Dutch biopharmaceutical company Crucell NV and the Aeras Global TB Vaccine Foundation have started a Phase II clinical trial of a jointly developed tuberculosis (TB) vaccine candidate, AERAS-402 /Crucell Ad35, in HIV infected adults.
The suppliers aim to test safety and efficacy in adults in Klerksdorp, a gold mining centre in North West province. Aeras-sponsored TB vaccine candidates will be tested for safety in people living with HIV. Among people living with HIV in Africa and Asia, TB is a leading cause of death. People with HIV living in countries with high TB prevalence are 20 times more likely to develop TB than those who are HIV negative.
According to the World Health Organisation (WHO) 2009 TB surveillance report, one in four TB deaths globally is HIV related, twice as many as previously recognised. In 2007, there were an estimated 1.4-million new cases of TB among people living with HIV and 456 000 deaths. Some 71% of people with TB in SA are co-infected with HIV.
Dr Jaap Goudsmit, Crucell's chief scientific officer, said there were many potential uses of the new TB vaccine, and it was crucial to test the safety and immune responses in those who have been infected with HIV. “We aim to reduce the global burden of this fatal disease."
Enrollment of study volunteers for the first stage of the Phase II trial has started. In October 2008, the first Phase II study in adults who have had active TB started in South Africa. AERAS-402 has demonstrated an acceptable safety profile. Preliminary data indicate that the candidate vaccine induces CD8-cell immune responses in patients who have completed TB treatment.
TB vaccine study at Klerksdorp
Dutch biopharmaceutical company Crucell NV and the Aeras Global TB Vaccine Foundation have started a Phase II clinical trial of a jointly developed tuberculosis (TB) vaccine candidate, AERAS-402 /Crucell Ad35, in HIV infected adults.
The suppliers aim to test safety and efficacy in adults in Klerksdorp, a gold mining centre in North West province. Aeras-sponsored TB vaccine candidates will be tested for safety in people living with HIV. Among people living with HIV in Africa and Asia, TB is a leading cause of death. People with HIV living in countries with high TB prevalence are 20 times more likely to develop TB than those who are HIV negative.
According to the World Health Organisation (WHO) 2009 TB surveillance report, one in four TB deaths globally is HIV related, twice as many as previously recognised. In 2007, there were an estimated 1.4-million new cases of TB among people living with HIV and 456 000 deaths. Some 71% of people with TB in SA are co-infected with HIV.
Dr Jaap Goudsmit, Crucell's chief scientific officer, said there were many potential uses of the new TB vaccine, and it was crucial to test the safety and immune responses in those who have been infected with HIV. “We aim to reduce the global burden of this fatal disease."
Enrollment of study volunteers for the first stage of the Phase II trial has started. In October 2008, the first Phase II study in adults who have had active TB started in South Africa. AERAS-402 has demonstrated an acceptable safety profile. Preliminary data indicate that the candidate vaccine induces CD8-cell immune responses in patients who have completed TB treatment.
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