Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 163 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

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE September 29, 2015
Last Update Posted Date July 13, 2017
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • Number of subjects with positive parasitemia [ Time Frame: 28 days ]
    positive parasitemia detected by qRT-PCR
  • 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]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DSM265 Prophylaxis of Plasmodium Falciparum Malaria
Official Title  ICMJE 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
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).

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: DSM265
    DSM265 400 mg single oral dose
  • 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
  • Biological: Infective mosquito bite
    Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum
Study Arms  ICMJE
  • Experimental: Cohort 1 Active DSM265
    Interventions:
    • Drug: DSM265
    • Biological: Sporozoites
  • Placebo Comparator: Cohort 1 Placebo
    Interventions:
    • Drug: Placebo
    • Biological: Sporozoites
  • Experimental: Cohort 2a Active DSM265
    Interventions:
    • Drug: DSM265
    • Biological: Sporozoites
  • Placebo Comparator: Cohort 2a Placebo
    Interventions:
    • Drug: Placebo
    • Biological: Sporozoites
  • Experimental: Cohort 2b Active DSM265
    Interventions:
    • Drug: DSM265
    • Biological: Infective mosquito bite
  • Placebo Comparator: Cohort 2b Placebo
    Interventions:
    • Drug: Placebo
    • Biological: Infective mosquito bite
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02562872
Other Study ID Numbers  ICMJE MMV_DSM265_14_03
CDMRP-PR130402 ( Other Grant/Funding Number: US Department of Defense )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medicines for Malaria Venture
Study Sponsor  ICMJE Medicines for Malaria Venture
Collaborators  ICMJE
  • Fred Hutchinson Cancer Research Center
  • United States Department of Defense
  • Center for Infectious Disease Research
Investigators  ICMJE
Principal Investigator: James G Kublin, MD/MPH Fred Hutchinson Cancer Research Centre
PRS Account Medicines for Malaria Venture
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP