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

NCT01831934 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: SU-18615R21HD061709-01A1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MELAS Syndrome

Keywords

Mitochondrial disorder; Trivalent inactivated influenza vaccine; Adolescents and adults; Immune response; Metabolic response

Outcome Measures

Primary Outcomes (1)

• Clinical Safety of TIV Vaccine

  We will measure solicited local and systemic adverse events and SAEs for 1 month following immunization

  Day 0 to Day28

Other Outcomes (1)

• Measurement of Intracellular Glutathione by Hi-D FACS (CD4 and CD8 T Cells) and Tandem Mass Spectrometry (Whole Blood)

  Day 0-Day28

Study Arms (2)

MELAS group:13-60 years of age.

EXPERIMENTAL

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

Biological: Fluzone®

Control Group: 18-65 years of age

EXPERIMENTAL

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

Biological: Fluzone®

Interventions

Fluzone® BIOLOGICAL

This vaccine is given intramuscularly, either the 2010-2011 or 2011-2012 vaccination was given as appropriate

Also known as: trivalent inactivated influenza vaccine (TIV), FDA-licensed seasonal influenza vaccine

Control Group: 18-65 years of age; MELAS group:13-60 years of age.

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

MELAS Syndrome; Mitochondrial Diseases

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr Cornelia Dekker
• Organization: Stanford University School of Medicine, Dept. of Pediatrics

cdekker@stanford.edu

650-724-4437

Study Officials

• Cornelia L Dekker, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Gregory M Enns, MBChB

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: April 15, 2013
• Study Start: September 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: May 30, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)