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 clinicaltrials.gov to see if other locations are recruiting.
- biological : Intramuscular seasonal trivalent inactivated influenza vaccine
Phase: Phase 4
Ages Eligible For Study:
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).