Clinical Trial of Candidate Malaria Vaccine MSP3-LSP Launched in Tanga, Tanzania
Press Release
Dar-Es-Salaam, 18 January 2008
Researchers at the National Institute for Medical Research (NIMR) in Tanga, Tanzania are conducting a Phase Ib clinical trial in Korogwe district to evaluate the safety and immunological potential of a candidate malaria vaccine MSP3-LSP (merozoite surface protein 3-long synthetic peptide).
Having successfully undergone earlier testing on healthy adults in Switzerland and Burkina Faso, two different dosages (15 and 30 micrograms) of MSP3 are now being tested in a staggered process among child populations to further demonstrate its safety and any immediate or delayed adverse events. The trial is being run by a highly competent and experienced team of NIMR-Tanga researchers at the Kwashemshi Vaccination Centre in Korogwe district, under the leadership of Dr John P. Lusingu., the Principal Investigator for this trial.
The study which was approved by the Tanzania National Health Research Ethics Review Committee and the Tanzania Food and Drugs Authority, involves forty five healthy children, randomly selected, aged 1-2 years. Children are divided into two groups (first and second) comprising 23 and 22 children respectively. In the first group, 15 children are receiving a lower dose (15micrograms) of the test vaccine MSP3, the remaining 8 (control) are receiving Hepatitis B vaccine. In the second group, 15 children are receiving a higher dose (30 micrograms) of MSP3; the remaining 7 the controls, are also receiving a Hepatitis B vaccine as in the other control group. Immunizations in the two groups are staggered, i.e., immunization in the second group is administered two weeks later after a thorough safety evaluation of the outcome of vaccination with the lower dose. Each child will receive a total of three immunizations.
“Malaria accounts for 80% of deaths among children below five years in Tanzania. We are very proud to be part of a process aimed at finding lasting solutions against Tanzania’s biggest killer”, Said Dr Lusingu during the launch.
“Despite bearing the heaviest brunt of the malaria scourge and hence target beneficiaries for a malaria vaccine, we are employing a cautious approach in this trial by staggering the dosage. Besides, children will be closely monitored during the entire study period of 13 months”, he added.
The study is being sponsored by the African Malaria Network Trust (AMANET); a Dar es Salaam based pan-African NGO leading Africa in researching, developing and eventually deploying appropriate interventions against malaria. Besides funding for this trial, AMANET has contributed extensively in capacity strengthening, trial site development and training at NIMR-Tanga.
Vaccine trial participant recruitment at Kwashemshi village in Korogwe, Tanzania
MSP3 discovery results from an immuno-clinical approach. The mechanisms mediating protection in humans were analyzed by clinical experiments of passive protection in patients, and the main mechanism, which was employed to screen the ca. 5300 proteins of the malaria parasite (Plasmodium falciparum), identified MSP3 as the main target. It was then demonstrated that antibodies to MSP3 promotes the function a group of white blood cells (monocytes) which can attack and kill the parasite.
Antibodies directed against MSP3, are closely associated with protection against the disease, including among young children. This provides the hope of being able to readily induce a satisfactory level of protection against malaria, in this age-group that suffers the largest burden of malaria.
MSP3 was invented by Dr Pierre Druilhe and colleagues at the Biomedical Parasitological Unit of the Institute Pasteur in Paris, France. The vaccine batch currently under trial in Tanga was produced by Synprosis, a Biotechnology company based in Marseille, France.
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For further information contact:
Dr Charles L. Wanga
Communications Officer
African Malaria Network Trust [AMANET]
Third Floor, Commission for Science and Technology Building
Ali Hassan Mwinyi Rd
PO Box 33207
Dar es Salaam, TANZANIA.
clwanga@amanet-trust.org
www.amanet-trust.org
Tel: +255 22 2700018
Fax: +255 22 2700380
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