Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54

NCT03882528 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: S-18-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Malaria,Falciparum

Outcome Measures

Primary Outcomes (1)

• To Characterize the Infectivity of a New Lot of Plasmodium Falciparum Strain 3D7 Developing Parasitemia Within the Standard WRAIR CHMI Model.

  Number of challenged subjects exposed to the new lot of Plasmodium falciparum strain 3D7 parasites developing parasitemia (defined as 2 unambiguous malaria parasites on a single smear).

  Within 2 weeks

Secondary Outcomes (3)

• Diagnostic Efficacy; Time to Parasitemia by Blood Smear Method After the P Falciparum Challenge

  Within 2-3 weeks

• Diagnostic Efficacy; Time to Parasitemia (Days) by qPCR Method After the P Falciparum Challenge

  Within 2-3 weeks

• Diagnostic Efficacy; Quantification of Parasite Clearance Time (PCT) by Blood Smear and qPCR Methods After Initiation of Antimalarial Treatment

  Within 6 weeks

Study Arms (1)

Infective controls

EXPERIMENTAL

Controlled Human Malaria Infection (CHMI) will consist of exposure to Plasmodium falciparum sporozoites through the bites of infected mosquitoes. Beginning 5 days after the challenge, subjects will be evaluated daily for the development of malaria infection using a blood smear.

Biological: Plasmodium falciparum malaria parasite

Interventions

Plasmodium falciparum malaria parasite BIOLOGICAL

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).

Infective controls

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. James Moon, Principal Investigator
• Organization: Walter Reed Army Institute of Research

James.e.moon.mil@mail.mil

301-319-9176

Study Officials

• James E Moon, MD

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: March 20, 2019
• Study Start: March 4, 2019
• Primary Completion: April 25, 2019
• Study Completion: May 16, 2019
• Last Updated: March 30, 2021
• Results First Posted: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)