This study specifically seeks to quantify the contribution of relapes to the burden of P. vivax infections and disease by determining on the effect of radical pre-erythrocytic and erythrocytic clearance on subsequent rates of Plasmodium spp. infection and disease in children aged 5-10 years in a treatment to re-infection study design. In order the clear liver-stage/blood-stages G6PD-normal children were randomised to receive Chloroquine (3 days, standard dose) and Coartem (3 days, standard dose) plus either i) primaquine (20 days, 0.5mg/kg) or ii) placebo (20days). These drugs were administered over a period of 4 weeks. In addition to this epidemiological data, the study will assess the natural acquisition of cellular and humoral immune responses to P. falciparum and P. vivax, thus assisting in the determination of correlates of clinical immunity to P. falciparum and P. vivax in PNG children aged 5-10 years. These data will not only be essential for development of future vaccines against P. vivax and P falciparum but provide invaluable insight into the contribution of long-lasting liver-stages to the force of infection with P. vivax that will contribute towards designing more rational approaches to the treatment of P. vivax both in the context of case management and future attempts at elimination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
524
PNG Institute of Medical Research
Maprik, East Sepik Province, Papua New Guinea
Time to first or only Plasmodium vivax infection by light microscopy and PCR
Time frame: 8 months post-baseline
Time to first or only clinical P. vivax episode
Time frame: 8 months post-baseline
Time to first or only P. falciparum infection by light microscopy and PCR
Time frame: 8 months post-baseline
Time to first or only P. ovale infection by light microscopy and PCR
Time frame: 8 months post-baseline
Time to first or only P. malariae infection by light microscopy and PCR
Time frame: 8 months post-baseline
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