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

Completed · Phase 1

Conditions studied: Malaria

In brief

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.

Key facts

Study ID

NCT02313376

Run by

Seattle Children's Hospital

People needed

10

Starts

2014-12-01

Expected to finish

2015-08-01

Last updated by the study team

2015-11-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Seattle Biomedical Research Institute Malaria Clinical Trial Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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