NCT01831934

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

Metabolic and Immune Responses to TIV in Patients With Mitochondrial Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 13 Years – 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• MELAS Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone®	This vaccine is given intramuscularly, either the 2010-2011 or 2011-2012 vaccination was given as appropriate

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-12-01
• Completion: 2012-03-01
• First posted: 2013-04-15
• Last updated: 2017-05-30
• Results posted: 2017-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study