Reproducibility of Malaria Challenge in Healthy Volunteers

NCT01058226 | Completed Phase 1 DMC

• 1 other identifier: MC-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single arm, single intervention safety and immunogenicity study in 6 healthy, malaria-naive adults, conducted to demonstrate the successful implementation of the well-established malaria challenge model at the Seattle Biomedical Research Institute (Seattle BioMed).

Conditions

Healthy

Keywords

Experimental malaria challenge

Outcome Measures

Primary Outcomes (1)

• Development of malaria parasitemia and time to parasitemia demonstrated on peripheral blood smear

  Day 5 through Day 28 post challenge

Secondary Outcomes (5)

• Occurrence of unsolicited AEs

  Day 0 through Day 56 post challenge

• Local and systemic solicited adverse events (AEs)

  Day 5 through Day 28 post challenge

• Occurrence of serious AEs

  Day 0 through Day 56 post challenge

• Cell-mediated immune response to experimental malaria infection

  Day 0 through Day 56 post challenge

• Humoral immune responses to experimental malaria infection

  Day 0 through Day 56 post challenge

Interventions

Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites) BIOLOGICAL

Malaria sporozoite challenge with the wild-type NF54 strain of Plasmodium falciparum delivered by the bite of five infected Anopheles stephensi mosquitoes.

Eligibility Criteria

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

You may qualify if:

• Age 18 to 50 years
• Male or non-pregnant female
• Good general health
• Hemoglobin, WBC, platelets and creatinine within normal ranges
• ALT, AST, bilirubin, alkaline phosphatase \<1.25 times upper limit of normal
• Normal urine
• Negative HIV-1 and 2 blood test
• Negative Hepatitis B surface antigen (HBsAg)
• Negative anti-Hepatitis C virus antibodies (anti-HCV)
• Low risk for coronary heart disease (CHD)
• Ability and willingness to provide informed consent
• Assessment of Understanding questionnaire completed
• Reliable access to the trial center and availability for duration of study
• If the participant is biologically female, she must:
• Have negative serum or urine beta human chorionic gonadotropin pregnancy test performed within 3 days prior to challenge

You may not qualify if:

• Planned travel to malaria endemic area during the study period
• Recent travel to a malaria endemic area within 3 months of enrollment
• Prior receipt of an investigational malaria vaccine
• History of malaria diagnosis based on positive peripheral blood smear
• Use of malaria chemoprophylaxis with chloroquine within 5 months of malaria challenge, with atovaquone/proguanil within 2 months of malaria challenge or with mefloquine within 30 days prior to malaria challenge
• Recent or anticipated use of systemic antibiotics with anti-malarial effects during the study period
• Anticipated use of medications known to interact with chloroquine and/or atovaquone/proguanil during the study period
• Use of investigational or non-registered drug or vaccine within 30 days preceding challenge or planned use during the study period
• Immunosuppressive medications received within 6 months prior to challenge or planned use within 21 days after challenge
• Any vaccination received or planned within 30 days prior to challenge
• Blood products or immunoglobulins received within 120 days of challenge
• Screening laboratory abnormalities
• Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status
• History of anaphylaxis
• History of severe allergic reactions to mosquito bites

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• The PATH Malaria Vaccine Initiative (MVI): collaborator

Study Sites (1)

Seattle Biomedical Research Institue's Malaria Clinical Trial Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Talley AK, Healy SA, Finney OC, Murphy SC, Kublin J, Salas CJ, Lundebjerg S, Gilbert P, Van Voorhis WC, Whisler J, Wang R, Ockenhouse CF, Heppner DG, Kappe SH, Duffy PE. Safety and comparability of controlled human Plasmodium falciparum infection by mosquito bite in malaria-naive subjects at a new facility for sporozoite challenge. PLoS One. 2014 Nov 18;9(11):e109654. doi: 10.1371/journal.pone.0109654. eCollection 2014.

  PMID: 25405724 DERIVED

Study Officials

• Angela Talley, M.D.

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 28, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 31, 2011

Record last verified: 2011-03

Locations

US (1)