The purpose of this study is to assess safety and tolerability of escalating doses of a genetically attenuated parasite malaria vaccine (p52-/p36- GAP vaccine) in healthy malaria-naive adults. The study will also assess preliminary efficacy of p52-/p36- GAP vaccine following primary experimental challenge with P. falciparum sporozoites. Lastly, the study will assess immunogenicity of p52-/p36- GAP in malaria-naïve healthy adults and preliminary efficacy of p52-/p36- GAP vaccine following primary experimental re-challenge with P. falciparum sporozoites.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
6
Administered by five bites from GAP-infected Anopheles mosquito
Administered by 200 bites from GAP-infected Anopeles mosquito
Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States
Occurrence of Solicited Adverse Events (AE)
Time frame: From administration of study vaccine through 7 days (± 1 days) post dosing
Occurrence of Unsolicited AEs
Time frame: From administration of study vaccine through 28 days (± 4 days) post dosing
Occurrence of Laboratory Adverse Events (AE)
Volunteers with any laboratory abnormality.
Time frame: From administration of study vaccine through 7 days (± 1 days) post dosing
Detection of Breakthrough Peripheral Parasitemia by Thick Blood Film
Time frame: From 7 days after administration of vaccine through 28 days (+ 4 days) post-dosing
Occurrence of Serious Adverse Events (SAE)
Time frame: baseline through 28 days
Development of Parasitemia and Time to Parasitemia After Primary Malaria Challenge Following Administration of GAP
Time frame: From administration of study vaccine through the duration of the trial
Development of Parasitemia and Time to Parasitemia After Re-challenge Following Administration of GAP
Time frame: From administration of study vaccine through the duration of the trial
P. Falciparum Specific Cell-mediated Immune Responses
Time frame: From administration of study vaccine through the duration of the trial
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