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Safety, Attenuation and Immunogenicity of GAP3KO Administered Via A Stephensi Mosquitoes

Primary Purpose

Malaria

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GAP3KO
Sponsored by
Seattle Children's Research Institute (SCRI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Malaria

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Good general health
  • No hematologic, hepatic, or renal disease
  • Weight greater than 50 kg
  • Assessment of Understanding completed and passed prior to enrollment
  • Availability and reliable access to trial center
  • Females must use two forms of pregnancy prevention

Exclusion Criteria:

  • Recent (within 6 months) or planned travel to malaria endemic area
  • History of confirmed malaria diagnosis

  • Anticipated use of the following:

    • Investigational malaria vaccine at any time
    • Malaria chemoprophylaxis within 6 months
    • Chronic systemic immunosuppressive medications within 6 months
    • Blood products or immunoglobulin within 120 days
    • Systemic antibiotics with antimalarial effects within 30 days
    • Investigational product or vaccine within 30 days
    • Live vaccine within 28 days; killed vaccine within 14 days of GAP3KO
    • Medications known to significantly interact with chloroquine or Malarone

  • History of:

    • Sickle cell trait or other hemoglobinopathies
    • Splenectomy or functional asplenia
    • Systemic anaphylaxis
    • Severe allergic reaction to mosquito bites or malaria treatment drugs
    • History of chronic or active neurologic disease
    • Cardiac disease or stroke
  • Clinically significant medical condition, abnormal lab results
  • Clinically significant abnormal ECG
  • Moderate or high risk for coronary heart disease
  • Acute illness
  • Pregnant or nursing female
  • HIV, Hepatitis B, or Hepatitis C
  • Psychiatric condition that precludes compliance with the protocol
  • Suspected or known alcohol or drug abuse
  • Staff with direct involvement in conduct of the study or GAP activities

Sites / Locations

  • Seattle Biomedical Research Institute Malaria Clinical Trial Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GAP3KO

Arm Description

Outcomes

Primary Outcome Measures

Safety assessed by frequency of AEs, SAEs, and patent parasitemia via peripheral blood smear

Secondary Outcome Measures

CSP antibody titer
Percent inhibition of in vitro sporozoite

Full Information

First Posted
December 8, 2014
Last Updated
November 17, 2015
Sponsor
Seattle Children's Research Institute (SCRI)
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1. Study Identification

Unique Protocol Identification Number
NCT02313376
Brief Title
Safety, Attenuation and Immunogenicity of GAP3KO Administered Via A Stephensi Mosquitoes
Official Title
Trial to Assess the Safety, Attenuation and Immunogenicity of Genetically-attenuated p52-/p36-/sap1- Plasmodium Falciparum Parasites (GAP3KO) Administered Via Infected Anopheles Stephensi Mosquitoes to Malaria-Naïve Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seattle Children's Research Institute (SCRI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study designed to evaluate safety and tolerability of a genetically attenuated P. falciparum (GAP3KO) that arrests early in the liver stage of the parasite life cycle. Study will also confirm the attenuation of the GAP3KO parasites using peripheral blood smears. Secondary objectives are to evaluate the humoral immune responses to GAP3KO.
Detailed Description
This single arm, open-label, phase 1 safety study is designed to evaluate the safety and tolerability of a genetically attenuated P. falciparum (GAP3KO) that arrests early in the liver stage of the parasite life cycle. The study will also confirm the attenuation of the GAP3KO parasites using peripheral blood smears. The secondary objectives of the study are to evaluate the humoral immune responses to GAP3KO. A total of 10 healthy, malaria-naïve adult subjects will be enrolled to receive GAP3KO via the bite of 150-200 GAP3K0-infected A. stephensi mosquitoes under controlled conditions. Subjects will be evaluated for safety, reactogenicity, and signs and symptoms of malaria to confirm attenuation for 28 days, including monitoring in a hotel setting 8-18 days post GAP 3KO administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GAP3KO
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
GAP3KO
Intervention Description
GAP3KO administered via the bite of 150-200 GAP3KO-infected A. stephensi mosquitoes under controlled conditions.
Primary Outcome Measure Information:
Title
Safety assessed by frequency of AEs, SAEs, and patent parasitemia via peripheral blood smear
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
CSP antibody titer
Time Frame
28 days
Title
Percent inhibition of in vitro sporozoite
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Good general health No hematologic, hepatic, or renal disease Weight greater than 50 kg Assessment of Understanding completed and passed prior to enrollment Availability and reliable access to trial center Females must use two forms of pregnancy prevention Exclusion Criteria: Recent (within 6 months) or planned travel to malaria endemic area History of confirmed malaria diagnosis Anticipated use of the following: Investigational malaria vaccine at any time Malaria chemoprophylaxis within 6 months Chronic systemic immunosuppressive medications within 6 months Blood products or immunoglobulin within 120 days Systemic antibiotics with antimalarial effects within 30 days Investigational product or vaccine within 30 days Live vaccine within 28 days; killed vaccine within 14 days of GAP3KO Medications known to significantly interact with chloroquine or Malarone History of: Sickle cell trait or other hemoglobinopathies Splenectomy or functional asplenia Systemic anaphylaxis Severe allergic reaction to mosquito bites or malaria treatment drugs History of chronic or active neurologic disease Cardiac disease or stroke Clinically significant medical condition, abnormal lab results Clinically significant abnormal ECG Moderate or high risk for coronary heart disease Acute illness Pregnant or nursing female HIV, Hepatitis B, or Hepatitis C Psychiatric condition that precludes compliance with the protocol Suspected or known alcohol or drug abuse Staff with direct involvement in conduct of the study or GAP activities
Facility Information:
Facility Name
Seattle Biomedical Research Institute Malaria Clinical Trial Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety, Attenuation and Immunogenicity of GAP3KO Administered Via A Stephensi Mosquitoes

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