Intercell announces first data from its Phase I clinical trial with vaccine candidate to prevent Clostridium difficile infections
Second part of the study in the target population of elderly subjects will be initiated
Intercell AG announced first data from a Phase I clinical trial with the companyʹs vaccine candidate IC84 to prevent disease caused by the bacterium Clostridium difficile (C. difficile). The pathogen is one of the main causes of nosocomial diarrhea.
Intercellʹs vaccine candidate is a recombinant protein vaccine consisting of two truncated toxins A and B from C. difficile. The toxins are known to be disease‐causing and anti‐toxin immunity can be protective.
This Phase I trial is a first‐in‐man study to obtain safety and immunogenicity data. The first part of the study is in a population of healthy adults up to 65 years. The second part is in healthy elderly subjects above 65 years of age as this age group is considered to represent the main target population for a C. difficile vaccine.
The first part of the study has enrolled 60 healthy adults (18‐65 years). Three different alumadjuvanted vaccine candidate concentrations were tested in a 3 times–vaccination schedule; two of the three vaccine concentrations were additionally tested without adjuvant. An independent Data Safety Monitoring Board (DSMB) reviewed safety as primary objective of the study and did not identify any safety concern in any of the IC84 treatment arms. IC84 induced antibodies reacted with both native toxins A and B of C. difficile. A dose response to the vaccine candidate could be observed; the non‐adjuvanted candidates were at least as immunogenic as the adjuvanted for both toxins, respectively.
Functionality of IC84‐induced antibodies could be shown in toxin‐neutralizing assays.
Based on the data form the first part of the study, the two higher doses will be carried forward to the second part of the study for dose‐confirmation in elderly. Also, the necessity of the adjuvant will need to be confirmed in the elderly, who might respond differently to vaccination than the younger subjects due to immunosenescence. Modification of the vaccination schedule will be implemented to potentially further optimize the immune response in elderly.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
