21 March 2021 TB vaccine moves into phase II study in people living with HIV.
Researchers at the South African Tuberculosis Vaccine Initiative (SATVI) research site in Worcester have started recruitment for a phase II vaccine trial to see if the M72/AS01E TB vaccine is safe and immunogenic in people living with HIV. This trial, sponsored by Gates MRI, is already ongoing at other sites across South Africa.
CAPE TOWN: In a previous multi-centered trial of this vaccine, conducted in HIV-negative people, the M72/AS01E vaccine was able to prevent TB in half of the participants who received it ,over three years’ follow up (Tait et al., 2019).
"The M72/AS01E provided approximately 50% protection against progression to active pulmonary tuberculosis for 3 years in M. tuberculosis–infected, HIV-negative adults" (Tait et al., 2019).
In this study, researchers will study the immune response in young adults living with HIV whose viral load is very low (where their body has the HIV virus under control). Participants in this study must be between 16–35 years of age, must have been on antiretroviral therapy (ARV) for at least the past 3 months and must have received TB preventive therapy in the past. The participants will receive two doses of M72/AS01E 28 days apart and thereafter be followed up for 1 year.
Approvals have been received from the South Africa Health Products Regulatory Authority (SAPHRA), the Department of Health and the University of Cape Town Human Research Ethics Committee. This trial is preparatory to the planned phase III trial, also sponsored by Gates MRI.
Why do we need a TB vaccine to protect people living with HIV?
Tuberculosis (TB) is caused by a germ which is spread from one person to another through the air, mostly infecting the lungs resulting in what is known as pulmonary TB. Whilst the TB disease is easily treated, it requires six months of daily treatment. Data from the World Health Organisation shows that in 2019 over 58 000 people died of TB, of which 36 000 were HIV positive. Approximately 60% of all TB in South Africa is in people co-infected with HIV.
Online resources about the previous results of the Phase IIb trial of M72/AS01E vaccine to prevent TB in HIV negative population (Tait et al., 2019).
Read journal article online NEJM. Click here. Watch the NEJM Quicktake on the previous Phase IIb M72AS/01E vaccine to prevent TB in HIV negative population. Click here. End