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.: PACTR201105000289276 Date of Approval: 15/04/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Phase II double-blind, randomised, placebo-controlled study the safety and immunogenicity of H1/IC31 (trademarked), in HIV-infected adults without TB
Official scientific title Phase II double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of H1/IC31 (trademarked), an adjuvanted TB subunit vaccine, in HIV-infected adults with CD4+ lymphocyte counts greater than 350 cells per mm cubed
Brief summary describing the background and objectives of the trial This is a Phase II, randomized, double-blind, placebo controlled trial evaluating the safety and immunogenicity of H1/IC31 (trademarked) administered to HIV-infected adult subjects with no evidence of TB disease
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 HIV/AIDS,Tuberculosis
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 10/01/2012
Actual trial start date 10/01/2012
Anticipated date of last follow up 10/09/2012
Actual Last follow-up date 10/09/2012
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Completed
Publication URL http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0114602
Secondary Ids Issuing authority/Trial register
Medicines Control Council N2/8/19/2 (2593) #20110301
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 Computer generated randomisation codes. Randomisation will be performed on Study Day 0 prior to administration of study vaccine. Subjects will be randomly allocated in a 5 to 1 ratio to either vaccine or placebo arms. sealed opaque envelopes which are locked in a safe prior to distribution Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Study Vaccine H1/IC31 ,5ml per injection single injection day 1 and day 56 Two intramuscular injections 40
Control Group Placebo .5ml per injection single injection day 1 and day 56 Two intramuscular injections 8 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. TB negative 2. HIV infected 3. CD4 count greater than 350 cells per ml cubed Evidence of or suspected active TB 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 University of Witwatersrand, Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
c/o 8 Blackwood Avenue Parktown 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 17/06/2011 NIMR / MRCC
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the safety of the H1/IC31 (trademarked) TB vaccine in HIV-infected adults Day 0, 3, 14, 54, 56, 59, 70, 182
Primary Outcome To evaluate the induction of cellular and humoral immunity of the H1/IC31 (trademarked) TB vaccine in HIV-infected adults Day 0, 3, 14, 54, 56, 59, 70, 182
Secondary Outcome To describe the effect of H1/IC31 (trademarked) TB vaccine in HIV-infected adults on CD4+ lymphocyte counts Day 0, 14, 56, 70, 182
Secondary Outcome To describe the effect of H1/IC31 (trademarked) TB vaccine in HIV-infected adults on HIV viral loads Day 0, 14, 56, 70, 182
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Aurum Institute,Tembisa Hospital Cnr. Flint Mazibuko & Rev RJ Namane Drive Tembisa 1736 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP P.O. Box 93015 The Hague 2509 AA Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Statens Serum Institut Orestads Boulevard, 5 Copenhagen S Denmark Commercial Sector/Industry
Primary Sponsor Statens Serum Institut 5, Artillerivej Copenhagen S DK-2300 Denmark Charities/Societies/Foundation
Secondary Sponsor EDCTP P.O. Box 93015 The Hague 2509 AA Netherlands Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr Klaus Reither Ifakara Health Institute / Bagamoyo Research and Training Centre Bagamoyo 0000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nicolene Gardiner rwills@auruminstitute.org +27 10 590 1399 The Aurum Institute, Tembisa Hospital
City Postal code Country Position/Affiliation
Orangeview, Tembisa 0000 South Africa Principal Investigator
Role Name Email Phone Street address
Public Enquiries Gavin Churchyard gchurhyard@auruminstitute.org 010 590 1300 29 Queens Road
City Postal code Country Position/Affiliation
Parktown, Johannesburg 2011 South Africa Responsible Contact Person (public)
Role Name Email Phone Street address
Scientific Enquiries Trevor Beattie tbeattie@auruminstitute.org +27 (0) 10 590 1319 29 Queens Road
City Postal code Country Position/Affiliation
Parktown, Johannesburg 2193 South Africa Research Project Manager
REPORTING
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