A Study of MVA85A in Healthy Infants
This study has been completed.
Sponsor:
Aeras
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
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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
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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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| 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
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. |
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| 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] |
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| <=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] |
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| Female | 691 | 682 | 1373 |
| Male | 708 | 716 | 1424 |
|
Region of Enrollment
[units: participants] |
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| 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 ] |
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 |
| Safety Issue | No |
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. |
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| 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 | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
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 ] |
Serious Adverse Events| 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
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 |
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| No text entered. |