Completed

Metabolic and Immune Responses to TIV in Patients With Mitochondrial Disease

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What is being tested

Fluzone®

+ Fluzone®

Biological
Who is being recruted

Brain Diseases+18

+ Brain Diseases, Metabolic

+ Cardiovascular Diseases

From 13 to 65 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 4
Interventional
Study Start: September 2010
See protocol details

Summary

Principal SponsorStanford University
Last updated: May 30, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01831934
Principal SponsorStanford University
Last updated: May 30, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

22 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 13 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain Diseases, MetabolicCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersMetabolic DiseasesMetabolism, Inborn ErrorsMuscular DiseasesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeuromuscular DiseasesNutritional and Metabolic DiseasesVascular DiseasesMitochondrial EncephalomyopathiesMitochondrial MyopathiesBrain Diseases, Metabolic, InbornGenetic Diseases, InbornCerebral Small Vessel DiseasesMELAS SyndromeMitochondrial Diseases

Criteria

6 inclusion criteria required to participate
Acceptable medical history by screening evaluation and brief clinical assessment
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
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)
Available for follow-up for the planned duration of the study
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18 exclusion criteria prevent from participating
Active systemic or serious concurrent illness, including febrile illness, within the 3 days prior to study vaccination
Allergy to egg or egg products or allergy to vaccine components, including thimerosal
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
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Fluzone® 2010-2011 Formula or 2011-2012 depending on year

Group II

Experimental
Fluzone® 2010-2011 Formula or 2011-2012 depending on year

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Stanford University School of Medicine

Stanford, United StatesOpen Stanford University School of Medicine in Google Maps
CompletedOne Study Center