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Trial record 2 of 154 for:    Center for Infectious Disease Research | malaria

DSM265 Prophylaxis of Plasmodium Falciparum Malaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562872
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : July 13, 2017
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
United States Department of Defense
Center for Infectious Disease Research
Information provided by (Responsible Party):
Medicines for Malaria Venture

Brief Summary:

The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265 including up to two cohorts of healthy male and female volunteers aged 18 to 45 years.

The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).


Condition or disease Intervention/treatment Phase
Healthy Drug: DSM265 Drug: Placebo Biological: Sporozoites Biological: Infective mosquito bite Phase 1

Detailed Description:

Cohort 1:

  • Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200 cryopreserved Plasmodium falciparum sporozoites)
  • Drug administration on Day -3
  • 8 subjects: 6 DSM265 400 mg: 2 matching placebo Clinical safety review of Cohort 1 in order to proceed to Cohorts 2a and 2b

Cohort 2a:

  • Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200 cryopreserved Plasmodium falciparum sporozoites)
  • Drug administration on Day -X (to be defined following safety and pharmacokinetic data)
  • 8 subjects: 6 DSM265 400 mg: 2 matching placebo

Cohort 2b:

  • Controlled human malaria infection on Day 0 (infected mosquito bite)
  • Drug administration on Day -X (to be defined following safety and pharmacokinetic data)
  • 8 subjects: 6 DSM265 400 mg: 2 matching placebo

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Proof-of-concept, Single Center Study in Healthy Adult Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Prophylactic Activity of Single Dose DSM265 in a Controlled Human Malarial Infection Challenge Either by Direct Venous Inoculation of Plasmodium Falciparum Sporozoites or Mosquito-borne Plasmodium Falciparum
Actual Study Start Date : March 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Cohort 1 Active DSM265 Drug: DSM265
DSM265 400 mg single oral dose

Biological: Sporozoites
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Other Name: PfSPZ

Placebo Comparator: Cohort 1 Placebo Drug: Placebo
Placebo to match DSM265, single oral dose

Biological: Sporozoites
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Other Name: PfSPZ

Experimental: Cohort 2a Active DSM265 Drug: DSM265
DSM265 400 mg single oral dose

Biological: Sporozoites
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Other Name: PfSPZ

Placebo Comparator: Cohort 2a Placebo Drug: Placebo
Placebo to match DSM265, single oral dose

Biological: Sporozoites
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Other Name: PfSPZ

Experimental: Cohort 2b Active DSM265 Drug: DSM265
DSM265 400 mg single oral dose

Biological: Infective mosquito bite
Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum

Placebo Comparator: Cohort 2b Placebo Drug: Placebo
Placebo to match DSM265, single oral dose

Biological: Infective mosquito bite
Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum




Primary Outcome Measures :
  1. Number of subjects with positive parasitemia [ Time Frame: 28 days ]
    positive parasitemia detected by qRT-PCR

  2. Time interval between challenge and the first positive parasitemia [ Time Frame: 28 days ]
    Time from infection to peripheral parasitemia (qRT-PCR) in DSM265 / placebo treated subjects in each cohort given as a geometric mean [days]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Good health based on medical history and physical examination
  • body mass index >18 and <30kg/m2
  • Laboratory results without clinically significant findings within 60 days
  • Males must use medically acceptable form of contraception from the dose of DSM265/Placebo for 120 days
  • Women must be of non-child bearing potential or willing and able to practice one of the required continuous acceptable methods of contraception and have negative pregnancy tests
  • Able & willing to comply with all study requirements throughout the study
  • Agree to undergo all study procedures, attend all study visits and stay overnight for observation if required, to last follow-up visit
  • Willing to undergo a controlled human malaria infection by mosquito bites / inoculation
  • Able and willing to answer all questions on informed consent correctly, and to sign the informed consent form
  • Reachable constantly by mobile phone or email throughout the study period
  • Refrain from blood donation throughout the study
  • Willing to take atovaquone-proguanil, Chloroquine or other registered antimalarial

Exclusion Criteria:

  • Any history of malaria; any severe reactions to mosquito or insect bites; any history of anaphylaxis
  • Plans to travel to malaria endemic region during the study period
  • Previous participation in any malaria vaccine study or controlled human malaria infection study
  • Participation in any other clinical study within 30 days of enrollment or plan to participate in another investigational vaccine/drug research during the study
  • Breastfeeding or planning to become pregnant during the time of the study
  • Positive Human Immunodeficiency Virus, Hepatitis B or C tests
  • Any confirmed/suspected immunosuppressive or immunodeficient state
  • History of serious psychiatric condition that may affect participation in the study, or history of convulsions, seizures, or of severe head trauma
  • Symptoms, physical signs or laboratory values suggestive of systemic disorders
  • History of cancer (except basal cell carcinoma of the skin)
  • History of arrhythmias or documented prolonged QTcF-interval (>450 msec) or 12-lead ECG demonstrating specific abnormalities
  • Moderate risk or higher for cardiovascular event within 5 years (>10%)
  • Positive family history in 1st or 2nd degree relative <50 years for cardiac disease, or history of, or known active cardiac disease
  • history of: psoriasis or porphyria which may be exacerbated by chloroquine; splenectomy, or sickle cell anaemia or other red blood cell disorders; allergy or contra-indication to chloroquine or atovaquone-proguanil
  • Treatment with an investigational drug within 28 days or 5 half-lives of study medication; use of any drugs or dietary supplements within 7 days or 5 half-lives prior to study medication. Herbal supplements must be discontinued at least 28 days prior to study medication. As an exception, acetaminophen or ibuprofen may be used as approved by the investigator
  • Use of any prohibited medication
  • Grapefruit or product containing grapefruit from28 days before study medication or throughout the study
  • History of drug or alcohol abuse within 12 months prior to dosing, or laboratory evidence of abuse
  • Current smoking of more than 10 cigarettes or equivalent per day
  • Plan for major surgery between enrolment and study completion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562872


Locations
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United States, Washington
Fred Hutchinson Cancer Research Center - Prevention Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Medicines for Malaria Venture
Fred Hutchinson Cancer Research Center
United States Department of Defense
Center for Infectious Disease Research
Investigators
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Principal Investigator: James G Kublin, MD/MPH Fred Hutchinson Cancer Research Centre

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Responsible Party: Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT02562872     History of Changes
Other Study ID Numbers: MMV_DSM265_14_03
CDMRP-PR130402 ( Other Grant/Funding Number: US Department of Defense )
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medicines for Malaria Venture:
Controlled
Human
Malaria
Infection
Healthy
Volunteer
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs