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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Metabolic and Immune Responses to TIV in Patients With Mitochondrial Disease

Brief Summary: This pilot clinical study evaluated the safety and metabolic responses to a licensed inactivated seasonal influenza vaccine (TIV) in mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes syndrome (MELAS) volunteers and controls.

Detailed Summary:

This pilot clinical study evaluated the safety and metabolic responses to a licensed inactivated seasonal influenza vaccine (TIV). This study will consist of two cohorts: MELAS syndrome volunteers (a specific identified disorder of mitochondrial dysfunction: mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes) between 13-60 years OR adult control volunteers between 18-65 years of age. Both cohorts will receive the same treatment: a single vaccination with an FDA-licensed intramuscular seasonal trivalent inactivated influenza vaccine (TIV).

All participants will receive a single administration of a licensed influenza vaccine. Prior to vaccination, participants will provide information regarding health history and responses to health questionnaires. A blood sample and urine specimen were collected prior to vaccination, and at 6 hours, 5-7 days and 26-30 days post-immunization.


Sponsor: Stanford University

Current Primary Outcome: Clinical Safety of TIV Vaccine [ Time Frame: Day 0 to Day28 ]

We will measure solicited local and systemic adverse events and SAEs for 1 month following immunization


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

  • Measurement of intracellular ROS and RNS by Hi-D FACS [ Time Frame: Day 0 to Day 28 ]

    Intracellular ROS (iROS) will be measured by established protocols using the fluorescent dye DHR123 (Dihydrorhodamine 123).

    Intracellular RNS (iRNS) will be measured by established protocols using the fluorescent dye DAF-FM, DA (4-amino-5methylamino-2',7'-difluorofluorescein, diacetate)

  • Measurement of intracellular glutathione by Hi-D FACS (CD4 and CD8 T cells) and tandem mass spectrometry (whole blood) [ Time Frame: Day 0-Day 28 ]
    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.
  • Comprehensive immune response profile to influenza [ Time Frame: Day 0 to Day 28 ]
    We will conduct a comprehensive analysis of serum cytokines, white blood cell subsets, gene expression and influenza-specific antibody and T cell responses in patients with mitochondrial dysfunction vs. controls


Information By: Stanford University

Dates:
Date Received: March 19, 2013
Date Started: September 2010
Date Completion:
Last Updated: March 17, 2017
Last Verified: March 2017