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.: PACTR201311000639144 Date of Approval: 06/09/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Study to evaluate the efficacy of GlaxoSmithKline (GSK) Biologicals candidate tuberculosis (TB) vaccine in adults
Official scientific title Efficacy of GSK Biologicals candidate tuberculosis (TB) vaccine GSK 692342 against TB disease, in adults living in a TB endemic region
Brief summary describing the background and objectives of the trial The purpose of this study is to evaluate the protective efficacy of two doses of GSK Biologicals candidate TB vaccine against pulmonary TB, as compared to placebo. The efficacy will be evaluated in adults living in TB endemic countries and aged 18 - 50 years because pulmonary TB occurs frequently in these countries and age range. In addition, the safety and immunogenicity of the candidate tuberculosis vaccine will be evaluated in a subset of volunteers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 18/09/2013
Actual trial start date 19/08/2014
Anticipated date of last follow up 31/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 3506
Actual target sample size (number of participants) 3738
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
115616 Protocol Number
NCT01755598 Clinical Trials.gov
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Central randomization system on Internet Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tuberculosis vaccination 2 Subjects will receive 2 doses of the candidate tuberculosis vaccine (Day 0 and Day 30) 1753
Control Group Placebo 2 Subjects will receive 2 doses of placebo (Day 0 and Day 30) 1753 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. -A male or female between, and including, 18 and 50 years of age at the time of obtaining informed consent. -Written (or thumb printed and witnessed) informed consent obtained from the subject. -Baseline positive IGRA test result. -Baseline negative HIV screen. -Baseline negative clinical screening questionnaire and negative sputum sample for Pulmonary TB disease. -Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination. -Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. -Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 25 days prior to vaccination, and has a negative pregnancy test on the day of screening and the day of first vaccination, and has agreed to continue adequate contraception during the entire vaccination period and for 2 months after completion of the vaccination series. -Current TB disease or history of TB disease and/or treatment for TB. -Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. -Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each dose of vaccine. -History of previous administration of experimental Mtb vaccines. -Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.Inhaled and topical steroids are allowed. -Any condition or illness or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine. -Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. -Planned participation or participation in another experimental protocol during the study. -Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. -Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. -History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. -History of medically confirmed autoimmune disease. -Pregnant or lactating female. -Female planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination period and/or before 2 months after completion of the vaccination series. 18 Year(s) 50 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 26/10/2012 WITS Health Consortium Ethics Committee
Ethics Committee Address
Street address City Postal code Country
8 Blackwood Avenue, Parktown Johannesburg South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incident cases of Definite Pulmonary TB disease not associated with HIV-infection, meeting the first case definition. Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36).
Secondary Outcome Incident cases of Definite Xpert MTB/Rif positive Pulmonary TB disease not associated with HIV-infection, meeting the second case definition. Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36).
Secondary Outcome Incident cases of Definite Pulmonary TB disease meeting the third case definition. Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36).
Secondary Outcome Incident cases of Definite Pulmonary TB disease meeting the fourth case definition. Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36).
Secondary Outcome Incident cases of Clinical TB disease meeting the fifth case definition. Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36).
Secondary Outcome Occurrence of Serious Adverse Events (SAEs). During the entire study period (Day 0 to Month 36).
Secondary Outcome Occurrence of unsolicited Adverse Events (AEs). During the 30-day follow-up period following vaccination (Day of vaccination and 29 subsequent days).
Secondary Outcome Occurrence of solicited local and general AEs in the safety and immune sub-cohort. During the 7-day follow-up period following vaccination (day of vaccination and 6 subsequent days after each vaccine dose).
Secondary Outcome Occurrence of all potential Immune-Mediated Diseases (pIMDs). Over a period starting at Day 0 until 6 months post dose 2 (Month 7).
Secondary Outcome Occurrence of grade greater or equal to 2 haematological and biochemical levels in the safety and immune sub-cohort. Days 0, 7, 30 and 37.
Secondary Outcome Evaluation of cell-mediated immune (CMI) responses with respect to components of the study vaccine, in the safety and immune sub-cohort. Prior to dose 1 (Day 0), 1 month post dose 2 (Day 60) and Years 1, 2 and 3.
Secondary Outcome Evaluation of humoral immune responses with respect to components of the study vaccine, in the safety and immune sub-cohort. Prior to dose 1 (Day 0), 1 month post dose 2 (Day 60) and Years 1, 2 and 3.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Setshaba Research Centre 2088 Block H Soshanguve 0152 South Africa
AURUM Institute Gavin J Churchyard Legacy Centre, 201 Jade Square Centre Cnr OR Tambo and Margaretha Prinsloo streets Klerksdorp 2571 South Africa
KEMRI Siaya Research Centre, Kemri Kisumu Kenya
ZAMBART Zambart Project, Ridgeway Campus Lusaka Zambia
SATVI Institute of Infectious Disease and Molecular Medicine (IIDMM), Wernher & Beit North Wing, UCT Faculty of Health Sciences, Anzio Road, Observatory Cape Town 7925 South Africa
Centre for Infection Disease research in Zambia (CIDRZ) Kalingalinga Research Site, Counting House Unit A TB Project, Thabo Mbeki Road Lusaka Zambia
TASK Task Applied Science M2, Karl Bremer Hospital, Mike Pienaar Boulevard Bellville 7530 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
GlaxoSmithKline Rue de l'Institut 89 Rixensart 1330 Belgium
Aeras 1405 Research Blvd Rockville, MD 1405 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor GlaxoSmithKline Biologicals Rue de l'Institut 89 Rixensart 1330 Belgium Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Aeras 1405 Research Blvd Rockville, MD 20850 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Clinical Disclosure Advisor GSKClinicalSupportHD@gsk.com 001-877-379-3718 Rue de l¿Institut, 89
City Postal code Country Position/Affiliation
Rixensart 1330 Belgium Clinical Disclosure Advisor
Role Name Email Phone Street address
Public Enquiries Clinical Disclosure Advisor GSKClinicalSupportHD@gsk.com 001-877-379-3718 Rue de l¿Institut, 89
City Postal code Country Position/Affiliation
Rixensart 1330 Belgium Clinical Disclosure Advisor
Role Name Email Phone Street address
Scientific Enquiries Clinical Disclosure Advisor GSKClinicalSupportHD@gsk.com 001-877-379-3718 Rue de l¿Institut, 89
City Postal code Country Position/Affiliation
Rixensart 1330 Belgium Clinical Disclosure Advisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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