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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: www.pactr.org

Trial no.: PACTR201203000306280 Date registered: 2011/06/23
TRIAL DESCRIPTION
Public title Phase II, AERAS-402 in BCG Vaccinated Infants
Official scientific title A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter, Proof-of-concept Study to Evaluate the Safety and Efficacy of AERAS-402 in BCG-vaccinated, HIV-uninfected Infants Without Evidence of Tuberculosis
Brief summary describing the background
and objectives of the trial
AERAS-402 presents Mycobacterium tuberculosis antigens in the setting of new, live, replication-deficient adenovirus vaccine that may increase T cell-mediated immunity and thus protection from TB. Since BCG-vaccinated infants are the population for which AERAS-402 may be indicated, AERAS-402 will be given to infants at least 16 weeks old who have already received BCG. This study will include a dose-finding phase followed by a safety and efficacy phase at a selected dose of AERAS-402
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Tuberculosis ,
Purpose of the trial Prevention
Anticipated trial start date 2010-05-07
Actual trial start date 2010-10-07
Anticipated date of last follow up 2012-12-31
Actual date of last follow up
Anticipated target sample size (number of participants) 4192   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
C-029-402

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 then stratified (by site and HIV exposure status) Central randomisation by phone/fax Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group AERAS-402 2 injections, 28 days apart Study day 0 and study day 28 Vaccine 2144
Control group Placebo 2 injections, 28 days apart Study day 0 and study day 28 Placebo 2048 Placebo

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Subjects must meet all of the following criteria at the time of subject ID assignment: 1. Parent/legal guardian has completed the written informed consent process 2. Is age ¿112 days (16 weeks) and ¿182 days (26 weeks) on Study Day 0 3. Has general good health, confirmed by medical history and physical examination 4. Is up to date on all EPI immunizations for his/her age with a minimum of 14 days between the last EPI vaccination and administration of study vaccine on Study Day 0 5. Known HIV status of subject's biological mother, as determined at screening unless there is prior written documentation of maternal HIV infection, or written documentation of a negative HIV test result on a sample obtained from the mother within 28 days prior to their baby's enrollment; HIV-infected women who are breastfeeding an infant enrolled in the study must be on HAART 6. Has ability to complete follow-up period as required by the protocol 7. Parent/legal guardian is able and willing to stay in contact with the study site for the duration of the study and to provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study 8. Has completed simultaneous enrollment in Aeras Vaccine Development Registry protocol 9. Had BCG vaccination ¿ 3 months prior to randomization documented by medical card Subjects must have none of the following at the time of subject ID assignment: 1. Acute illness, evidence of any significant active infection or temperature ¿37.5°C on the day of randomization 2. Used immunosuppressive medication within 45 days before entry into the study (inhaled and topical corticosteroids are permitted) 3. Received immunoglobulin or blood products within 45 days before entry into the study 4. Ever received any investigational drug therapy or investigational vaccine 5. History or laboratory evidence of human immunodeficiency virus (HIV) infection 6. History of allergic disease or reactions to any component of the study vaccine 7. Previous medical history that may compromise the safety of the participant in the study 8. Evidence of a new acute illness that may compromise the safety of the participant in the study 9.Inability to discontinue daily medications during the study, except for breastfeeding HIV-exposed infants who will be allowed to continue on cotrimoxazole prophylaxis during the study. 10.History or evidence of any systemic disease on physical examination or any acute or chronic illness that may interfere with the evaluation of the safety or immunogenicity of the vaccine, e.g., including masses between the leg and abdomen (e.g., inguinal hernia or lymphadenopathy) 11. History or evidence of active tuberculosis 12. A positive or indeterminate QuantiFERON®¿TB Gold In-Tube test on Study Day 0 13. A household contact with active TB disease 112 Days 182 Days 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 2010/04/29 KEMRI/National Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
1578 Busia Road Kisumu 40100 Kenya
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 2010/06/17 US CDC IRB
Ethics Committee Address
Street address City Postal code Country

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Tb Disease When there is a medical suspicion of TB disease and when a household contact is identified with TB disease.

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya Medical Research Institute (KEMRI) 1578 Busia Road Kisumu 40100 Kenya

FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation United States of America
European and Developing Countries Clinical Trials Partnership P.O. Box 93015 The Hague 2509 AA Netherlands
DGIS PO Box 20061 The Hague 2500 EB Netherlands

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aeras 1405 Research Boulevard Rockville 20850 United States of America Foundation

COLLABORATORS
Name Street address City Postal code Country
US NIH Bethesda United States of America
Crucell P.O. Box 2048 Leiden 2301 CA Netherlands

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Videlis Nduba vnduba@ke.cdc.gov +254 724 522 474 +254 572 022 981
Street address City Postal code Country Position / Affiliation
1578 Busia Road Kisumu 40100 Kenya
Role Name Email Phone Fax
Public Enquiries Ms Annmarie Leadman aleadman@aeras.org +1.240-599-3018 +13015472901
Street address City Postal code Country Position / Affiliation
1405 Research Boulevard Rockville 20850 United States of America Director of Communications
Role Name Email Phone Fax
Scientific Enquiries Dr Bruce McClain bmcclain@aeras.org +1 301 547 2913 +1 301 547 2901
Street address City Postal code Country Position / Affiliation
1405 Research Boulevard Rockville 20850 United States of America Chief Medical Officer, Aeras
Role Name Email Phone Fax
Public Enquiries Ms Annmarie Leadman aleadman@aeras.org +1240-599-3018 +13015472901
Street address City Postal code Country Position / Affiliation
1405 Research Boulevard Rockville 20850 United States of America Director of Communications