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ANNUAL REPORT 2015

SATVI ANNUAL REPORT 2015

contentsVision and Mission 2

Directors Foreword 3

About SATVI 4

Governance: Executive Committee and Senior Clinical Research Team 5

Highlights 2015 9

Research Outputs 22

Postgraduate Students and Postdoctoral Fellows 24

SATVI Staff 25

Community Involvement 27

Community Advisory Board 30

Funders 31

Collaborators 32

our

vision

our

missionA World Without TB Innovative and High Quality

TB Vaccine Research in Africa to Impact the Global Epidemic

vision &

mission

SATVI ANNUAL REPORT 2015 3

2015 was a year of extraordinary activity for SATVI. The

clinical and laboratory teams completed three Phase

1-2 trials of novel TB vaccines in adult and infant study

populations; finished enrolment in two large Phase 2 TB

vaccine trials, including a proof of concept efficacy trial of

the GSK M72 candidate vaccine in TB-infected adults and a

Prevention of Infection (POI) trial of the Sanofi H4 candidate

vaccine and BCG in adolescents; and started recruitment

for clinical trials of a recombinant BCG vaccine (VPM-1002)

in newborns; a live attenuated Mycobacterium tuberculosis

vaccine (MTBVAC) in adults and infants; and an adjuvanted

subunit vaccine (ID93+GLA-SE) in recently treated TB

patients.

Our research remains firmly focused on development of

a new TB vaccine that is safe and effective in infants,

children, and adults, including persons who are HIV

infected. At the same time, we have made a concerted

effort to diversify our TB research portfolio. After a lengthy

preparation period, we enrolled our first participants into an

AIDS Clinical Trial Group (ACTG) household contact study

of multidrug-resistant TB patients. The study marks the

first of several TB diagnostic and therapeutic studies in the

SATVI pipeline.

SATVI’s research outputs continue to increase, with a total

of 29 papers published by SATVI authors in 2015, including

the report of a first-in-human trial of the adjuvanted subunit

vaccine H56:IC31 (Staten Serum Institut).

The year ended on a high note, with the award of a multi-

million dollar grant for a clinical trial that will test a screen

and treat strategy to target preventive therapy for persons

with a transcriptomic signature of risk for TB disease.

CORTIS (The Correlate of Risk Targeted Intervention

Study) will start in mid-2016. We also led a successful

application to a joint SAMRC-NIAID call to establish the

Clinical Research Unit for Advancement of Tuberculosis

Biomarker-Targeted Interventions, part of the new RePORT

SA network.

We also bade farewell to Dr Zameer Brey, who joined the Bill

& Melinda Gates Foundation’s South Africa Office, and we

welcome Dr Masooda Kaskar, who joins us from Novartis to

take up the reins of the COO position in 2016.

A big ‘thank you’ goes to the Breede Valley community in

which we work, our study participants and their families,

who are deeply invested in our research to prevent and

cure TB. The achievements of the past year would also not

have been possible without the help of our many local and

international partners, and we begin 2016 in the same spirit

of active and equal collaboration towards a shared goal –

“a World without TB”.

Mark Hatherill

Director

directors foreword4


about satviWHO WE ARE

The South African Tuberculosis Vaccine Initiative

(SATVI) is a tuberculosis research group with a

research focus that spans several disciplines

including paediatrics, infectious diseases,

epidemiology, public health, immunology, systems

biology and clinical sciences. SATVI has a large

and well-developed clinical field site in the Boland

Overberg region, with the core on the premises of

the Brewelskloof TB Hospital in Worcester, from

where most clinical/epidemiological studies and

clinical trials of new TB vaccines are conducted.

The Clinical Trials work is led by SATVI Director,

Associate Professor Mark Hatherill; and the

Immunology and Laboratory-based work is led by

Associate Professor Tom Scriba.

OUR WORK

SATVI was launched in 2001 at the University

of Cape Town (UCT) and has developed into a

sophisticated world class TB vaccine clinical

research centre with state of the art immunology

laboratories located within the Institute of

Infectious Disease and Molecular Medicine (IDM)

of the University of Cape Town, and at the

Worcester field site.

SATVI is regarded as a leader in tuberculosis

vaccine clinical research worldwide and is the

largest dedicated tuberculosis vaccine research

group on the African continent. Our laboratories are

accredited, which means adherence to the highest

international standards.

OUR OUTPUTS

SATVI has been extraordinarily productive in terms

of clinical trial activities, having conducted 22

Phase I–IV trials of BCG and nine novel TB vaccine

candidates, among more than 25,000 research

participants, during the last 15 years. The group’s

publication output, since 2006, stands at more

than 175 co-authored papers, of which the majority

have a SATVI first or senior author. The active

SATVI postgraduate program has also produced

10 PhD graduates and several Masters graduates

during the same period.


governancesatvi Executive Committee and senior Research team

The Executive Committee is comprised of:

Director, Associate Professor: Mark Hatherill

Deputy Director Immunology, Associate Professor: Tom Scriba

Outgoing Chief Operations Officer: Dr Zameer Brey

Incoming Chief Operations Officer: Dr Masooda Kaskar

Worcester Field Site Manager: Mrs Marwou de Kock.

From left to right: Dr Masooda Kaskar, Mrs Marwou de Kock, Associate Professor Mark Hatherill, Associate Professor Tom Scriba.


ExECUTIVE COMMITTEE:

assoCiatE PRofEssoR MaRk HatHERill,

DiRECtoR

Mark Hatherill is a specialist

paediatrician, with

accreditation in critical care,

and an experienced clinical

trialist who is active in the

design and implementation

of innovative trials of new

TB vaccines and preventive

therapy, through several consortia. He is a Full Member of

the Institute of Infectious Disease & Molecular Medicine

(IDM) at the University of Cape Town; a member of the SA

Department of Health TB Think Tank, Working Group on

Diagnostics, Drugs and Vaccines; and a member of the

Global TB Vaccine Partnership, Working Group on

Experimental Medicine.

Dr Hatherill is funded by competitive grants from the Bill &

Melinda Gates Foundation (BMGF), Joint Global Health

Trials scheme (UK MRC/ Wellcome Trust/DfID), SA Medical

Research Council, US National Institutes of Health, and

multiple Aeras contracts.

assoCiatE PRofEssoR toM sCRiba,

DEPuty DiRECtoR

Tom Scriba (PhD) is Deputy

Director, Immunology and

directs the Clinical

Immunology Laboratory at

SATVI. He was trained in

Biological Sciences at

Stellenbosch University and

obtained a DPhil (PhD) in

T cell Immunology at Oxford University. He returned to

South Africa in 2006 to complete a postdoctoral fellowship

in Paediatric and Clinical Immunology in Tuberculosis and

Vaccinology at the Institute of Infectious Disease and

Molecular Medicine (IDM), University of Cape Town. He is

Full Member of the IDM, member of the AERAS Biomarker

and Correlates Working Group and the Bill and Melinda

Gates Foundation (BMGF) Collaboration for TB Vaccine

Discovery. He is funded by competitive grants from the

BMGF, the National Research Foundation, SA Medical

Research Council, US National Institutes of Health and the

European Union.

DR ZaMEER bREy,

CHiEf oPERatioNs offiCER (outGoiNG)

Zameer Brey, the outgoing

Chief Operations Officer,

departed from SATVI during

August 2015 for the Bill and

Melinda Gates Foundation.

DR MasooDa kaskaR,

CHiEf oPERatioNs offiCER (iNCoMiNG)

Masooda Kaskar joined

SATVI in January 2016. She

has held several senior

leadership positions within

the Pharmaceutical Industry.

At Novartis she was instru-

mental in developing and

implementing Transformational

Growth Plans that resulted in establishing Novartis’s

Leadership position within the industry. Her experience

spans Strategy, Operations, Marketing as well as

Managed Health Care. As Head of the Respiratory Division

she was instrumental in driving improvements in the area

of Cystic Fibrosis management as well as changing the

landscape of Severe Asthma by launching the first anti-IgE

therapy for the treatment of Severe Allergic Asthma in

South Africa. Masooda holds an MBCHB degree from the

University of Cape Town, as well as a MBA from UCT

Graduate School of Business.

MaRwou DE koCk,

fiElD sitE MaNaGER

Marwou de Kock graduated

from the Cape Peninsula

University of Technology with

a Degree in Biomedical

Science. She subsequently

completed a Degree in

Laboratory Management and

is currently writing a Masters

Dissertation in Clinical

Research Administration. She has been working at SATVI

since 2002 and has an intricate knowledge of the site, the

people and procedures in the laboratory, as well as clinical

operations. She started in the SATVI Field Site laboratory

and developed it into a world class facility that received

SANAS Accreditation in 2010. She is currently responsible

for managing the SATVI Field Site, overseeing and

managing service delivery for all operations, as well as

coordinating and implementing multiple research projects

at the Field Site.


DR MiCHElE taMERis,

PRiNCiPal iNvEstiGatoR

Michele Tameris graduated from the

University of Cape Town with

MBChB in 1980. Thereafter she

worked for many years in the public

health sector in Cape Town and in

Worcester. In 2003 she joined SATVI

as a clinical researcher and since

2005 has been Sub-Investigator on

16 novel TB vaccine trials and Principal Investigator on 5.

These trials have been of 9 novel TB vaccines and have

included first in man trials, phase 1, 2a and 2b trials

including the first phase 2b infant efficacy trial of a new TB

vaccine. She has been awarded two Wellcome Trust

International Engagement awards (2012 and 2014) for

projects using drama to improve community

understanding of TB clinical research.

DR HENNiE GElDENHuys,


After working in private general

practice for 10 years Hennie

Geldenhuys joined SATVI full-time

in 2007. He is actively involved in

the design, conduct, and analysis

of vaccine clinical trials and other

research studies in tuberculosis. He

has fulfilled the role of Investigator

and Principal Investigator on a number of clinical trials,

and has published a number of scientific papers. Hennie is

based at SATVI’s field site in the town of Worcester. His

research interests include alternative vaccine

administration methods, clinical trials with adolescents,

quality management in clinical trials, and the science of

translating research protocols into field practice.

DR JustiN sHENJE,


Justin Shenje is a clinical researcher

who has worked in various countries

across Southern Africa, including

Zimbabwe, Swaziland and South

Africa. A common theme across this

region is a high burden of tuberculosis

(TB) and HIV, which has fostered his

keen interest in tuberculosis and HIV

research. Currently Justin Shenje is the principal

investigator for our first AIDS Clinical Trials Group (ACTG)

study, A5300. This is an observational study aimed at

describing household contacts of Multi-Drug Resistant

(MDR) TB cases. He is also a clinical investigator on

several TB vaccine studies and has experience in TB

therapeutic studies and HIV prevention research.

SENIOR CLINICAL RESEARCH TEAM:


DR aNGEliQuE luabEya,


Angelique Kany Kany

Luabeya graduated as a

Medical doctor in 1996 from

the University of Kinshasa

(DR Congo) and holds a

Masters degree in

Epidemiology from the

London School of Tropical

Medicine (LSHTM). She

joined SATVI in 2009 as a

clinical investigator from the

Africa Centre for Health and

Populations Studies at University of Kwa Zulu Natal and

has been involved as Principal Investigator in the

implementation and conduct of clinical trials of new

TB vaccines (AERAS C035-456, IDRI-TBVPx-203, and

VPM1002-ZA-2.13TB) in healthy adults, TB patients and

newborns. She has produced a number of scientific

publications and has a particular research interest in the

design and conduct of TB diagnostic studies (tuberculosis

case finding by oral swab PCR), clinical immunology

studies and health systems operational research in the

area of TB prevention in young children.

DR Elisa NEMEs,

sENioR REsEaRCH offiCER

Elisa completed her PhD in

HIV-specific T cell

immunology in Italy and

France. She then worked

on paediatric immune

responses to HIV and TB in

Cameroon. She joined

SATVI in 2011, where she

has been involved in basic

immunology studies,

clinical trials of new TB vaccines and studies of host

correlates of risk of TB disease in BCG-vaccinated infants

and of BCG/TB immune reconstitution inflammatory

syndrome in HIV+ children.

DR aDaM PENN-NiCHolsoN,

REsEaRCH offiCER

After receiving his PhD in the

USA, Adam worked in

industry on the development

and manufacture of vaccines.

He joined SATVI in 2011.

Adam’s main focus is on the

discovery of blood-based

biomarkers that prospectively

predict TB disease risk, and

understanding the biology

involved in progression from latent M. tuberculosis

infection to active TB disease. He also provides scientific

oversight of several clinical TB vaccine trials currently

being conducted at SATVI.


highlights2015

A RANDOMIZED, PARTIALLY-BLINDED, CLINICAL TRIAL

OF ISONIAZID AND RIFAPENTINE (3HP) THERAPY TO

PREVENT PULMONARY TUBERCULOSIS IN HIGH-RISK

INDIVIDUALS IDENTIFIED BY A TRANSCRIPTOMIC

CORRELATE OF RISK

SATVI, in partnership with the Center for Infectious

Disease Research in Seattle, has recently completed a

decade-long project to develop a biomarker test that

predicts whether a person is at risk of developing TB.

This prognostic blood test, which is based on the

human immune response, can predict whether a

person will develop TB more than 12 months in

advance.

SATVI investigators will now evaluate, in a large clinical

trial, whether targeted preventive therapy for people

with a positive biomarker test can stop them from

developing TB.

This international collaboration is led by SATVI, in

partnership with the Aurum Institute, Stellenbosch

University Immunology Research Group, Centre for the

AIDS Programme of Research in South Africa (CAPRISA),

London School of Hygiene and Tropical Medicine

(LSHTM), and Fred Hutchinson Cancer Research

Center (FHCRC).

This clinical trial, funded by the Bill & Melinda Gates

Foundation, will start in 2016 and will run for 2 years.

If this trial is successful, mass campaigns using a ‘screen

& treat’ strategy have potential for major impact on the

global epidemic, by stopping TB before it becomes

infectious and can be transmitted to others.

CORRELATE OF RISK TARGETED INTERVENTION (CORTIS) STUDY


STRATEGIC VISION OF SATVI

During July 2015 SATVI conducted a review of its Strategic Objectives

and identified the following Strategic Priority Areas:

1. High Impact TB Research

2. To build a cutting edge team for Research

3. To ensure Financial Sustainability

4. To build the SATVI brand

5. To limit risks


PHASE II RANDOMISED CONTROLLED TRIAL TO EVALUATE SAFETY AND

IMMUNOGENICITY OF MVA85A AND SELECTIVE DELAYED BACILLE CALMETTE-GUERIN

(BCG) VACCINATION IN INFANTS OF HIV INFECTED MOTHERS

Principal Investigator: Mark Hatherill

Sponsor: University of Cape Town

Follow-up of all 248 HIV exposed infants was completed by SATVI and the Stellenbosch

University teams (Principal Investigator: Anneke Hesseling) in this trial to test the safety

and immunogenicity of MVA85A vaccination at birth. The trial findings will be released

shortly.

A RANDOMISED, PLACEBO CONTROLLED, PARTIALLY BLINDED PHASED II STUDY TO

EVALUATE THE SAFETY, IMMUNOGENICITY AND PREVENTION OF INFECTION WITH

MYCOBACTERIUM TUBERCULOSIS OF AERAS 404 AND BCG REVACCINATION IN HEALTHY

ADOLESCENTS


Sponsor: AERAS

Study team.

Enrolment of 990 healthy, QuantiFERON negative adolescents was completed in the first

trial to test the concept that BCG and the Aeras-404 vaccine might offer protection against

primary tuberculosis infection. Follow-up is ongoing.

EFFICACY OF GSK BIOLOGICALS’ CANDIDATE TUBERCULOSIS VACCINE, M72, AGAINST TB

DISEASE IN ADULTS LIVING IN A TB ENDEMIC REGION


Sponsor: Glaxo Smith Kline

Study team.

Enrolment of 658 healthy, QuantiFERON positive adults was completed in this large,

multi-centre trial that will test protection against active tuberculosis disease. Follow-up is

ongoing.

ONGOING CLINICAL TRIALS


A PHASE II, RANDOMISED, OBSERVER-BLINDED, SINGLE CENTRE TRIAL EVALUATING THE

IMMUNOGENICITY AND SAFETY OF TWO DOSES OF AN ADJUVENATED TB SUBUNIT

VACCINE (AG85B-ESAT-6+IC31) USING 2 DIFFERENT VACCINATION SCHEDULES IN

HEALTHY ADOLESCENTS.

Principal Investigator: Hennie Geldenhuys

Funder: Statens Serum Institute (SSI)

In this trial the H1:IC31 TB vaccine candidate was tested in 240 adolescents for safety

and immunogenicity. The last participant visit was conducted in December 2013. All of

the substantial immunology endpoints (Elispot and intracellular cytokine staining by flow

cytometry) were performed by the SATVI laboratory. The clinical trial report and manuscript

are in preparation.

PHASE 1B RANDOMIZED, DOUBLE-BLIND, DOSE-FINDING CLINICAL TRIAL TO EVALUATE

THE SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF MTBVAC, IN COMPARISON

WITH BCG VACCINE SSI, IN HEALTHY HIV-NEGATIVE NEWBORNS AND ADULTS LIVING IN A

TUBERCULOSIS ENDEMIC REGION

Principal Investigator: Michele Tameris

Funder: Biofabri

During 2015 we vaccinated the first adult participants in the MTBVAC study, a clinical trial

which will evaluate the safety of the novel TB vaccine MTBVAC, firstly in adults, followed by

a dose-escalation trial of the safety and immunogenicity of MTBVAC compared to BCG in

newborns.

This novel vaccine, MTBVAC, has been developed to replace BCG, currently the only

registered TB vaccine available and routinely given at birth to all newborns. The first trial

of MTBVAC in humans was conducted in 2013 in Switzerland, with very good safety and

immunogenicity results.

This clinical trial is an important step in the development of the vaccine and is sponsored

by Biofabri. MTBVAC, which will be the first vaccine to be fully developed in Spain, was

designed by Professor Carlos Martin of the University of Zaragoza.

PHASE I/II, SAFETY AND IMMUNOGENICITY STUDY OF A RECOMBINANT PROTEIN

TUBERCULOSIS VACCINE (AERAS-404) IN BCG-PRIMED INFANTS


Funders: AERAS, National Institute of Allergy and Infectious Diseases (NIAID) & Eunice

Kennedy Shriver National Institute of Child Health and Human

Development (NICHD).

We vaccinated the first infant participant in the IMPAACT P 1113 Study with the

Aeras-404 (also known as HyVac4 or H4:IC31) candidate TB vaccine in 2015.

Study team with first participant.

Participating babies are between 9 and 14 weeks old and are receiving 3 doses of

AERAS-404 with follow up for about 15 months. The timing of the doses with respect

to routine EPI schedule and dose strength differs across 6 cohorts. Three other sites

are part of this trial – KIDCRU at Stellenbosch University, PHRU in Johannesburg and

Shandukani in Soweto.


A PHASE 1 B, RANDOMISED, DOUBLE BLIND, PLACEBO- CONTROLLED, DOSE ESCALATION

STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF THE ID 93+GLA-SE VACCINE

IN BCG VACCINATED HEALTHY ADULTS


Funder: Infectious Disease Research Institute (IDRI)

The enrolment of 66 healthy adults (QFT negative and QFT positive) into the 4 cohorts of

this Phase 1b safety, immunogenicity and dose finding trial of the adjuvanted

vaccine ID93+GLA-SE started in September 2013 and was completed in September 2014.

Follow-up was completed at the end June 2015. Data analyses are ongoing.

PHASE II DOUBLE-BLIND, RANDOMIZED, CONTROLLED STUDY TO EVALUATE SAFETY

AND IMMUNOGENICITY OF VPM1002 IN COMPARISON WITH BCG IN HIV-EXPOSED AND

HIV-UNEXPOSED, BCG-NAIVE NEWBORN INFANTS

Principal Investigator: Angelique Luabeya

Funder: Serum Institute of India

Study team with first participant.

This Phase IIa trial of the VPM1002 vaccine is the first study to investigate

VPM1002 in HIV-exposed newborn infants in a setting with a high burden of TB,

where BCG is routinely recommended at or around birth by the World Health

Organization (WHO). This is a double-blinded, randomized and controlled parallel-

group trial design to assess the safety and immunogenicity of a single dose of

VPM1002 in comparison with the current commercially available, standard BCG.

SATVI has enrolled 13 babies since August 2015 and the trial is ongoing.

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND PLACEBO- CONTROLLED, CLINICAL TRIAL

TO EVALUATE SAFETY AND IMMUNOGENICITY OF THE ID93 + GLA-SE VACCINE IN HIV

UNINFECTED ADULT TB PATIENTS AFTER TREATMENT COMPLETION


Funder: Infectious Disease Research Institute (IDRI)

The purpose of this study is to evaluate the safety and immunogenicity of two

doses of ID93 + GLA-SE vaccine when administered to HIV uninfected adult

pulmonary TB patients, following successful completion of TB treatment with

confirmed bacteriologic cure. SATVI has enrolled 13 patients since June 2015

for the first cohort (n=20) of this trial, which is still ongoing. This trial is being

conducted in preparation for a future Phase 2b prevention of TB recurrence trial in

the same population.

Dr Angelique Luabeya with the VPM 1002 Study team.


STUDY OF MDR TB CASES AND THEIR HOUSEHOLD CONTACTS: OPERATIONAL FEASIBILITY

TO INFORM PHOENIX TRIAL DESIGN

Principal Investigator: Justin Shenje

Sponsor: AIDS Clinical Trial Group (ACTG)

Dr Justice Shenje with study team.

The SATVI team started their first ACTG study in November 2015, which is known as

A5300. The A5300 study seeks to evaluate the feasibility of conducting a clinical trial which

intends to determine the safety and efficacy of Bedaquiline (a new TB drug) in preventing

the transmission of TB to household contacts of MDR TB cases.

A PHASE I/II A DOUBLE BLIND, RANDOMISED, PLACEBO- CONTROLLED, DOSE-FINDING

STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF AERAS-456 IN HIV NEGATIVE

ADULTS WITH AND WITHOUT LATENT TUBERCULOSIS INFECTION


Funder: AERAS

This Phase IIa trial of the H56:IC31 (designated Aeras456) vaccine, which incorporates

three M. tuberculosis-specific antigens that target several stages of the complex host-

pathogen interaction, is being conducted in HIV-uninfected South African adults with

or without latent M. tuberculosis infection, in collaboration with Statens Serum Institute

(Denmark) and AERAS (USA). Participant vaccination and follow-up have been completed

and data analyses are ongoing.


TUBERCULOSIS CASE FINDING BY ORAL SWAB


Funder: National Institute of Health

This project will evaluate oral swab analysis (OSA) as a novel alternative to sputum

analysis for pulmonary TB diagnosis and active case finding. The hypothesis is that

oral swabs are simpler, cleaner, non-invasive, less hazardous and more uniform

alternatives to sputum. If validated, OSA could facilitate point-of-care (POC)

strategies that are not feasible for sputum testing. It could also enable TB diagnosis

in patients who cannot produce diagnostic sputum samples, including children. The

study will start recruitment in February 2016.

Tuberculosis Case Finding by Oral Swab as alternative to Sputum Analysis.

OTHER STUDIES


CORRELATE OF RISK TARGETED INTERVENTION STUDY – CORTIS

A RANDOMIZED, PARTIALLY-BLINDED, CLINICAL TRIAL OF ISONIAZID AND RIFAPENTINE

(3HP) THERAPY TO PREVENT PULMONARY TUBERCULOSIS IN HIGH-RISK INDIVIDUALS

IDENTIFIED BY A TRANSCRIPTOMIC CORRELATE OF RISK.

National Principal Investigator: Mark Hatherill

SATVI Principal Investigator: Michele Tameris

Sponsor: University of Cape Town

This multicenter clinical trial, to be conducted in collaboration with our partners

at Aurum, CAPRISA, Stellenbosch University, Fred Hutchinson Cancer Research

Center and the London School of Hygiene and Tropical Medicine, is funded by a

multi-million dollar grant from the Bill & Melinda Gates Foundation. The trial builds

on a decade-long effort by scientists at SATVI and the Center for Infectious Disease

Research, Seattle, to develop a Correlate of Risk for TB. We will now use this

transcriptomic signature to target persons at high risk of developing TB disease for

preventive therapy. The CORTIS trial will enroll 3,200 participants at 4 sites in South

Africa and is scheduled to start in mid-2016.

PLANNED CLINICAL TRIALS


In addition to its focus on TB vaccines, SATVI is contributing to the exciting and

growing field of clinical research into new drugs for drug sensitive and resistant TB.

In 2016 at least three new clinical trials are expected to start in collaboration with

the AIDS Clinical Trial Group (ACTG) network, of which SATVI became an accredited

clinical research site in 2015. These trials include the A5343 trial (A Trial of the

Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and

in Combination, among Participants Taking Multidrug Treatment for Drug-Resistant

Pulmonary Tuberculosis), A5349 (Rifapentine-containing treatment shortening

regimens for pulmonary tuberculosis: a randomized, open-label, controlled, phase 3

clinical trial) and the STAND trial (A Phase 3 Open-Label Partially Randomized Trial

to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin

plus PA-824 plus Pyrazinamide after 4 and 6 months of Treatment in Adult Subjects

with Drug-Sensitive Smear-Positive Pulmonary Tuberculosis and after 6 months of

Treatment in Adult Subjects with Multi-Drug Resistant, Smear-Positive Pulmonary

Tuberculosis).

ExPANSION INTO STUDIES OF NEW DRUGS FOR DRUG SENSITIVE AND RESISTANT TB


DRAMA SETS THE STAGE


Funder: Welcome Trust

Supported by a Wellcome Trust International Engagement

award in 2012, SATVI facilitated a drama production to

promote awareness about TB vaccine clinical research,

titled “Carina’s Choice” with learners from Worcester

Secondary School as actors and UCT drama school

students as mentors. A very successful roadshow

to 8 local high schools reached approximately 8 000

adolescents in 2013. DVDs with English or xhosa subtitles

have been produced for distribution as well as free

download access on SATVI website.

https://www.youtube.com/watch?v=pAosgZO-O0k

Drama performed at local schools.

BEAT TB – IT’S YOUR CHOICE


Funder: Welcome Trust

A second Wellcome Trust International Engagement

grant was awarded in October 2014 for a street

theatre project, which commenced in 2015 and

will run until the end of 2016. This will build on

work in the first drama project, taking the issue

of TB research into the streets, targeting the local

adult population.

Beat TB Street Theatre Project, November 2015.

AWARENESS-RAISING


INDUCTION OF NON-CLASSICAL T CELL RESPONSES BY BCG VACCINATION

Principal Investigators: Tom Scriba and Mark Hatherill

Funder: TB Research Unit of the National Institutes of

Health

BCG is the only licensed and partially efficacious vaccine

against TB disease. One third of the global population is

estimated to be latently M. tuberculosis infected (LTBI),

and hence at risk of TB disease. These infected individuals

may benefit from vaccination. We performed a Phase I

trial of BCG revaccination to study induced immune

responses. BCG contains a wide range of antigens,

which include protein antigens presented by classical

T cells and restricted to specific human leukocyte antigen

(HLA) haplotypes. BCG also contains lipid antigens and

microbial metabolites presented by unconventional

T cells, which are not restricted by donor HLA haplotypes.

In our study, we found that BCG re-vaccination of LTBI

individuals induces a wide variety of conventional T cell

responses, as well as responses by unconventional

T cells.

In addition, BCG-reactive innate natural killer cells

persisted up to one year post-vaccination. These results

collectively suggest that BCG induces a variety of donor-

unrestricted immune responses, which may guide novel

vaccine development strategies.

PREDICTIVE GENE EXPRESSION SIGNATURES FOR INCIDENT TB IN HIV-INFECTED PERSONS

Principal Investigator: Tom Scriba

Funder: Strategic Health Innovation Partnerships of the

SA Medical Research Council

A large proportion of TB cases are co-infected with HIV

and underlying HIV infection significantly increases risk

of TB disease in individuals with latent M. tuberculosis

infection. We have successfully developed and validated

a transcriptomic correlate of risk (CoR) that can predict

progression from M. tuberculosis infection in healthy

persons to TB disease.

This project aims to determine if the transcriptomic

CoR can predict risk of incident TB in HIV-infected

persons. We are retrieving stored samples from

completed clinical trials or cohort studies of

TB in HIV-infected populations, performed in

South Africa. Gene expression signatures of

candidate transcriptomic CoR are being measured

by microfluidic qRT-PCR in progressors, who

developed microbiologically confirmed TB, or

in controls, who remained healthy. The project

is highly collaborative and involves scientists

from SATVI, CAPRISA, the Desmond Tutu HIV

Centre, Stellenbosch University and the Center for

Infectious Disease Research in Seattle, USA.

POINT-OF-CARE MEDICAL DEVICE FOR MONITORING THE FUNCTIONAL IMMUNE RESPONSE TO MYCOBACTERIA


Funder: Bill & Melinda Gates Foundation

Diagnosis of TB disease is challenging and requires

collection of a good quality sputum specimen from the

patient and detection of the M. tuberculosis bacterium.

A test that could be performed at the point of patient care

in resource-poor settings and that does not depend on

sputum would be a major advance in the fight against TB.

This project aims to test novel and standardized whole

blood assays to identify immune response signatures that

can discriminate between asymptomatic M. tuberculosis

infection and active TB disease. We are measuring many

features of the immune response, including release of

soluble immune mediators, phenotype and function of cell

types important to control M. tuberculosis as well as gene

expression. The project is a collaboration with the Pasteur

Institute in Paris, France.

IMMUNOLOGY


PRIMING OF CD4 T CELL RESPONSES IN ACUTE MYCOBACTERIUM TUBERCULOSIS INFECTION


Funders: South Africa Medical Research Council

(SA MRC)

An improved understanding of the events underlying

priming of T cell responses during acute M. tuberculosis

infection of humans is critical to inform vaccination

strategies aimed at initial containment of M. tuberculosis

infection.

In this project we aimed to determine the phenotypic

and activation profiles of M. tuberculosis-specific CD4

T cells during and after new acquisition of M. tuberculosis

infection in a longitudinal study of adolescents. Acute

infection was defined by Quantiferon assay conversion.

We used HLA-class II tetramers bearing ESAT-6 and CFP-

10 peptides to detect M. tuberculosis-specific CD4 T cells

and performed phenotypic analysis using multiparameter

flow cytometry.

During the early stages of human infection,

M. tuberculosis-specific CD4 T cells are highly activated

and display an effector phenotype, consistent with high

levels of bacterial replication. Following acute infection

M. tuberculosis-specific CD4 T cells transition to a central

memory phenotype and express lower levels of activation

markers. As observed previously in experimental

M. tuberculosis infection of mice, these data suggest that

established infection in humans is associated with lower

levels of antigen stimulation than acute infection, likely due

to lower bacterial replication.

CORRELATES OF RISK OF IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME IN HIV+ CHILDREN STARTING ANTIRETROVIRAL TREATMENT

Principal Investigator: Elisa Nemes

Funders: International Maternal Pediatric Adolescent AIDS

Clinical Trials Network (IMPAACT) and Miami Center for

AIDS Research

Immune Reconstitution Inflammatory Syndrome (IRIS) is

an over-exuberant host inflammatory response to pre-

existing infections or live vaccines such as BCG, which

manifests in some HIV-infected persons when damaged

immunity is restored after starting antiretroviral treatment

(ART). This project aims to identify host immune correlates

of risk of IRIS in HIV-infected children starting ART.

We are comparing mycobacteria and HIV-specific immune

responses and whole blood gene expression profiles in

children who initiated ART and who either developed

IRIS or who remained free of disease. Identification of

predictive biomarkers would facilitate IRIS diagnosis and

allow development of preventative interventions.


FULL IDM MEMBERSHIP

During September 2015 Associate Professor Tom Scriba

was appointed a Full Member of the Institute of Infectious

Disease and Molecular Medicine (IDM) in recognition of

his achievements in TB vaccinology and immunology

research.

MEIRING NAUDE MEDAL

Associate Professor Tom Scriba was presented with

the Meiring Naude Medal by the Royal Society during

September 2015. The medal is awarded to outstanding

early career scientists, who have already made a mark

in their field and who are poised to become scientific

leaders.

SCHOLARSHIP AWARDS

Dr Elisa Nemes was selected for the International Society

for the Advancement of Cytometry (ISAC) Scholars

Program, which is designed to enhance the scientific and

leadership experiences of scientific research leaders in the

field of cytometry. This is in recognition of scientific skills,

research accomplishments, leadership potential and ability

to achieve career goals.

Dr Angelique Luabeya, Principal Investigator was awarded

an European & Developing Countries Clinical Trials

Partnership -TDR Clinical Research Fellowship. She will be

based at GSK in Siena, Italy for 12 months in 2016.

MEMBERSHIP OF COMMITTEES

Marwou de Kock, Field Site Manager was elected Chair

of the Faculty of Health Sciences Clinical Research

Operations Management (CROM) Working Group.

Simba Mabwe, Worcester Laboratory Manager was

elected to the AIDS Clinical Trial Group (ACTG) Laboratory

Technologist Committee.

AWARDS, PRIZES AND HONOURS


research outputsDuring 2015, our publication output was 28 articles, which appeared in international peer reviewed journals. Fifteen of these had first and/or last authors from SATVI including reports of five Phase I/II trials of BCG or novel TB vaccine candidates.

PUBLICATIONS IN PEER REVIEWED JOURNALS

1. First-in-human trial of a live-attenuatedMycobacterium tuberculosis vaccine. GeldmacherC, Hatherill M. Lancet Respir Med. 2015Dec;3(12):906-7.

2. Evaluation of Xpert® MTB/RIF Assay in InducedSputum and Gastric Lavage Samples from YoungChildren with Suspected Tuberculosis from theMVA85A TB Vaccine Trial. Bunyasi EW, TamerisM, Geldenhuys H, Schmidt BM, Luabeya AK,Mulenga H, Scriba TJ, Hanekom WA, MahomedH, McShane H, Hatherill M. PLoS One. 2015 Nov10;10(11):e0141623.

3. The TB-specific CD4(+) T cell immune repertoirein both cynomolgus and rhesus macaques largelyoverlap with humans. Mothé BR, LindestamArlehamn CS, Dow C, Dillon MB, Wiseman RW,Bohn P, Karl J, Golden NA, Gilpin T, Foreman TW,Rodgers MA, Mehra S, Scriba TJ, Flynn JL, KaushalD, O’Connor DH, Sette A. Tuberculosis (Edinb). 2015Dec;95(6):722-35.

4. T Cell Responses against Mycobacterial Lipids andProteins Are Poorly Correlated in South AfricanAdolescents. Seshadri C, Lin L, Scriba TJ, PetersonG, Freidrich D, Frahm N, DeRosa SC, Moody DB,

Prandi J, Gilleron M, Mahomed H, Jiang W, Finak G, Hanekom WA, Gottardo R, McElrath MJ, Hawn TR. J Immunol. 2015 Nov 15;195 (10):4595-603.

5. A side-by-side comparison of T cell reactivity tofifty-nine Mycobacterium tuberculosis antigensin diverse populations from five continents.Carpenter C, Sidney J, Kolla R, Nayak K, TomiyamaH, Tomiyama C, Padilla OA, Rozot V, Ahamed SF,Ponte C, Rolla V, Antas PR, Chandele A, Kenneth J,Laxmi S, Makgotlho E, Vanini V, Ippolito G, KazanovaAS, Panteleev AV, Hanekom W, Mayanja-Kizza H,Lewinsohn D, Saito M, McElrath MJ, Boom WH,Goletti D, Gilman R, Lyadova IV, Scriba TJ, KallasEG, Murali-Krishna K, Sette A, Lindestam ArlehamnCS. Tuberculosis (Edinb). 2015 Dec;95(6):713-21.

6. Risk of Disease After Isoniazid Preventive Therapyfor Mycobacterium tuberculosis Exposure inYoung HIV-uninfected Children. Luabeya KK,Tameris MD, Geldenhuys HD, Mulenga H, VanSchalkwyk A, Hughes EJ, Toefey A, Scriba TJ,Hussey G, Mahomed H, McShane H, Landry B,Hanekom WA, Hatherill M. Pediatr Infect Dis J. 2015Nov;34(11):1218-22.

7. The Role of Clinical Symptoms in theDiagnosis of Intrathoracic Tuberculosis in YoungChildren. Mulenga H, Tameris MD, Luabeya KK,Geldenhuys H, Scriba TJ, Hussey GD, Mahomed H,Landry BS, Hanekom WA, McShane H, Hatherill M.Pediatr Infect Dis J. 2015 Nov;34(11):1157-62.

8. First-in-human trial of the post-exposuretuberculosis vaccine H56:IC31 in Mycobacteriumtuberculosis infected and non-infected healthyadults. Luabeya AK, Kagina BM, Tameris MD,

Geldenhuys H, Hoff ST, Shi Z, Kromann I, Hatherill M, Mahomed H, Hanekom WA, Andersen P, Scriba TJ and the H56-032 Trial Study Group. Vaccine. 2015 Aug 7;33(33):4130-40.

9. Safety and immunogenicity of candidate vaccineM72/AS01E in adolescents in a TB endemicsetting. Penn-Nicholson A, Geldenhuys H, Burny W,van der Most R, Day CL, Jongert E, Moris P, HatherillM, Ofori-Anyinam O, Hanekom W and the VaccineStudy Team. Vaccine. 2015 Jul 31;33(32):4025-34.

10. The tuberculosis vaccine H4:IC31 is safe andinduces a persistent polyfunctional CD4 T cellresponse in South African adults: A randomizedcontrolled trial. Geldenhuys H, Mearns H, Miles DJ,Tameris M, Hokey D, Shi Z, Bennett S, AndersenP, Kromann I, Hoff ST, Hanekom WA, Mahomed H,Hatherill M, Scriba TJ and the H4:IC31 Trial StudyGroup. Vaccine. 2015 Jul 9;33(30):3592-9.

11. Mycobacteria-Specific Cytokine Responses DetectTuberculosis Infection and Distinguish Latent fromActive Tuberculosis. Tebruegge M, Dutta B, DonathS, Ritz N, Forbes B, Camacho-Badilla K, Clifford V,Zufferey C, Robins-Browne R, Hanekom W, GrahamSM, Connell T, Curtis N. Am J Respir Crit Care Med.2015 Aug 15;192(4):485-99.

12. COMPASS identifies T-cell subsets correlated withclinical outcomes. Lin L, Finak G, Ushey K, SeshadriC, Hawn TR, Frahm N, Scriba TJ, Mahomed H,Hanekom W, Bart PA, Pantaleo G, Tomaras GD,Rerks-Ngarm S, Kaewkungwal J, Nitayaphan S,Pitisuttithum P, Michael NL, Kim JH, Robb ML,O’Connell RJ, Karasavvas N, Gilbert P, C De Rosa


S, McElrath MJ, Gottardo R. Nat Biotechnol. 2015 Jun;33(6):610-6.

13. A population response analysis approach to assignclass II HLA-epitope restrictions. Paul S, DillonMB, Lindestam Arlehamn CS, Huang H, Davis MM,McKinney DM, Scriba TJ, Sidney J, Peters B, SetteA. J Immunol. 2015 Jun 15;194(12):6164-76.

14. A double-blind, randomised, placebo-controlled,dose-finding trial of the novel tuberculosis vaccineAERAS-402, an adenovirus-vectored fusionprotein, in healthy, BCG-vaccinated infants. TamerisM, Hokey DA, Nduba V, Sacarlal J, Laher F, KiringaG, Gondo K, Lazarus EM, Gray GE, NachmanS, Mahomed H, Downing K, Abel B, Scriba TJ,McClain JB, Pau MG, Hendriks J, DheenadhayalanV, Ishmukhamedov S, Luabeya AK, GeldenhuysH, Shepherd B, Blatner G, Cardenas V, Walker R,Hanekom WA, Sadoff J, Douoguih M, Barker L,Hatherill M. Vaccine. 2015 Jun 9;33(25):2944-54.

15. Development and validation of a broad scheme forprediction of HLA class II restricted T cell epitopes.Paul S, Lindestam Arlehamn CS, Scriba TJ, DillonMB, Oseroff C, Hinz D, McKinney DM, Carrasco ProS, Sidney J, Peters B, Sette A. J Immunol Methods.2015 Jul;422:28-34.

16. A randomized clinical trial in adults and newbornsin South Africa to compare the safety andimmunogenicity of bacille Calmette-Guérin (BCG)vaccine administration via a disposable-syringe jetinjector to conventional technique with needle andsyringe. Geldenhuys HD, Mearns H, Foster J, SaxonE, Kagina B, Saganic L, Jarrahian C, Tameris MD,Dintwe OB, Van Rooyen M, Luabeya KK, Hussey G,Scriba TJ, Hatherill M, Zehrung D. Vaccine. 2015 Sep8;33(37):4719-26.

17. Mycobacterium tuberculosis-specific CD4 T cellsare the principal source of IFN-y in QuantiFERONassays in healthy persons. Penn-Nicholson A,

Nemes E, Hanekom WA, Hatherill M, Scriba TJ. Tuberculosis (Edinb). 2015 May;95(3):350-1.

18. Innovative clinical trial designs to rationalizeTB vaccine development. Ellis RD, Hatherill M,Tait D, Snowden M, Churchyard G, Hanekom W,Evans T, Ginsberg AM. Tuberculosis (Edinb). 2015May;95(3):352-7.

19. Detection of Mycobacterium tuberculosis DNA onthe oral mucosa of tuberculosis patients. Wood RC,Luabeya AK, Weigel KM, Wilbur AK, Jones-EngelL, Hatherill M, Cangelosi GA. Sci Rep. 2015 Mar2;5:8668.

20. A Review and Proposed Approach to theNeutrophilic Dermatoses of Childhood. WebbK, Hlela C, Jordaan HF, Suliman S, Scriba T,Lipsker D, Scott C. Pediatr Dermatol. 2015 Jul-Aug;32(4):437-46.

21. T cells and adaptive immunity to Mycobacteriumtuberculosis in humans. Jasenosky LD, Scriba TJ,Hanekom WA, Goldfeld AE. Immunol Rev. 2015Mar;264(1):74-87.

22. The dynamics of QuantiFERON-TB gold in-tubeconversion and reversion in a cohort of SouthAfrican adolescents. Andrews JR, Hatherill M,Mahomed H, Hanekom WA, Campo M, Hawn TR,Scriba TJ. Am J Respir Crit Care Med. 2015 Mar1;191(5):584-91.

23. The impact of HIV exposure and maternalMycobacterium tuberculosis infection on infantimmune responses to bacille Calmette-Guérinvaccination. Jones CE, Hesseling AC, Tena-CokiNG, Scriba TJ, Chegou NN, Kidd M, Wilkinson RJ,Kampmann B. AIDS. 2015 Jan 14;29(2):155-65.

24. Qualification of a whole blood intracellular cytokinestaining assay to measure mycobacteria-specificCD4 and CD8 T cell immunity by flow cytometry.Kagina BM, Mansoor N, Kpamegan EP, Penn-

Nicholson A, Nemes E, Smit E, Gelderbloem S, Soares AP, Abel B, Keyser A, Sidibana M, Hughes JE, Kaplan G, Hussey GD, Hanekom WA, Scriba TJ. J Immunol Methods. 2015 Feb;417:22-33.

25. Differential leukocyte counting and immunophenotyping in cryopreserved ex vivo whole blood. Nemes E, Kagina BM, Smit E, Africa H, Steyn M, Hanekom WA, Scriba TJ. Cytometry A. 2015 Feb;87(2):157-65.

26. Combined use of Mycobacterium tuberculosis-specific CD4 and CD8 T-cell responses is a powerful diagnostic tool of active tuberculosis. Rozot V, Patrizia A, Vigano S, Mazza-Stalder J, Idrizi E, Day CL, Perreau M, Lazor-Blanchet C, Ohmiti K, Goletti D, Bart PA, Hanekom W, Scriba TJ, NicodL, Pantaleo G, Harari A. Clin Infect Dis. 2015 Feb1;60(3):432-7.

27. Relationship between female genital tract infections, mucosal interleukin-17 production and local T helper type 17 cells. Masson L, Salkinder AL, Olivier AJ, McKinnon LR, Gamieldien H, Mlisana K, Scriba TJ, Lewis DA, Little F, Jaspan HB, Ronacher K, Denny L, Abdool Karim SS, Passmore JA. Immunology. 2015 Dec;146(4):557-67.

28. Antiviral Innate Immune Activation in HIV-Infected Adults Negatively Affects H1/IC31-Induced Vaccine-Specific Memory CD4+ T cells. Lenz N, Schindler T, Kagina BM, Zhang JD, Lukindo T, Mpina M, Bang P, Kromann I, Hoff ST, Andersen P, Reither K, Churchyard GJ, Certa U, Daubenberger CA. Clin Vaccine Immunol. 2015 Jul;22(7):688-96.


postgraduate students and postdoctoral fellows

Dr Munyaradzi Musvosvi obtained his PhD, December 2015.SATVI students participated in the 46th Union World Conference on Lung Health from 2–6 December 2015.

The SATVI Postdoctoral research team was involved with a series of workshops aimed at school pupils, teaching them the sciences of TB and TB vaccine development, in conjunction with the Clinical Infectious Diseases Research Initiative (CIDRI).

Dr Adam Penn-Nicholson presented a workshop at the Shanghai International School about TB and the work that SATVI does – May 2015.

SATVI attracts students from

mainly Africa and Europe, who

want to study tuberculosis within

a clinical research environment.

In 2015, SATVI took in one BSc

Honours, four MPhil, two MSc

and two PhD students, as well

as 8 postdoctoral research

fellows.


satvistaff


During 2015 we organised the following initiatives/

activities to either develop staff or involve staff in the

local community:

• BrightSparksInnovationProgram

• StaffWellnessProgram

• Women’sDay

• CasualDay

• CANSATea

• CommemoratingMandelaDay

• SecretaryandBossesDay

• QuarterlyStaffMeetingsandTeambuildingto

promote communication, teambuilding, cooperation

and cohesion.

• TrainingofHealthandSafetyCommittees

• ParticipationintheUnionWorldConferenceon

Lung Health

Work session during quarterly staff meeting, May 2015. Sister Rachel Oelofse knitted a blanket which was raffled to raise funds for Mandela Day. The proceeds were used to support local causes SATVI had identified.

Staff who attended the Union World Conference on Lung Health, 2–6 December 2015.

Staff Wellness Day, November 2015.

SATVI staff who celebrated Nurses Day on 12 May 2015.


During the year under review we have sustained our involvement in the

Cape Winelands community through several initiatives, including:

MANDELA DAY

For Mandela Day, we supported the establishment of a Victim Support

Centre at the Maria Pieterse Clinic, the donation of equipment to the

Cornerstone Therapeutic Centre (Drug Rehabilitation Centre), Brave

Hearts Care Centre for children and Zwelethemba Book Club. Staff also

donated goods and toys from their own coffers which we donated to the

Brave Heart Centre in De Doorns.

Handing over equipment to Victim Support Centre, Maria Pieterse Clinic, Worcester.

community involvement


For World TB Day we partnered with AERAS to bring the

Kick TB Progam to schools in the Worcester area and held

a Kick TB Wellness Program on Saturday 28 March 2015

in Zwelethemba.

SCHOOL TB AWARENESS RAISING PROGRAM – PARTNERSHIP WITH AERAS

On World TB Day, which falls on 24 March annually,

we rolled the Kick TB Program out at four (4)

schools in the Worcester area, reaching 5 000

learners with health messages about the signs and

symptoms of TB and how to prevent it. The schools

that participated in the program were Roodewal

Primary, Alfred Stamper, Avian Park Primary and

Vusisiwe Secondary School.

Kick TB Program at Vusisiwe Secondary School.

Kick TB Program at Roodewal Primary.

WORLD TB WELLNESS DAY

This year SATVI marked World TB Day with a number

of initiatives culminating in a World TB Wellness Day

which took place at the Zwelethemba Sport Stadium on

Saturday 28 March 2015.

The Kick TB Soccer tournament was launched on

Saturday 7 March 2015 in partnership with the South

African Football Association (SAFA), which saw soccer

clubs in the under 13, 15 and 17 categories playing

against each other with six (6) teams emerging to play

against each other for the Kick TB Cup on Saturday

28 March 2015. The day’s proceedings included a 3.5 km

Fun Run, Kick TB Soccer Tournament, health screening by

the Department of Health, Indigenous Games, a keynote

speech by Professor Marian Jacobs (UCT retired Dean

of Health Faculty). Local artists provided entertainment.

SATVI staff volunteered to provide essential services

like catering, health and safety, marshalling and event

management.

3.5 km Fun Run.

Soccer Tournament.

WORLD TB DAY


SATVI Laboratory Manager Simba Mabwe and Dr Katrina Downing participating in Fun Run.

Retired Dean of Health Sciences Faculty, Professor Marian Jacobs addressing audience.

Mass TB Awareness Programme.

TB AWARENESS RAISING AT WORCESTER MALL

On Friday 27 March SATVI coordinated a TB Awareness

Program at the local shopping mall which included a

screening facility by the Department of Health, information

exhibitions by organisations like the Boland Hospice,

SATVI and a local sport organisation who conducted

recruitment for a local road race.

PARTICIPATING ORGANISATIONS:The organisations who made the program a

success were:-

• CapeWinelandsDistrictMunicipality,for

providing funding.

• DepartmentofHealth,whoprovidedhealth

screening and program support.

• GovernmentCommunications(GCIS),

which assisted with marketing and

communications.

• BreedeValleyMunicipalityforprovidingthe

venue.

• SouthAfricanFootballAssociation

Winelands (SAFA), who managed the soccer

tournament.

• Privatesectordonors,whocontributed

financially and in kind to make the day a

success.

Through an information stall we distributed information about TB and the work that SATVI does.

Soccer teams played against each other for the 2015 Kick TB Cup.


community advisory boardACTG

The Boland Research CAB, which is a member of

the AIDS Clinical Trials Group (ACTG) network, an

international clinical trial organisation, participated in

the Annual ACTG Network meeting in the USA held

during June 2015. The Chairperson, Belinda Ameterra,

was elected as a member of the Site Management and

Clinical Care Committee (SMCCC), a sub-committee

of the Global CAB of ACTG.

Rural Research Days, Ukwanda Rural Health, University of Stellenbosch, Worcester.

YOUTH CAB

During 2015 the CAB has been further expanded to include

a youth CAB and the new members received training in

Good Clinical Practice.

ExTERNAL RELATIONSHIPS

During March 2015 the CAB participated in the proceedings

of the Rural Health Days organised by Ukwanda Rural

Health School (University of Stelllenbosch) presenting a

paper titled “Boland Research Community Advisory Board”.

The Boland Research CAB also participated in the founding

proceedings of the UCT Core CAB, a forum created by UCT

comprising of CAB representatives from various CAB's

within the UCT clinical research community.

The CAB also participated in a Youth Training program

hosted by Post-Doctoral students from the Clinical

Infectious Diseases Research Initiative (CIDRI) and SATVI.

A video which is a product of this project, was also

screened to the broader CAB.Dr Hennie Geldenhuys addressing CAB members.

Members of Youth CAB during GCP training.

During 2015 we supported the CAB through

structured capacity development, logistical and

administrative support.

The Community Advisory Board (CAB) serves as an

important consultation channel around the development

of consenting processes, understanding the aims of

clinical research studies conducted, the identification of

and dealing with ethical issues, and generally improving

the relationship between the community, government,

researchers and health care providers.


funders


collaborators

TUBERCULOSISFOUNDATION

To eliminate TB

!!®

DEPARTMENT OF

ENVIRONMENTAL & OCCUPATIONAL HEALTH SCIENCES

UNIVERSITY of WASHINGTONSchool of Public Health

South African Tuberculosis Vaccine Initiative (SATVI)

Institute of Infectious Disease and Molecular Medicine (IDM),

Health Sciences Faculty, University of Cape Town

Werner & Beit Building, Anzio Road, Observatory, 7925

(T) 021 – 406 6014/13/12 www.satvi.uct.ac.za

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