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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877448
• Other study ID #: BVX002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2009
• Est. completion date: November 2009

Study information

• Verified date: February 2023
• Source: BiondVax Pharmaceuticals ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Influenza, Human

Intervention

Biological:
• Adjuvanted Multimeric-001 250 Mcg

• Multimeric-001 250 Mcg

• Phosphate Buffered saline

• Adjuvanted PBS

• Adjuvanted Multimeric-001 500 Mcg

• Multimeric-001 500 Mcg

• Multimeric-001 125 Mcg

Locations

Country	Name	City	State
Israel	Tasmc Crc	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
BiondVax Pharmaceuticals ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of adverse events per cohort	day 0 until day 42 (termination visit)
Primary	Treatment-related Adverse Events	Number of treatment-related adverse events per cohort	Day 0 until day 42 (termination visit)