A Phase I, Randomized, Controlled, Double-Blind, Single Centre Trial to Evaluate the Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years

The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies. 30 Gabonese children aged 1-5 years will be enrolled and randomly allocated to receive either malaria vaccine or rabies vaccine without the investigator or the participants knowing what they received. They will receive 3 doses each at one month intervals, and will be followed up for one year to evaluate safety parameters. 30 and 100µg doses for the candidate malaria vaccine GMZ 2 will be evaluated for safety.
This is the second time that candidate malaria vaccine GMZ 2 is being tested in Africa, the first time being in Gabonese adults where the product was found to be safe.

开始日期2008-06-01

申办/合作机构

African Malaria Network Trust

NCT00652275 / Unknown status临床2期IIT

Phase IIb Immunogenicity, Efficacy and Safety Study of P. Falciparum Vaccine Candidate, MSP3-LSP Adjuvanted in Aluminium Hydroxide Versus Verorab Control in Healthy Children Aged 12-48 Months in Mali.

This study will be the fourth time that the candidate malaria vaccine Merozoite Surface Protein - long synthetic chain, will be tested in malaria endemic populations.in the past,once tested in adults and twice in children proved to be safe in all three occasions for this phase IIb study in children to proceed. This study will include children who will be randomly allocated to either receive the malaria vaccine adjuvanted with Aluminium Hydroxide or the Verorab control. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be followed-up for immediate reactions to vaccination, extended safety profile and immunological response associated with protection from malaria. These children will be followed up for over a longer term of two years. Blood will be taken to evaluate the biological safety parameters and also the immune responses.

开始日期2008-05-01

申办/合作机构

African Malaria Network Trust

NCT00469651 / Unknown status临床1期IIT

A Double Blind, Randomized, Controlled Phase Ib Field Trial in 12 to 24 Month Old Children in Tanzania to Evaluate the Safety and Immunogenicity of Candidate Malaria Vaccine MSP 3 Versus Hepatitis B Vaccine

This study will evaluate the safety of candidate malaria vaccine MSP3 in children aged 12-24 months in Tanzania in a highland area with low malaria transmission.
Written informed consent will be sought from all guardians/parents of potentially participating children. Eligible children will be randomly allocated to receive either the the study vaccine (MSP3 for a total of 30 children)) or the control vaccine (hepatitis B for a total of 15 children). The vaccines will be given in 3 immunizations one month apart to all the study children and neither the clinical investigators nor the children's parents will be aware of which vaccine has been administered during the initial four months of the study. The study is designed to begin with a lower dose of the MSP3 vaccine (15µg of MSP3 for 15 children) and then followed by the higher dose(30µg MSP3 for 15 children). Following each immunization, children will be evaluated for a seven day solicited symptoms. Unsolicited symptoms will also be collected throughout the study duration.
The study will be overseen by an international safety monitoring committee who will follow safety matters closely as the trial progresses. The study will also be approved by the Tanzania National ethics Committee, The Tanzania Food and Drugs Authority, and the London school of hygiene and tropical medicine ethics committee. The study is planned to last 13 months for each participant.

开始日期2007-10-01

申办/合作机构

African Malaria Network Trust

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2010-12-01·Malaria Journal3区 · 医学

Engaging diverse communities participating in clinical trials: case examples from across Africa

3区 · 医学

ArticleOA

作者: Aceme Nyika ; Mahamadou S Sissoko ; Deus Rs Ishengoma ; Alfred B Tiono ; Martha Lemnge ; Mahamadou A. Thera ; Sally Mmanyi Mtenga ; Wen L Kilama ; John Lusingu ; Roma Chilengi ; Ogobara K. Doumbo ; Sodiomon B Sirima

BACKGROUNDIn the advent of increasing international collaborative research involving participants drawn from populations with diverse cultural backgrounds, community engagement becomes very critical for the smooth conduction of the research. The African Malaria Network Trust (AMANET) is a pan-African non-governmental organization that sponsors and technically supports malaria vaccine trials in various African countries.CASE DESCRIPTIONAMANET sponsored phase Ib or IIb clinical trials of several malaria vaccine candidates in various Africa countries. In Burkina Faso, Mali and Tanzania trials of the merozoite surface protein 3 -- in its Long Synthetic Peptide configuration (MSP3 LSP) -- were conducted. In Mali, the apical membrane antigen 1 (AMA1) was tested, while a hybrid of glutamate rich protein (GLURP) and MSP3 (GMZ2) was tested in Gabon. AMANET recognizes the importance of engaging with the communities from which trial participants are drawn, hence community engagement was given priority in all project activities conducted in the various countries.DISCUSSION AND EVALUATIONExisting local social systems were used to engage the communities from which clinical trial participants were drawn. This article focuses on community engagement activities employed at various AMANET-supported clinical trial sites in different countries, highlighting subtle differences in the approaches used. The paper also gives some general pros and cons of community engagement.CONCLUSIONSCommunity engagement enables two-way sharing of accurate information and ideas between researchers and researched communities, which helps to create an environment conducive to smooth research activities with enhanced sense of research ownership by the communities.

2010-12-01·Malaria Journal

Design of a Phase IIb, randomized, controlled, double-blind, multi-centre study to evaluate the efficacy, safety, and immunogenicity of the GMZ2 candidate malaria vaccine in Ugandan, Ghanaian, Burkinabe and Gabonese children aged 12-60 months

作者: Alfred Tiono ; Fred Kironde ; Ramadhani A Noor ; Roma Chilengi ; Sodiomon Sirima ; Benjamin Mordmuller ; Ateba Ngoa ; Frank Atuguba ; Paul Milligan ; Saadou Issifou ; Brenda Okech ; Soren Jepsen ; Kalifa Bojang ; Michael Thiesen ; Kaddu Mukasa

The malaria vaccine candidate GMZ2 is a recombinant fusion protein of Plasmodium falciparum Glutamate Rich Protein and Merozoite Surface Protein 3, adjuvanted with aluminium hydroxide. Trials in malaria naive adults in Germany and in Gabon in adults exposed to malaria and subsequently in children 1-5yrs showed that three doses of 100ug GMZ2 are well tolerated and immunogenic. The aim of this phase 2b trial is to determine whether the GZ2 vaccine can protect against clinical attacks of malaria in children aged 1-5yrs, to obtain more extensive data on safety, tolerability and immunogenicity, and to determine if the vaccine can prevent anaemia and reduce the parasite density and gametocyte carriage. The primary endpoint is the incidence of clinical malaria defined as fever or history of fever in the previous 24 hours with parasite density of 5000 asexual parasites per ul or more, detected by passive surveillance over a 6 month period from the third vaccination. All malaria episodes will be included in the calculation of vaccine efficacy. This endpoint is chosen in order to have the optimum power to detect a protective effect; efficacy will also be calculated using a range of different parasite density cutoff values. Children will be followed for a total of 22 months from the third vaccination. Immune responses to the vaccine antigens GMZ2, GLURP and MSP3 will be assessed by measuring antigen specific IgG by ELISA, and antigen specific memory B-cell responses by ELISPOT. Functionality of the immune response will be assessed by growth inhibition of P. falciparum in the presence or absence of monocytes. Cell mediated immunogenicity will be assessed by cytokine profiling and intracellular cell staining following stimulation with the vaccine antigen, and the quality of the antibody response by type and subclass-specific ELISA. The planning of the trial was complicated by the need to take account of the changing epidemiology of malaria. Baseline studies were conducted in five potential trial sites to determine the current incidence of malaria; in each site two cohorts of children were followed to estimate the incidence of malaria by active and passive surveillance and by passive surveillance alone. Four sites with higher malaria incidence were chosen for recruitment. A total sample size of 1840 will be enrolled in each of the four sites in 2010/11.

2010-09-01·Vaccine3区 · 医学

Safety and immunogenicity of the malaria vaccine candidate GMZ2 in malaria-exposed, adult individuals from Lambaréné, Gabon

3区 · 医学

Article

作者: Egeruan Babatunde Imoukhuede ; Wen L. Kilama ; Benjamin Mordmüller ; Nathalie Imbault ; Ramadhani Noor ; Roma Chilengi ; Paul Milligan ; Carolin Treut ; Benedikt Greutelaers ; Odile Leroy ; Peter G. Kremsner ; Søren Jepsen ; Saadou Issifou ; Katja Szywon ; Michael Theisen ; Rolf Fendel ; Ludovic Mewono ; Meral Esen ; Raymund E. Mürbeth

Malaria is still one of the major public health threats in sub-Saharan Africa. An effective vaccine could be a sustainable control measure that can be integrated into existing health infrastructures. The malaria vaccine candidate GMZ2 is a recombinant fusion protein of conserved parts of Plasmodium falciparum Glutamate Rich Protein and Merozoite Surface Protein 3 adjuvanted with aluminium hydroxide. GMZ2 is immunogenic and well tolerated in malaria-naive adults from Germany. To assess safety and immunogenicity in malaria-exposed individuals, 40 adults from Lambaréné, Gabon were randomly assigned to receive either 100 μg GMZ2 or a rabies control vaccine three times in monthly intervals. Both vaccines were well tolerated. One month after a full course of vaccination, GMZ2-vaccinated individuals had 1.4-fold (95% confidence interval: [1.1, 1.7]) higher baseline-corrected anti-GMZ2 antibody levels and more GMZ2-specific memory B-cells compared to the rabies group (p=0.039), despite a high prevalence of GMZ2-specific immune reactivity due to previous intense exposure to P. falciparum.

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