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"We cannot win the battle against AIDS if we do not also fight TB. TB is too often a death sentence for people with AIDS."

Nelson Mandela, July 2004

News

October 2014 TB trial carried out in South Africa finds new once-weekly treatment

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Research carried out by the Aurum Institute in Johannesburg, and the South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine (University of Cape Town), has found an alternative way to treat tuberculosis with fewer tablets than today’s recommended course of treatment. The novel drug combination makes it easier for patients to complete their course of treatment.

TB is a major health problem in South Africa. In 2012 there were 530,000 new cases of the disease, and 31,000 people died from it (excluding HIV deaths). Most cases of TB are curable if treated effectively and promptly. The standard treatment is four drugs daily for two months followed by two drugs daily for four months –around 360 tablets over a six-month period. The RIFAQUIN trial results show that a combination of the drugs Rifapentine and Moxifloxacin could reduce the number of tablets in a course of treatment to around 140 over the same six month period. Trial participants took Ethambutol, Moxifloxacin, Rifampicin, and Pyrazinamide daily during the first two months of treatment and then Rifapentine and Moxifloxacin once a week during the last four months.


The trial was carried out in Botswana, South Africa, Zambia and Zimbabwe, and led by St George’s, University of London together with the Medical Research Council Clinical Trials Unit at UCL. A total of 827 people took part in the trial, 464 of whom were from South Africa.

The results showed 96 percent of patients taking the six-month Rifapentine and Moxifloxacin combination were cured, which was as good as the standard treatment. Study participants were assessed 12 months after they had finished their treatment.

Associate Professor Mark Hatherill, lead investigator for the trial in Cape Town, said:
“The burden of taking tablets is huge for TB patients. Consequently, even with the best will in the world, patients sometimes stop their treatment once they begin to feel better. Over a long period of time this has led to more drug resistant strains.”

Dr Salome Charalambous, lead investigator for the trial in Johannesburg, said: “Less tablets means there is a higher chance of the patient completing their treatment. It also makes it easier for clinics to supervise treatment. This is particularly important for countries like South Africa, where clinics are very busy, and where it is not uncommon for patients to travel many miles to receive each treatment.”

The drug combination could also be used in patients with drug resistant strains because it doesn’t contain isoniazid, the drug that patients are most likely to be resistant to. The trial was also designed to test whether the length of treatment could be reduced from six months to four months. The results showed that the combination of Rifapentine and Moxifloxacin after the first two months of treatment does not allow shortening of treatment from six to four months. Patients still need to take their treatment for six months, but the new once-weekly drug combination could make that easier.


SATVI Investigator, Doctor Hennie Geldenhuys, said that “A large and complex trial like this is challenging but it shows that important research such as this can be performed to high standards in the developing world. The results make it worth the hard work."

Research Nurse, Danelle Van As, said that “This study was very exciting because of the possibility that TB patients may take less tablets daily and that the time of treating TB could be shortened.
RIFAQUIN is a unique TB trial, as it investigated both shortening and simplifying treatment, and used higher doses of Rifapentine than other studies that have looked at shortening TB treatment using Fluroquinolones.
The findings, which were funded by the European and Developing Countries Clinical Trials Partnership, are published in the New England Journal of Medicine Today of 23 October 2014.
The researchers point out that a number of considerations need further investigation before health services could prescribe the once-weekly treatment combination. These include the cost effectiveness of the new regimen, and more data on the effectiveness of the proposed regimen in HIV-positive patients, who are particularly at risk of TB.

   

June 2014- Safety and reactogenicity of BCG revaccination with isoniazid pretreatment in TST positive adults.

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Title of Paper Published:Safety and reactogenicity of BCG revaccination with isoniazid pretreatment in TST positive adults.

Authors:Hatherill M, Geldenhuys H, Pienaar B, Suliman S, Chheng P, Debanne SM, Hoft DF, Boom WH, Hanekom WA, Johnson JL.

Journal published in: Vaccine. 2014 Jun 30;32(31):3982-8. doi: 10.1016/j.vaccine.2014.04.084. Epub 2014 May 9.

Impact factor: 3.492

Abstract:

Global tuberculosis (TB) control may require mass vaccination with a new TB vaccine, such as a recombinant bacille Calmette Guerin (BCG) or attenuated Mycobacterium tuberculosis (MTB). The safety profile of live mycobacterial vaccines in latently infected adults with prior infant BCG vaccination is unknown.

OBJECTIVES:

Evaluate safety and reactogenicity of BCG revaccination, with or without isoniazid (INH) pretreatment, in adults with latent MTB infection (LTBI).

METHODS:

Eighty-two healthy, HIV uninfected, South African adults, with a BCG scar and tuberculin skin test (TST) diameter ≥ 15 mm, were randomized to receive 6 months of INH, starting either before, or 6 months after, intradermal revaccination with BCG Vaccine SSI (Statens Serum Institut, Copenhagen). Safety and reactogenicity data are reported through 3 months post BCG revaccination.

RESULTS:

Baseline characteristics were similar between treatment arms. Mean baseline TST diameter was 20 ± 4 mm. Seventy-two subjects received BCG revaccination. Injection site erythema (68%) and induration (86%) peaked 1 week after revaccination. Ulceration (76%) peaked at 2 weeks, and resolved by 3 months in all but 3 subjects. Diameter of ulceration was >10mm in only 8%, but a residual scar was common (85%). No regional lymphadenitis or serious morbidity related to BCG was seen. Reactogenicity was not affected by INH pretreatment.

CONCLUSION:

BCG revaccination of MTB infected adults is safe, well tolerated, and reactogenicity is similar to that of primary BCG vaccination. Clinical trials of live recombinant BCG or attenuated MTB vaccines may be considered in latently infected adults, with or without INH pretreatment (ClinicalTrials.gov identifier: NCT01119521).

Copyright © 2014 Elsevier Ltd. All rights reserved.

KEYWORDS:

BCG; Isoniazid; LTBI; Revaccination; Safety 

   

July 2014 A controlled trial of sputum induction and routine collection methods for TB diagnosis in a South African community.

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Title of Paper: A controlled trial of sputum induction and routine collection methods for TB diagnosis in a South African community.

Authors:Geldenhuys HD, Whitelaw A, Tameris MD, Van As D, Luabeya KK, Mahomed H, Hussey G, Hanekom WA, Hatherill M.

Journal Published in:Eur J Clin Microbiol Infect Dis. 2014 Jul 15. [Epub ahead of print]

Impact factor: 3.024

Abstract:

The diagnostic yield of pulmonary tuberculosis (TB) by sputum induction (SI) at the first point of contact with health services, conducted in all patients with suspected TB regardless of the ability to expectorate spontaneously, has not been evaluated. We compared the diagnostic yield of SI to routine sputum collection in a South African community setting. Ambulatory patients with suspected TB provided a 'spot' expectorated sputum sample, an SI sample by hypertonic (5 %) saline nebulization, and early morning expectorated sputum sample. The diagnostic yield of sputum smear microscopy and liquid culture (denominator all subjects with any positive Mycobacterium tuberculosis culture), and time-to-positivity of culture were compared between SI and expectorated samples. A total of 555 subjects completed the SI procedure, of whom 132 (24 %) were human immunodeficiency virus (HIV)-infected. One hundred and twenty-nine samples (129, 23 %) were M. tuberculosis culture-positive. The time-to-positivity of Mycobacteria Growth Indicator Tube (MGIT) culture was shorter for SI (median difference 2 days, p = 0.63) and for early morning expectorated sputum (median difference 2 days, p = 0.02) compared to spot expectorated sputum. However, there was no difference in the culture-positive diagnostic yield between SI and spot expectorated sputum [difference +0.7 %; confidence interval (CI) -7.0 to +8.5 %, p = 0.82] or SI and early morning expectorated sputum (difference +4.7 %; CI -3.2 to +12.5 %, p = 0.20) for all subjects or for HIV-infected subjects. SI reduces the time to positive M. tuberculosis culture, but does not increase the rate of positive culture compared to routine expectorated sputum collection. SI cannot be recommended as the routine collection method at first contact among ambulatory patients with suspected TB in high-burden communities.

   

SATVI gets approval from USA based clinical research organisation

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SATVI gets site approval from USA based clinical research organisation

Scientists at the UCT based South African Tuberculosis Vaccine Initiative (SATVI) were ecstatic with the announcement by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), USA that SATVI meets it’s stringent requirements for participation in international clinical trials. On Tuesday 19 August 2014, the DAIDS Branch Chief, Ms Donna Germuda announced that “SATVI has met all the stringent requirements of the DAIDS site approval process”.

SATVI Site Accreditation DAIDS 19 August 2014

   

4 August 2014 Joint collaboration between UCT biomedical research units to expose children to the world of biomedical TB research.

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In a unique collaboration between five research units attached to the Institute of Infectious Disease and Molecular Medicine (IDM) in the Faculty of Health Sciences, research laboratory staff have joined forces in developing and rolling out a training program which empowers children with knowledge about the biomedical world and practical media skills. The public engagement program, funded by the Wellcome Trust, was developed by IDM students Anastasia Koch, Zanele Ditse, Olivia Carulei and Hanif Esmail, in close collaboration with local artists Ed Young and Herman de Klerk, with the support of staff from the South African Tuberculosis Vaccine Initiative (SATVI), the Clinical Infectious Diseases Research Initiative (CIDRI), the Desmond Tutu HIV Centre (DTHC) and the Molecular Mycobacteriology Research Unit (MMRU).
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According to Anastasia Koch, PhD student attached to the Molecular Mycobacteriology Research Unit of the University of Cape Town, “the project started in an organic, informal way as part of the UCT Post-Graduate Student Council,
   

14 August 2014- SATVI Accredited as UCT Research Site

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SATVI accredited as a University of Cape Town Research Centre

“SATVI has a world-beating track record of successful TB vaccine trials, coupled with highly innovative TB immunology studies, which together are responsible for the group’s increased publication output in high impact journals”
Picture Mark Announcement SATVI research centre
The South African Tuberculosis Vaccine Initiative (SATVI) has joined the ranks of established UCT research groupings with the approval of its accreditation as a Research Centre of the University of Cape Town. According to Professor Mark Hatherill, SATVI Director, the organisation has just received the exciting news that SATVI has been awarded formal accreditation as a Research Centre by the University of Cape Town.He said “accreditation offers major benefits for the organisation, which will gain from an improved governance environment, five-yearly cycles of strategic review, and the potential to leverage additional funding for students and post-doctoral fellows.
 
   

18 July 2014-SATVI supports local community based community organisations

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SATVI demonstrate its supports for local community based community organisations with the donation of equipment, material and time on Mandela Day

Group Picture Social Res Team

In celebration of Mandela Day, staff from the South African Tuberculosis Vaccine Initiative (SATVI), did their bit with a generous donation of equipment, material and time to the Worcester-based Sean Kelly Centre for Multiple Disabled Children, Pionier School for Blind and the Thuthuzela Centre for Victims of Violence.

At Sean Kelly Centre for Multiple Sensory Disabled, the group handed over toys, personal toiletries, sweet parcels, tracksuits, fleecy blankets and a DVD player.

The Thuthuzela Care Centre, which provides victim support to victims of domestic violence, received personal toiletries, underwear, coffee, tea and sugar, sweet parcels, whilst the Pioneer Hostel for the Blind, received a makeover with sheets, pillow cases, pillows, comforters. The donation was rounded of by a music sound system, dvd player, shower curtains. Staff had made up table cloths in their own time at their homes

   

SATVI Director departs from UCT to focus on global TB Strategy at Bill Gates Foundation

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Group Staff Picture

Handover Picune 2014

Professor Willem Hanekom, who has been with the South African Tuberculosis Vaccine Initiative (SATVI) for the past eight years, recently said his farewells to staff, friends and colleagues at the University of Cape Town, before taking up a key position at the Bill and Melinda Gates Foundation, where he will be focusing on the development of a global policy for TB vaccine development.

Willem who has been appointed Deputy Director, Program lead for TB Vaccines, at the Seattle based Bill Gates Foundation, was the Director of SATVI since 2011 and has vast expertise in clinical trials involving protective host responses to TB and has contributed to more than 120 publications. Willem is past president of the Federation of African Immunological Societies, and has served on multiple international advisory committees in TB vaccine development and translational immunology.

   

SATVI Appoints New Director

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It is my great pleasure to announce the appointment of SATVI's new Director! Congratulations to Associate Professor Mark Hatherill on his appointment!!!

There has been a formal process which involved several stakeholders at the University to appoint our new Director. Mark will be formally inaugurated at an upcoming staff meeting but we would like to thank Professor Mizrahi and Professor Hussey for their support during this transition.

We would like to thank Willem for building a solid foundation at SATVI during his tenure and developing a clear strategy. We are really excited about the next chapter at SATVI under Mark's Leadership.

We are ALL looking forward to working with Mark in achieving our vision of 'A World without TB'.

Kind Regards
Zameer on behalf of Exco

   

Applications for a postdoctoral fellowship in systems immunology

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We are inviting applications for a postdoctoral fellowship in systems immunology to conduct research on a large project aimed at identifying and validating immune correlates of risk of TB in collaboration with global leaders in systems biology at Seattle Biomedical Research Institute.

For more information click here