Status:
COMPLETED
Safety, Attenuation and Immunogenicity of GAP3KO Administered Via A Stephensi Mosquitoes
Lead Sponsor:
Seattle Children's Hospital
Conditions:
Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 atte...
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02313376
Start Date
December 1 2014
End Date
August 1 2015
Last Update
November 18 2015
Active Locations (1)
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1
Seattle Biomedical Research Institute Malaria Clinical Trial Center
Seattle, Washington, United States, 98109