Effect of RTS,S/AS01 vaccine booster dose on cellular immune responses in African infants and children.

RTS,S/AS01, the first approved malaria vaccine, demonstrated moderate efficacy during the phase 3 pediatric trial. We previously investigated cell-mediated immune (CMI) responses following the primary 3-dose immunization and now report responses to the booster dose given 18 months later. Thirty CMI markers were measured by Luminex in supernatants of peripheral blood mononuclear cells from 709 children and infants after RTS,S/AS01 antigen stimulation, and their associations with malaria risk and antibodies one month post-booster and one year later were assessed.

The Ifakara Health Institute's Bagamoyo Research and Training Centre: a well-established clinical trials site in Tanzania.

Bagamoyo Research and Training Centre (BRTC), a branch of the Ifakara Health Institute (IHI), established in late 2004, has evolved into a leading site in performing high-quality Phase II and Phase III malaria vaccine and drug trials according to ICH/GCP standards. Several Phase II and III trials and assessments of interventions focused on better diagnosis, treatment and prevention of malaria have been completed successfully. Expansion into the areas of TB, with the set up of a new BSL-3, and HIV/AIDS marks the commitment of the site to developing into a regional centre of excellence for both clinical trials and epidemiological research.

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

Objective: 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.