A Clinical Trial to Evaluate Plasmodium Falciparum 7G8 and NF54 Challenge Strains (PfSPZ) in a Head-to-head Comparative Study - (ECG-CHMI)

• Status: Withdrawn
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A comparison of Malaria events (symptoms and signs of malaria) experienced by subjects infected with PfSPZ Challenge (NF54) vs. PfSPZ Challenge (7G8).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: U.S. Army Medical Research and Development Command
• Collaborator: Naval Medical Research Center
• Treatments: Artemether; Artemether, Lumefantrine Drug Combination; Atovaquone; Atovaquone, proguanil drug combination; Lumefantrine; Proguanil; Vaccines

Criteria

Inclusion Criteria:

• Adults (male or non-lactating, non-pregnant female)

• Between the ages of 18 and 45 (inclusive) at the time of enrollment

• Body weight equal to or greater than 110 lbs

• Available and willing to participate for duration of study

• Able and willing to provide a written informed consent

• Able to complete an Assessment of Understanding with a score of at least 80% correct

• In good general health with no clinically significant health problems as established by medical history, physical examination, and laboratory screening

• Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (Section 5.4.5.3) from 14 days prior to CHMI and agree to continue using such precautions during the study until at least 2 months after CHMI

• If female subjects are unable to bear children due to menopause or have had a procedure performed (e.g. tubal ligation or hysterectomy), a medical note from a physician is required

• If post-menopausal, subjects must have experienced at least 1 year of amenorrhea and provide a medical note from her physician documenting this medical history

• Agree not to travel to a malaria endemic area during the course of the study

• Agree to refrain from blood donation from the time of CHMI and for 3 years following CHMI

• Must be willing to take anti-malarial treatment after CHMI

• Must agree to stay in a pre-determined hotel near the NMRC CTC from approximately 7 days after CHMI until antimalarial treatment is completed or through 18 days post CHMI

• For active-duty military personnel, documentation of their command's approval to participate

Exclusion Criteria:

• Pregnant (positive urine pregnancy test) or nursing at screening or plans to become pregnant or nurse at any period from the time of enrollment through 56 days after CHMI.

• Receipt of any investigational malaria vaccine

• Any history of malaria infection

• Travel to a malaria endemic region within 6 months of enrollment or during the study (from enrollment through 2 months after CHMI)

• History of long-term residence (>5 years) in an area known to have significant transmission of P falciparum (http://www.cdc.gov/malaria/map/)

• History of clinically significant contact dermatitis

• Seropositive for the human immunodeficiency virus (HIV), hepatitis C virus (HCV), and/or hepatitis B surface antigen (HBsAg)

• Positive sickle cell screening test, including evidence of sickle cell trait or sickle cell anemia (due to its effect on subject's susceptibility to malaria)

• History of thalassemia or thalassemia trait (due to its effect on subject's susceptibility to malaria)

• Participation in any clinical study involving another investigational vaccine, drug, or other products within 60 days prior to enrollment or plan to participate in such a clinical study during or within 1 month following the active study phase of the study (from the day enrollment through 2 months after CHMI)

• Allergy to any component of the PfSPZ Challenge formulation, Malarone® (atovaquone-proguanil), and/or Coartem® (artemether-lumefantrine)

• History of porphyria