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Trial record 4 of 11 for:    "mitochondrial encephalomyopathy, lactic acidosis, and strokelike episodes" OR "MELAS Syndrome"

Responses to Influenza Vaccine in Patients With Mitochondrial Disorders (MELAS)

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ClinicalTrials.gov Identifier: NCT01831934
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : April 21, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: MELAS Syndrome
Intervention: Biological: Fluzone®

  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
  Description
MELAS Group:13-60 Years of Age.

Fluzone® 2011-2012 Formula

Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses.

Control Group: 18-65 Years of Age

Fluzone® 2011-2012 Formula

Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses.


Participant Flow:   Overall Study
    MELAS Group:13-60 Years of Age.   Control Group: 18-65 Years of Age
STARTED   12   10 
COMPLETED   11 [1]   10 
NOT COMPLETED   1   0 
[1] Volunteer consented but not enrolled after reporting a prior bad reaction to influenza vaccine.



  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
  Description
MELAS Group

Fluzone®

Fluzone®

Control Group

Fluzone®

Fluzone®

Total Total of all reporting groups

Baseline Measures
   MELAS Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   10   22 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.74  (8.06)   37.39  (10.04)   38.13  (8.99) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  75.0%      6  60.0%      15  68.2% 
Male      3  25.0%      4  40.0%      7  31.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   8.3%      0   0.0%      1   4.5% 
Not Hispanic or Latino      11  91.7%      9  90.0%      20  90.9% 
Unknown or Not Reported      0   0.0%      1  10.0%      1   4.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   8.3%      4  40.0%      5  22.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      9  75.0%      4  40.0%      13  59.1% 
More than one race      2  16.7%      1  10.0%      3  13.6% 
Unknown or Not Reported      0   0.0%      1  10.0%      1   4.5% 
Region of Enrollment 
[Units: Participants]
     
United States   12   10   22 


  Outcome Measures

1.  Primary:   Clinical Safety of TIV Vaccine   [ Time Frame: Day 0 to Day28 ]

2.  Other Pre-specified:   Measurement of Intracellular Glutathione by Hi-D FACS (CD4 and CD8 T Cells) and Tandem Mass Spectrometry (Whole Blood)   [ Time Frame: Day 0-Day28 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  More Information

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: Dr Cornelia Dekker
Organization: Stanford University School of Medicine, Dept. of Pediatrics
phone: 650-724-4437
e-mail: cdekker@stanford.edu



Responsible Party: Cornelia L. Dekker, Stanford University
ClinicalTrials.gov Identifier: NCT01831934     History of Changes
Other Study ID Numbers: SU-18615
R21HD061709-01A1 ( U.S. NIH Grant/Contract )
First Submitted: March 19, 2013
First Posted: April 15, 2013
Results First Submitted: January 11, 2017
Results First Posted: April 21, 2017
Last Update Posted: May 30, 2017