A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)

Study Overview
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Brief Summary
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A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy volunteers.

Official Title
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A Phase I/II, Randomized, Single-Blind, Placebo-Controlled Escalating Double-Dose Safety Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Biological: Adjuvanted Multimeric-001 250 Mcg
* Biological: Multimeric-001 250 Mcg
* Biological: Phosphate Buffered saline
* Biological: Adjuvanted PBS
* Biological: Adjuvanted Multimeric-001 500 Mcg
* Biological: Multimeric-001 500 Mcg
* Biological: Multimeric-001 125 Mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females between 18 and 55 years (inclusive) of age. Non-smoking (by declaration) for a period of at least 6 months. Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study. Haematology and Chemistry values within normal ranges or with no clinical significance Subjects who provide written informed consent to participate in the study Exclusion Criteria: Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications. Ongoing flu symptoms or influenza Any clinically significant abnormality upon physical examination or in the clinical laboratory test at screening visit. Treatment with immune immunosuppressant drugs or other immune enhancing drugs. Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within one year prior to the screening visit. Administration of any vaccine 30 days before the screening visit. Known history of drug or alcohol abuse. Known history of HIV, hepatitis C or B virus (HCV or HBV) Subjects with known Guillain Barré Syndrome in the past 2 or more hospitalization within the last year prior to screening visit Increased liver enzymes 2.5 times above the upper reference level Known hypersensitivity and/or allergy to any drugs Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator. Subjects who participated in another clinical study within 30 days prior to study entry Subjects who are non-cooperative or unwilling to sign consent form. Pregnant or lactating women at entry to study and those that are unwilling to agree to continue precautions for two months after completion of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimeric-001 250 Mcg<br>Multimeric-001 250 Mcg in PBS | Biological: Adjuvanted Multimeric-001 250 Mcg<br> <br> |
| Experimental: Adjuvanted Multimeric-001 250 Mcg<br>250 Mcg in montanide | Biological: Multimeric-001 250 Mcg<br> <br> |
| Placebo Comparator: Phosphate Buffered saline<br>Non-adjuvanted placebo | Biological: Phosphate Buffered saline<br> <br> |
| Placebo Comparator: Adjuvanted PBS<br>Adjuvant was montanide | Biological: Adjuvanted PBS<br> <br> |
| Experimental: Multimeric-001 500 Mcg<br>Multimeric-001 in PBS | Biological: Multimeric-001 500 Mcg<br> <br> |
| Experimental: Adjuvanted Multimeric-001 500 Mcg<br>Adjuvant was montanide | Biological: Adjuvanted Multimeric-001 500 Mcg<br> <br> |
| Experimental: Multimeric-001 125 Mcg<br>Multimeric-001 in PBS | Biological: Multimeric-001 125 Mcg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of adverse events per cohort | day 0 until day 42 (termination visit) | 
| Treatment-related Adverse Events | Number of treatment-related adverse events per cohort | Day 0 until day 42 (termination visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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INFLUENZA, VACCINE, UNIVERSAL, SAFETY