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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201105000289276 |
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Date of registration:
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15/04/2011 |
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Primary sponsor: |
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Public title:
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Phase II double-blind, randomised, placebo-controlled study the safety and immunogenicity of H1/IC31 (trademarked), in HIV-infected adults without TB
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Scientific title:
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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 |
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Date of first enrolment:
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2012-01-10 |
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Target sample size:
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48 |
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Recruitment status: |
Closed to recruitment: follow up complete |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201105000289276 |
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Study type:
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interventional |
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Study design:
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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,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Lesego
Khantsi |
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Address:
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29 Queens Road
2011
Parktown, Johannesburg
South Africa |
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Telephone:
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011 926 8445 |
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Email:
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lkhantsi@auruminstitute.org |
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Affiliation:
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Research contact person |
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Name:
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Gavin
Churchyard |
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Address:
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29 Queens Road
2011
Parktown, Johannesburg
South Africa |
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Telephone:
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010 590 1300 |
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Email:
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gchurhyard@auruminstitute.org |
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Affiliation:
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Responsible Contact Person (public) |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. TB negative
2. HIV infected
3. CD4 count greater than 350 cells per ml cubed
Exclusion criteria: Evidence of or suspected active TB
Age minimum:
18 Year
Age maximum:
50 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
null
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Primary Outcome(s)
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To evaluate the induction of cellular and humoral immunity of the H1/IC31 (trademarked) TB vaccine in HIV-infected adults
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To evaluate the safety of the H1/IC31 (trademarked) TB vaccine in HIV-infected adults
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Secondary Outcome(s)
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To describe the effect of H1/IC31 (trademarked) TB vaccine in HIV-infected adults on CD4+ lymphocyte counts
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To describe the effect of H1/IC31 (trademarked) TB vaccine in HIV-infected adults on HIV viral loads
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Source(s) of Monetary Support
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EDCTP
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Statens Serum Institut
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