Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine. (MTBVAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02013245
Recruitment Status : Completed
First Posted : December 17, 2013
Results First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Universidad de Zaragoza
Centre Hospitalier Universitaire Vaudois
TuBerculosis Vaccine Initiative
Information provided by (Responsible Party):
Biofabri, S.L

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Tuberculosis
Interventions: Biological: MTBVAC live vaccine
Biological: Commercially available BCG live vaccine

  Participant Flow

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
MTBVAC Group 1 Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
MTBVAC Group 2 Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
MTBVAC Group 3 Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
BCG Control Group Intervention: Commercially available BCG live vaccine (dose 5 x 10^5 CFU)

Participant Flow:   Overall Study
    MTBVAC Group 1   MTBVAC Group 2   MTBVAC Group 3   BCG Control Group
STARTED   9   9   9   9 
COMPLETED   9   8   9   9 
NOT COMPLETED   0   1   0   0 

  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.
No text entered.

Reporting Groups
Group 1 MTBVAC low dose group (5 x 10^3 CFU MTBVAC)
Group 2 MTBVAC intermediate dose group (5 x 10^4 CFU MTBVAC)
Group 3 MTBVAC high dose group (5 x 10^5 CFU MTBVAC)
BCG Control Group BCG standard dose group (5 x 10^5 CFU BCG)
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Group 3   BCG Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   9   9   9   36 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      9 100.0%      9 100.0%      9 100.0%      9 100.0%      36 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 28  (9.6)   28.2  (3.2)   27.1  (6.1)   25.6  (3.4)   27.2  (6.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      3  33.3%      6  66.7%      7  77.8%      6  66.7%      22  61.1% 
Male      6  66.7%      3  33.3%      2  22.2%      3  33.3%      14  38.9% 
Region of Enrollment 
[Units: Participants]
Switzerland   9   9   9   9   36 

  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events up to 210 Days After Vaccination   [ Time Frame: 7 months follow up ]

2.  Secondary:   Number of Participants With Three-cytokine-positive CD4+ T-cell Response   [ Time Frame: Day 28 ]

  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
This is a first-in-human Phase 1 trial designed to evaluate the safety and tolerability profile of MTBVAC in comparison to BCG.

  More Information

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. François Spertini, Associate Professor, Division Immunology & Allergy
Organization: Centre Hospitalier Universitaire Vaudois (CHUV)
phone: +41 21 31 40 799

Publications of Results:
Other Publications:

Responsible Party: Biofabri, S.L Identifier: NCT02013245     History of Changes
Other Study ID Numbers: MTBVAC-01
First Submitted: December 3, 2013
First Posted: December 17, 2013
Results First Submitted: March 15, 2016
Results First Posted: March 24, 2017
Last Update Posted: March 24, 2017