Clinical trial NCT00877448: A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: INFLUENZA
VACCINE
UNIVERSAL
SAFETY
Lead sponsor: BiondVax Pharmaceuticals ltd.
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: day 0 until day 42 (termination visit)
measure: Treatment-related Adverse Events
timeFrame: Day 0 until day 42 (termination visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tasmc Crc
Study officials:
affiliation: Sourasky Medical Center, Tel Aviv, Israel
name: Jacob Atsmon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atsmon J, Kate-Ilovitz E, Shaikevich D, Singer Y, Volokhov I, Haim KY, Ben-Yedidia T. Safety and immunogenicity of multimeric-001--a novel universal influenza vaccine. J Clin Immunol. 2012 Jun;32(3):595-603. doi: 10.1007/s10875-011-9632-5. Epub 2012 Feb 9.