MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Influenza Vaccines, Aged

In brief

This is a Phase 1,2 randomized, double-blind, multi-center, clinical trial, in participants aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion adjuvant (MAS-1 adjuvant, Mercia Pharma, Inc, Scarsdale, NY) combined with each of the three reduced HA antigen dose levels of trivalent influenza virus vaccine compared with licensed, unadjuvanted, standard dose trivalent virus (TIV). Immunogenicity for each of the three viral strains (A/H1N1, A/H3N2, and B virus) in the concurrent influenza seasonal vaccine will be assessed.

Key facts

Study ID

NCT01623232

Run by

US Department of Veterans Affairs

People needed

0

Starts

2012-10-01

Expected to finish

2014-06-01

Last updated by the study team

2012-09-26

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants must meet all of the following inclusion criteria at Screening/Baseline to participate in this study:
• Ambulatory persons aged at least 65 years or older on the day of enrollment. Participants will be considered ambulatory if they are not institutionalized, bedridden, or homebound.
• Written informed consent form and Authorization to Obtain and Release Protected Health Information (HIPAA) form signed.
• Medically stable. Participants may have clinically stable underlying chronic conditions such as, but not limited to hypertension, diabetes, congestive heart failure, ischemic heart disease, or chronic lung disease, but their symptoms/signs must be controlled, as judged by the investigator, based on physical examination and medical history. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 4 weeks before receipt of the test article, are eligible.
• Body Mass Index (BMI)<40
• Normal ranges for safety labs including:
• WBC count 3,600 - 11,200 cells/mm3
• Platelets: 150,000-450,000/mm3
• Hemoglobin >sex-specific institutional lower limit of normal (Female 11 g/dL and Male 12.5 g/dL).
• Chemistry Panel: ALT, AST, total bilirubin <1.1 times and CPK <1.25 times the upper limit of normal for the study; glucose 65 to 100 mg/dL; creatinine 0.40 to 1.40 mg/dL
• Absolute neutrophil, lymphocyte and eosinophil counts are within the study normal range.
• Normal urine dipstick: negative or trace urine protein, negative or trace urine blood.
• Able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if…

• Participants who meet any of the exclusion criteria at Screening/Baseline will be excluded from study participation. Participants will not be able to participate if they have:
• Systemic hypersensitivity to eggs, chicken proteins, or any of the other vaccine components, or a history of a life-threatening reaction to TIV or a vaccine containing any of the same substances.
• History of congenital or acquired immunodeficiency, Human Immunodeficiency Virus infection, hepatitis C or B virus infection, or autoimmune disease, or immunosuppressive therapy or radiation therapy in the preceding six months.
• Systemic corticosteroid therapy, as follows:
• Continuous use with a dosage equivalent to >15 mg per day of oral prednisone for 90 days preceding vaccination.
• Sporadic use with a dosage equivalent to >40 mg per day of oral prednisone for >14 consecutive days in the 90 days preceding vaccination.
• Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and history of neoplastic disease but disease-free for 5 years).
• Current alcohol abuse or drug addiction that may interfere with trial procedures.
• Receipt of blood or blood-derived products in the past three months.
• Receipt of influenza vaccine in the past six months.
• Receipt of any other vaccine in the past four weeks.
• Planned receipt of another vaccine in the four weeks following the trial vaccination.
• Planned participation in another clinical trial during the present trial period. Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.
• Thrombocytopenia or bleeding disorder contraindicating IM vaccination. Anticoagulation is only a relative contraindication to IM vaccine injections (39). Exclusion from participation on this basis is at the discretion of the participant and the investigator after full discussion of the risks.
• History of Guillain-Barr syndrome.
• An acute febrile illness within 24 hours prior to vaccination. Vaccination will be deferred until the participant has been afebrile for at least 24 hours.
• Signs and symptoms of an acute infectious respiratory ill

Where it is running

• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
• Iowa City VA Health Care System, Iowa City, IA — Iowa City, Iowa, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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