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A Study of MVA85A in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00953927
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : December 12, 2013
Last Update Posted : May 24, 2016
Sponsor:
Collaborators:
University of Oxford
University of Cape Town
Information provided by (Responsible Party):
Aeras

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Tuberculosis
Interventions: Biological: MVA85A/AERAS-485
Biological: Candida Skin Test Antigen

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Investigational Vaccine MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
Control Group Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.

Participant Flow:   Overall Study
    Investigational Vaccine   Control Group
STARTED   1399   1398 
COMPLETED   1294   1303 
NOT COMPLETED   105   95 
Lost to Follow-up                61                65 
Withdrawal by Subject                36                25 
Death                7                4 
Other study discontinuation                1                1 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants.   [ Time Frame: AEs recorded 28 days post-vaccination; SAEs recorded for entire study period. ]

2.  Secondary:   To Evaluate the Efficacy of the MVA85A/AERAS-485 Vaccine Compared to Controls in Prevention of Tuberculosis Using an Endpoint Derived From Epidemiological Cohort Surveys in BCG Vaccinated Infants.   [ Time Frame: 15 to 36 months post-vaccination ]

3.  Secondary:   To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by Flow Cytometric Intracellular Cytokine Staining of CD4 and CD8 T Cells.   [ Time Frame: 28 days post-vaccination ]

4.  Secondary:   To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the ex Vivo Enzyme Linked Immunospot (ELISPOT) Test Used in Previous MVA85A/AERAS-485 Human Trials.   [ Time Frame: 7 days post-vaccination ]

5.  Secondary:   To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the University of Capetown (UCT) Whole Blood Intracellular Cytokine Assay.   [ Time Frame: 28 days post-vaccination ]

6.  Secondary:   To Discover Correlates of Protection From Tuberculosis in Infants Vaccinated With MVA85A/AERAS-485.   [ Time Frame: 15 to 36 months post-vaccination ]

7.  Secondary:   To Evaluate the QuantiFERON Conversion Rate at Final Study Assessment in MVA85A/AERAS-485 Recipients Compared to Controls in Infants Without a Diagnosis of Tuberculosis During the Trial.   [ Time Frame: 15 to 36 months post-vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information