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Phase 1 N=2 Prevention

Dose Escalation PfSPZ-CVac

Malaria

Enrolled (actual)
2
Serious AEs
3.6%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With P.Falciparum Blood Stage Infection — 0; 0; 0; 0 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Chloroquine Phosphate (Drug); Pyrimethamine (Drug); Sanaria PfSPZ Challenge (Biological)
Age
Adult · 18+ yrs
Sex
All
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
Jun 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With P.Falciparum Blood Stage Infection
0; 0; 0; 0; 0
PRIMARY
Number of Participants Requiring Treatment With Additional Anti-malarial Medication
0; 0; 0
PRIMARY
Number of Participants With Local and Systemic Adverse Events (AEs)
2; 2; 3; 8; 9; 10
PRIMARY
Number of Participants With Serious Adverse Events (SAEs)
0; 0; 0; 0; 0; 2

Summary

Background: People get malaria from bites from infected mosquitos. Researchers are studying a vaccine strategy. They will give people malaria parasites by injecting them with live infectious malaria parasites with antimalarial medications and then see if this strategy prevents malaria infection while off antimalarial medications. Objective: To see if combining a high dose of live, infectious malaria parasites (known as Sanaria PfSPZ Challenge) and two FDA approved drugs that kill malaria parasites (pyrimethamine [PYR] OR chloroquine [CQ]) is safe and can provide people protection against malaria. Eligibility: Healthy adults ages 18-50 who: * are not pregnant or breastfeeding or planning on becoming pregnant while in the study * are not infected with HIV, Hepatitis B or Hepatitis C * have reliable early morning access to the NIH Clinical Center * are able to come to the outpatient clinic frequently, sometimes daily * have not been diagnosed with malaria within the past 10 years Design: * Participants will be screened with medical history and physical exam. They will have heart, blood, and urine tests. * Participants will have blood drawn for tests at most visits. * Participants will keep track of their temperature and symptoms during some sections of the study. * Participants will join one part of the study. Part 1 is one month: * Participants will get the parasites by an injection into a vein on day 1 and receive antimalarial medications. * They will have daily visits on days 7-14 * They will take another antimalarial at visits on days 15-17. * The final visit will be on day 29. Part 2 is seven months: * For the first 3 months, participants will get the parasite injection into a vein for 3 injections in total. Each injection will occur once per month while taking an antimalarial drug. * They will have daily visits on days 7-14 after the first injection, and on days 7-11 after the second and third injection. * They will have a final (fourth) injection around month 6 without any antimalarial medication. * After this fourth injection, participants may have up to 21 daily visits from day 7 after injection until end of study. Part 3 is one month: * Participants will get the parasites by injection into a vein on day 1 without antimalarial medications. * They will have visits almost every day starting day 7 from injection. * They will take an antimalarial medication when they are diagnosed with malaria * They will return for final end of study visit on days 27-29.

Eligibility Criteria

  • INCLUSION CRITERIA:
  • Age greater than or equal to 18 and less than or equal to 50 years.
  • In good general health and without clinically significant medical history
  • Malaria comprehension exam completed, passed (a score of greater than or equal to 80% or per investigator s discretion) and reviewed prior to enrollment
  • Reliable access to the clinical trial center and availability to participate for duration of study
  • Females of childbearing potential must be willing to use reliable contraception (as defined below) from 21 days prior to study day -2 to 28 days following last Sanaria PfSPZ Challenge exposure
  • Subject to the judgment and discretion of the PI, female participants who meet ANY ONE of the criteria listed immediately below, may not be required to take any additional measures to avoid pregnancy. Such participants will be counseled on risks at the time of consent and at appropriate points (e.g. when pregnancy testing occurs) during the study:
  • Females who have had their uterus, and/or BOTH ovaries removed
  • Females who have had BOTH fallopian tubes surgically 'tied' or removed
  • Females who are above the age of 45 and have spontaneously had no menses at any point during the past 12 or more consecutive months (i.e. have reached menopause)
  • Females who, in the conservative and reasonable judgment of the PI (e.g. due to sexual orientation or serious life choice (such as being celibate clergy or transgender), during the entire trial will NOT participate in any potentially reproductive sexual contact
  • Females who, in the conservative and reasonable judgment of the PI, are in a monogamous stable relationship with a male who has undergone vasectomy at least 4 months prior or another procedure/medical condition that deems the male sterile
  • Subject to the judgment and discretion of the PI, female participants who DO NOT meet ANY of the criteria listed above, will be appropriately counseled on reproductive risks and pregnancy avoidance, and will be required to adhere to the following measures and agree to 2 methods of pregnancy prevention as noted below:
  • CATEGORY 1: a highly effective hormonal method to prevent pregnancy [e.g. CONSISTENT, CONTINUOUS use of contraceptive pill, patch, ring, implant or injection], and/or IUD or equivalent
  • IN ADDITION TO CATEGORY 2: a barrier method to be used at the time of potentially reproductive sexual activity (e.g. [male/female condom, 'cap,' or diaphragm] + spermicide).

EXCLUSION CRITERIA

  • Currently is breast-feeding (if female).
  • Pregnancy as determined by a positive urine or serum human choriogonadotropin (beta- hCG) test at any point during the study (if female).
  • Recent travel to a malaria endemic area within 5 years of enrollment (Endemic areas are defined per the CDC website. Factors such as but not limited to use of antimalaria prophylaxis during travel, length of stay, activities during the travel, history of illnesses within 30 days of travel will be considered to determine the likelihood that the subject was exposed to malaria)
  • Planned travel to a malaria endemic area (as defined by the Center for Disease Control) during the study period
  • Reported history of confirmed malaria diagnosis on peripheral blood smear or by clinical history in the past 10 years.
  • Hemoglobin, WBC, platelets, ALT, and creatinine outside of local lab normal range (subjects may be included at the investigator s discretion for not clinically significant values outside of normal range)
  • Abnormal urinalysis as defined by positive urine glucose, protein, and red blood cells. Subject can be included if investigator determine the abnormality is not clinically significant .
  • BMI 35
  • Anticipated use during the study period, or use within the following periods prior to enrollment:
  • Investigational malaria vaccine within the last five years
  • Malaria chemoprophylaxis within 6 months
  • Chronic systemic immunosuppressive medications (>14 days) within 6 months (e.g.cytotoxic medications, oral
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03083847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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