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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201403000646306 Date of Registration: 13/09/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title THYB-04
Official scientific title A phase II, randomized, observer-blinded, single centre trial evaluating the immunogenicity and safety of 2 doses of an adjuvated TB subunit vaccine (Ag85B-ESAT-6 + IC31®) using 2 different vaccination schedules in healthy adolescents
Brief summary describing the background and objectives of the trial The primary objectives of the study are to determine the safety and the IFN response of an adjuvated TB subunit vaccine (Ag85B-ESAT-6 + IC31®) using 2 different doses and 2 different vaccination schedules in healthy adolescents.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) THYB 04
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Prevention
Anticipated trial start date 27/08/2012
Actual trial start date 27/08/2012
Anticipated date of last follow up 19/12/2013
Actual Last follow-up date 19/12/2013
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 240
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised ¿Simple randomisation using a radomisation table created by a computer software program ¿Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vaccine Group 1: 15 ug (day 0) + 15 ug (day 56) 8 months 60
Experimental Group vaccine Group 2: 50 ug vaccine (day 0) + 50 ug vaccine (day 56) 8 months 60
Experimental Group vaccine + placebo Group 3: 15 ug vaccine (day 0) + placebo (day 56) 8 months 60
Experimental Group vaccine + placebo Group 4: 50 ug vaccine (day 0) + placebo (day 56) 8 months 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male or female 2. Healthy based on medical examination/history at the inclusion 3. Age 12-18 years (inclusive) 4. Signed informed consent 5. Signed informed assent 6. Prepared to grant authorized persons access to the medical records 7. If of childbearing potential, she must have abstained from sex or used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for the duration of the trial. 8. The volunteer is likely to comply with instructions 1. Confirmed current or prior active TB disease based on clinical evaluation (history, physical findings and investigations) 2. Vaccinated with any vaccine 3 months before first vaccination 3. Administration of immune modulating drugs (oral steroids, immunosuppressive drugs or immunoglobulins) (inhaled and topical steroids excluded) 4. HIV sero-positive or unwilling to be tested for HIV 5. Participation in other clinical trials involving an experimental investigational product. 6. Known hypersensitivity to any of the vaccine components 7. Laboratory parameters outside of normal range considered clinically relevant in the opinion of the investigator. 8. Female participants who will most likely fail to abstain or to use adequate contraceptive precautions for 30 days prior to vaccination, and those who will most likely fail to agree to continue adequate contraceptive precautions for the duration of the trial 9. Positive pregnancy test 10. Breast feeding females 12 Year(s) 18 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 22/06/2012 Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Cape Town South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Safety and IFN safety visit 2,5,8,9,10 IFN: visit 2,4,5,7,8,10
Secondary Outcome Secondary/exploratory immunology visit 2-10
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
SATVI, Brewelskloof Hospital Haarlem Street Worcester South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Statens Serum Institut Artillerivej 5 Copenhagen S 2300 Denmark Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Hendrik Geldenhuys Haarlem Street Worcester South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hendrik Geldenhuys hennie.geldenhuys@uct.ac.za +27233465400 HaarlemStreet
City Postal code Country Position/Affiliation
Worcester South Africa
Role Name Email Phone Street address
Public Enquiries Soren Hoff sho@ssi.dk 32683496 Artillerivej 5
City Postal code Country Position/Affiliation
Copenhagen 2300 S Denmark Statens Erum Instiut
Role Name Email Phone Street address
Scientific Enquiries Søren Hoff sho@ssi.dk 32683496 Artillerivej 5
City Postal code Country Position/Affiliation
Copenhagen 2300 S Denmark Statens Serum Institut
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