Safety, Attenuation and Immunogenicity of GAP3KO Administered Via A Stephensi Mosquitoes
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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 8, 2014
CompletedFirst Posted
Study publicly available on registry
December 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedNovember 18, 2015
November 1, 2015
2 months
December 8, 2014
November 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Safety assessed by frequency of AEs, SAEs, and patent parasitemia via peripheral blood smear
28 Days
Secondary Outcomes (2)
CSP antibody titer
28 days
Percent inhibition of in vitro sporozoite
28 days
Study Arms (1)
GAP3KO
EXPERIMENTALInterventions
GAP3KO administered via the bite of 150-200 GAP3KO-infected A. stephensi mosquitoes under controlled conditions.
Eligibility Criteria
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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seattle Biomedical Research Institute Malaria Clinical Trial Center
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2014
First Posted
December 10, 2014
Study Start
December 1, 2014
Primary Completion
February 1, 2015
Study Completion
August 1, 2015
Last Updated
November 18, 2015
Record last verified: 2015-11