Open Access Highly Accessed Study protocol

Does treatment of intestinal helminth infections influence malaria? Background and methodology of a longitudinal study of clinical, parasitological and immunological parameters in Nangapanda, Flores, Indonesia (ImmunoSPIN Study)

Aprilianto E Wiria12, Margaretta A Prasetyani1, Firdaus Hamid23, Linda J Wammes2, Bertrand Lell4, Iwan Ariawan5, Hae Won Uh6, Heri Wibowo1, Yenny Djuardi1, Sitti Wahyuni7, Inge Sutanto1, Linda May2, Adrian JF Luty8, Jaco J Verweij2, Erliyani Sartono2, Maria Yazdanbakhsh2* and Taniawati Supali1*

Author Affiliations

1 Department of Parasitology, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia

2 Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands

3 Department of Microbiology, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia

4 Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon; Department of Parasitology, Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany

5 Department of Biostatistics, School of of Public Health, University of Indonesia, Jakarta, Indonesia

6 Department of Biostatistics, Leiden University Medical Centre, Leiden, The Netherlands

7 Department of Parasitology, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia

8 Department of Medical Microbiology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

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BMC Infectious Diseases 2010, 10:77  doi:10.1186/1471-2334-10-77

Published: 25 March 2010

Abstract

Background

Given that helminth infections are thought to have strong immunomodulatory activity, the question whether helminth infections might affect responses to malaria antigens needs to be addressed. Different cross-sectional studies using diverse methodologies have reported that helminth infections might either exacerbate or reduce the severity of malaria attacks. The same discrepancies have been reported for parasitemia.

Methods/Design

To determine the effect of geohelminth infections and their treatment on malaria infection and disease outcome, as well as on immunological parameters, the area of Nangapanda on Flores Island, Indonesia, where malaria and helminth parasites are co-endemic was selected for a longitudinal study. Here a Double-blind randomized trial will be performed, incorporating repeated treatment with albendazole (400 mg) or placebo at three monthly intervals. Household characteristic data, anthropometry, the presence of intestinal helminth and Plasmodium spp infections, and the incidence of malaria episodes are recorded. In vitro cultures of whole blood, stimulated with a number of antigens, mitogens and toll like receptor ligands provide relevant immunological parameters at baseline and following 1 and 2 years of treatment rounds. The primary outcome of the study is the prevalence of Plasmodium falciparum and P. vivax infection. The secondary outcome will be incidence and severity of malaria episodes detected via both passive and active follow-up. The tertiary outcome is the inflammatory cytokine profile in response to parasite antigens. The project also facilitates the transfer of state of the art methodologies and technologies, molecular diagnosis of parasitic diseases, immunology and epidemiology from Europe to Indonesia.

Discussion

The study will provide data on the effect of helminth infections on malaria. It will also give information on anthelminthic treatment efficacy and effectiveness and could help develop evidence-based policymaking.

Trial registration

This study was approved by The Ethical Committee of Faculty of Medicine, University of Indonesia, ref:194/PT02.FK/Etik/2006 and has been filed by ethics committee of the Leiden University Medical Center. Clinical trial number:ISRCTN83830814. The study is reported in accordance with the CONSORT guidelines for cluster-randomized studies.