Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202312739012205 Date of Approval: 13/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sisonke Boost Open Label Study
Official scientific title Open-label, single-arm phase 3B implementation study to evaluate the effectiveness of the homologous boost of Ad26.COV2.S COVID-19 vaccine following the prime dose among Sisonke participants in South Africa (VAC31518COV30XX)
Brief summary describing the background and objectives of the trial At the conception of this study the second and third Covid-19 waves had ensued and were fueled by variant viruses (Beta then Delta), which had increased transmissibility by about 50% and had an impact on vaccine efficacy. South African researchers and policy makers were leading the way in contributing to the international COVID-19 response by conducting several vaccine trials and informing global understanding of the importance of new viral variants. The serious concern was that new variants may have less sensitivity to the vaccines currently in production. The current study is an open-label, single-arm phase 3B vaccine implementation study. The overall goal will be to monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine as a booster shot at least 2 months after the prime Ad26 vaccination on severe COVID, hospitalizations and deaths among Sisonke participants in South Africa. The Vaccine effectiveness (VE) of those who receive the Janssen (homologous boost) will be compared with Sisonke participants who elect not to be boosted at all and with unvaccinated South Africans who are also essential workers. The outcomes assessed will include; hospitalizations and deaths, diversity of breakthrough infections, vaccine boost uptake and incidence of severe SARS CoV-2 infections. Primary Objectives: To assess the effectiveness of Ad26.COV2.S (Janssen) boost vaccine on severe COVID, hospitalizations and deaths in Sisonke participants as compared to unboosted Sisonke participants (single Ad26 vaccine only). Secondary objectives: To assess the effectiveness of Ad26.COV2.S (Janssen) boost vaccine on severe COVID, hospitalizations and deaths in Sisonke participants as compared to the vaccinated and unvaccinated populations (no vaccination) in South Africa. To estimate the incidence of symptomatic SARS CoV-2 infections among boosted Sisonke participants. To monitor the genetic diversity of breakthrough SARS CoV-2 infections. To estimate booster vaccine upt
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) Sisonke Boost
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Covid-19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/11/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 01/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 500000
Actual target sample size (number of participants) 240747
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ad26.COV2.S Ad26.COV2.S by Janssen administered as a single dose followed by a single booster injection Participants will receive a homologous Ad26.COV2.S booster dose of vaccine at least 6 months post the prime vaccination. Ad26.COV2.S is a monovalent vaccine composed of a recombinant, replication-incompetent adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein. 240747
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 18 and older All Sisonke participants Received a priming Ad26.SARS.COV.2.S vaccination as part of the Sisonke study Participants who are pregnant or report breastfeeding at the time of enrolment may be included. Willingness and ability to comply with vaccination plan and other study procedures. Capable of giving electronic or personal signed informed consent as described, which includes compliance with the requirements in this protocol. Participants who have received boosting vaccination through other means. Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant• Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee. Participants with a history of heparin-induced thrombocytopenia or thrombosis with thrombocytopenia syndrome (TTS) The following participants will be strongly advised to discuss their participation with their practitioner/ health provider and/or the Sisonke safety desk and/or the site PI. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine. Participants who are thought to have suffered a neurological adverse event considered related to the priming Janssen Covid-19 vaccine. Participants reporting a non-infective SAE within the first 28 days following the priming dose of Janssen Covid-19 vaccine in the Sisonke 3B trial 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 105 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/11/2021 UKZN The Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
BREC, Research Office, UKZN, Research Office Govan Mbeki Centre Westville Campus Durban Durban 4000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/11/2021 University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E53 Room 46, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/11/2021 University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E53 Room 46, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/11/2021 University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E53 Room 46, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/11/2021 University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E53 Room 46, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/11/2021 UKZN The Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
BREC, Research Office, UKZN, Research Office Govan Mbeki Centre Westville Campus Durban Durban 4000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/11/2021 Human Research Ethics Committee Medical University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
31 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/11/2021 Health Research Ethics Committee 2 Stellenbosch University Faculty of Health Sciences
Ethics Committee Address
Street address City Postal code Country
Health Research Ethics Committee 2 Stellenbosch University Faculty of Health Sciences Cape Town 7600 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/10/2021 Sefako Makgatho University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Molotlegi Street, Ga-Rankuwa, Pretoria Pretoria 0204 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/11/2021 SAMRC Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Drive, Parowvallei Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/11/2021 Pharma Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road Lyttelton Manor Ext 3 Centurion Pretoria 0157 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the effectiveness of Ad26.COV2.S vaccine as a homologous boost on severe COVID, hospitalizations and deaths in Sisonke participants as compared with the unboosted Sisonke populations. Post-booster vaccination
Secondary Outcome To assess the effectiveness of Ad26.COV2.S vaccine as a homologous boost on severe COVID, hospitalizations and deaths in Sisonke participants as compared vaccinated and unvaccinated populations of essential workers in South Africa. Throughout follow-up period
Secondary Outcome To estimate the incidence of symptomatic SARS CoV-2 infections in Sisonke participants following a boost compared with the unboosted Sisonke populations and general vaccinated and unvaccinated population in South Africa Throughout follow-up period
Secondary Outcome To estimate booster dose uptake among Sisonke participants in South Africa Throughout Sisonke 1 follow-up period
Secondary Outcome To monitor the genetic diversity of breakthrough SARS CoV-2 infections. Throughout follow-up period
Secondary Outcome To monitor safety in the case of homologous boosts in Sisonke participants Throughout follow-up period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
PHOENIX Pharma 2 Eastbourne Road, Mount Croix, Port Elizabeth 6000 South Africa
Desmond Tutu Health Foundation Clinical Trials Unit J52 Old Main Building, Groote Schuur Hospital, Cape Town 7925 South Africa
TASK Applied Science 1 De Lange Street, Bellville, Cape Town 7530 South Africa
PHRU Kliptown Walter Sisulu Cebtre, Soweto Johannesburg 2000 South Africa
FAMCRU Tygerberg Academic Hospital, Francie van Zijl Drive Parow Valley 7505 South Africa
Chatsworth Clinical Research Centre R.K. Khan Circle Chatsworth 4030 South Africa
JOSHA Research Centre 28 East Burger Street Bloemfontein 9300 South Africa
Setshaba Research Centre 2088 Block H Soshanguve 0152 South Africa
The Aurum Institute Tembisa Cnr Rev RTJ Namane and Flint Mazibuko Drive, Tembisa 1632 South Africa
Qhakaza Mbokodo Research Centre 15 Parklane, Mkhamba Gardens, Ladysmith Ladysmith 3370 South Africa
The Aurum Institute Klerksdorp Jade Square Centre, Cnr Margaretha Prinsloo and OR Tambo Drive Klerksdorp 2571 South Africa
Aurum Institute Rustenburg 50 Steen Street, Cnr Pretorius Stree Rustenburg 0299 South Africa
Emavundleni Research Centre 14 Sonwabile Drive, Old Crossroads, Klipfontein Cape Town 7750 South Africa
Synexus Stanza 02 Shilovhane street, Mamelodi East, Pretoria 0122 South Africa
ThembaLethu CHRU Helen Joseph Hospital, Perth Road, Westdene Johannesburg 2000 South Africa
CAPRISA Ethekwini Warwick Avenue, Berea Durban 4001 South Africa
Desmond Tutu Health Foundation Guinea Fowl Road, Sunnydale Cape Town 7975 South Africa
PHRU Baragwanath Hospital Chris Hani Baragwanath Academic Hospital, Chris Hani Road, Soweto 1862 South Africa
Khayelitsha CRS Site B CHC, 98 Sulani Drive Khayelitsha 7784 South Africa
Tongaat HPRU SAMRC 12-14 Tesco Drive, Tongaat 4400 South Africa
SATVI Brewelskloof Hospital Haarlem Worcester 6850 South Africa
CAPRISA Vulindlela Mafakatini Primary Healthcare Clinic, Road P402, Ward 9, uMgungundlovu District Durban 4000 South Africa
Bothas Hill CRS No. 1 Zulu Road, Valley Trust, Bothas Hill 3660 South Africa
Synexus Watermeyer 60 Stamvrug Street, Val de Grace, Pretoria 0184 South Africa
Synexus Helderberg Suite 7G and H Arun Place, Sir Lowrys Pass Road Somerset West 7130 South Africa
NeMACRU Sir Henry Elliot Hospital, 17 Hospital Road, Mthatha 5099 South Africa
MECRU CRS Sefako Makgatho Health Science University, Medunsa Ga Rankuwa 0204 South Africa
Mzansi Ethical Research Centre 184 Cowen Ntuli Street Middleburg 1055 South Africa
Ndlovu Research Centre Plot 1140 Elandsdoorn Dennilton 0470 South Africa
Shandukani Research Centre Hillbrow Health Precinct, Corner Esselen Street and Klein Street, Hillbrow Johannesburg 2001 South Africa
The Aurum Institute Pretoria Ditsela Place Jan Shoba St Hatfield Pretoria 0028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
SAMRC Francie van Zijl Drive, Parowvallei, Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council Francie van Zijl Drive, Parowvallei Cape Town 7505 South Africa Other Collaborative Groups
Secondary Sponsor Fred Hutchinson Cancer Research Center 1100 Fairview Ave, Seattle Seattle WA 98109 United States of America Funding Agency
Secondary Sponsor NDOH Building A, Loftus Park 2nd Floor 405 Kirkness Stree Pretoria 0001 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
National Department of Health of South Africa National Department of Health Civitas Building Cnr Thabo Sehume and Struben Streets Pretoria Pretoria 0001 South Africa
National Institute of Communicable Diseases 1 Modderfontein Road, Sandringham Johannesburg 2131 South Africa
KwaZulu Natal Research Innovation and Sequencing Platform KwaZulu Natal Research Innovation and Sequencing Platform UKZN Durban Durban 4001 South Africa
Fred Hutchinson Cancer Research Center 1100 Fairview Ave N Seattle Seattle United States of America
Hutchinson Center Research Institute of South Africa Chris Hani Baragwanath Academic Hospital Soweto Johannesburg 2196 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Glenda Gray glenda.gray@mrc.ac.za +27123398524 Francie van Zijl Drive, Parowvallei,
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa National Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Linda Gail Bekker linda-gail.bekker@hiv-research.org.za +27216506970 The Desmond Tutu HIV Centre University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa National Principal Investigator
Role Name Email Phone Street address
Principal Investigator Daniel Malan niel.malan@phoenixpharma.co.za +27413733832 Phoenix Pharma, 2 Eastbourne Road, Mount Croix
City Postal code Country Position/Affiliation
Port Elizabeth 6001 South Africa PI
Role Name Email Phone Street address
Principal Investigator Sheetal Kassim Sheetal.Kassim@hiv-research.org.za +27214066958 Desmond Tutu Health Foundation Clinical Trials Unit, J52 Old Main Building, Groote Schuur Hospital, Main Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa PI
Role Name Email Phone Street address
Principal Investigator Andreas Diacon ahd@task.org.za +27219171226 TASK Applied Science, Central, 1 De Lange Street, Bellville
City Postal code Country Position/Affiliation
Cape Town 7530 South Africa PI
Role Name Email Phone Street address
Principal Investigator Erica Lazarus lazaruse@phru.co.za +271134240754 PHRU Kliptown, Office no. 7, Walter Sisulu Square, Corner Union and Klipspruit Valley Roads, Kliptown
City Postal code Country Position/Affiliation
Soweto 1805 South Africa PI
Role Name Email Phone Street address
Principal Investigator Shaun Barnabas barnabas@sun.ac.za +27219384292 FAMCRU, Ward J8, Tygerberg Academic Hospital, Francie van Zijl Drive, Parow Valley,
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa PI
Role Name Email Phone Street address
Principal Investigator Logashvari Naidoo logashvari.naidoo@mrc.ac.za +27314014150 HPRU Chatsworth, R.K. Khan Circle,
City Postal code Country Position/Affiliation
Chatsworth 4030 South Africa PI
Role Name Email Phone Street address
Principal Investigator Johannes Lombaard josha.research@power4u.co.za +27514128160 Josha Research, 28 East Burger Street,
City Postal code Country Position/Affiliation
Bloemfontein 9300 South Africa PI
Role Name Email Phone Street address
Principal Investigator Khatija Ahmed kahmed@setshaba.org.za +27127992422 Setshaba Research Centre, 2088 Block H
City Postal code Country Position/Affiliation
Soshanguve 0152 South Africa PI
Role Name Email Phone Street address
Principal Investigator Kathryn Mngadi kmngadi@auruminstitute.org +27605031870 Aurum Institute, Clinic 4, cnr Rev RTJ Namane and Flint Mazibuko Drive, Hospital View
City Postal code Country Position/Affiliation
Tembisa 1632 South Africa PI
Role Name Email Phone Street address
Principal Investigator Craig Innes cinnes@auruminstitute.org +27871351616 Aurum Institute, 201 Jade Square Centre, Cnr Margaretha Prinsloo and OR Tambo Drive
City Postal code Country Position/Affiliation
Klerksdorp 2571 South Africa PI
Role Name Email Phone Street address
Principal Investigator Lawrence Brumskine wbrumskine@auruminstitute.org +27871351575 Aurum Ruestenburg, First Floor, 50 Steen Street, Cnr Pretorius Street,
City Postal code Country Position/Affiliation
Rustenburg 0299 South Africa PI
Role Name Email Phone Street address
Principal Investigator Scott Mahoney lulu.nair@hiv-research.org.za +27216505851 Emavundleni Research Centre, 14 Sonwabile Drive, Old Crossroads, Klipfontein,
City Postal code Country Position/Affiliation
Cape Town 7750 South Africa PI
Role Name Email Phone Street address
Principal Investigator Sheena Kotze sheena.kotze@synexus.com +27829034743 Synexus Stanza, 02 Shilovhane street, Mamelodi East,
City Postal code Country Position/Affiliation
Pretoria 0122 South Africa PI
Role Name Email Phone Street address
Principal Investigator Sharla Badal Faesen sfaesen@witshealth.co.za +27112768800 Themba Lethu Clinic, Helen Joseph Hospital, Perth Road, Westdene,
City Postal code Country Position/Affiliation
Johannesburg 2000 South Africa PI
Role Name Email Phone Street address
Principal Investigator Nivashnee Naicker ivashnee.naicker@caprisa.org +27316550618 CAPRISA CRS Ethekwini, No. 3 Richards Road, Warwick Avenue, Berea, Durban, 4001, KwaZulu-Natal,
City Postal code Country Position/Affiliation
Durban 4001 South Africa PI
Role Name Email Phone Street address
Principal Investigator Katherine Gill katherine.gill@hiv-research.org.za +27217853121 Masiphumelele Research Office, DTHF, Guinea Fowl Road, Sunnydale, 7975
City Postal code Country Position/Affiliation
Cape Town 7975 South Africa PI
Role Name Email Phone Street address
Principal Investigator Amy Ward amyward41@gmail.com +27216505530 Khayelitsha CRS, Site B CHC, 98 Sulani Drive, Khayelitsha
City Postal code Country Position/Affiliation
Cape Town 7784 South Africa PI
Role Name Email Phone Street address
Principal Investigator Vimla Naicker vimla.naicker@mrc.ac.za +27329442208 HPRU SAMRC Tongaat, 12-14 Tesco Drive, Tongaat,
City Postal code Country Position/Affiliation
Tongaat 4400 South Africa PI
Role Name Email Phone Street address
Principal Investigator Kany Luabeya Angelique.luabeya@uct.ac.za +27233465400 SATVI, Project Office, Brewelskloof Hospital Haarlem Street
City Postal code Country Position/Affiliation
Worcester 6850 South Africa PI
Role Name Email Phone Street address
Principal Investigator Disebo Makhaza disebo.makhaza@caprisa.org +27316550687 CAPRISA Vulindlela, near Mafakatini Primary Healthcare Clinic, Road P402, Ward 9, uMgungundlovu District
City Postal code Country Position/Affiliation
Piertermaritzburg 3200 South Africa PI
Role Name Email Phone Street address
Principal Investigator Elizabeth Spooner Elizabeth.Spooner@mrc.ac.za +27317771585 SAMRC HPRU, No. 1 Zulu Road, Valley Trust, Bothas Hill, Kwa-Zulu Natal, 3660
City Postal code Country Position/Affiliation
Bothas Hill 3660 South Africa PI
Role Name Email Phone Street address
Principal Investigator Elane van Nieuwenhuizen elane.vannieuwenhuizen@synexus.com +27128037733 Synexus Watermeyer, 60 Stamvrug Street, Val de Grace, Pretoria, Gauteng, 0184
City Postal code Country Position/Affiliation
Pretoria 0184 South Africa PI
Role Name Email Phone Street address
Principal Investigator Dorothea Urbach dorothea.urbach@synexus.com +27218501039 Synexus Helderberg, Suite 7G and H Arun Place, Sir Lowrys Pass Road,
City Postal code Country Position/Affiliation
Cape Town 7130 South Africa PI
Role Name Email Phone Street address
Principal Investigator Thozama Dubula tdubula@witshealth.co.za +270745021944 NeMACRU, Sir Henry Elliot Hospital, 17 Hospital Road, Mthatha, Eastern Cape, South Africa, 5099
City Postal code Country Position/Affiliation
Mthatha 5099 South Africa PI
Role Name Email Phone Street address
Principal Investigator Maphoshane Nchabeleng maphoshane.nchabeleng@smu.ac.za +27125215667 MeCRU, Sefako Makgatho Health Science University, Medunsa
City Postal code Country Position/Affiliation
Pretoria 0204 South Africa PI
Role Name Email Phone Street address
Principal Investigator Friederick Petrick fgpetrick@merc.za.net +27132825218 MERC,184 Cowen Ntuli Street
City Postal code Country Position/Affiliation
Middleburg 1055 South Africa PI
Role Name Email Phone Street address
Principal Investigator Rebone Maboa rmaboa@ndlovu.com +27139838700 Ndlovu Research Centre, Plot 1140 Elandsdoorn
City Postal code Country Position/Affiliation
Dennilton 0470 South Africa PI
Role Name Email Phone Street address
Principal Investigator Faeezah Patel FPatel@wrhi.ac.za +27113585300 Shandukani Research Centre, 2nd Floor, Hillbrow Health Precinct, Cnr Esselen Street and Klein Street
City Postal code Country Position/Affiliation
Johannesburg 2001 South Africa PI
Role Name Email Phone Street address
Principal Investigator Coert Grobbelaar email@auruminstitute.org +27105901800 Aurum Institute, Pretoria, Ditsela Place Jan Shoba St Hatfield
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa PI
Role Name Email Phone Street address
Principal Investigator Philippus Kotze plkotze@gmail.com +27366312372 Qhakaza Mbokodo Research Clinic, 15 Parklane, Mkhamba Gardens
City Postal code Country Position/Affiliation
Ladysmith 3370 South Africa PI
Role Name Email Phone Street address
Principal Investigator Erica Lazarus laherf@phru.co.za +27119899720 New Nurses Home, Chris Hani Baragwanath Academic Hospital, Chris Hani Road
City Postal code Country Position/Affiliation
Soweto 1862 South Africa PI
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The results of the trial will be shared with trial participants in a manner clearly stipulated by the protocol team. The Study Report will also be made available in line with the country, international and sponsor regulations. At this point what this entails is that only the protocol team and regulatory authorities will have access to de-identified data through the use of trial-specific participant IDs. The study protocol as well as the Statistical Analysis Plan (SAP) can be made available. The Clinical Study Report (CSR) will be submitted to the regulatory authority and research ethics committees in line with local regulatory requirements. The data analysis will be analysed by the protocol team to meet the study requirements in de-identified format and no other external bodies that did not take part in the study will have access to the study data – unless prior sponsor and ethics committee permission was sought. Any requests for data use beyond the study closure will have to be directed to the study sponsor for processing bearing in mind that only de-identified data will be available at that point forth. Clinical Study Report,Statistical Analysis Plan,Study Protocol 3 years Final Study Report from the protocol team
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://sanctr.samrc.ac.za/TrialURLHyperlinksDisplay.aspx?TrialID=5755 No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information