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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


  Baseline Characteristics

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

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. ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

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

Measure Type Secondary
Measure Title To Discover Correlates of Protection From Tuberculosis in Infants Vaccinated With MVA85A/AERAS-485.
Measure Description Investigations for determining correlates of immune protection to TB will not be completed as planned because the study did not show TB protection in MVA85A/AERAS-485 recipients.
Time Frame 15 to 36 months post-vaccination  

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
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.

Measured Values
   Investigational Vaccine   Control Group 
Participants Analyzed   0   0 
To Discover Correlates of Protection From Tuberculosis in Infants Vaccinated With MVA85A/AERAS-485.       

No statistical analysis provided for To Discover Correlates of Protection From Tuberculosis in Infants Vaccinated With MVA85A/AERAS-485.



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 ]
  Show Outcome Measure 7


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information