By Esther Nakkazi
The first-ever controlled malaria infection trial, administered with malaria parasites by injection rather than mosquito bites, which could extend Africa nations ability to develop malaria drugs and vaccines to save millions of lives has happened in Tanzania.
The study was only possible because scientists led by Stephen L. Hoffman, chief executive and scientific officer of the US company Sanaria Inc., a for profit company, in Rockville, Maryland developed technology that allowed sporozoites to be harvested from mosquitoes salivary glands- an infectious stage of malaria parasite Plasmodium falciparum- and be used in a syringe to infect volunteers with malaria safely.
Salim Abdullah the Principal Investigator of the study and also the Chief Executive Director of Ifakara Health Institute (IHI) where the study was carried out in Tanzania, told this reporter that the study is significant as it opens a new area of assessment of malaria drugs and vaccines for Africa.
“We can now carry out experimental infection, which is stage one assessment of malaria drugs and vaccines to find out if they are suitable for Africa,” Abdullah told this reporter.
Apparently, before this technology was developed, African research sites could only do stage 2 and 3 assessment of malaria drugs and vaccines. No sites in Africa were able to do stage one assessment, which also ‘challenges’ their effectiveness because of the resources needed and even in Europe and the US where these malaria insectaries exist, they are only a handful.
So for any Stage one assessment of a vaccine effectiveness, in Africa, volunteers were subject to exposure to live infective mosquito bites in a specially constructed insectary. This could allow for introduction of new live species of mosquitoes in new environments, raising public health concerns and inflation of malaria research costs.
This is a promising development, said Ambrose Talisuna, a Senior Clinical Research Fellow for Public Health and Health Systems Research at the University of Oxford-KEMRI-Wellcome Trust Research Programme.
"I think the majority of countries in Africa will need better tools than we have available today to eliminate malaria and this development should be commended,” said Talisman.
Hoffman said that this “innovation is a game-changer for malaria research and development in Africa. This is about making available within Africa the same research tools to study malaria that we have in the USA and Europe. The IHI has now established that they can be equal partners with any clinical trial center anywhere in the world to do these first-in-humans, Phase 1 types of trials,” said Hoffman, in a press release.
He said it would also enable mass administration of vaccines in Africa to halt transmission and eliminate malaria from geographically defined areas. In an earlier communication with this reporter (March 2014) by email about a malaria vaccine being tested in Tanzania at IHI. He said he was hopeful that in about three to five years, a safe, reliable whole-parasite vaccine could be a commercial reality, providing benefits to a huge population and saving millions of lives.
In the study, which took place between February and August 2012, the researchers recruited a group of 30 highly educated Tanzanian men, residents of Dar es Salaam, who had minimal exposure to malaria during the previous five years.
The scientists compared the infection rate to that of a similar group of Dutch volunteers who participated in a similar study in the Netherlands in 2011. After about two weeks, all but two of the 23 Tanzanian volunteers injected with live sporozoites developed active infections, a rate similar to the Dutch volunteers. Once active infection was established, volunteers were immediately treated for malaria and cleared of parasites. None of the volunteers developed serious side effects related to the study. Mild side effects included low-grade fever, headaches and fatigue.
Dr. Abudullah said the Tanzanian government was keen on this particular study and supported it financially, because it links directly to socio-economic development. “Once we manufacture our drugs we can do phase one assessment here,” he said. His team was also impressed with the willingness of the volunteers to participate in the study.
Hoffman said their goal is to have drugs and a vaccine that can be used to immunize entire populations, halt transmission and eliminate malaria especially in malaria endemic countries, most of them in Africa. ‘This is one step toward achieving that goal and has an enormous impact.’
According to the WHO , there were about 207 million malaria cases and an estimated 627, 000 malaria deaths in 2012 worldwide.
ends-
The first-ever controlled malaria infection trial, administered with malaria parasites by injection rather than mosquito bites, which could extend Africa nations ability to develop malaria drugs and vaccines to save millions of lives has happened in Tanzania.
The study was only possible because scientists led by Stephen L. Hoffman, chief executive and scientific officer of the US company Sanaria Inc., a for profit company, in Rockville, Maryland developed technology that allowed sporozoites to be harvested from mosquitoes salivary glands- an infectious stage of malaria parasite Plasmodium falciparum- and be used in a syringe to infect volunteers with malaria safely.
Salim Abdullah the Principal Investigator of the study and also the Chief Executive Director of Ifakara Health Institute (IHI) where the study was carried out in Tanzania, told this reporter that the study is significant as it opens a new area of assessment of malaria drugs and vaccines for Africa.
“We can now carry out experimental infection, which is stage one assessment of malaria drugs and vaccines to find out if they are suitable for Africa,” Abdullah told this reporter.
Apparently, before this technology was developed, African research sites could only do stage 2 and 3 assessment of malaria drugs and vaccines. No sites in Africa were able to do stage one assessment, which also ‘challenges’ their effectiveness because of the resources needed and even in Europe and the US where these malaria insectaries exist, they are only a handful.
So for any Stage one assessment of a vaccine effectiveness, in Africa, volunteers were subject to exposure to live infective mosquito bites in a specially constructed insectary. This could allow for introduction of new live species of mosquitoes in new environments, raising public health concerns and inflation of malaria research costs.
This is a promising development, said Ambrose Talisuna, a Senior Clinical Research Fellow for Public Health and Health Systems Research at the University of Oxford-KEMRI-Wellcome Trust Research Programme.
"I think the majority of countries in Africa will need better tools than we have available today to eliminate malaria and this development should be commended,” said Talisman.
Hoffman said that this “innovation is a game-changer for malaria research and development in Africa. This is about making available within Africa the same research tools to study malaria that we have in the USA and Europe. The IHI has now established that they can be equal partners with any clinical trial center anywhere in the world to do these first-in-humans, Phase 1 types of trials,” said Hoffman, in a press release.
He said it would also enable mass administration of vaccines in Africa to halt transmission and eliminate malaria from geographically defined areas. In an earlier communication with this reporter (March 2014) by email about a malaria vaccine being tested in Tanzania at IHI. He said he was hopeful that in about three to five years, a safe, reliable whole-parasite vaccine could be a commercial reality, providing benefits to a huge population and saving millions of lives.
In the study, which took place between February and August 2012, the researchers recruited a group of 30 highly educated Tanzanian men, residents of Dar es Salaam, who had minimal exposure to malaria during the previous five years.
The scientists compared the infection rate to that of a similar group of Dutch volunteers who participated in a similar study in the Netherlands in 2011. After about two weeks, all but two of the 23 Tanzanian volunteers injected with live sporozoites developed active infections, a rate similar to the Dutch volunteers. Once active infection was established, volunteers were immediately treated for malaria and cleared of parasites. None of the volunteers developed serious side effects related to the study. Mild side effects included low-grade fever, headaches and fatigue.
Dr. Abudullah said the Tanzanian government was keen on this particular study and supported it financially, because it links directly to socio-economic development. “Once we manufacture our drugs we can do phase one assessment here,” he said. His team was also impressed with the willingness of the volunteers to participate in the study.
Hoffman said their goal is to have drugs and a vaccine that can be used to immunize entire populations, halt transmission and eliminate malaria especially in malaria endemic countries, most of them in Africa. ‘This is one step toward achieving that goal and has an enormous impact.’
According to the WHO , there were about 207 million malaria cases and an estimated 627, 000 malaria deaths in 2012 worldwide.
ends-
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