Date: 2013-08-26
Type of information: Initiation of preclinical development
phase: 1
Announcement: results
Company: Intercell (Austria) now Valvena
Product: IC84
Action
mechanism: vaccine. Intercell's 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.
Disease: Clostridium difficile infections
Therapeutic area: Infectious diseases
Country:
Trial
details: First data from the Phase I study (Phase Ia) in a population of healthy adults aged 18-65 years showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies in this study population (See below). This supported the decision to carry forward the vaccine candidate for safety and dose-confirmation in the elderly.
The second part of the Phase I study (Phase Ib) will enroll 80 healthy elderly subjects above 65 years of age, as this age group represents the main target population for a C. difficile vaccine. Two vaccine concentrations will be tested with and without alum to confirm the vaccine dose and necessity of the adjuvant in the elderly. Compared to the Phase Ia part of the study in healthy young adults, the vaccination schedule has been modified to potentially optimize the immune response in elderly subjects who might respond differently to the vaccination due to their immunosenescence.
Latest
news: * On August 26, 2013,Valneva has announced positive Phase Ia/Ib results for the company’s vaccine candidate IC84 to prevent diseases caused by the bacterium Clostridium difficile. IC84 showed a favorable safety and tolerability profile in both study populations, elderly subjects and adults, with local tolerability being even better in elderly subjects. The investigational vaccine induced antibodies that reacted with both native toxins A and B of C. difficile in both study populations. Functionality of IC84-induced antibodies could be shown in toxin-neutralizing assays in both study populations. Immune responses in elderly subjects, where immunosenescence (i.e., lower immune response) is expected, was comparable to adults: similarly high antibody titers with a plateau response could be reached with the non-adjuvanted middle dose after three vaccinations for both toxins in both study populations and were identified as the optimal schedule, dose and formulation both for adults and elderly subjects for future studies.
* On March 1, 2012, Intercell has announced the start of the second half of a Phase I clinical trial with the company's vaccine candidate IC84 to prevent disease caused by Clostridium difficile.
* On October 24, 2011, Intercell has announced first data from a Phase I clinical trial with IC84 to prevent disease caused by Clostridium difficile. 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 immuneresponse in elderly. Second part of the study in the target population of elderly subjects will be initiated.
