Pevion Biotech AG today announced further data from the ongoing clinical study of its therapeutic Candida vaccine PEV7, demonstrating the generation of specific and functional B cell memory in 100% of vaccinees. Furthermore, the results again confirm the capability of Pevion's second generation virosomal vaccine platform to induce strong and long-lasting immunity in humans against otherwise weak antigens .
Following the previously announced positive safety and immunogenicity results of PEV7, the Company further investigated the vaccine-induced generation of B cell memory. To this end, half of the group of volunteers vaccinated with the intramuscular low dose of PEV7 received a single booster immunization fourteen months after the primary vaccination course. All vaccinees showed a rapid, specific response either in serum or in cervicovaginal secretion or in both, after antibody titers had come down to baseline six months prior to the boost in this low-dose group.
"Based on analyses of antibody functionality, as monitored by competitive target inhibition, and antigen specific reactivity, we have evidence for an affinity maturation of these antibodies," explained Christian Moser, Head of Research at Pevion. "We are very satisfied to see such an excellent induction of memory by the PEV7 vaccine even at low dose, and we are now looking forward to obtain the results from the high-dose group. Moreover, this is the first time for a second generation virosome-based vaccine that we verified the generation of memory in humans by means of a booster immunization."
The follow-up of the group of volunteers vaccinated with the intramuscular high dose of PEV7 is ongoing and so far has shown high and persistent antibody titers until six months after completion of the vaccination course. In order to evaluate the intravaginal application of PEV7 in capsule form, an additional study arm is ongoing. First volunteers have already been safely vaccinated.
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