Biotech company, Valneva, announced further positive Phase 1 results for its chikungunya vaccine
candidate, VLA1553 today.

Chikungunya virus/CDC

The objectives of VLA1553-101 Phase 1 study were to assess the overall safety and immunogenicity profile after a single vaccination across three dose levels.

Today´s analysis (Part B) of the ongoing study includes the overall safety and immunogenicity results up to Month 7, unblinded on a group level and including first results from the “intrinsic human viral challenge”.

VLA1553 was generally safe in all dose groups. The low and medium dose groups were well tolerated and showed a superior safety profile, including viremia, compared to the high dose. No adverse events of special interest (e.g. chikungunya infection related) were reported up to month 7 and the product candidate´s local tolerability profile was excellent.

The results showed an excellent immunogenicity profile in all vaccinated dose groups after a single vaccination with a 100% Seroconversion achieved at Day 14 after a single vaccination in all dose groups and fully sustained at 100% at Month 6.

A subset of study subjects were re-vaccinated after 6 months. For those subjects there was no anamnestic response observed which demonstrates that a single vaccination of VLA1553 is sufficient to induce sustaining, high titer, neutralizing antibodies. Vaccinees were protected from vaccine induced viremia serving as “intrinsic human viral challenge“.

Wolfgang Bender, M.D., Ph.D., Chief Medical Officer of Valneva commented, “We are thrilled about these exciting results confirming that we have identified a highly immunogenic and safe final product candidate which we now aim to progress into pivotal trials as quickly as possible. In addition and as hoped, the data indicate that vaccinated subjects are protected from chikungunya viremia. This marks a very important milestone getting us a step closer to a highly competitively differentiated vaccine addressing a serious threat to public health.”