Challenges of establishing a Community Advisory Board (CAB) in a low-income, low-resource setting: experiences from Bagamoyo, Tanzania

OBJECTIVE\ud \ud Community Advisory Boards are now seen as standard practice for clinical vaccine and drug trials worldwide. In the past, most Community Advisory Boards (CABs) were established by activists and lobbyists to monitor HIV/AIDS vaccine and drug trials in developed countries. In Africa the first CAB was established in Uganda in 1990 in conjunction with an HIV vaccine project and has since been followed by others in South Africa, Zimbabwe, and Kenya. In 2007, the Bagamoyo branch of the Ifakara Health Institute initiated the formation of a CAB. The aim was to properly educate and empower elected CAB members to become full partners in all research activities concerning the public within the Bagamoyo area.\ud \ud METHODS AND RESULTS\ud \ud Beginning in 2007, staff visited each of the 24 villages within the study area to inform the communities about the proposed CAB and asked them to elect two individuals to represent their village on the CAB. The first attempt was hampered by community leaders selecting themselves, which led to inconsistent attendance, gender imbalance, and political infighting. New criteria for the selection of representatives were implemented to exclude governmental leaders, illiterate representatives and to promote a one-to-one gender balance. The newly appointed representatives underwent training and have participated in CAB meetings largely devoid of the negative issues previously encountered.\ud \ud CONCLUSION\ud \ud The successfully established CAB has led to improved relations with the community and facilitated the recruitment of study subjects. Our experiences show that, it is possible to establish a non-specific CAB in a low-income setting

Experience and Challenges from Clinical Trials with Malaria Vaccines in Africa.

Malaria vaccines are considered amongst the most important modalities for potential elimination of malaria disease and transmission. Research and development in this field has been an area of intense effort by many groups over the last few decades. Despite this, there is currently no licensed malaria vaccine. Researchers, clinical trialists and vaccine developers have been working on many approached to make malaria vaccine available.African research institutions have developed and demonstrated a great capacity to undertake clinical trials in accordance to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards in the last decade; particularly in the field of malaria vaccines and anti-malarial drugs. This capacity is a result of networking among African scientists in collaboration with other partners; this has traversed both clinical trials and malaria control programmes as part of the Global Malaria Action Plan (GMAP). GMAP outlined and support global strategies toward the elimination and eradication of malaria in many areas, translating in reduction in public health burden, especially for African children. In the sub-Saharan region the capacity to undertake more clinical trials remains small in comparison to the actual need.However, sustainability of the already developed capacity is essential and crucial for the evaluation of different interventions and diagnostic tools/strategies for other diseases like TB, HIV, neglected tropical diseases and non-communicable diseases. There is urgent need for innovative mechanisms for the sustainability and expansion of the capacity in clinical trials in sub-Saharan Africa as the catalyst for health improvement and maintained

First results of phase 3 trial of RTS,S/AS01 malaria vaccine in african children

Background An ongoing phase 3 study of the efficacy, safety, and immunogenicity of candidate malaria vaccine RTS,S/AS01 is being conducted in seven African countries. Methods From March 2009 through January 2011, we enrolled 15,460 children in two age categories - 6 to 12 weeks of age and 5 to 17 months of age - for vaccination with either RTS,S/AS01 or a non-malaria comparator vaccine. The primary end point of the analysis was vaccine efficacy against clinical malaria during the 12 months after vaccination in the first 6000 children 5 to 17 months of age at enrollment who received all three doses of vaccine according to protocol. After 250 children had an episode of severe malaria, we evaluated vaccine efficacy against severe malaria in both age categories. Results In the 14 months after the first dose of vaccine, the incidence of first episodes of clinical malaria in the first 6000 children in the older age category was 0.32 episodes per person-year in the RTS,S/AS01 group and 0.55 episodes per person-year in the control group, for an efficacy of 50.4% (95% confidence interval [CI], 45.8 to 54.6) in the intention-to-treat population and 55.8% (97.5% CI, 50.6 to 60.4) in the per-protocol population. Vaccine efficacy against severe malaria was 45.1% (95% CI, 23.8 to 60.5) in the intention-to-treat population and 47.3% (95% CI, 22.4 to 64.2) in the per-protocol population. Vaccine efficacy against severe malaria in the combined age categories was 34.8% (95% CI, 16.2 to 49.2) in the per-protocol population during an average follow-up of 11 months. Serious adverse events occurred with a similar frequency in the two study groups. Among children in the older age category, the rate of generalized convulsive seizures after RTS,S/AS01 vaccination was 1.04 per 1000 doses (95% CI, 0.62 to 1.64). Conclusions The RTS,S/AS01 vaccine provided protection against both clinical and severe malaria in African children. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619 .