<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/NCT02996695</url>
  </required_header>
  <id_info>
    <org_study_id>15-0052</org_study_id>
    <secondary_id>HHSN272201300022I</secondary_id>
    <nct_id>NCT02996695</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Sanaria's PfSPZ-CVac in Malian Adults</brief_title>
  <official_title>Safety, Tolerability, Immunogenicity and Protective Efficacy Against Naturally-Transmitted Malaria of Infectious, Cryopreserved Plasmodium Falciparum Sporozoites (PfSPZ Challenge) Administered by Direct Venous Inoculation Under Chloroquine Chemoprophylaxis (PfSPZ-CVac), in Malian Adults: A Randomized, Double Blind, Placebo-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac&#xD;
      safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in&#xD;
      malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of&#xD;
      PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides&#xD;
      sterile protection against naturally-occurring malaria in malaria-experienced adults. The&#xD;
      study population includes 62 healthy, malaria-experienced adults aged 18-45 years, inclusive,&#xD;
      residing in Bougoula Hameau and surrounding villages, Mali. The primary objective of this&#xD;
      study is to assess the safety and tolerability of PfSPZ Challenge compared to placebo among&#xD;
      malaria-experienced adults taking chloroquine prophylaxis (PfSPZ-CVac)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single site, double-blinded, randomized, placebo-controlled clinical trial of&#xD;
      PfSPZ-CVac safety, tolerability, immunogenicity and efficacy against naturally occurring&#xD;
      malaria in malaria-exposed Malian adults. The overall goal of the study is to evaluate if a&#xD;
      regimen of PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and&#xD;
      provides sterile protection against naturally-occurring malaria in malaria-experienced&#xD;
      adults. Participants will receive three immunizing PfSPZ Challenge injections via direct&#xD;
      venous inoculation (DVI) four weeks apart under chloroquine chemoprophylaxis. The PfSPZ&#xD;
      Challenge dose will be 204,800 PfSPZ. This is based on results of studies in Europe and in&#xD;
      Africa. In Tübingen, Germany, 100% of malaria-naïve adults who received three doses of 51,200&#xD;
      PfSPZ every four weeks under chloroquine chemoprophylaxis were protected against homologous&#xD;
      controlled human malaria infection (CHMI). At the same time, studies of PfSPZ Vaccine in&#xD;
      malaria-experienced adults in Mali and in Tanzania demonstrate that higher doses of PfSPZ are&#xD;
      required to demonstrate immunogenicity and high grade protection in malaria-experienced&#xD;
      adults that is comparable to that achieved in malaria-naïve adults studied in the USA. For&#xD;
      this reason, the dose selected for this study is four-fold higher than the dose used for&#xD;
      Tübingen, Germany. Controls will receive 0.9% sodium chloride (NaCl) as placebo. All&#xD;
      participants will receive a standard chemoprophylactic regimen of chloroquine (CQ) for 10&#xD;
      weeks. Chloroquine will be given as a loading dose (600mg chloroquine base) two days before&#xD;
      the first administration of PfSPZ Challenge, followed by weekly doses of chloroquine (300mg&#xD;
      chloroquine base weekly). Participants will also be treated with a 7-day regimen of&#xD;
      artesunate (200 mg per day) after the last PfSPZ Challenge dose of 204,800 sporozoites for&#xD;
      malaria parasite clearance, one week after the last CQ dose is given. A total of 62&#xD;
      participants will be randomized in a 1:1 ratio to one of two groups and will be inoculated&#xD;
      with PfSPZ Challenge or 0.9% NaCl by DVI so that a total of 62 adults will participate in the&#xD;
      study. Participants will be recruited from the MRTC's Bougoula-Hameau site. All volunteers&#xD;
      recruited will be healthy adults aged between 18 and 45 years. Safety and infectivity data&#xD;
      will be collected. Volunteers, clinical and laboratory investigators will be blinded to group&#xD;
      allocation. Participants will be followed every four weeks after the last vaccination as&#xD;
      outpatients for active malaria diagnosis and treatment. Passive follow-up will be&#xD;
      accomplished by continuous availability of study staff onsite to diagnose and treat malaria&#xD;
      and other medical issues that arise. The primary objective of this study is to assess the&#xD;
      safety and tolerability of PfSPZ Challenge compared to placebo among malaria-experienced&#xD;
      adults taking chloroquine prophylaxis (PfSPZ-CVac). The secondary objectives are: 1. to&#xD;
      assess the protective efficacy of PfSPZ-CVac against naturally transmitted P. falciparum&#xD;
      malaria infection as diagnosed by thick blood smear microscopy, 2. To assess protective&#xD;
      efficacy of PfSPZ-CVac against naturally transmitted P. falciparum malaria infection as&#xD;
      diagnosed by qPCR, 3. to assess the expanded efficacy of PfSPZ-CVac compared to placebo, and&#xD;
      4. to examine the immune response to P. falciparum malaria infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 6, 2017</start_date>
  <completion_date type="Actual">June 22, 2018</completion_date>
  <primary_completion_date type="Actual">June 22, 2018</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of serious adverse events (SAEs)</measure>
    <time_frame>45 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of solicited local and systemic adverse events (AE)</measure>
    <time_frame>Day 12 after vaccination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of unsolicited AEs related to study product</measure>
    <time_frame>Day 12 after vaccination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The severity of solicited local and systemic adverse events (AE)</measure>
    <time_frame>Day 12 after vaccination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The severity of unsolicited AEs related to study product</measure>
    <time_frame>Day 12 after vaccination</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antibody titers against P. falciparum circumsporozoite protein (CSP) and other P. falciparum proteins at serology time points</measure>
    <time_frame>Days 3, 15, 31, 43,59, 71-77,87,245,and 413</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of cell-mediated immunity as assessed by cells producing interferon gamma and/or IL-2</measure>
    <time_frame>Days 3, 15, 31, 43,59, 71-77,87,245,and 413</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to P. falciparum parasitemia, detected by qPCR</measure>
    <time_frame>within six months after the last vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to P. falciparum parasitemia, detected by qPCR</measure>
    <time_frame>within twelve months after the last vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to P. falciparum parasitemia, detected by thick blood film microscopy</measure>
    <time_frame>within twelve months after the last vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to P. falciparum parasitemia, detected by thick blood smear microscopy</measure>
    <time_frame>Within six months after the last vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Plasmodium Falciparum Infection</condition>
  <arm_group>
    <arm_group_label>204,800 PfSPZ of PfSPZ Challenge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>204,800 PfSPZ of PfSPZ Challenge every 4 weeks x 3 doses by DVI, n=31</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NaCl placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>NaCl placebo every 4 weeks x 3 doses by DVI, n=31</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Artesunate</intervention_name>
    <description>Artesunate is a succinic ester of artemether.</description>
    <arm_group_label>204,800 PfSPZ of PfSPZ Challenge</arm_group_label>
    <arm_group_label>NaCl placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chloroquine</intervention_name>
    <description>4-aminoquinolone, antimalarial agent for oral administration</description>
    <arm_group_label>204,800 PfSPZ of PfSPZ Challenge</arm_group_label>
    <arm_group_label>NaCl placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PfSPZ (NF54) Challenge</intervention_name>
    <description>Cryopreserved Plasmodium falciparum (Pf) fully infectious sporozoites (SPZ) that have been developed to be used to infect volunteers in controlled human malaria infection (CHMI) to assess the efficacy of antimalarial drugs and vaccines. The PfSPZ (NF54) Challenge contains a laboratory malaria strain isolated from a Dutch traveler to Africa.</description>
    <arm_group_label>204,800 PfSPZ of PfSPZ Challenge</arm_group_label>
    <arm_group_label>NaCl placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>NaCl placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A male or non-pregnant female aged 18-45 years inclusive at the time of screening.&#xD;
&#xD;
          2. For women of childbearing potential, willingness not to become pregnant or breastfeed&#xD;
             until one month after the last CQ dose*.&#xD;
&#xD;
             *Pre-menopausal female participants will be referred to the local family planning&#xD;
             clinic, which offers several means of contraception that are approved and recommended&#xD;
             by the Mali Ministry of Health. Contraception (male or female condoms, diaphragm or&#xD;
             cervical cap with spermicide, intrauterine device, or hormone-based contraceptive)&#xD;
             should be started 30 days before the first vaccination and continue until 30 days&#xD;
             after last vaccination.&#xD;
&#xD;
          3. Written informed consent obtained from the participant before screening.&#xD;
&#xD;
          4. Available and willing to participate in follow-up for the duration of study.&#xD;
&#xD;
          5. Residing in Bougoula Hameau region and environs.&#xD;
&#xD;
          6. In general good health based on clinical and laboratory investigation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous vaccination with an investigational malaria vaccine.&#xD;
&#xD;
          2. Use of an investigational or non-registered drug or vaccine other than the study&#xD;
             vaccine(s) within 30 days before the first study vaccination, or planned use up to 30&#xD;
             days after last vaccination.&#xD;
&#xD;
          3. Chronic administration (defined as more than 14 days) of immunosuppressants or other&#xD;
             immune-modifying drugs within six months before the first vaccination*.&#xD;
&#xD;
             *This includes any dose level of oral steroids, but not inhaled steroids or topical&#xD;
             steroids.&#xD;
&#xD;
          4. Planned administration/administration of a vaccine not foreseen by the study protocol&#xD;
             within 30 days before the first study vaccination with the exception of tetanus&#xD;
             toxoid.&#xD;
&#xD;
          5. Confirmed or suspected immunosuppressive or immunodeficient condition.&#xD;
&#xD;
          6. Confirmed or suspected autoimmune disease.&#xD;
&#xD;
          7. History of allergic reactions or anaphylaxis to chloroquine, 4-aminoquinolone&#xD;
             derivatives, artesunate and artemisinin derivatives, vaccinations or to any vaccine&#xD;
             component.&#xD;
&#xD;
          8. History of serious allergic reactions to any substance, requiring hospitalization or&#xD;
             emergent medical care.&#xD;
&#xD;
          9. History of allergy to any component of the PfSPZ Challenge product, including human&#xD;
             serum albumin.&#xD;
&#xD;
         10. Use or planned use of any drug with anti-malarial activity during the course of the&#xD;
             study except for antimalarial medication administered by study clinicians.&#xD;
&#xD;
         11. History of splenectomy.&#xD;
&#xD;
         12. Confirmed pregnancy.&#xD;
&#xD;
         13. Laboratory evidence of liver disease (ALT &gt; upper limit of normal).&#xD;
&#xD;
         14. Laboratory evidence of renal disease (serum or plasma creatinine &gt; upper limit of&#xD;
             normal).&#xD;
&#xD;
         15. Laboratory evidence of hematologic disease (platelet count &lt;114,000/mm^3 for males and&#xD;
             &lt;144,000/mm^3 for females, or hemoglobin &lt;11.2 g/dL for males and &lt;9.5 g/dL for&#xD;
             females).&#xD;
&#xD;
         16. Seropositive for hepatitis B surface antigen or hepatitis C virus (hepatitis C&#xD;
             antibody).&#xD;
&#xD;
         17. Seropositive for HIV.&#xD;
&#xD;
         18. Sickle cell trait carriage or sickle cell disease.&#xD;
&#xD;
         19. Administration of immunoglobulin and/or any blood products within the three months&#xD;
             preceding the first study. vaccination or planned administration during the study&#xD;
             period.&#xD;
&#xD;
         20. Simultaneous participation in any other interventional clinical trial.&#xD;
&#xD;
         21. Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition,&#xD;
             severe malnutrition, or any other clinical findings that may increase the risk of&#xD;
             participating in the study*.&#xD;
&#xD;
             *As determined by the PI.&#xD;
&#xD;
         22. Has evidence of increased cardiovascular disease risk (defined as &gt; 10 percent, 5 year&#xD;
             risk) as determined by the method of Gaziano*.&#xD;
&#xD;
             *Risk factors include sex, age (years), systolic blood pressure (mm Hg), smoking&#xD;
             status, body mass index (BMI, kg/mm^2), reported diabetes status, and blood pressure.&#xD;
&#xD;
         23. Abnormal screening ECG*.&#xD;
&#xD;
             *Pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy,&#xD;
             non-sinus rhythm except isolated premature atrial or ventricular contractions, right&#xD;
             or left bundle branch block, advanced A-V heart block (secondary or tertiary), QT/QTc&#xD;
             interval &gt;450 ms.&#xD;
&#xD;
         24. Other condition that in the opinion of the PI would jeopardize the safety or rights of&#xD;
             a participant in the trial or would render the participant unable to comply with the&#xD;
             protocol.&#xD;
&#xD;
         25. Documented history of non-febrile seizures or atypical (complex) febrile seizures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Bamako - Epidemiology of Parasitic Diseases - Malaria Research and Training Center</name>
      <address>
        <city>Sikasso</city>
        <country>Mali</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mali</country>
  </location_countries>
  <verification_date>July 19, 2017</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>November 27, 2019</last_update_submitted>
  <last_update_submitted_qc>November 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chloroquine Chemoprophylaxis</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Immunogenicity</keyword>
  <keyword>Malaria</keyword>
  <keyword>Placebo</keyword>
  <keyword>Plasmodium falciparum Sporozoites</keyword>
  <keyword>Safety</keyword>
  <keyword>Tolerability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Artesunate</mesh_term>
    <mesh_term>Chloroquine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02996695
org study id: 15-0052
secondary id: HHSN272201300022I
nct id: NCT02996695
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac
      safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in
      malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of
      PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides
      sterile protection against naturally-occurring malaria in malaria-experienced adults. The
      study population includes 62 healthy, malaria-experienced adults aged 18-45 years, inclusive,
      residing in Bougoula Hameau and surrounding villages, Mali. The primary objective of this
      study is to assess the safety and tolerability of PfSPZ Challenge compared to placebo among
      malaria-experienced adults taking chloroquine prophylaxis (PfSPZ-CVac)
This is a single site, double-blinded, randomized, placebo-controlled clinical trial of
      PfSPZ-CVac safety, tolerability, immunogenicity and efficacy against naturally occurring
      malaria in malaria-exposed Malian adults. The overall goal of the study is to evaluate if a
      regimen of PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and
      provides sterile protection against naturally-occurring malaria in malaria-experienced
      adults. Participants will receive three immunizing PfSPZ Challenge injections via direct
      venous inoculation (DVI) four weeks apart under chloroquine chemoprophylaxis. The PfSPZ
      Challenge dose will be 204,800 PfSPZ. This is based on results of studies in Europe and in
      Africa. In Tübingen, Germany, 100% of malaria-naïve adults who received three doses of 51,200
      PfSPZ every four weeks under chloroquine chemoprophylaxis were protected against homologous
      controlled human malaria infection (CHMI). At the same time, studies of PfSPZ Vaccine in
      malaria-experienced adults in Mali and in Tanzania demonstrate that higher doses of PfSPZ are
      required to demonstrate immunogenicity and high grade protection in malaria-experienced
      adults that is comparable to that achieved in malaria-naïve adults studied in the USA. For
      this reason, the dose selected for this study is four-fold higher than the dose used for
      Tübingen, Germany. Controls will receive 0.9% sodium chloride (NaCl) as placebo. All
      participants will receive a standard chemoprophylactic regimen of chloroquine (CQ) for 10
      weeks. Chloroquine will be given as a loading dose (600mg chloroquine base) two days before
      the first administration of PfSPZ Challenge, followed by weekly doses of chloroquine (300mg
      chloroquine base weekly). Participants will also be treated with a 7-day regimen of
      artesunate (200 mg per day) after the last PfSPZ Challenge dose of 204,800 sporozoites for
      malaria parasite clearance, one week after the last CQ dose is given. A total of 62
      participants will be randomized in a 1:1 ratio to one of two groups and will be inoculated
      with PfSPZ Challenge or 0.9% NaCl by DVI so that a total of 62 adults will participate in the
      study. Participants will be recruited from the MRTC's Bougoula-Hameau site. All volunteers
      recruited will be healthy adults aged between 18 and 45 years. Safety and infectivity data
      will be collected. Volunteers, clinical and laboratory investigators will be blinded to group
      allocation. Participants will be followed every four weeks after the last vaccination as
      outpatients for active malaria diagnosis and treatment. Passive follow-up will be
      accomplished by continuous availability of study staff onsite to diagnose and treat malaria
      and other medical issues that arise. The primary objective of this study is to assess the
      safety and tolerability of PfSPZ Challenge compared to placebo among malaria-experienced
      adults taking chloroquine prophylaxis (PfSPZ-CVac). The secondary objectives are: 1. to
      assess the protective efficacy of PfSPZ-CVac against naturally transmitted P. falciparum
      malaria infection as diagnosed by thick blood smear microscopy, 2. To assess protective
      efficacy of PfSPZ-CVac against naturally transmitted P. falciparum malaria infection as
      diagnosed by qPCR, 3. to assess the expanded efficacy of PfSPZ-CVac compared to placebo, and
      4. to examine the immune response to P. falciparum malaria infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: The number of serious adverse events (SAEs)
time frame: 45 days
measure: The number of solicited local and systemic adverse events (AE)
time frame: Day 12 after vaccination
measure: The number of unsolicited AEs related to study product
time frame: Day 12 after vaccination
measure: The severity of solicited local and systemic adverse events (AE)
time frame: Day 12 after vaccination
measure: The severity of unsolicited AEs related to study product
time frame: Day 12 after vaccination
measure: Antibody titers against P. falciparum circumsporozoite protein (CSP) and other P. falciparum proteins at serology time points
time frame: Days 3, 15, 31, 43,59, 71-77,87,245,and 413
measure: Markers of cell-mediated immunity as assessed by cells producing interferon gamma and/or IL-2
time frame: Days 3, 15, 31, 43,59, 71-77,87,245,and 413
measure: Time to P. falciparum parasitemia, detected by qPCR
time frame: within six months after the last vaccination
measure: Time to P. falciparum parasitemia, detected by qPCR
time frame: within twelve months after the last vaccination
measure: Time to P. falciparum parasitemia, detected by thick blood film microscopy
time frame: within twelve months after the last vaccination
measure: Time to P. falciparum parasitemia, detected by thick blood smear microscopy
time frame: Within six months after the last vaccination
arm group label: 204,800 PfSPZ of PfSPZ Challenge
arm group type: Experimental
description: 204,800 PfSPZ of PfSPZ Challenge every 4 weeks x 3 doses by DVI, n=31
arm group label: NaCl placebo
arm group type: Placebo Comparator
description: NaCl placebo every 4 weeks x 3 doses by DVI, n=31
intervention type: Drug
intervention name: Artesunate
description: Artesunate is a succinic ester of artemether.
arm group label: 204,800 PfSPZ of PfSPZ Challenge
arm group label: NaCl placebo
intervention type: Drug
intervention name: Chloroquine
description: 4-aminoquinolone, antimalarial agent for oral administration
arm group label: 204,800 PfSPZ of PfSPZ Challenge
arm group label: NaCl placebo
intervention type: Biological
intervention name: PfSPZ (NF54) Challenge
description: Cryopreserved Plasmodium falciparum (Pf) fully infectious sporozoites (SPZ) that have been developed to be used to infect volunteers in controlled human malaria infection (CHMI) to assess the efficacy of antimalarial drugs and vaccines. The PfSPZ (NF54) Challenge contains a laboratory malaria strain isolated from a Dutch traveler to Africa.
arm group label: 204,800 PfSPZ of PfSPZ Challenge
arm group label: NaCl placebo
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: NaCl placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Mali
responsible party type: Sponsor
mesh term: Malaria
mesh term: Artesunate
mesh term: Chloroquine