Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54
Condition: Malaria,Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Intervention: Plasmodium falciparum malaria parasite
Intervention description: Laboratory cultured Plasmodium falciparum strain 3D7 delivered via the bite of 5 infected mosquitoes with salivary gland scores of at least 2+ (11-100 sporozoites observed).
Phase: Phase 1
Study type: Interventional
Primary purpose: Screening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Objectives:

      Primary:

      • To characterize the infectivity of the new lot of Plasmodium falciparum strain 3D7 within
      the standard WRAIR CHMI model as compared to the current lot (historical data)

      Secondary:

        -  To assess safety of the new lot of P falciparum parasites

        -  To assess the kinetics of detecting parasitemia and parasite clearance by quantitative
           polymerase chain reaction (qPCR) as compared to blood smear

        -  To obtain plasma samples to restore the testing control pool for malaria serology
           testing and for future malaria research
    

Eligibility criteria:

        Inclusion Criteria:

          -  To be eligible for this study, you must meet ALL of the following conditions:

               -  You are between the ages of 18 and 50 years old.

               -  You are willing and able to participate in all planned study visits for the
                  duration of the study.

               -  You are in good general health based on your medical history, physical
                  examination, EKG, and screening laboratories.

               -  You are able to understand and sign this informed consent.

               -  You pass the written test called the 'Assessment of Understanding' with a score
                  of at least 80% (8 out of 10 questions correct).

               -  You agree not to donate blood during the study and for 3 years after the malaria
                  challenge.

               -  You agree not to travel to place(s) where there is malaria during the time of the
                  study.

               -  If you are a female, you must agree to consistently use effective birth control
                  (e.g., oral or implanted contraceptives, intrauterine device (IUD), diaphragm
                  with spermicide, abstinence, cervical cap) during the period from the day of
                  screening (today) through 3 months after the malaria challenge.

               -  You must be willing to take anti-malarial treatment after CHMI, if indicated.

               -  You must agree to stay in a pre-determined hotel near the NMRC CTC during the
                  designated post-CHMI follow-up period from approximately 7 days after malaria
                  challenge until antimalarial treatment is completed, if indicated.

               -  If you are an active duty military or federal employee, you must have approval
                  from your supervisory chain to participate. The appropriate approval form will be
                  provided to you.

        Exclusion Criteria:

          -  You must not have any of the following:

               -  Any history of malaria infection or having been given a malaria vaccine

               -  Any history travel to a country with falciparum malaria in the past 6 months, or
                  planned travel to such an area during the course of the study

               -  Any history of having lived in an area with falciparum malaria for more than 5
                  years.

               -  Any use of medications that prevent or treat malaria during the 1 month prior to
                  challenge or planned use during the study (outside of the drugs provided by the
                  study team).

               -  Any serious medical illness or condition involving the heart, liver, lungs, or
                  kidneys

               -  Any significant risk for developing heart disease in the next 5 years. The risk
                  for developing heart disease in the next 5 years will be determined by a
                  combination of the following factors: high blood pressure, smoking, weight,
                  family history of heart disease and the presence of diabetes

               -  Any medical illness or condition involving your blood or immune system (to
                  include sickle cell trait or thalassemia trait)

               -  Any abnormal (as determined by a physician) screening laboratory test results

               -  Any history of neurologic disease (including migraines or seizures)

               -  Any history of psoriasis (itchy skin rash) or porphyria (rare disturbance of
                  metabolism), since these conditions could get worse after treatment with
                  chloroquine (a medication for treating malaria).

               -  You have had your spleen removed

               -  Any past or current infection with HIV, Hepatitis C, or Hepatitis B

               -  Any use of investigational drugs or vaccines within 1 month before starting the
                  study

               -  Any allergy to or inability to take the anti-malaria medications used in this
                  study

               -  Any history of allergic reaction to mosquito bites that required hospitalization

               -  You must not be pregnant or nursing, or have any plans to become pregnant or
                  breastfeed during the period from now through 3 months after malaria challenge

               -  Any chronic use of steroids or other medications that affect the immune system in
                  the 6 months before malaria challenge. Inhaled and topical (used on the skin)
                  steroids are allowed.

               -  You plan to have surgery between enrollment and 3 months after malaria challenge.

               -  Any active alcohol or drug abuse

               -  You have any other physical or psychologic condition or laboratory abnormality
                  that the study doctor thinks may increase your risk of having side effects or
                  compromise the results of the study.