Tag Archives: Valneva

Valneva Announces End To Phase II Study For Vaccine Candidate VLA84 – Prevention of C. difficile Infection (CDI)

Valneva SE July 26, 2016 announced the successful completion of its Phase II study for its prophylactic vaccine candidate VLA84 targeting primary prevention of C. difficile infection (CDI), which is emerging as a leading cause of life-threatening, healthcare-associated infections (HAIs) worldwide.

Valneva previously announced positive top-line data from the Phase II study at the end of 2015. 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 observed. The study met its primary endpoint in terms of identifying the dose/formulation with the highest seroconversion 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 long-term 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.

Thomas Lingelbach, President and CEO, and Franck Grimaud, Deputy CEO of Valneva, commented, “We are pleased with the positive final data generated in this Phase II trial and believe that our C. difficile candidate has the potential to address a growing unmet medical need. Infections caused by C. difficile are responsible for almost 30 thousand deaths every year in the US alone. There is currently no vaccine on the market that can protect patients and we are determined to find a partner to advance our vaccine candidate further.”

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 trial was conducted in Germany and the United States under an Investigational New Drug application (IND) and enrolled 500 volunteers who were randomized in several study groups: low-dose vaccine without adjuvant, high-dose vaccine with or without adjuvant (Aluminium hydroxide), or placebo.

Valneva confirmed Phase III readiness through an independent Scientific Advisory Board (SAB) and is ready to support an end-of Phase II meeting (EOP2 meeting) with the regulatory authorities once the final Phase III design has been agreed with a partner.  As announced previously, Valneva expects to enter into a partnering agreement for this program by year end 2016.

Currently, no vaccine against C. difficile is approved and antibiotic treatment of the established disease has significant limitations with recurrence in approximately 20% of cases. The incidence of nosocomial infections is steadily increasing due to the growing number of medical interventions. Valneva estimates that the total market potential for prophylactic C. difficile products may exceed $1 billion annually

To read the article in its entirety please click on the following link:

http://outbreaknewstoday.com/c-diff-vaccine-candidate-valneva-announces-end-to-phase-ii-study-71382/

Valneva’s C difficile Vaccine Candidate Reported Positive Phase II Results

Racing against big-name vaccines players, Valneva reported positive Phase II results this week for its GlaxoSmithKline-partnered C. difficile vaccine candidate, saying the shot proved to be “highly immunogenic” while also offering a good safety and a tolerable profile.

The trial, conducted in Germany and the United States, tested the vaccine candidate in 500 volunteers separated into two age groups: 50 to 64 and 65 and above. Researchers reported that the vaccine was immunogenic at all doses and formulations tested, with a high-dose formulation containing no adjuvant generating a superior response.

With the results, the Lyon, France-headquartered company said it’ll announce further development steps after its final Phase II closeout in Q2 2016.

To read this article in its entirety click on the link below:

http://www.fiercevaccines.com/story/valnevas-c-diff-vaccine-found-be-highly-immunogenic-phii/2015-12-01

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

C. diff. – Valneva Announced the Start of Phase II Clinical Trial of its C. diff. Vaccine Candidate

NewsSpeakerValneva Announces Start of Phase II Clinical Trial of its Clostridium difficile vaccine candidate

  • First Study participant(s) enrolled in Phase II trial which aims to enable Phase III entry upon successful completion
  • Study to enroll 500 healthy subjects aged 50 years and older in the United States and Germany
  • First results are expected in Q4 2015

                   * News Provided in English, French, and German *

Lyon (France), December 18, 2014European biotechnology company Valneva SE (“Valneva”) announced today 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

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Valneva annonce l`initiation de l`essai clinique de Phase II pour son candidat vaccin contre le Clostridium difficile

  • Premier volontaire recruté pour l`essai de Phase II qui, une fois achevé, devrait conduire à l`initiation de la Phase III
  • L`étude de Phase II vise à recruter 500 volontaires âgés de 50 ans et plus aux Etats-Unis et en Allemagne
  • Premiers résultats attendus au T4 2015

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Lyon (France), 18 décembre 2014 -La société de biotechnologie européenne Valneva SE (“Valneva”) annonce aujourd`hui le lancement de  l`essai clinique de Phase II de son candidat vaccin prophylactique VLA84 contre le Clostridium difficile (C. difficile), principale cause de diarrhée nosocomiale. Les données de Phase I chez des adultes et des personnes âgées en bonne santé ont démontré un bon profil d`innocuité et d`immunogénicité du candidat vaccin ainsi qu`un bon fonctionnement des anticorps produits, conduisant ainsi la société à faire progresser son candidat vaccin en Phase II.

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Valneva gibt den Start einer klinischen Phase-II Studie mit seinem Impfstoffkandidaten gegen Clostridium difficile bekannt

  • Erste(r) Studienteilnehmer wurde(n) in die Phase II-Studie aufgenommen, die nach erfolgreichem Abschluss eine Phase III-Studie ermöglichen soll
  • Studie wird 500 gesunde Probanden im Alter von 50 Jahren oder älter in den USA und Deutschland umfassen
  • Erste Ergebnisse werden im 4. Quartal 2015 erwartet

Lyon (Frankreich), 18. Dezember 2014 – Das europäische Biotech Unternehmen Valneva SE (“Valneva”) hat heute den Start der klinischen Phase II-Studie ihres prophylaktischen Impfstoffkandidaten VLA84 gegen Clostridum difficile (C. difficile), die Hauptursache von nosokomialen Durchfallerkrankungen, bekannt gegeben. Die Daten aus der vorangegangenen Phase I-Studie in gesunden jüngeren Erwachsenen und älteren Personen zeigten bereits erste gute Sicherheits-  und Immunogenitätsdaten des Impfstoffkandidaten, und deuteten auf die Funktionalität der induzierten Antikörper hin, weshalb sich das Unternehmen für die Weiterentwicklung des Impfstoffkandidaten  in einer Phase II entschieden hat.

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.