Date: 2012-05-14
Type of information:
phase: 1
Announcement: results
Company: Isconova (Sweden)
Product: influenza vaccine using Isconova’s adjuvant product Matrix M™
Action mechanism:
Disease: influenza
Therapeutic area: Infectious diseases
Country:
Trial
details: • Vaxigrip® (seasonal influenza split vaccine) adjuvanted with Matrix M™ was tested and compared with Vaxigrip® alone in two groups (n= 44 per group) of elderly subjects , aged 65-75.
• The specific T-cell mediated response was significantly higher in the group receiving the Matrix M™ adjuvanted vaccine. This was measured with respect to the percentage of influenza virus reactive CD4+ cells producing:
o Interferon gamma at day 28 and 90 (P<0.05).
• Both the adjuvanted and non-adjuvanted vaccines induced high levels of antibodies and both groups conform to all three EMA serological assessment criteria for regulatory approval of seasonal influenza vaccines;
o The Hemagglutination Inhibition (HI) Seroconversion Rate;
was higher against all three strains in the Matrix M™ adjuvanted vaccine. Even at day 150, seroconversion rates were 8% or higher among elderly receiving the Matrix M™ adjuvanted vaccine.
o The Geometric Mean Titer (GMT) increase of HI;
was higher for all three strains in the Matrix M™ adjuvanted vaccine at day 28 and 150.
o The Seroprotection Rate by HI;
was equal or higher for all three strains in the Matrix M™ adjuvanted vaccine at day 28 and 150.
• The GMT increase of Virus Neutralization Antibodies (VNA) was significantly higher for the homologous H1N1 strain in the Matrix M™ adjuvanted vaccine group at day 28 and 90. In addition, the GMT increase of VNA was higher for the homologous B strain in the Matrix M™ adjuvanted vaccine group at day 28 and 150.
• The Matrix M™ adjuvanted vaccine was well tolerated. An expected increase of minor side-effects compared to the non-adjuvanted comparator vaccine was observed. The reactogenicity was mild and transient. No severe side effects were recorded.
• The results of this phase I study in elderly subjects demonstrate that Matrix M™ is well tolerated and significantly stimulates the T-cell response. Furthermore, the results indicate an increase of the serological response and duration.
• The study forms a part of the clinical proof of concept for the further development of Matrix M™ adjuvanted seasonal influenza vaccines with the potential for an increased clinical efficacy in the elderly population.
Latest
news: * On May 14, 2012, Isconova AB, a vaccine adjuvant company, has announced first results from a successful phase I study using the Company’s proprietary vaccine adjuvant, Matrix M™. This study forms part of the clinical proof of concept for Matrix M™ and its utility in improving the clinical efficacy of seasonal influenza vaccines in the elderly (See See http://biopharmanalyses.fr/clinical-trails/?pageid=435). Both the primary as well as secondary clinical endpoints were reached. In this trial, a group of elderly subjects (aged 65-75) were administered either Vaxigrip® (seasonal influenza split vaccine) adjuvanted with Matrix M™ or Vaxigrip® alone. The adjuvanted vaccine was well tolerated with an excellent safety profile. An increased number of minor side-effects compared to the non-adjuvanted comparator vaccine were observed, however these were mild and transient. No severe side-effects were recorded.
Both the adjuvanted and non-adjuvanted vaccines fulfilled all three EMA serological assessment criteria for regulatory approval of seasonal influenza vaccines. Higher antibody responses were seen in the Matrix M™ adjuvanted group.
Interferon gamma producing CD4 cells were found at significantly higher levels in the Matrix M™ group on days 28 and 90 and were still elevated on day 150. These cells are considered to be an important marker of a potent immune response.
The study confirms the clinical superiority of the Matrix M™ adjuvanted vaccine, already demonstrated by the use of Matrix M™ in the previously conducted pandemic influenza vaccine study in man (PanFluVac), by Isconova’s partner J&J / Crucell, including the important increase in the cell mediated immune response.
