The number of people getting infected with Tuberculosis (TB) in Nyanza region of Kenya is on the rise, researchers warn. They say that Nyanza has the greatest TB burden in the country with the disease notification currently standing at 440 per 100,000 of cases reported countrywide.

TB is an airborne infectious disease caused by bacteria which primarily affects the lungs. It is a leading infectious disease that is the leading cause of death for people living with HIV in Africa. It also affects extra-pulmonary (Virtually any body organ can be affected).?Kenya is ranked fourth after South Africa, Nigeria and Ethiopia in terms of TB burden in Africa,? said the Deputy Nyanza North Provincial TB and Leprosy Coordinator, Malyca Timothy. He added that most people die of TB due to lack of information.

Timothy said that, with a population of 39 million in Kenya, 102,843 were cases of TB detected in the region in 2011 with HIV prevalence of 7.1%. But 39% are TB patients with HIV infections.

Some of the most risk factors for TB infection includes HIV epidemic, poverty, overcrowding, malnutrition, poor ventilation, poor lighting and pool of untreated PTB+ patients.

Globally, tuberculosis is a health problem of monumental proportions. Out of six billion people in the world approximately two billion people have once been infected with it.

In Kenya, the World Health Organization (WHO) reports that HIV prevalence among patients registered with TB program in Nyanza at 75%, taking the huge 52% of all the cases reported in the country.

This has prompted a renewed vigour by researchers at the Kenya Medical Research Institute/Centre for Disease Control and Prevention (KEMRI/CDC) in Kisumu City to double their efforts in getting a vaccine for the disease.

Already, researchers in the country in conjunction with the Public Health and Sanitation ministry officials in Kisumu are conducting the second phase of candidate TB vaccine referred to as AERAS 402/Crucell AD35.

The Siaya district hospital medical superintendent, Dr.Jacktone Omotto, explained that the vaccine on trial is being evaluated as a booster vaccine to the current available Bacille Calmette-Guerin (BGC).

He named Karemo, Asembo and Gem of Siaya and Bondo districts as areas in Nyanza where the trials of the vaccine on infants are being conducted.

A TB prevalence survey conducted between 2006 and 2009 indicates that the prevalence of pulmonary tuberculosis in Asembo and Gem (a high HIV prevalence setting) is 6.0 per 1,000 for the two strains of the disease.

According to Dr. Videlis Nduba who is the Principle Investigator Tuberculosis Research branch at KEMRI/CDC centre at Kisian Kisumu city, the branch had conducted various studies to access TB rates in 5,000 adolescents and 2,000 infants in Siaya district which has one of the highest prevalence?s TB in Kenya.

?Notably, the vast majority of patients with TB (both persons with and without HIV) were not on TB treatment and had not been diagnosed with TB,? Dr Nduba said.
He noted that this suggested that there is a large reservoir of undiagnosed TB in the community.

Dr. Nduba said that in 2009, the Walter Reed Project- Kisumu completed a phase I clinical trial at Kombewa clinical trials centre to find the new TB vaccine.

He disclosed that both studies that are currently going on at Karemo division of Siaya district and the total TB case notification rate in the area stand at 400 per 100,000.

?At least 2,900 infants and 5,000 adolescents were enrolled for further study to find the new TB vaccine,? he added. He was speaking at Boro health centre in Siaya County during the vaccine trial verification.

The TB prevalence survey in Asembo and Gem found that there was a high prevalence of pulmonary tuberculosis where HIV was greatly manifested.

The study was divided into two, one targeting 15 years and below to make findings on prevalence rates, with the other targeting those above 18 year sought to establish the level of care given to those infected.

The participants were enrolled following the home visits and sputum examination and other examinations.

?Out of the 20,000 participants, 100 people were diagnosed with active pulmonary TB and were referred for treatment,? Dr.Nduba said.

The medics said that the global plan to stop TB sets out the actions and the funding needed to accelerate progress towards achieving diagnosis and treatment and development of new tools to fight TB, new diagnostics, drugs and vaccines.

The deadly relationship between HIV and TB and the emergence of drug resistant forms of TB have created a pandemic that is even more severe and complex than it was when the World Health Organization (WHO) declared TB a global health emergency.

Research say the number of people who get sick with TB has more than doubled in countries with high HIV prevalence in the past 15 years the same was manifest in Nyanza.

?HIV is the greatest risk factor for developing tuberculosis because its effects on the immune system make people infected with HIV most susceptible to TB,? notes Dr. Nduba.

The WHO reports that more people are suffering from TB than ever before thereby indicating that without new tools and increased resources to fight it, then it will take more than a thousand years to eliminate TB.

The report also indicates that in 2009, 9.4 million people became sick with TB and 1.7 million people died from the disease.

The researchers said that Kenya is ranked 13 out of the 22 countries with the most TB cases. Nearly 25% of TB deaths were of people infected with HIV.

However, in Kenya 120,000 people became sick with tuberculosis in 2009. 53,000 of them were living with HIV while 6,200 Kenyans died of TB as per figures from 2009 and World Health Organization Global Tuberculosis Control 2010.

The Aeras and the Infectious Disease Research Institute (IDRI) last week announced the start of the first clinical trial of IDRI?s novel tuberculosis vaccine candidate, ID93 + GLA-SE. The Phase I clinical trial will assess the safety, tolerability and immunogenicity of the vaccine candidate in 60 healthy adult volunteers.

The study will be conducted by Johnson County Clin-Trials in Lenexa, Kansas, in close collaboration with Areas and IDRI.

Tuberculosis (TB), which kills more people than any other infectious disease except HIV, has orphaned 10 million children, and costs the global economy an estimated $1 billion every day.

An increasing number of diagnosed multidrug-resistant TB cases are making the disease more difficult to control and multiplying the cost and time it takes to treat patients, which can take two years or longer for multidrug-resistant TB.

The vaccine candidate targets both active tuberculosis, which makes nearly 9 million people sick each year, and latent TB, which lies dormant in one-third of the world?s population and reactivates when their immune systems are compromised.

?An effective TB vaccine for adolescents and adults would be the single most cost-effective intervention against tuberculosis,? said Tom Evans, Aeras Chief Scientific Officer. ?With cases of drug-resistant TB on the rise, it is urgent to deliver an effective TB vaccine regimen to those who need it as soon as possible.?

The vaccine candidate, ID93 + GLA-SE, is composed of a recombinant fusion-protein antigen designed by IDRI to recognize both active and latent TB, plus IDRI?s proprietary adjuvant, GLA-SE, which has been previously tested in humans.

In pre-clinical studies, the vaccine candidate had an acceptable safety profile in animals and demonstrated substantial protection against Mycobacterium tuberculosis ? the bacterium that causes TB.

?With NIH support enabling our TB program, IDRI has designed and tested the safety and efficacy of this vaccine candidate in several pre-clinical models,? said Steven Reed, Ph.D., IDRI president, founder and Chief Scientific Officer.

?The start of the first clinical trial is a significant milestone following nearly seven years of work on this vaccine candidate, which is designed to produce a robust immune response to prevent, and possibly to treat, TB,? he said.

The currently available TB vaccine, Bacille Calmette-Gu?rin (BCG), developed 90 years ago, reduces the risk of severe forms of TB in early childhood but has been ineffective in controlling the global TB epidemic despite widespread use.

The Aeras and IDRI, two non-profit product development partnerships, are committed to making new TB vaccines available to those who need them most in TB endemic countries.

According to the WHO, one-third of the world?s population is infected with latent M. tuberculosis. Nearly 9 million people became sick with TB and 1.4 million people died from TB in 2010. Current guidelines require a minimum of six to nine months of treatment.

TB is changing and evolving, making new vaccines more crucial for controlling the pandemic. TB is the leading cause of death for people living with HIV/AIDS, particularly in Africa. Multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) are hampering treatment and control efforts.

The XDR-TB data available in Kenya for 2012 MDR-TB cases of which 7% were XDR. Since 2002 a total of 45 countries have reported at least 1 XDR- TB case. ?In Kenya, 3 patients so far diagnosed, 2 have since died with one patient on treatment,? said Timothy.

However, about 385 people in Kenya were confirmed to be on treatment (MDR-TB) in 2011.

The ID93 + GLA-SE is an investigational vaccine for the prevention of tuberculosis (TB). The vaccine consists of ID93, which is a recombinant fusion polyprotein comprised of Mycobacterium tuberculosis antigens associated with virulence or latency (Rv2608, Rv3619, Rv3620, and Rv1813) and Glucopyranosyl Lipid A ? Stable Emulsion (GLA SE) as an immunological adjuvant. GLA is a Toll-like receptor 4 (TLR4) agonist that is formulated in an oil-in-water emulsion (SE)).

Aeras is the world?s largest and only fully integrated tuberculosis vaccine development organization dedicated to addressing a pathogen that has chronically infected almost a third of the world?s population.

In collaboration with global partners in Africa, Asia, North America and Europe, Aeras is supporting the clinical testing of six vaccine candidates as well as a robust portfolio of pre-clinical candidates.

The Infectious Disease Research Institute (IDRI) is a Seattle-based not-for-profit organization committed to applying innovative science to the research and development of products to prevent, detect, and treat infectious diseases of poverty.

By integrating capabilities, including early stage drug discovery, preclinical testing, manufacturing, and clinical trials, IDRI strives to create an efficient pathway bringing scientific innovation from the laboratory to the people who need it most.

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