BiondVax Pharmaceuticals Ltd. (TASE: BNDX), an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a Universal Influenza Vaccine, today announced that it has begun to immunize subjects in a Phase IIa clinical trial of the Multimeric-001 Universal Flu Vaccine candidate. The study will evaluate the safety and immunogenicity of the Multimeric-001 vaccine. The vaccine is comprised of a unique, proprietary combination of conserved epitopes from influenza virus proteins, designed to stimulate both humoral (antibody-mediated) and cell-mediated immunity against both Type A and Type B influenza strains, and is thereby intended to provide protection against all seasonal and pandemic flu strains.
The Phase IIa study is a randomized, double-blind, placebo-controlled, multi-center, safety and immunogenicity study in 200 healthy volunteers. The study is being conducted at two clinical research centers in Israel, the Hadassah Clinical Research Center at Hadassah University Hospital in Jerusalem ("Hadassah") and the Tel Aviv Sourasky Medical Center ("Ichilov"). The principal investigators conducting the clinical trial are Prof. Yoseph Caraco, Director of the Clinical Research Center at Hadassah and Dr. Jacob Atsmon, Director of the Clinical Research Center at Ichilov.
Dr. Ron Babecoff, BiondVax's President and CEO, said, "The commencement of this Phase IIa study is a major milestone in the clinical development of the Multimeric-001 universal influenza vaccine. After the excellent results we achieved in our two previous Phase I/II trials, in which the Multimeric-001 vaccine was shown to be safe and immunogenic in both younger and older adults, we are excited to be embarking on this new important phase in the development of the universal influenza vaccine."
In the study, a total of 200 subjects, both male and female, 18-49 years old, will be divided into six groups, enabling the assessment of the safety and immunogenicity of the Multimeric-001 firstly as a standalone vaccine, secondly as a primer for a subsequent partial dose of a commercially available trivalent inactivated vaccine (TIV), and lastly when the Multimeric-001 vaccine is co-administered together with a TIV.
Participants in the first group will receive two 500 microgram doses of an adjuvanted formulation of the Multimeric-001 vaccine (the formulation that performed best in the previous Phase I/II trials), 21 days apart. These participants will then receive a subsequent partial (15%) dose of a TIV, 60 days after their second immunization. Participants in this treatment group will be compared against two control groups: one group that will receive two administrations of placebo 21 days apart, also followed 60 days later by a partial (15%) dose of TIV, and another group that will only receive two administrations of adjuvanted placebo, 21 days apart.
Participants in the fourth and fifth groups will receive a single 500 microgram dose of the adjuvanted formulation of the Multimeric-001 vaccine, co-administered with either a 15% or 50% dose of the TIV, respectively. These groups will be compared against a control group that will receive a placebo formulation co-administered with the higher of the two TIV doses.
The primary objectives of the Phase IIa study are to assess safety and immunogenicity, as measured by the level of IgG antibodies to the Multimeric-001 vaccine. The secondary objectives of the study are to measure additional antibody and cellular immune responses, in particular neutralization by complement, Hemagglutination inhibition (HI) responses (a measure of protection) against various strains of influenza, as well as proliferation of Interleukin-2 (IL-2) and Interferon-gamma cytokines. The company expects to report study results by mid-2011.
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