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A Study of MVA85A in Healthy Infants

This study has been completed.
Sponsor:
Collaborators:
University of Oxford
University of Cape Town
Information provided by (Responsible Party):
Aeras
ClinicalTrials.gov Identifier:
NCT00953927
First received: July 31, 2009
Last updated: April 25, 2016
Last verified: April 2016
Results First Received: October 23, 2013  
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
Condition: Tuberculosis
Interventions: Biological: MVA85A/AERAS-485
Biological: Candida Skin Test Antigen

  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
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
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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.
Intent to treat population

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.
Total Total of all reporting groups

Baseline Measures
    Investigational Vaccine   Control Group   Total
Overall Participants Analyzed 
[Units: Participants]
 1399   1398   2797 
Age 
[Units: Participants]
     
<=18 years   1399   1398   2797 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 .401  (.039)   .399  (.037)   .400  (.038) 
Gender 
[Units: Participants]
     
Female   691   682   1373 
Male   708   716   1424 
Region of Enrollment 
[Units: Participants]
     
South Africa   1399   1398   2797 


  Outcome Measures
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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
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Time Frame No text entered.
Additional Description Two subjects within the control group were randomized but did not receive control vaccination.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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.

Other Adverse Events
    Investigational Vaccine   Control Group
Total, other (not including serious) adverse events     
# participants affected / at risk   1319/1399 (94.28%)   1064/1396 (76.22%) 
Gastrointestinal disorders     
Diarrhoea     
# participants affected / at risk   259/1399 (18.51%)   216/1396 (15.47%) 
# events   308   245 
Vomiting     
# participants affected / at risk   191/1399 (13.65%)   157/1396 (11.25%) 
# events   240   199 
General disorders     
Injection site erythema     
# participants affected / at risk   1121/1399 (80.13%)   446/1396 (31.95%) 
# events   1183   459 
Injection site exfoliation     
# participants affected / at risk   143/1399 (10.22%)   13/1396 (0.93%) 
# events   143   13 
Injection site pain     
# participants affected / at risk   363/1399 (25.95%)   154/1396 (11.03%) 
# events   421   175 
Injection site swelling     
# participants affected / at risk   1050/1399 (75.05%)   267/1396 (19.13%) 
# events   1146   273 
Injection site warmth     
# participants affected / at risk   473/1399 (33.81%)   222/1396 (15.90%) 
# events   561   279 
Irritability     
# participants affected / at risk   523/1399 (37.38%)   431/1396 (30.87%) 
# events   659   553 
Pyrexia     
# participants affected / at risk   372/1399 (26.59%)   271/1396 (19.41%) 
# events   449   323 
Infections and infestations     
Rhinitis     
# participants affected / at risk   65/1399 (4.65%)   79/1396 (5.66%) 
# events   67   79 
Upper respiratory tract infection     
# participants affected / at risk   183/1399 (13.08%)   172/1396 (12.32%) 
# events   192   180 
Metabolism and nutrition disorders     
Hypophagia     
# participants affected / at risk   321/1399 (22.94%)   285/1396 (20.42%) 
# events   389   357 
Nervous system disorders     
Hypersomnia     
# participants affected / at risk   376/1399 (26.88%)   324/1396 (23.21%) 
# events   478   419 
Somnolence     
# participants affected / at risk   295/1399 (21.09%)   237/1396 (16.98%) 
# events   368   296 
Psychiatric disorders     
Insomnia     
# participants affected / at risk   398/1399 (28.45%)   359/1396 (25.72%) 
# events   513   447 



  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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