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Trial record 4 of 10 for:    "mitochondrial encephalomyopathy, lactic acidosis, and strokelike episodes" OR "MELAS Syndrome"

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01831934
First Posted: April 15, 2013
Last Update Posted: May 30, 2017
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.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University
  Purpose
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.

Condition Intervention Phase
MELAS Syndrome Biological: Fluzone® Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Metabolic and Immune Responses to TIV in Patients With Mitochondrial Disease

Resource links provided by NLM:


Further study details as provided by Cornelia L. Dekker, Stanford University:

Primary Outcome Measures:
  • 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


Other Outcome Measures:
  • Measurement of Intracellular Glutathione by Hi-D FACS (CD4 and CD8 T Cells) and Tandem Mass Spectrometry (Whole Blood) [ Time Frame: Day 0-Day28 ]
    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.


Enrollment: 22
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MELAS group:13-60 years of age.
Fluzone® 2010-2011 Formula or 2011-2012 depending on year
Biological: Fluzone®
This vaccine is given intramuscularly, either the 2010-2011 or 2011-2012 vaccination was given as appropriate
Other Names:
  • trivalent inactivated influenza vaccine (TIV)
  • FDA-licensed seasonal influenza vaccine
Experimental: Control Group: 18-65 years of age
Fluzone® 2010-2011 Formula or 2011-2012 depending on year
Biological: Fluzone®
This vaccine is given intramuscularly, either the 2010-2011 or 2011-2012 vaccination was given as appropriate
Other Names:
  • trivalent inactivated influenza vaccine (TIV)
  • FDA-licensed seasonal influenza vaccine

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Inclusion criteria include:

  • Age between 13-60 years for MELAS volunteers OR age between 18-65 years for adult control volunteers. Control volunteers will be age-matched +/-5 years to enrolled MELAS volunteers. If the MELAS volunteer has diabetes and uses insulin daily, their control will be an adult with diabetes who uses insulin daily.
  • General good health at time of enrollment
  • Willing and able to sign Informed Consent
  • Available for follow-up for the planned duration of the study
  • Acceptable medical history by screening evaluation and brief clinical assessment
  • All female participants of childbearing potential must use an acceptable method of contraception and not become pregnant for the duration of the clinical phase of the study (approximately 1 month to completion of Visit 4). (Acceptable contraception may include but is not limited to implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).

Exclusion Criteria:Exclusion criteria will include:

  • Allergy to egg or egg products or allergy to vaccine components, including thimerosal
  • Active systemic or serious concurrent illness, including febrile illness, within the 3 days prior to study vaccination
  • History of immunodeficiency, known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  • Blood pressure >150 systolic or >95 diastolic at Visit 1.
  • Hospitalization in the past year for congestive heart failure or emphysema.
  • History of chronic Hepatitis B or C.
  • Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays are permissible).
  • Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
  • Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  • History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  • Receipt of blood or blood products within the past 6 months
  • Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
  • Inactivated vaccine 14 days prior to vaccination or live, attenuated vaccine within 60 days of vaccination
  • History of Guillain-Barré Syndrome
  • Pregnant or lactating woman
  • Use of investigational agents within 30 days prior to enrollment
  • Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
  • Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831934


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Cornelia L Dekker, MD Stanford University
Principal Investigator: Gregory M Enns, MBChB Stanford University
  More Information

Additional Information:
Responsible Party: Cornelia L. Dekker, Professor, Pediatrics, 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
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cornelia L. Dekker, Stanford University:
Mitochondrial disorder
Trivalent inactivated influenza vaccine
Adolescents and adults
Immune response
Metabolic response

Additional relevant MeSH terms:
MELAS Syndrome
Mitochondrial Diseases
Metabolic Diseases
Mitochondrial Encephalomyopathies
Mitochondrial Myopathies
Muscular Diseases
Musculoskeletal Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Neuromuscular Diseases
Vascular Diseases
Cardiovascular Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Vaccines
Immunologic Factors
Physiological Effects of Drugs