Study of AERAS-402 in Healthy Infants

This study has been completed.
Sponsor:
Collaborator:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
Aeras
ClinicalTrials.gov Identifier:
NCT01198366
First received: September 7, 2010
Last updated: August 3, 2015
Last verified: August 2015
Results First Received: June 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Tuberculosis
Interventions: Biological: AERAS-402 1.5 x 10^10 vp
Biological: AERAS-402 3.0 x 10^10 vp
Biological: AERAS-402 1.0 x 10^11 vp
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
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
Dose Finding - Group 1

Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.

Placebo: Sterile buffer

Dose Finding - Group 2

Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.

AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.

Dose Finding - Group 3

Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.

AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.

Dose Finding - Group 4

Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.

AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.

Expanded Safety Phase - Group 5

Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.

AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.

Expanded Safety Phase - Group 5 Placebo

Subjects received 3 doses of placebo on days 0, 28 and 280.

Placebo: Sterile buffer


Participant Flow:   Overall Study
    Dose Finding - Group 1     Dose Finding - Group 2     Dose Finding - Group 3     Dose Finding - Group 4     Expanded Safety Phase - Group 5     Expanded Safety Phase - Group 5 Placebo  
STARTED     52     51     51     52     140     141  
COMPLETED     40     44     43     47     125     128  
NOT COMPLETED     12     7     8     5     15     13  



  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.
No text entered.

Reporting Groups
  Description
Dose Finding - Group 1

Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.

Placebo: Sterile buffer

Dose Finding - Group 2

Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.

AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.

Dose Finding - Group 3

Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.

AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.

Dose Finding - Group 4

Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.

AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.

Expanded Safety Phase - Group 5

Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.

AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.

Expanded Safety Phase - Group 5 Placebo

Subjects received 3 doses of placebo on days 0, 28 and 280.

Placebo: Sterile buffer

Total Total of all reporting groups

Baseline Measures
    Dose Finding - Group 1     Dose Finding - Group 2     Dose Finding - Group 3     Dose Finding - Group 4     Expanded Safety Phase - Group 5     Expanded Safety Phase - Group 5 Placebo     Total  
Number of Participants  
[units: participants]
  52     51     51     52     140     141     487  
Age, Customized [1]
[units: Days]
Mean (Standard Deviation)
             
Age at Study Day 0 in Days     145.3  (18.15)     144.5  (17.83)     138.6  (19.45)     149.1  (21.44)     145.2  (19.98)     150.2  (20.22)     146.3  (19.97)  
Gender  
[units: participants]
             
Female     22     20     30     20     68     57     217  
Male     30     31     21     32     72     84     270  
Race/Ethnicity, Customized  
[units: participants]
             
Black     42     44     41     43     102     98     370  
Coloured     10     7     10     9     38     43     117  
White     0     0     0     0     0     0     0  
Asian     0     0     0     0     0     0     0  
Other     0     0     0     0     0     0     0  
Region of Enrollment [2]
[units: participants]
             
Mozambique     4     3     3     4     0     0     14  
South Africa     12     12     12     12     59     59     166  
Kenya     36     36     36     36     70     71     285  
South Africa     0     0     0     0     11     11     22  
[1] ≥112 days (16 weeks) and ≤182 days (26 weeks) on Study Day 0
[2] Two sites in South Africa - Worcester and Soweto. Soweto only participated in Group 5.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adverse Events Collected Per Subject   [ Time Frame: Up to 24 months post vaccination ]

2.  Secondary:   Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects   [ Time Frame: 28 days post last vaccination ]

3.  Secondary:   Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay   [ Time Frame: 28 days post last vaccination ]

4.  Secondary:   Antigen-specific Antibody Response - Mean Optical Density (Mean OD)   [ Time Frame: 28 day post last vaccination ]

5.  Secondary:   Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination   [ Time Frame: up to 24 months post vaccination ]


  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
Organization: Aeras
phone: 301-547-2919
e-mail: blandry@aeras.org


No publications provided


Responsible Party: Aeras
ClinicalTrials.gov Identifier: NCT01198366     History of Changes
Other Study ID Numbers: C-029-402
Study First Received: September 7, 2010
Results First Received: June 10, 2015
Last Updated: August 3, 2015
Health Authority: Kenya: Pharmacy and Poisons Board
South Africa: Medicines Control Council
Mozambique: Ministry of Health (MISAU)