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: February 4, 2014
Last verified: February 2014
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  
Number of Participants  
[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
  Show All 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
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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.

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.

Serious Adverse Events
    Investigational Vaccine     Control Group  
Total, serious adverse events      
# participants affected / at risk     257/1399 (18.37%)     258/1396 (18.48%)  
Congenital, familial and genetic disorders      
Cryptorchism      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Phimosis      
# participants affected / at risk     1/1399 (0.07%)     2/1396 (0.14%)  
# events     1     2  
Gastrointestinal disorders      
Abnormal faeces      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Aphthous stomatitis      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Constipation      
# participants affected / at risk     1/1399 (0.07%)     1/1396 (0.07%)  
# events     1     1  
Diarrhoea      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Enteritis      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Gastrooesophageal reflux disease      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Intestinal functional disorder      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Intussusception      
# participants affected / at risk     0/1399 (0.00%)     2/1396 (0.14%)  
# events     0     2  
Stomatitis      
# participants affected / at risk     1/1399 (0.07%)     1/1396 (0.07%)  
# events     1     1  
Vomiting      
# participants affected / at risk     3/1399 (0.21%)     0/1396 (0.00%)  
# events     3     0  
General disorders      
Pyrexia      
# participants affected / at risk     1/1399 (0.07%)     3/1396 (0.21%)  
# events     1     3  
Sudden death      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Hepatobiliary disorders      
Hepatosplenomegaly      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Infections and infestations      
Abscess      
# participants affected / at risk     1/1399 (0.07%)     3/1396 (0.21%)  
# events     1     3  
Bronchiolitis      
# participants affected / at risk     10/1399 (0.71%)     8/1396 (0.57%)  
# events     11     8  
Bronchitis      
# participants affected / at risk     0/1399 (0.00%)     2/1396 (0.14%)  
# events     0     2  
Bronchopneumonia      
# participants affected / at risk     27/1399 (1.93%)     28/1396 (2.01%)  
# events     29     30  
Burn infection      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Cellulitis      
# participants affected / at risk     2/1399 (0.14%)     2/1396 (0.14%)  
# events     2     2  
Croup infectious      
# participants affected / at risk     8/1399 (0.57%)     11/1396 (0.79%)  
# events     8     12  
Dysentery      
# participants affected / at risk     1/1399 (0.07%)     1/1396 (0.07%)  
# events     1     1  
Empyema      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Escherichia urinary tract infection      
# participants affected / at risk     3/1399 (0.21%)     0/1396 (0.00%)  
# events     3     0  
Gastroenteritis      
# participants affected / at risk     91/1399 (6.50%)     88/1396 (6.30%)  
# events     101     94  
Hepatitis A      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Impetigo      
# participants affected / at risk     2/1399 (0.14%)     2/1396 (0.14%)  
# events     2     2  
Liver abscess      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Lobar pneumonia      
# participants affected / at risk     0/1399 (0.00%)     2/1396 (0.14%)  
# events     0     2  
Lower respiratory tract infection      
# participants affected / at risk     25/1399 (1.79%)     29/1396 (2.08%)  
# events     26     30  
Lower respiratory tract infection viral      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Measles      
# participants affected / at risk     2/1399 (0.14%)     0/1396 (0.00%)  
# events     2     0  
Meningitis      
# participants affected / at risk     3/1399 (0.21%)     2/1396 (0.14%)  
# events     3     2  
Meningitis bacterial      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Meningitis tuberculous      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Meningitis viral      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Oral herpes      
# participants affected / at risk     3/1399 (0.21%)     2/1396 (0.14%)  
# events     3     2  
Pneumonia      
# participants affected / at risk     31/1399 (2.22%)     25/1396 (1.79%)  
# events     35     27  
Pneumonia measles      
# participants affected / at risk     2/1399 (0.14%)     0/1396 (0.00%)  
# events     2     0  
Pneumonia respiratory syncytial viral      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Pneumonia viral      
# participants affected / at risk     1/1399 (0.07%)     2/1396 (0.14%)  
# events     1     2  
Pulmonary tuberculosis      
# participants affected / at risk     6/1399 (0.43%)     5/1396 (0.36%)  
# events     6     5  
Respiratory tract infection      
# participants affected / at risk     6/1399 (0.43%)     10/1396 (0.72%)  
# events     6     10  
Sepsis      
# participants affected / at risk     3/1399 (0.21%)     0/1396 (0.00%)  
# events     3     0  
Subcutaneous abscess      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Tonsillitis      
# participants affected / at risk     2/1399 (0.14%)     3/1396 (0.21%)  
# events     2     3  
Tuberculosis      
# participants affected / at risk     5/1399 (0.36%)     5/1396 (0.36%)  
# events     5     5  
Upper respiratory tract infection      
# participants affected / at risk     5/1399 (0.36%)     3/1396 (0.21%)  
# events     5     3  
Urinary tract infection      
# participants affected / at risk     8/1399 (0.57%)     4/1396 (0.29%)  
# events     8     4  
Varicella      
# participants affected / at risk     1/1399 (0.07%)     1/1396 (0.07%)  
# events     1     1  
Injury, poisoning and procedural complications      
Accidental drug intake by child      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Accidental exposure      
# participants affected / at risk     0/1399 (0.00%)     3/1396 (0.21%)  
# events     0     4  
Burns third degree      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Concussion      
# participants affected / at risk     1/1399 (0.07%)     1/1396 (0.07%)  
# events     1     1  
Excoriation      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Eye injury      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Femur fracture      
# participants affected / at risk     2/1399 (0.14%)     4/1396 (0.29%)  
# events     2     4  
Head injury      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Injury      
# participants affected / at risk     0/1399 (0.00%)     2/1396 (0.14%)  
# events     0     2  
Near drowning      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Pneumonitis chemical      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Skin laceration      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Thermal burn      
# participants affected / at risk     7/1399 (0.50%)     10/1396 (0.72%)  
# events     7     10  
Tibia fracture      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Investigations      
HIV test positive      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Metabolism and nutrition disorders      
Kwashiorkor      
# participants affected / at risk     4/1399 (0.29%)     1/1396 (0.07%)  
# events     4     1  
Malnutrition      
# participants affected / at risk     2/1399 (0.14%)     0/1396 (0.00%)  
# events     2     0  
Nervous system disorders      
Altered state of consciousness      
# participants affected / at risk     1/1399 (0.07%)     1/1396 (0.07%)  
# events     1     1  
Cerebral infarction      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Convulsion      
# participants affected / at risk     2/1399 (0.14%)     1/1396 (0.07%)  
# events     2     1  
Encephalitis      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Febrile convulsion      
# participants affected / at risk     7/1399 (0.50%)     12/1396 (0.86%)  
# events     7     12  
Guillain-Barre syndrome      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Reproductive system and breast disorders      
Balanitis      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Respiratory, thoracic and mediastinal disorders      
Acute respiratory distress syndrome      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Apnoeic attack      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Asphyxia      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Asthma      
# participants affected / at risk     3/1399 (0.21%)     3/1396 (0.21%)  
# events     4     3  
Bronchospasm      
# participants affected / at risk     1/1399 (0.07%)     2/1396 (0.14%)  
# events     1     2  
Obstructive airways disorder      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Pneumonitis      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Sleep apnoea syndrome      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Status asthmaticus      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  
Skin and subcutaneous tissue disorders      
Dermatitis      
# participants affected / at risk     0/1399 (0.00%)     1/1396 (0.07%)  
# events     0     1  
Eczema      
# participants affected / at risk     1/1399 (0.07%)     1/1396 (0.07%)  
# events     1     1  
Surgical and medical procedures      
Finger amputation      
# participants affected / at risk     1/1399 (0.07%)     0/1396 (0.00%)  
# events     1     0  




  Other Adverse Events


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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: 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: NCT00953927     History of Changes
Other Study ID Numbers: C-020-485, Oxford TB020
Study First Received: July 31, 2009
Results First Received: October 23, 2013
Last Updated: February 4, 2014
Health Authority: South Africa: Medicines Control Council
South Africa: Human Research Ethics Committee
United Kingdom: Research Ethics Committee