Infectious Disease Research Institute commences clinical trial of its leishmaniasis vaccine in Sudan

Aug 28 2009

IDRI (Infectious Disease Research Institute) announced today the start of a clinical trial in Sudan to test its leishmaniasis vaccine candidate for the treatment of post kala-azar dermal leishmaniasis (PKDL), a complication of visceral leishmaniasis (VL) which is observed in 50% of patients treated for VL in the country, predominantly affecting children. This trial reflects IDRI's commitment to develop innovative, affordable products against all forms of leishmaniasis, one of the most neglected infectious diseases.

PKDL is characterized by extensive skin lesions that can require months of additional daily injections of drugs that are either toxic, incompletely effective or very expensive. Importantly, PKDL patients play a significant role in the transmission of the disease because the parasite responsible for leishmaniasis is present in large numbers in the skin lesions and can be transmitted to healthy persons through the bites of sandflies.

"Sudan has the highest number of cases of PKDL in the world," said Professor Eltahir Awad Gasim Khalil, Institute of Endemic Diseases, University of Khartoum and Principal Investigator of the study. "Current drug treatments are inadequate and we urgently need a practical and affordable approach to treat patients with PKDL and ultimately help control leishmaniasis infection in our country."

This new phase 1 clinical trial is testing the vaccine candidate's safety and ability to induce an immune response against the disease when given in combination with a standard drug treatment. A total of 42 patients diagnosed with persistent PKDL will be recruited in the double-blind study. In addition to the daily drug therapy, 28 patients will be randomly assigned to receive IDRI's vaccine candidate and 14 to receive placebo, both administered as three subcutaneous injections every other week. The study enrollment started with adults prior to the recruitment of adolescents and subsequently children. The total duration of safety follow up of each patient will be approximately 12 months.

Dr. Steven Reed, IDRI's Founder and Head of Research and Development said: "Therapeutic vaccines could prove a vital part of the treatment approach to leishmaniasis. They work by helping the patient's own immune system kill the parasite. Based on the promising results of our clinical trials in South America, we strongly believe that a therapeutic vaccine can improve leishmaniasis treatment efficacy."

IDRI has been working on leishmaniasis for more than 15 years with the support of the National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation. IDRI's leishmaniasis vaccine candidate has already been evaluated with favorable results in completed clinical trials in healthy adults in the U.S., Colombia, and India, and in adult patients with different forms of leishmaniasis in Peru and Brazil.

IDRI is actively developing new methods of diagnosis and care management for patients suffering from leishmaniasis. If successful, these diagnostic and therapeutic tools would complement each other to provide an improved strategy against this long-neglected disease.

About Leishmaniasis

Leishmaniasis is a widespread parasitic illness that constitutes a major health problem in many countries of Asia, Africa, and Latin America. Leishmania parasites are transmitted to humans through the bite of infected sandflies. Visceral leishmaniasis, the most severe form of the disease, causes fatal infections of internal organs, while the cutaneous form causes serious disfiguring skin lesions. About 500,000 new cases of visceral leishmaniasis occur each year, and 10% of these patients, who are mostly children, will die.