World’s first Malaria Vaccine on target for 2015

Health experts are adamant that the the world’s first malaria vaccine will be available on the market by 2015 as another option for malaria prevention, after a hugely encouraging study showed that thousands of deaths could be prevented from the deadly disease.

Publishing their findings in PLOS Medicine, researchers involved in clinical trials of the drug RTS,S, reported that for every 1,000 children who receive the vaccine, around 800 cases of malaria could be prevented.

In follow-up trials 18 months after the initial injections, researchers found RTS,S was remarkably able to offer protection even at that stage.

The vaccine’s manufacturer is pharmaceutical giant GlaxoSmithKline (GSK), the company who produce popular cold sore treatment Zovirax (aciclovir) and weight loss treatment Alli, and they have now requested regulatory approval, meaning this is the first vaccine of its kind to arrive at this milestone.

Several African countries were involved in the trials, mainly as around 90% of deaths from malaria occur in sub-Saharan Africa (SSA), and shockingly 77% of the deaths are children under the age of 5.
An estimated 1,500 infants and children were administered the new RTS,S vaccine and researchers analysed them all again after 18 months, discovering that cases of malaria declined by half in youngsters. For infants (at six to 12 weeks of age when first vaccinated) RTS,S managed to reduce malaria cases by a quarter.

GSK commented: “Over 18 months of follow-up, RTS,S was shown to almost halve the number of malaria cases in young children (aged 5-17 months at first vaccination) and to reduce by around a quarter the malaria cases in infants (aged 6-12 weeks at first vaccination).”

Quite commendably, GSK have pledged to offer their RTS,S vaccine at cost price plus 5%, stating such a move would help to provide the funding for continued research into prevention and treatments for various tropical diseases.

Despite the effectiveness of the malaria vaccine appearing to decline somewhat over time, the report claims it could be highly beneficial to areas where there are high rates of malaria.

For instance, trials demonstrated that in certain Kenyan cities where people are at risk of repeated infection of the deadly disease, around 2,000 cases of clinical malaria were averted for every 1,000 children that were given the vaccine.

GSK say that the vaccine combined with other preventative measures like bed nets and insect repellents (i.e. Jungle Formula), may offer a massive step forward in the battle against malaria. According to the latest estimates into the disease, released in December 2013, there were a staggering 207 million cases of malaria during 2012 and in Africa a child dies every minute because of it.
Scientists are also conducting investigations to determine if a booster may offer even more chances of success.

Professor Sanjeev Krishna of St George’s University of London, did not participate in trials of the vaccine, but did offer a review of the paper for the journal. He said: “This is a milestone. The landscape of malaria vaccine development is littered with carcasses, with vaccines dying left, right and centre. To get to this stage is very encouraging indeed. We eagerly await the next results to see how long-lasting protection is and whether a booster adds further potential. We need to keep a watchful eye for adverse events but everything appears on track for the vaccine to be approved as early as next year.”

GSK’s malaria vaccine could be in use by 2015

The world’s very first malaria vaccine could finally be available in 2015 and in widespread use after “significant” results were shown during an ongoing clinical trial. This would offer a significant boost alongside current options for malaria treatment and prevention.

British pharmaceutical giant GlaxoSmithKline (GSK) are behind the development of the new vaccine and say they will be submitting an application for a licence from the European Medicines Agency in the new year.

The vaccine, currently being referred to as RTS, S, has been developed by both GSK together with the non-profit Path Malaria Vaccine Initiative (MVI), supported by funding from the Bill & Melinda Gates Foundation. Trial data has so far been promising in the quest to fight a deadly disease which kills an estimated 660,000 people every year.

RTS, S is one of 20 such vaccines in development, but looks on course to be the first to receive European Medicines Agency approval following hugely encouraging results from Africa’s largest ever clinical trial, involving almost 15,500 babies and children across seven African countries.

Testing showed that after 18 of receiving their vaccination, infants aged between five to 17 months were an incredible 46% less at risk of malaria in comparison to those unvaccinated.  However, infants aged six to 12 weeks when vaccinated were only 27% less at risk.

If the vaccine is fully proved to be safe and effective for use, the World Health Organisation has suggested they are willing to support its widespread use from 2015 onwards. GSK have said they will help to provide fund research into tropical diseases by selling the vaccine at cost price plus 5%, and scientists will next investigate whether a ‘booster dose’ can lengthen protection against malaria in the long-term.

Halidou Tinto, one of the study’s principal investigators, is greatly excited by the vaccines possibilities, saying it had “the potential to have a significant public health impact.”

Tinto commented: “Many millions of malaria cases fill the wards of our hospitals. Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease.”

GSK chief executive Sir Andrew Witty said: “While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive. These data support our decision to submit a regulatory application for the vaccine candidate which, if successful, would bring us a step closer to having an additional tool to fight this deadly disease.”

David Lalloo, professor of tropical medicine at Liverpool School of Tropical Medicine, said: “We’ve known about this vaccine for a number of years now and all the studies have shown that it affects around 50 per cent and in younger age groups who don’t have such a good immune response that is down to around 30 per cent. The other concern is that there have been several studies that show it wanes over time…there are still uncertainties about duration and effects. Having said that, given the huge number of malaria deaths and malaria cases, even a relatively small reduction has the potential to make a big difference.”

Huge breakthrough in the quest for a malaria vaccine

A vaccine for one of the world’s biggest killers – malaria – has become a step closer after researchers in the U.S.  made a breakthrough in a small early-stage clinical trial.

The new malaria vaccine is being tentatively named ‘PfSPZ’ and is unique as it contains sporozoites (SPZ) – a life cycle stage of live but weakened malaria Plasmodium falciparum parasites.

Details of the Phase-1 clinical trial were published yesterday in the journal Science. Developers of the vaccine say that the weakened, early stage parasites can actually help a person build up an immunity following an injection of a high enough dosage into the bloodstream.

Lead author Dr Robert Seder, from the Vaccine Research Center at the National Institutes of Health, in Maryland, said: “We were excited and thrilled by the result, but it is important that we repeat it, extend it and do it in larger numbers.”

It has been common knowledge amongst health experts for several decades that exposure to mosquitoes treated with radiation is highly effective as a malaria prevention method.

Unfortunately, evidence shows that roughly 1,000 mosquito bites are required over a time period to gradually develop a sufficient level of immunity.  Therefore, it is simply an unfeasible way to protect people.

Dr Seder added: “Based on the history, we knew dose was important because you needed 1,000 mosquito bites to get protection – this validates that. It allows us in future studies to increase the dose and alter the schedule of the vaccine to further optimise it. The next critical questions will be whether the vaccine is durable over a long period of time and can the vaccine protect against other strains of malaria.”

The new vaccine is being developed by a biotech company called Sanaria, based in Maryland, U.S., who irradiated lab-grown mosquitoes before extracting the malaria-causing parasite Plasmodium falciparum.

Their Phase-1 clinical trial of PfSPZ involved 57 volunteers aged 18 to 45 who had no previous history of the malaria disease. The researchers administered varying strengths of PfSPZ to 40 of the participants and the other 17 received no vaccine whatsoever.

After a week’s analysis, no severe side effects were noted in any of the participants in the study. However, to determine how effective the malaria vaccine actually was, each person – including those who didn’t receive the vaccine – was exposed to bites from five malaria infected mosquitoes.

A week later everybody was analysed for infection and those not given the vaccine received treatment for malaria. It was found that those given high doses were significantly less likely to contract malaria in comparison to the others in the study.

Just three of the 15 participants who received higher doses actually became infected. However, 16 of 17 participants in the lower dosage group became infected and 11 of the 12 participants who were not vaccinated then became infected.

The study, conducted between October 2011 and October 2012, was hugely promising due to the fact none of the participants experienced any side effects from the vaccine. However, the researchers admit it could be years before the vaccine is available in communities where it is needed.

Dr William Schaffner, head of the preventive medicine department at Vanderbilt University’s medical school, said although it was a ‘scientific advance’, it could be as long as a 10 year wait before the malaria vaccine is scientifically proved, given approval, and made available for distribution.

He told CCN: “This is not a vaccine that’s ready for travellers to the developing world anytime soon. However, from the point of view of science dealing with one of the big-three infectious causes of death around the world, it’s a notable advance. And everybody will be holding their breath, watching to see whether this next trial works and how well it works.”

Of course, if you are travelling abroad in the next 10 years and need malaria prevention and treatment, there are other medications available right now. These include Doxycycline, Malarone, Paludrine, and Jungle Formula Maximum Pump Spray.  In addition, don’t forget to check the NHS Fit For Travel website where you will find the recommended malaria medication for your destination.

Dismay at the effectiveness of GSK’s malaria vaccine

The expectations and anticipation regarding the world’s first potential malaria vaccine have been dealt a blow after trial results demonstrated that the protection the vaccine offers, can significantly diminish and disappear altogether over time, disappointing researchers who had high hopes for it.

Developed by British pharmaceutical giant GlaxoSmithKline (GSK), the new vaccine is currently only referred to as ‘RTS,S’. Scientists state that full data from final-stage trials which include 15,000 children, are expected by the end of 2014. However, early results from the vaccine are not encouraging and expose the difficulties in creating a vaccine that offers full protection from a deadly disease such as malaria that claims the lives of more than 650,000 children every year – the most ‘at risk’ group in regards to mosquito bites.

The vaccine has been primarily engineered to help babies aged between six to 12 weeks and in a large-scale phase III trial that was carried out last year, only a third of babies aged within this range were prevented from becoming ill after being administered the new vaccine. Moreover, the protection was lower than what was evident in older children.

Microsoft co-founder Bill Gates, worth an estimated £40bn, was one of the backers behind the research, and after those results emerged last year he commented: “The efficacy came back lower than we had hoped, but developing a vaccine against a parasite is a very hard thing to do.”

Christopher Plowe, a malaria researcher at the University of Maryland School of Medicine in the United States, who was not involved in the RTS,S trial, also spoke on the findings last year, saying: “The results are kind of disappointing because we’d all like to see a malaria vaccine that has closer to 80 percent or 100 percent efficacy.”

Results of the latest data were published this week in the New England Journal of Medicine. Although the RTS,S vaccine was found to have a rate of protecting peaking at 53%, after an average of merely eight months, the level of protection had declined at an alarming rate.

Ally Olotu of the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme in Kenya, who led the follow-up study, said: “It was a bit surprising to see the efficacy waned so significantly over time. In the fourth year, the vaccine did not show any protection.”

A GSK spokesperson commented on the latest results, stating that because they were derived from a small, mid-stage trial, they did not “provide definitive answers about the duration of protection or how the vaccine candidate works in different malaria transmission settings.”

Phillip Bejon, a researcher at the KEMRI-Wellcome Trust programme, was involved with the study and he said in spite of the decreasing effectiveness, “there is still a clear benefit to the vaccine.”

Bejon added: “Many of the children (in Africa) will experience multiple episodes of clinical malaria infection, but overall we found that 65 cases of malaria were averted over the four-year period for every 100 children vaccinated. We now need to look at whether offering a vaccine booster can sustain efficacy for longer.”