A Phase 1, randomized, double-blind, controlled trial to evaluate the safety and immunogenicity of increasing intranasal doses or of three intramuscular doses of the adjuvant Gram-positive Enhancer Matrix (GEM) administered with a standard dose of trivalent inactivated influenza vaccine (TIV) antigens, compared to a standard dose of TIV antigens administered either intranasally or intramuscularly in healthy adult volunteers; followed by a randomized, double-blind, controlled evaluation of safety
- Conditions
- griep vaccination10047438
- Registration Number
- NL-OMON36678
- Lead Sponsor
- Mucosis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 134
• Male or female aged 18 - 49 years inclusive ;OR ;• Male or female aged 65 years or older ;• Able to give written informed consent to participate;• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and to be contacted by telephone throughout the follow-up period.;• Healthy- Subjects must be free of any clinically significant disease, as determined by medical history, physical examination, vital signs, and safety laboratory examinations at baseline;• A Body Mass Index (BMI) between 18 and 32, inclusive. BMI = weight (kg)/height2 (m2). ;• Subjects* clinical laboratory tests (CBC, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator and within allowed expanded range supplied by sponsor. Subject*s liver function test results (ie, AST, ALT) must not be elevated above the normal limits at Screening;• The Screening 12 lead ECG conduction intervals must be within gender specific normal range (QTc males * 430 msec, PR interval * 200 msec).;• Vital sign measurements (taken after ~3 minutes in a supine position) must be within the following ranges: (Individuals with values outside (or indicate lower or higher) of these ranges may be enrolled if clinically acceptable to the investigator and sponsor.) ;o oral body temperature, between 35.0*C and 37.5*C;o systolic blood pressure, 90 to 140 mm Hg;o diastolic blood pressure, 45 to 90 mm Hg;o pulse rate, 40 to 100 bpm;• ;• ;• Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose. and / or should fulfill one of the following criteria:;A At least one year post-menopausal;;B. Surgically sterile;C Willing to abstain from sexual intercourse or use another reliable form of contraception approved by the Investigator (e.g., intrauterine device, female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) for 30 days prior to first vaccination, throughout study duration and until 28 days after vaccination.
• Presence of significant uncontrolled medical or psychiatric illness (acute or chronic). This includes institution of a new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening ;• Receipt of a 2010/2011 influenza vaccine in the vaccination season 2010/2011.;• HI titers against the vaccine strains >= 1:10 for 2 or more strains;• Subjects who are positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.;• Subjects positive for Hematuria on screening urinalysis.;• Positive serology for HIV-1 or HIV-2.;• Cancer, or treatment for cancer, within 3 years, excluding basal cell carcinoma or squamous cell carcinoma, which is allowed.;• Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus.;• Presently receiving or history of receiving, during the preceding 3-month period, any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulins, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Topical corticosteroids will be allowed. ;• Receipt or planned administration of a non-study vaccine within 30 days prior to vaccination and during the study. If for a subject included in the study, immunization on an emergency basis with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) becomes necessary, the subject will remain in the study provided the tetanus vaccine is administered up to 8 days before the second dose of the study vaccine or at least 8 days after a dose of study vaccine. Administration of study vaccine can be delayed if a non-study vaccine has been administered and will be given as soon as acceptable, as described above.;• Positive history of illicit drug or alcohol abuse within the previous 6 months or positive drug or alcohol screen.;• History of anaphylactic type reaction to injected vaccines.;• History of drug or chemical abuse in the year before the study.;• Treatment with another investigational medicinal product (IMP) within 3 months prior to screening or more than 4 times in the past year.;• Receipt of any investigational product or nonregistered drug within the 30 days prior to vaccination or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period.;• Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period.;• Loss of blood outside the limits of Sanquin within 3 months prior to screening. ;• Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study.;• Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical examination) with or without fever, or a fever >38ºC. Study vaccine can be administered to persons with a minor illness, such as diarrhea. However, in subjects suffering from mild upper respiratory tract infection with or without low-grade fever, vaccination must be delayed until the subject has recovered.;• Any condition that, in the Investigator*s opinion, might interfere with the primary study objectives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primairy study parameters are safety and tolerability parameters</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondairy study parameters is the immunogenicity of the combination GEM +<br /><br>vaccin:<br /><br>Haemaglutination Inhibition Titers<br /><br>Mucosal IgA<br /><br>Total and subtype IgG<br /><br>Cell Medicated Immunity<br /><br>Microneutralization with mucosal IgA</p><br>