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WHO sets new malaria treatment guidelines as GSK publishes additional data on candidate malaria vaccine

24 April 2015 Mark Hollis

In the lead-up to World Malaria Day, the World Health Organization has published new guidelines on the clinical management of malaria. In addition, GSK has published final results from a Phase III clinical trial of its candidate malaria vaccine.

With World Malaria Day on 25 April and as part of commemorations, the World Health Organization (WHO) has issued a revised set of guidelines for the treatment of malaria. You can also read the a press statement regarding the guidelines. Despite effective treatment and prevention strategies, existing data from the WHO suggests that in 2013 there were more than 198 million cases of malaria, of which 584,000 resulted in fatalities. Although rates have been in decline for a number of years, they remain high, with death rates remaining especially high among children under the age of five years. Within this age group, high fatality rates have been due to the fact that only one in five children infected with malaria in Africa obtain treatment while 15 million expectant mothers do not receive any preventive malaria drugs. Bed nets coverage, a key means of combating infection, remains patchy in parts of the world, with some 278 million households in Africa lacking even one bed net.

The new treatment guidelines from the WHO suggest that where malaria is suspected, rapid diagnostic (RDT) tests should be utilised to quickly identify causes of infection and obtain alternative treatment where necessary. Access to RDT tests has increased during 2008-2013, with some 319 million RDT test kits purchased in 2013, up from 46 million in 2008. Where uncomplicated malaria is confirmed, the WHO recommends the use of artemisinin-based combination therapies (ACTs). These are already marketed globally and sales of this treatment has increased from 11 million courses of treatment in 2005 to 395 million in 2013. However, despite dramatic increases in sales of both test kits and treatments, in many parts of the world, especially Africa, a high number of patients attending public healthcare facilities fail to receive testing and/or treatment.

GlaxoSmithKline publishes vaccine trial data
Also coinciding with World Malaria Day, UK pharma major GlaxoSmithKline (GSK) has published final clinical trial data from a Phase III trial of its RTS,S/AS01 candidate malaria vaccine. The trial, from which some data have already been published, involved 15,459 children and young infants in sub-Saharan Africa given either three doses of RTS,S/AS01 at less than one month, one month, and two months, and an additional booster at the 20th month (R3R group), the three doses of the RTS,S/AS01 vaccine with another vaccine given in place of the booster (R3C group), or a comparator vaccine at the same time points (C3C group).

Among the 8,922 children enrolled in the trial, 6,616 cases of malaria were identified in the R3R group, compared with 7,396 in the R3C group and 9,585 in the C3C group, during a follow-up period of which the median was 48 months. Among the 6,537 infants enrolled and followed up in the same period, 4,993 cases occurred in the R3R group, 5,444 in the R3C group, and 6,170 in the C3C group. In terms of averted cases, per 1,000 children, 19 cases of severe malaria were averted in the R3R group, compared with eight in the R3C group.

Outlook and implications
In a report by the BBC, the trial's author Professor Brian Greenwood suggested that the clinical trial results were "a little disappointing". Although he cautioned that due to the life cycle of the malaria parasite, obtaining high levels of efficacy would be challenging. Although perhaps not spectacular, the vaccine results do suggest that a significant number of lives could be saved through the effective rollout of the vaccine. Indeed, GSK has stated that the results suggest the vaccine could offer "substantial public health benefits. This is presumably especially so because, although the effectiveness of the vaccine wanes with time, the most critical time for malaria infection appears to be among the young.

However, an effective rollout of the vaccine is likely to prove extremely challenging in the parts of the world where rates of malaria are high. At present, the organisers of vaccination campaigns face significant challenges in reaching all infants in inoculation drives with one dose of vaccine. These challenges to the supply chain, awareness campaigns, and patient compliance are likely to be compounded where more doses require storage, logistics, and children's families to commit to travelling sometimes large distances to access vaccination administration sites. Alongside these additional resources, vaccination providers would probably be required to provide patient education. There is a common belief that vaccines provide universal protection, and given the protection profile of this vaccine, patients' families would probably need to be counselled to continue employing traditional prevention activities such as the use of bed nets.

Compliance with the course of treatment is essential, as patients vaccinated with the vaccine may potentially be unable to develop the increased immunity that repeated infection may provide. Therefore, patients who are not fully compliant, or provided with all the doses, could potentially be at risk. The extent of this risk remains unknown at present and the study authors note that additional studies need to be undertaken to understand if this is a risk factor and if so how it can be managed.

Although not a golden ticket to the prevention of malaria, many would argue that it forms one of many tools to reducing malaria among a toolbox of interventions. To others, the approval of a vaccine may be a concern. Should the vaccine receive approval, research funders may question the need to fund the development of another vaccine that could in theory provide greater efficacy. This thinking may be compounded should GSK win a large tender to supply the vaccine to a global vaccination supplier, effectively locking others out of potentially lucrative tenders. However, few would question the good intentions of GSK, which has funded the large trials, spent significant money on R&D activities, and will probably provide the vaccine at low costs to patients. It remains to be seen if this generosity will translate into a stifled R&D environment for other vaccines.

Aside from vaccine development, the latest news from the WHO suggests that much still needs to be done to improve access to and compliance with traditional treatments, especially if emerging trends such as drug resistance are to be combated. To this end, the WHO has set out plans to develop a new strategy, which should be debated at the its general assembly next month. The contents of this strategy will probably focus on the eradication of malaria, but, with so many challenges remaining, this could prove a substantial task.

Mark Hollis is a life sciences analyst for IHS
Posted 24 April 2015

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