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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: April 25, 2016
Last verified: April 2016
Results First Received: June 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   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 
Overall Participants Analyzed 
[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) 
[1] ≥112 days (16 weeks) and ≤182 days (26 weeks) on Study Day 0
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 [1] 
[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] 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


Publications:

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: April 25, 2016