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

NCT04203186 | Withdrawn DMC

• 1 other identifier: 19239
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Plasmodium Falciparum

Outcome Measures

Primary Outcomes (2)

• Difference in the pre-patent period

  The difference in the time of first malaria event (symptom or sign of malaria),in subjects infected with PfSPZ Challenge (NF54) vs. PfSPZ Challenge (7G8)

  29 days

• Difference in the total number of malaria events

  The difference in the total number of Grade 2 or greater malaria events (symptoms and signs of malaria) experienced by subjects infected with PfSPZ Challenge (NF54) vs PfSPZ Challenge (7G8)

  29 days

Secondary Outcomes (2)

• Determine differences in pre-patent periods

  29 days

• Determine differences in the growth rate of parasites

  29 days

Study Arms (2)

Group 1 - PfSPZ, (NF54) strain

ACTIVE COMPARATOR

Group 1 (N=9) will receive PfSPZ Challenge (NF54) A one-time dose of 3,200 aseptic, purified, cryopreserved, non-attenuated Plasmodium falciparum (Pf) NF54 sporozoites (Pf SPZ Challenge) Mode of administration: Direct venous inoculation (DVI) through a 25 gauge needle and syringe

Drug: atovaquone-proguanil

Group 2 - PfSPZ, (7G8) strain

ACTIVE COMPARATOR

Group 2 (N=9) will receive PfSPZ Challenge (7G8) A one-time dose of 3,200 aseptic, purified, cryopreserved, non-attenuated Plasmodium falciparum 7G8 sporozoites (Pf SPZ Challenge) Mode of administration: Direct venous inoculation (DVI) through a 25 gauge needle and syringe

Drug: atovaquone-proguanil

Interventions

atovaquone-proguanil DRUG

Malaria standard treatment regimen

Also known as: artemether/lumefantrine (AL; Coartem)

Group 1 - PfSPZ, (NF54) strain; Group 2 - PfSPZ, (7G8) strain

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Naval Medical Research Center: collaborator

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

atovaquone, proguanil drug combination; Artemether; Lumefantrine; Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind, randomized, placebo-controlled trial
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 2 parallel test groups to directly compare clinical and laboratory characteristics

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: March 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 8, 2020

Record last verified: 2020-05