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Human studies of whole-parasite malaria vaccine from Sanaria begin

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Thursday, April 23, 2009, 12:41 This news item was posted in Clinical Trials, Pharma category and has 0 Comments so far.

 

The whole-parasite vaccine approach is unique to malaria as it offers higher level of protection.

First-in-man studies of whole-parasite malaria vaccine have begun in adult volunteers in US. 

The new malaria vaccine uses a weakened form of the whole malaria parasite harvested from irradiated mosquitoes instead of small portions of the parasite approach, unlike other malaria vaccine.

Most of the malaria vaccines in clinical development consist of recombinant or genetically engineered proteins that represent small portions of the parasite.

But Sanaria’s Plasmodium falciparum sporozoite vaccine candidate contains a weakened form of the entire malaria parasite. Such live vaccines are used for other diseases including smallpox, polio, and measles.

When the attenuated parasite is given to individuals, they are expected to become immune to malaria and not get sick.

The whole-parasite malaria vaccine has technological challenges associated with translating this approach into an effective and safe vaccine based on live parasites, which are widely viewed as insurmountable.

However, Sanaria claims that it has developed novel technologies and constructed a unique manufacturing facility that allows scientists to manufacture the candidate vaccine.

Sanaria also cites evidence for higher levels of protection with the whole-parasite malaria vaccine approach from previous studies in which volunteers were exposed to the bites of mosquitoes harboring weakened parasites.

The whole-parasite malaria vaccine, which has passed through the stringent safety, sterility, purity, potency, and reproducibility requirements of the US Food and Drug Administration’s (FDA), will be assessed in healthy US volunteers at two sites in Maryland — the US Naval Medical Research Center Clinical Trials Center in Bethesda and the Center for Vaccine Development at the University of Maryland School of Medicine in Baltimore.

104 volunteers will be recruited for the safety and efficacy study. The inoculation of the first groups expected to begin in mid-May.

“Initiation of this trial expands the spectrum of malaria vaccines in clinical development today,” said Dr. Christian Loucq, director of MVI. “This trial marks a major achievement in a collaborative development effort that aims to determine whether Sanaria’s vaccine candidate is safe and effective.”

The whole-parasite malaria vaccine is the result of  public-private collaboration between the Maryland-based company Sanaria Inc.and the PATH Malaria Vaccine Initiative (MVI).

“The Sanaria team has been able to systematically overcome obstacle after obstacle in a remarkably short time. I look forward to working with the rest of the team to bring this vaccine over the finish line and into widespread use to prevent the devastating illnesses and deaths caused by malaria,” said Adel Mahmoud, former president of Merck Vaccines and member of Sanaria’s board of directors.

Ultimately, the measure of success will be a safe, effective licensed vaccine that is widely deployed to prevent malaria, especially in African children.”The first clinical trial of Sanaria’s candidate malaria vaccine is a watershed event. It is the culmination of a remarkable translational research effort by Sanaria directed at realizing the dream of a practical malaria vaccine preparation based upon whole parasites,” states Michael Good, Director of the Queensland Institute of Medical Research.

Myron M. Levine, Director of the University of Maryland School of Medicine’s Center for Vaccine Development notes, “Development of Sanaria’s vaccine candidate is based in part on the findings from parallel studies conducted in the early 1970s by teams at the Center for Vaccine Development and the Naval Medical Research Center — findings that were never translated into a vaccine development effort because the task was considered to be impossible.”

Founded in 2003, Sanaria Inc. the primary mission of Sanaria is to develop and commercialize a malaria sporozoite vaccine against Plasmodium falciparum.

The PATH Malaria Vaccine Initiative (MVI) is a global programme established at PATH through an initial grant from the Bill & Melinda Gates Foundation. MVI’s mission is to accelerate the development of malaria vaccines and ensure their availability and accessibility in the developing world.

Falciparum Malaria

Caused by the protozoan parasite Plasmodium falciparum, falciparum malaria is responsible for more than 95 percent of malaria-associated severe illness and death world-wide, and the malaria parasite for which there is the most significant drug resistance. P. falciparum (or malignant) malaria has the highest rates of complications and mortality. In addition it accounts for 80% of all human malarial infections. It is more prevalent in sub-Saharan Africa than in other regions of the world.

It is carried through the common vectors –mosquitoes, chiefly Anopheles albimanus, Anopheles freeborni, Anopheles maculates and Anopheles stephensi.

The common medication used against f.malaria include  Tetracycline (Sumycin), hydroxychloroquine (Plaquenil),  chloroquine-oral, (Aralen), mefloquine-oral (Lariam).

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