Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in HIV-Infected Adults (C-030-485)

This study has been completed.
Sponsor:
Collaborators:
University of Oxford
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
Aeras
ClinicalTrials.gov Identifier:
NCT01151189
First received: June 24, 2010
Last updated: July 29, 2015
Last verified: July 2015
Results First Received: June 30, 2015  
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: MVA85A/AERAS-485
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
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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
Placebo

The placebo is a licensed product manufactured by Allermed, Inc. and is used for evaluation of delayed-type of hypersensitivity reactions in adults.

Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.

MVA85A/AERAS-485

MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.

MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485.


Participant Flow:   Overall Study
    Placebo     MVA85A/AERAS-485  
STARTED     326     324  
Received Vaccine     325     324  
COMPLETED     311     314  
NOT COMPLETED     15     10  



  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.

Safety:

All randomized subjects who received a dose of study vaccine, based on actual treatment received.


Reporting Groups
  Description
Placebo Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.
MVA85A/AERAS-485

MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.

MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485.

Total Total of all reporting groups

Baseline Measures
    Placebo     MVA85A/AERAS-485     Total  
Number of Participants  
[units: participants]
  325     324     649  
Age  
[units: years]
Mean (Standard Deviation)
  37.8  (6.61)     37.7  (6.69)     37.7  (6.65)  
Gender  
[units: participants]
     
Female     255     265     520  
Male     70     59     129  
Race/Ethnicity, Customized  
[units: participants]
     
Black     304     302     606  
Coloured     21     22     43  
White     0     0     0  
Asian     0     0     0  
Region of Enrollment  
[units: participants]
     
Senegal     179     178     357  
South Africa     146     146     292  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Adverse Events   [ Time Frame: Adverse Events (AEs) are recorded for 28 days post vaccination, Serious Adverse Events (SAEs) for at least 6 months post second vaccination. ]

2.  Secondary:   Number of TB Cases   [ Time Frame: For at least 6 months post second vaccination up to 33 months total follow-up. ]

3.  Secondary:   CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in Anti-retroviral Therapy Negative (ART -)Subjects   [ Time Frame: Up to 6 months post second vaccination. ]

4.  Secondary:   CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Subjects   [ Time Frame: Up to 6 months post second vaccination. ]

5.  Secondary:   HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART - Participants   [ Time Frame: Up to 6 months post second vaccination. ]

6.  Secondary:   HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Participants.   [ Time Frame: Up tp 6 months post second vaccination ]

7.  Secondary:   Counts of Spot-forming Units After Stimulation With AG85A Peptide Pool.   [ Time Frame: 28 days post second vaccination. ]

8.  Secondary:   Immunogenicity of MVA85A/AERAS-485 Compared to Placebo as Described by Flow Cytometric Intracellular Cytokine Staining (ICS) of CD4+ and CD8+ T Cells After Stimulation With a Peptide Pool of Mycobacterial Antigens.   [ Time Frame: 7 days post second vaccination. ]

9.  Secondary:   QuantiFERON (QFN) Conversion Rate in MVA85A/AERAS-485 Recipients Compared to Control Subjects Without a Diagnosis of Tuberculosis During the Trial.   [ Time Frame: For at least 6 months post second vaccination up to 33 months total follow-up. ]


  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: Product Director; Bernard Landry
Organization: Aeras
phone: 301-547-2919
e-mail: blandry@aeras.org


No publications provided by Aeras

Publications automatically indexed to this study:

Responsible Party: Aeras
ClinicalTrials.gov Identifier: NCT01151189     History of Changes
Other Study ID Numbers: C-030-485
Study First Received: June 24, 2010
Results First Received: June 30, 2015
Last Updated: July 29, 2015
Health Authority: South Africa: Medicines Control Council