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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®
Enrollment 22

Recruitment Details  
Pre-assignment Details  
Arm/Group Title MELAS Group:13-60 Years of Age. Control Group: 18-65 Years of Age
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Fluzone® 2011-2012 Formula

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

Fluzone® 2011-2012 Formula

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

Period Title: Overall Study
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.
Arm/Group Title MELAS Group Control Group Total
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Fluzone®

Fluzone®

Fluzone®

Fluzone®

Total of all reporting groups
Overall Number of Baseline Participants 12 10 22
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 10 participants 22 participants
38.74  (8.06) 37.39  (10.04) 38.13  (8.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
Female
9
  75.0%
6
  60.0%
15
  68.2%
Male
3
  25.0%
4
  40.0%
7
  31.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 10 participants 22 participants
12 10 22
1.Primary Outcome
Title Clinical Safety of TIV Vaccine
Hide Description We will measure solicited local and systemic adverse events and SAEs for 1 month following immunization
Time Frame Day 0 to Day28
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title MELAS Group Control Group
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Fluzone® 2011-2012 Formula

Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly

Fluzone® 2011-2012 Formula

Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly

Overall Number of Participants Analyzed 12 10
Measure Type: Count of Participants
Unit of Measure: Participants
Number of Adverse Events
4
  33.3%
0
   0.0%
Number of Severe Adverse Events
0
   0.0%
0
   0.0%
Number with no Adverse Events
8
  66.7%
10
 100.0%
2.Other Pre-specified Outcome
Title Measurement of Intracellular Glutathione by Hi-D FACS (CD4 and CD8 T Cells) and Tandem Mass Spectrometry (Whole Blood)
Hide Description This method relies on the ability of intracellular glutathione S-transferases to tag GSH to bimane to yield a bimane-GS conjugate that fluoresces at 440 nm.
Time Frame Day 0-Day28
Outcome Measure Data Not Reported
Time Frame 30 days post immunization
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MELAS Group Control Group
Hide Arm/Group Description

Fluzone®

Fluzone®

Fluzone®

Fluzone®

All-Cause Mortality
MELAS Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
MELAS Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MELAS Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/12 (33.33%)      0/10 (0.00%)    
General disorders     
Nasal Discharge   2/12 (16.67%)  2 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle Spasm  [1]  1/12 (8.33%)  1 0/10 (0.00%)  0
Nervous system disorders     
Seizure  [2]  1/12 (8.33%)  3 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
report of occasional intermittent spasm of right jaw four days post vaccination
[2]
A volunteer experienced 3 seizures lasting approximately 10 minutes. These were of the same type as his baseline seizures, but different in length and frequency. He was seen by his regular neurologist who left his medications unchanged.
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
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