A Study to Assess the Safety and Immunogenicity of an IM Influenza Vaccine (Multimeric-001) Followed by Administration of TIV to Elderly Volunteers - Full Text View

Purpose

This is a second Phase II study comprising 120 participants. Eligible subjects will be randomized to receive one of the following administrations (as two single IM injections with an interval of 21 days between each injection Administration A (prime): Multimeric-001 Administration B (boost): TIV.

Condition	Intervention	Phase
Influenza Healthy	Biological: Multimeric-001 Biological: Multimeric-001, 500 mcg Biological: Multimeric-001, 500mcg Biological: Saline and TIV	Phase 2

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: Prevention
Official Title:	A Phase II Multicenter, Randomized, Placebo Controlled Study to Assess the Safety and Immunogenicity of an IM Influenza Vaccine (Multimeric-001) Followed by Administration of TIV to Elderly Volunteers.

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 BiondVax Pharmaceuticals ltd.:

Primary Outcome Measures:

Number of participants with adverse events [ Time Frame: 63 days ] [ Designated as safety issue: Yes ]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability Number of Participants with Adverse Events possible/probably related to the study drug in each treatment group

Secondary Outcome Measures:

Immunity induced by priming and boosting [ Time Frame: 63 days ] [ Designated as safety issue: No ]
- Hemagglutination Inhibition (HI) test for anti influenza antibodies
- Anti Multimeric-001 antibody titer
- Anti influenza HI antibody titer.

Estimated Enrollment:	120
Study Start Date:	August 2011
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Two Multimeric-001 priming administrations followed by TIV boost	Biological: Multimeric-001 Multimeric-001, 500 mcg Multimeric-001 will be injected in 2 doses with the interval of 19-23 days between them.
Experimental: Group B Multimeric-001, 500 mcg Multimeric-001 will be injected in 1 doses followed by TIV booster immunization	Biological: Multimeric-001, 500 mcg Multimeric-001 will be injected once and followed by TIV booster immunization with the interval of 19-23 days between them.
Experimental: Group C Adjuvanted Multimeric-001 will be injected once, followed by TIV booster immunization with the interval of 19-23 days between them.	Biological: Multimeric-001, 500mcg Adjuvanted (Aluminum phosphate) Multimeric-001 will be injected once and followed by TIV booster immunization with the interval of 19-23 days between them.
Active Comparator: Group D Saline will be injected once followed by TIV immunization with the interval of 19-23 days between them.	Biological: Saline and TIV PBS (Placebo) will be injected once followed by TIV that serves as an active comparator with the interval of 19-23 days between them.

Detailed Description:

This is a Phase II multi-center, randomized, two stage, double-blind, placebo-controlled, single-dose administration study comprising 120 participants. Eligible elderly subjects will be randomized to receive one of the following administrations (as two single IM injections with an interval of 21 days between each injection Administration A (prime): Adjuvanted or non adjuvanted Multimeric-001 500 mcg - ninety (90) subjects.

Administration B (Boost): commercial seasonal trivalent vaccine for 2012 - thirty (30) subjects. A control group of thirty (30) subjects will be injected with PBS followed by TIV administration 21 days later.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Males and females at the age of at least 65 years old
Eligible to receive the standard seasonal influenza vaccine according to the MOH guidelines.
Subjects who provide written informed consent to participate in the study.
Subjects able to adhere to the visit schedule and protocol requirements and are available to complete the study.
Haematology, chemistry and urinalysis values with no clinical significance or do not reflect a medical condition which, according to the physician's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
Male subjects must agree to use a condom during the full term of the study period (including follow up) if female partner is not using an acceptable contraceptive method.
Subjects who are seronegative to at least one of the strains included in the seasonal vaccine against influenza for 2011- 2012

Exclusion Criteria:

Known history of significant medical disorder which, in the investigator's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
Subjects with known Guillain Barré Syndrome in the past.
Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within eight months prior to the screening visit.
Known hypersensitivity associated with previous influenza vaccination.
Use of an influenza antiviral medication within 4 weeks of vaccination.
Known hypersensitivity and/or allergy to any drug or vaccine.
Known hypersensitivity to egg proteins (eggs or egg products), chicken proteins, or any of the components of the commercial vaccine (e.g., formaldehyde, and octoxinol 9 (Triton X-100) and neomycin).
Persons deficient in producing antibodies, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy.
History of any bleeding disorder or subjects with thrombocytopenia (since bleeding may occur following an intramuscular administration to these subjects).
Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at screening visit which, according to the physician's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
Positive serology for HIV, HCV antibody or HBsAg.
Any acute medical situation (e.g. acute infection, ongoing flu symptoms) with or without fever within 48 hours of vaccination, which is considered significant by the Investigator.
Subjects who participated in another interventional clinical study within 30 days prior to first dose
Subjects who are non-cooperative or unwilling to sign consent form.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419925

Contacts

Contact: Dr. Jacob Atzmon, MD

+972 36974845

QC@tasmc.health.gov.il

Locations

Israel
Hadassah medical center	Recruiting
Jerusalem, Israel
Contact: Prof Yosef Caraco, PhD +972 26778584 caraco@hadassah.org.il
Principal Investigator: Yosef Caraco, PhD

Sponsors and Collaborators

BiondVax Pharmaceuticals ltd.

Investigators

Principal Investigator:

Dr. Jacob Atzmon, MD

Tel Aviv Medical Center

More Information

No publications provided

Responsible Party:	Tamar Ben-Yedidia, CSO, BiondVax Pharmaceuticals ltd
ClinicalTrials.gov Identifier:	NCT01419925 History of Changes
Other Study ID Numbers:	BVX-005
Study First Received:	August 17, 2011
Last Updated:	August 17, 2011
Health Authority:	Israel: Ministry of Health

Keywords provided by BiondVax Pharmaceuticals ltd.:

influenza vaccine
peptide
universal

prime
boost
subjects eligible of receiving TIV are employed in the study

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 May 19, 2013