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Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults

This study has been completed.
Sponsor:
Collaborator:
Crucell Holland BV
Information provided by (Responsible Party):
Aeras
ClinicalTrials.gov Identifier:
NCT01017536
First received: November 18, 2009
Last updated: October 29, 2014
Last verified: October 2014
Results First Received: October 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Tuberculosis
HIV Infections
Interventions: Biological: AERAS-402
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
Investigational Vaccine AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.

Participant Flow:   Overall Study
    Placebo     Investigational Vaccine  
STARTED     13     13  
COMPLETED     13     13  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
Investigational Vaccine AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
Total Total of all reporting groups

Baseline Measures
    Placebo     Investigational Vaccine     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: years]
Mean ± Standard Deviation
  30.8  ± 6.49     30.5  ± 5.88     30.7  ± 6.07  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     13     26  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     11     12     23  
Male     2     1     3  
Region of Enrollment  
[units: participants]
     
South Africa     13     13     26  



  Outcome Measures
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1.  Primary:   CD4+ Lymphocyte Count   [ Time Frame: CD4+ counts from samples collected on Study days 0 and 182. ]

2.  Secondary:   HIV Viral Load in HIV-infected, BCG-vaccinated Adult Subjects Before and After Administration of AERAS-402   [ Time Frame: 6 months (day 182) post Study Day 0 vaccination. ]

3.  Secondary:   Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease   [ Time Frame: Study days 28 and 56 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Bernard Landry
Organization: Aeras
phone: 301-547-2900
e-mail: blandry@aeras.org


No publications provided


Responsible Party: Aeras
ClinicalTrials.gov Identifier: NCT01017536     History of Changes
Other Study ID Numbers: C-017-402
Study First Received: November 18, 2009
Results First Received: October 8, 2014
Last Updated: October 29, 2014
Health Authority: South Africa: Medicines Control Council