AMANET Announces Launch of Clinical Study of
Candidate Malaria Vaccine GMZ2 in Gabon
Press Release
Dar-Es-Salaam, 03 September 2007
The African Malaria Network Trust (AMANET) has launched a Clinical trial of a candidate malaria vaccine GMZ2 in Gabon. GMZ2 is a hybrid malaria vaccine composed of merozoite surface protein (MSP3) and glutamate rich protein (GLURP). The vaccine is adjuvanted with Aluminium Hydroxide.
This trial is the first time the vaccine is being tested in Africa and is involving 40 healthy adult volunteers resident in Lambaréné, Gabon. The study aims at evaluating whether the product is safe for use in malaria endemic populations. It is being conducted by a team of researchers and scientists at the Medical Research Unit (MRU) of the Albert Schweitzer Hospital (ASH) in Gabon, with Dr Saadou Issifou as the principal investigator of the study. MRU-ASH has an excellent track record of clinical trials at accepted international research and ethical standards.
“We are already in our third week after the first immunization with GMZ2. Three doses of GMZ2 will be given to study participants; the second dose will be given in the fifth week and the last dose will be given two months from now. In the meantime participants will be closely monitored on their progress, an activity which will continue for one year after completion of the trial”, said Dr Issifou.
In this randomised controlled study, 20 of the volunteers will receive the GMZ2 vaccine. The other 20 allocated to the comparator group will receive rabies vaccine. After approval by the AMANET scientific coordinating committee, the study was reviewed and approved by the Gabonese authorities and the regional ethics committee (Comite d’Etique Regional Independent de Lambarene). This study is also registered with the US public registry of clinical trials with a registration number NCT NCT00424944.
This project is sponsored by the African Malaria Network Trust (AMANET). AMANET is a Pan-African, not-for-profit organization that promotes capacity strengthening of malaria research and development (R&D). With a current focus on malaria vaccine development, AMANET is also sponsoring the development of two other candidate malaria vaccines in Mali and Burkina Faso. Presently, the sole funding for AMANET is from the European Commission’s Aid Cooperation Office (AIDCO) based in Belgium. With AIDCO support, AMANET is making substantial strides towards the search for affordable and efficacious tools to confront the malaria debacle which continues to decimate precious African lives.
GMZ2 is a recombinant blood stage vaccine comprising of two parts targeting two key components on the malaria parasite (Plasmodium falciparum) structure; MSP3 and GLURP. Recombinant meaning that GMZ2 was produced by joining segments of genetic material (DNA) from different sources with carrier microbe Lactobacillus lactis used in this case for the expression system. This vaccine was invented at the Staten Serum Institut, Copenhagen, Denmark by Dr Michael Thiesen.
GMZ2 works by targeting the malaria parasite in the blood stage (merozoite) of the infection and in doing so stimulates the body’s immune system to produce agents (antibodies) against GLURP and MSP3 targets on the malaria parasite. These anti-GLURP and anti-MSP3 antibodies have been demonstrated to be able to completely inhibit malaria parasite growth in animal experiments. In an earlier study of this candidate vaccine done by the University of Tübingen in malaria naïve German adults, GMZ2 was confirmed to be safe for use in humans. This and other studies have further confirmed that GMZ2 is able to induce those specific antibodies against GLURP and MSP3 targets in the parasite to substantial levels to block P. falciparum invasion.
The European Malaria Vaccine Initiative (EMVI) is responsible for the ultimate development of this vaccine. The EMVI is thus responsible for good manufacturing practice (GMP) production and takes product liability responsibility. The EMVI sponsored earlier preclinical development and Europe-based clinical trials. This product is now under the auspices of the special EMVI-AMANET seamless agreement whereby products developed by EMVI are taken to clinical testing in Africa under sponsorship of AMANET. The vaccine batch currently under study was manufactured by Henogen S.A, a bioengineering company based in Belgium.
This study is a major milestone in research and development for malaria vaccines. If proved safe, further trials of GMZ2 will be implemented in older children to demonstrate safety and immunogenicity before moving to studies on protection against clinical disease among infants. AMANET is proud of her contribution to the global fight against malaria. If a vaccine like GMZ2 succeeds, millions of children in Africa could be protected against malaria, and the millions of malaria episodes annually borne by Africa could be substantially reduced.
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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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