In this study, two experimental malaria vaccines (with adjuvants) are tested to evaluate and characterise how the vaccine exactly works on the immune system by comparing it to a control (without adjuvant). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
36
Three-dose vaccination by slow intramuscular injection. Three different formulations of this vaccine are tested (without adjuvant, with adjuvant AS01B, with adjuvant AS02A).
GSK Investigational Site
Ghent, Belgium
Anti-CS antibody titers.
Time frame: One month post Dose 3.
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms.
Time frame: During the 7-day follow-up period following vaccination after each vaccine dose.
Occurrence, intensity and relationship to vaccination of unsolicited symptoms.
Time frame: During the 30-day follow-up period following vaccination after each vaccine dose.
Occurrence of serious adverse events.
Time frame: Up until 1 month post dose 3.
Antibody responses to the P. falciparum circumsporozoite (CS) antigen.
Time frame: At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3.
Antibody responses to HBs antigen.
Time frame: At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3
Frequency of CS and Hepatitis B surface agent (HBs)-specific CD4+ and CD8+ T cells expressing Th1 specific activation markers and cytokines.
Time frame: At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3
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