimental
arm group label: 100 µg Na-APR-1 (M74)/Alhydrogel®
arm group type: Experimental
arm group label: 100 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF
arm group type: Experimental
arm group label: 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF
arm group type: Experimental
intervention type: Biological
intervention name: Na-APR-1 (M74)/Alhydrogel®
description: The Na-APR-1 (M74) candidate vaccine contains the recombinant Na-APR-1 (M74) protein expressed by Nicotiana plants. Purified Na-APR-1 (M74) was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10 mM imidazole, 150 mM sodium chloride and 0.3% Empigen BB, with pH 7.4 ± 0.1. The final concentration of Na-APR-1 (M74) in the drug product is 0.1 mg/ml, whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-APR-1 (M74) will be delivered by injecting different volumes of the 0.1 mg/ml Na-APR-1 (M74) preparation.
arm group label: 100 µg Na-APR-1 (M74)/Alhydrogel®
arm group label: 100 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF
arm group label: 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF
arm group label: 30 µg Na-APR-1 (M74)/Alhydrogel®
arm group label: 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF
arm group label: 30 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF
other name: Na-APR-1
other name: Necator americanus Aspartic Protease-1
intervention type: Biological
intervention name: Gluco-Pyranosylphospho-Lipid A Aqueous Formulation
description: GLA-AF contains a synthetic monophosphoryl lipid A (MPL) molecule that has Toll-Like Receptor-4 agonist activity. MPL is itself derived from the lipopolysaccharide (LPS) of Salmonella minnesota, a natural TLR4 agonist that is pyrogenic and can induce toxic shock. LPS, and more specifically, its lipid A component, has long been known for its strong adjuvant effects; however, its high toxicity has precluded its use in a vaccine formulation.
arm group label: 100 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF
arm group label: 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF
arm group label: 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF
arm group label: 30 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF
other name: GLA-AF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David J Diemert, MD
role: Principal Investigator
affiliation: George Washington University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Maria Elena Bottazzi PhD
investigator title: Sponsor
mesh term: Hookworm Infections
mesh term: Ancylostomiasis
mesh term: Aluminum Hydroxide
study doc: 