Study of Parenterally Administrated Adjuvanted Seasonal Influenza Vaccine in Healthy Elderly Volunteers - Full Text View

Purpose

The safety of parenterally administrated investigational vaccine (commercial influenza vaccine formulated with adjuvant Matrix M) in healthy adults (age 18-50) and healthy elderly (age 65-75), will be investigated in the study. Moreover, the study aims to study parameters associated with improved protection against clinical disease in elderly. Such parameters include HI-titres, a balanced Th1/Th2 response as well as a functional cellular immune response.

Vaccination will start in 22 healthy adults receiving the investigational vaccine. Vaccination of elderly will be initiated only after demonstration of safety in adults. 88 healthy elderly volunteers will be vaccinated, 44 will receive the seasonal influenza vaccine alone and 44 will receive the investigational vaccine. Vaccines will be administrated intramuscularly in the upper arm. One dose will be administered to each volunteer included in the study. Blood samples for basic immunological assessments of cellular and humoral immunity will be taken at day 0, 7, 28, 90 and 150.

The investigational vaccine is equal to one standard human dose of a commercial seasonal influenza vaccine to which 50 µg of adjuvant Matrix M has been added.

Condition	Intervention	Phase
Influenza	Biological: Matrix M Biological: Seasonal influenza vaccine	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	A Phase I Single Blinded Randomised Exploratory Trial in Elderly Volunteers to Assess and Compare Safety and Immunogenicity of Adjuvanted Seasonal Influenza Vaccine (Investigational Vaccine) to Standard Seasonal Influenza Vaccine.

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Isconova AB:

Primary Outcome Measures:

Safety in elderly and adults given a single parenterally administrated dose of seasonal influenza vaccine adjuvanted with Matrix M [ Time Frame: 1 - 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity in adults and elderly given a dose of seasonal influenza vaccine adjuvanted with Matrix M [ Time Frame: 1 - 7 months ] [ Designated as safety issue: Yes ]
Immunogenicity in elderly given a dose of seasonal influenza vaccine alone or adjuvanted with Matrix M [ Time Frame: 1 - 7 months ] [ Designated as safety issue: Yes ]

Enrollment:	110
Study Start Date:	May 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Matrix M adjuvanted influenza vaccine 1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M	Biological: Matrix M 1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M, total dosage volume 0.55 mL injected intramuscularly in the upper arm once at day 0.
Active Comparator: Seasonal influenza vaccine 1 human dose of seasonal influenza vaccine	Biological: Seasonal influenza vaccine 1 human dose of seasonal influenza vaccine

Eligibility

Ages Eligible for Study:	65 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Are aged 18 to 50 years for the young adult part of the study
Are aged 65 to 75 years for main study
Have signed a voluntary written informed consent. Volunteers should be cooperative, willing and able to participate and adhere to the Protocol requirements
Have minimum normal standard physical performance status

Exclusion Criteria:

Volunteer has received seasonal Influenza vaccine of same antigenic composition within 6 months prior to enrolment
Volunteer having vaccine specific HI titres ≥ 40
Volunteer is taking immunosuppressant drugs such as azathioprine, tacrolimus, cyclosporine, etc
Volunteers who have primary or secondary immunodeficiencies (e.g. Human Immunodeficiency Virus [HIV])
Volunteers who have an autoimmune disease
Volunteer is taking oral, intramuscular or intravenous corticosteroids. Use is not permitted within 1 month of Screening. Inhaled corticosteroids to treat respiratory insufficiency (e.g. chronic obstructive pulmonary disease [COPD]), are permitted
Volunteer has a concurrent severe or uncontrolled underlying medical disease unrelated but that is likely to compromise volunteer safety and affect the outcome of the study
Volunteer has a neurotoxicity (Grade ≥2)
Volunteer has diarrhoea (Grade ≥2)
Volunteer has received other vaccines, within 1 month prior to enrolment
Volunteer has a history of any severe or life-threatening hypersensitivity reaction
Volunteer has an unstable systemic disease (including active infection, uncontrolled hypertension [> 160/100], unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease)
Volunteer has recent history (within 6 months) of chronic alcohol or drug abuse of which may compromise the patient's safety or ability to participate in study activities
Volunteer has a history of psychiatric disorder that prevents patients from providing informed consent or following Protocol instructions
Volunteer is currently enrolled in an investigational device or drug trial, or < 1 month since completing an investigational device or drug trial
Female volunteers who are pregnant or lactating (only applicable for Pre-Study)
Volunteer has any other factor that in the opinion of the Investigator (or designee) would make the patient unsafe or unsuitable for the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444482

Locations

Hungary
Drug Reseach Center
Balatonfured, Hungary, 8231

Sponsors and Collaborators

Isconova AB

More Information

No publications provided

Responsible Party:	Isconova AB
ClinicalTrials.gov Identifier:	NCT01444482 History of Changes
Other Study ID Numbers:	ISC-Influenza-001
Study First Received:	August 19, 2011
Last Updated:	September 29, 2011
Health Authority:	Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013