A Study to Assess the Safety and Immunogenicity of M-001 Influenza Vaccine as a Primer to TIV in Elderly Volunteers

NCT01419925 | Completed Phase 2

• 1 other identifier: BVX-005
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

"Multimeric-001" (M-001) has been recently developed, containing conserved, common linear influenza epitopes that activate both cellular and humoral arms of the immune system against a wide variety of influenza A and B strains. Apart from its direct action, M-001 is an attractive candidate for priming immune responses to seasonal influenza vaccine in the elderly population. The current clinical study was designed to assess M-001's standalone and priming action in subjects over 65 years old. This is a second Phase II study comprising 120 participants. Eligible subjects were randomized to receive to receive either two sequential non-adjuvanted or a single non-adjuvanted or a single adjuvanted intramuscular injection of 500 mcg M-001 (treatment), or one placebo (saline) injection, before receiving the TIV.

Conditions

Influenza; Healthy

Keywords

influenza vaccine; peptide; universal; prime; boost; TIV; HAI; Hemagglutination Inhibition; elderly

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Number of Participants with Adverse Events as a Measure of Safety and Tolerability were similar (not statistically significant) in the experimental and control group Number of Participants with Adverse Events possible/probably related to the study drug in each treatment group: Group A: Twice M-001 - 9 AEs Group B: Once M-001 - 5 AEs Group C: Once Alum-M-001 - 13 AEs Group D: Placebo - 7 AEs

  63 days

Secondary Outcomes (2)

• Immunity induced by priming and boosting, measured by HAI

  21 days after boost immunization with TIV

• Cellular immunity

  21 days after M-001 immunization

Study Arms (4)

Group A

EXPERIMENTAL

Two Multimeric-001 administrations followed by TIV

Biological: Two Multimeric-001 administrations followed by TIV

Group B

EXPERIMENTAL

One administration of Multimeric-001 followed by TIV

Biological: One administration of Multimeric-001 followed by TIV

Group C

EXPERIMENTAL

One administration of adjuvanted M-001 followed by TIV

Biological: One administration of adjuvanted M-001 followed by TIV

Group D

ACTIVE COMPARATOR

One administration of placebo followed by TIV

Biological: One administration of placebo followed by TIV

Interventions

Two Multimeric-001 administrations followed by TIV BIOLOGICAL

Two administrations of non adjuvanted M-001, 500 mcg followed by TIV at intervals of 19-23 days

Group A

One administration of Multimeric-001 followed by TIV BIOLOGICAL

One administration of non adjuvanted Multimeric-001, 500 mcg, followed by TIV at intervals of 19-23 days

Group B

One administration of adjuvanted M-001 followed by TIV BIOLOGICAL

One administration of adjuvanted (Aluminum phosphate) Multimeric-001, 500 mcg, followed by TIV at intervals of 19-23 days

Group C

One administration of placebo followed by TIV BIOLOGICAL

One administration of saline (Placebo)followed by TIV at intervals of 19-23 days (serving as an active comparator)

Group D

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BiondVax Pharmaceuticals ltd.: lead

Study Sites (1)

Hadassah medical center

Jerusalem, Israel

Location

Related Publications (1)

• Atsmon J, Caraco Y, Ziv-Sefer S, Shaikevich D, Abramov E, Volokhov I, Bruzil S, Haima KY, Gottlieb T, Ben-Yedidia T. Priming by a novel universal influenza vaccine (Multimeric-001)-a gateway for improving immune response in the elderly population. Vaccine. 2014 Oct 7;32(44):5816-23. doi: 10.1016/j.vaccine.2014.08.031. Epub 2014 Aug 28.

  PMID: 25173483 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Dr. Jacob Atzmon, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 18, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

IL (1)