Date: 2016-07-25
Type of information: Completion of the trial
phase: 2
Announcement: completion of the trial
Company: Valneva (France - Austria)
Product: VLA84
Action
mechanism: vaccine. Valneva’s C. difficile vaccine program is part of the Strategic Alliance Agreement (SAA) which was signed between Valneva Austria GmbH (Intercell AG at that time) and Novartis in 2007 and was transferred to GSK at the beginning of 2015.
Disease: Clostridium difficile infection
Therapeutic area: Infectious diseases
Country: Germany, USA
Trial
details: The Phase II study (VLA84-201) will enroll 500 healthy subjects aged 50 years and older. This age group represents the target population for a prophylactic C. difficile vaccine as the risk to contract the infection-associated disease increases with age. The randomized, placebo-controlled, observer-blind study will be conducted in Germany as well as in the United States under an Investigational New Drug application (IND).
Latest
news: * On July 25, 2016, Valneva announced the successful completion of its Phase II study for its prophylactic vaccine candidate VLA84 targeting primary prevention of C. difficile infection (CDI). The company previously announced positive top-line data from the Phase II study at the end of 2015 (see below). These initial results, which included data up to Day 56 following initial vaccination, were presented at the American Society of Microbiology’s annual meeting, ASM Microbe 2016, on June 17 in Boston. VLA84 was immunogenic at all doses and formulations tested, in that Immunoglobulin G (IgG) and functional (neutralizing) antibody responses were * On November 30, 2015, Valneva announced positive Phase II results for its prophylactic vaccine candidate against Clostridium difficile (C. difficile) infection (CDI). The key objectives of this Phase II trial have been met, the vaccine candidate generated strong immune responses against C. difficile toxins A and B, and the safety and tolerability profile was good. Valneva´s vaccine candidate is targeting the prevention of primary symptomatic C.difficile infection. The vaccine is designed to produce an immune response to neutralize the effects of C. difficile toxins A and B, considered to be largely responsible for C.difficile infection. * On December 18, 2014, Valneva announced the initiation of the Phase II clinical trial of its VLA84 prophylactic vaccine candidate against Clostridium difficile (C. difficile), the main cause of nosocomial diarrhea. Data from the Phase I study in healthy elderly and adults showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies, supporting the Company’s decision to progress the vaccine candidate into Phase II.
observed. The study met its primary endpoint in terms of identifying the dose/formulation with the highest seroconversion1 rate against both toxins A and B and confirmed the favorable safety profile observed in Phase I.
Final Phase II results included the follow-up of study participants until Day 210. This longterm data confirmed the optimal vaccine dose and formulation that had been previously identified (high-dose formulation without adjuvant) with an immunogenicity profile at Day 210 in line with expectations. Long-term safety concerns were not seen in any of the different vaccine doses tested.
Valneva’s C. difficile Phase II trial was a randomized, placebo-controlled, observer-blind multi-center trial designed to further study and confirm the candidate vaccine’s safety, immunogenicity and proposed doses of immunizations in two different age groups (50 to 64 years of age and 65 years of age and older). The study design was agreed with regulators in Europe and the U.S. with the aim of potentially supporting a subsequent progression into Phase III.
Valneva´s vaccine candidate was immunogenic at all doses and formulations tested, in that IgG and functional antibody responses were seen. The study met its primary endpoint in terms of identifying the dose/formulation with the highest seroconversion rate against both toxins A and B on Day 56. The high-dose without adjuvant vaccine formulation generated a superior immune response. The observed seroconversion rate in this difficult to vaccinate older adults population, was considered at an appropriate response level and broadly in-line with published data from comparable prophylactic C. difficile vaccine trials.
The vaccine was generally safe and well tolerated in all treatment groups and there were no severe local reactions noted in any group. The adverse events (AE profile) of all tested doses / formulations appear in a range comparable to other well tolerated vaccines. Immune response and safety parameters will now be monitored until Day 210 and final study close-out is expected in the second quarter of 2016.
The Phase II study (VLA84-201) aims to confirm the optimal dose and formulation of the vaccine in two different age groups and to generate sufficient additional clinical data to advance the program into Phase III. Valneva expects to announce the first results of the Phase II study at the end of 2015.
Valneva’s C. difficile vaccine is part of the Strategic Alliance Agreement (SAA) which was signed between Valneva Austria and Novartis in 2007. Following completion of Phase II clinical development and if Novartis opts-in, Valneva will have the right, at its option, to either co-develop and profit-share with Novartis or to receive potential milestones for the remaining development period along with royalties tied to salesperformance
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