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Metabolic and Immune Responses to TIV in Patients With Mitochondrial Disease

This pilot clinical study, funded by the National Institutes of Health, will evaluate the safety and metabolic responses to a licensed inactivated seasonal influenza vaccine (TIV). This single arm 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 for 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).

Stanford is not currently accepting new patients for this trial. You may want to check to see if other locations are recruiting.



  • biological : Intramuscular seasonal trivalent inactivated influenza vaccine

Phase: Phase 4


Ages Eligible For Study:

13 Years - 65 Years

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).

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Greg Enns, MD
(650) 498-5798
Not Recruiting

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