Incidence of severe Plasmodium falciparum malaria as a primary endpoint for vaccine efficacy trials in Bandiagara, Mali.

Center for Vaccine Development, University of Maryland School of Medicine, 685 West Baltimore Street, HSF 480, Baltimore, MD, USA.
Vaccine (Impact Factor: 3.49). 08/2004; 22(23-24):3169-74. DOI: 10.1016/j.vaccine.2004.01.054
Source: PubMed

ABSTRACT Potential endpoints for blood stage malaria vaccine efficacy trials include uncomplicated malaria disease, which is hard to differentiate from other febrile illnesses, and mortality, which requires prohibitively large sample sizes. Strictly defined severe malaria predicts malaria-associated mortality where case fatality rates are known. To assess the suitability of severe malaria as a trial endpoint, we conducted a census in 1999 and measured the incidence of severe malaria from 1999 to 2001 in Bandiagara, Mali. The annual incidence of severe malaria in children <6 years of age was 2.3% (n = 2,284) yielding an estimated sample size of 4,580 for a vaccine trial designed to detect 50% efficacy with 80% power at P = 0.05 with 5% loss to follow-up. A trial using severe malaria as an endpoint in this setting would thus require expanding the study population or the length of the trial. This approach may be useful in assessing the suitability of potential sites for malaria vaccine trials.

  • [Show abstract] [Hide abstract]
    ABSTRACT: It has been estimated that nearly half of the world's population is at the risk of contracting malaria with sub Saharan Africa being the most risky area. The existing frontline malaria control interventions are not only expensive but also become ineffective owing to the emergence of insecticide and drug resistance. It calls for an innovative approach in terms of potential and reliable vaccine as an additional tool. Over centuries, the public health experts have been actively engaged to formulate a safe, affordable and potential malaria vaccine and accordingly a notable achievement has also been attained. However, many challenges are required to be flagged immediately and effectively to devise an ideal prophylactic malaria vaccine. Therefore, the global community has to remain waiting quite a few more years to build a wannabe malaria-free world in the near future.
    International journal of preventive medicine 05/2014; 5(5):529-538.
  • [Show abstract] [Hide abstract]
    ABSTRACT: Infection with Plasmodium falciparum, caused 627,000 deaths in 2012 in the world. P. falciparum infection causes myriads of clinical manifestations. Exact clinical manifestation resulting in poor prognosis in hyper-endemic epidemiological settings need to be ascertained to save human lives. A hospital-based study was conducted to elucidate the different severe clinical presentations of falciparum malaria and to examine the critical clinical and laboratory parameters on the prognosis of these severe manifestations in a stable hyper-endemic falciparum area in the state of Odisha, India.
    07/2014; 4(2):105-10. DOI:10.4103/2229-5070.138538
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background The recent decline in malaria incidence in many African countries has been attributed to the provision of prompt and effective anti-malarial treatment using artemisinin-based combination therapy (ACT) and to the widespread distribution of long-lasting, insecticide-treated bed nets (LLINs). At a malaria vaccine-testing site in Bandiagara, Mali, ACT was introduced in 2004, and LLINs have been distributed free of charge since 2007 to infants after they complete the Expanded Programme of Immunization (EPI) schedule and to pregnant women receiving antenatal care. These strategies may have an impact on malaria incidence. Methods To document malaria incidence, a cohort of 400 children aged 0 to 14 years was followed for three to four years up to July 2013. Monthly cross-sectional surveys were done to measure the prevalence of malaria infection and anaemia. Clinical disease was measured both actively and passively through continuous availability of primary medical care. Measured outcomes included asymptomatic Plasmodium infection, anaemia and clinical malaria episodes. Results The incidence rate of clinical malaria varied significantly from June 2009 to July 2013 without a clear downward trend. A sharp seasonality in malaria illness incidence was observed with higher clinical malaria incidence rates during the rainy season. Parasite and anaemia point prevalence also showed seasonal variation with much higher prevalence rates during rainy seasons compared to dry seasons. Conclusions Despite the scaling up of malaria prevention and treatment, including the widespread use of bed nets, better diagnosis and wider availability of ACT, malaria incidence did not decrease in Bandiagara during the study period.
    Malaria Journal 09/2014; 13(1):374. DOI:10.1186/1475-2875-13-374 · 3.49 Impact Factor