Intercell's Vaccine Enhancement Patch for Pandemic Flu Fails Phase 2 Trials
Intercell AG's (Vienna, Austria) investigational vaccine enhancement patch (VEP) system for avian H5N1 influenza has failed its Phase 2 clinical trial.
Intercell AG's (Vienna, Austria) investigational vaccine enhancement patch (VEP) system for avian H5N1 influenza has failed its Phase 2 clinical trial. Intercell is working under a contract with the US Department of Health and Human Services (HHS) to develop a dose-sparing approach with potential for a single dose immunization against pandemic influenza that combines an H5N1 vaccine with Intercell's adjuvant patch.
Following encouraging preclinical and clinical Phase 1 proof-of-concept trials conducted under the HHS contract, the clinical Phase 2 study was designed to determine the safety and the optimal combination/dose of an injectable H5N1 influenza vaccine (30 and 45 μg antigen) and Intrcell's VEP (50 and 100 μg LT adjuvant) applied at the injection site. A total of 500 healthy adults were recruited in 6 study groups.
The study was not able to identify the optimal combination of antigen and adjuvant because no statistically significant difference in seroprotection rates as measured by hemagglutinin inhibition (HI) assay was observed when comparing groups with and without VEP.
However, the study results demonstrated a good safety profile for all doses of injectable vaccine and adjuvant patches studied. Furthermore, a dose-dependent response to the H5N1 antigen was observed. Anti-LT IgG titers in study subjects receiving the patch confirmed that Intercell's VEP could consistently deliver the vaccine adjuvant.
Intercell intends to conduct further clinical evaluation using its VEP in combination with an injectable H5N1 vaccine to be supplied by GlaxoSmithKline as part of a collaborative agreement signed in December 2009. HHS and Intercell currently are considering the next steps for this development program.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
