Safety and Immunogenicity of Multimeric-001—a Novel Universal Influenza Vaccine

Abstract

This vaccine model differs fundamentally from the current influenza virus vaccines, as it does not contain the variable regions of the virus hemagglutinin and hence does not induce hemagglutination inhibition antibodies that serve as surrogate markers for protection. In order to demonstrate the potential efficacy of the Multimeric-001, an alternative assay was employed, in which the lysis of MDCK cells infected with different virus strains was shown, with the involvement of the complement mechanism. The humoral and cellular responses suggest a cross-immunity of the vaccine toward influenza virus strains regardless of mutations. These results corroborate the protective effect of the vaccine, previously shown in animals. Larger-scale studies are under way to further substantiate the safety and efficacy of the vaccine candidate.

Safety and tolerability evaluation of the use of Montanide ISA™51 as vaccine adjuvant: A systematic review

“…36 The study also included harboring diverse influenza B and T cell epitopes) with or without ISA 51. 11,12 In the study of Atsmon et al 2 immunizations were given and in the study of Pleguezuelos et al one immunization was given. Subjects in the phase I study of Pialoux et al all received 2 dosages of vCP125 antigens before they were randomized to receive 2 dosages of rgp160 antigens adjuvanted with alum or ISA 51.…”

“…None of the participants in the adjuvant control groups developed AEs above moderate. 43 The prophylactic vaccine trials performed by Atsmon et al, Herrera et al and Pialoux et al reported the number of AEs after each immunization 11,41,42 . For the trial of Pleguezuelos et al, only the number of systemic AEs that occurred after a single injection could be extracted.…”

“…10 Recently, ISA 51 was also tested in influenza vaccine trials. 11,12 The inclusion of a vaccine adjuvant should be justified by a favorable risk/benefit ratio; the risk including local and systemic Adverse Events (AEs). 3 To our knowledge, this is the first systematic review on the assessment of the safety and tolerability of ISA 51 and ISA 51-adjuvanted vaccines.…”

Recombinant and epitope-based vaccines on the road to the market and implications for vaccine design and production

“…The vaccine company developer (BiondVax) is currently planning phase-III studies, 15 after completing phase-II clinical trials where Multimeric-001 Ò proved to be safe and immunogenic in humans and successfully stimulated both humoral and cellular immune responses against a wide variety of influenza A and B strains. 16 Readers should note that Multimeric-001 Ò has not yet been proven clinically to be a universal vaccine; the immunological data are supportive but its universality is yet to be proven.…”

Development of a universal CTL-based vaccine for influenza

“…18,19 DNA vaccines and peptide based vaccines have already been assayed in humans with promising results. 20,21 While many of these strategies proved to be very efficient and in some cases induced significant increases in cross-reactive immune responses, they did not completely solve the problems derived from the high antigenic variability of influenza virus.…”