Vical starts PI trials for trivalent CMV
US-vaccines company Vical has initiated a Phase I clinical trial with its trivalent immunotherapeutic vaccine for cytomegalovirus (CMV), incorporating genes encoding three CMV proteins.
US-vaccines company Vical has initiated a Phase I clinical trial with its trivalent immunotherapeutic vaccine for cytomegalovirus (CMV), incorporating genes encoding three CMV proteins.
This trial and an ongoing Phase I trial of a bivalent CMV vaccine are testing for safety and immune responses in healthy volunteers, in preparation for planned proof-of-concept trials in hematopoietic cell transplant (HCT) and solid organ transplant (SOT) patients.
The bivalent CMV vaccine trial recently completed enrollment of 32 volunteers, and initial data are expected to be presented in November at the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy. 'Having established the safety and immunogenicity of both vaccines in laboratory animals,' said Dr David Kaslow, Vical's chief scientific officer, 'We are now evaluating the safety and immunogenicity of both vaccines in humans. Results from these initial clinical trials will allow us to make a data-driven decision on which vaccine to advance to proof-of-concept studies.'
Vical's CMV immunotherapeutic vaccines utilise Vical's patented DNA delivery technologies that have the ability to induce both cellular and antibody immune responses against target pathogens without the safety concerns that live-attenuated virus vaccines pose for immunocompromised patients. The bivalent vaccine uses plasmid DNA (closed loops of DNA) encoding two highly immunogenic proteins of the CMV virus, phosphoprotein 65 (pp65) and glycoprotein B (gB). The trivalent vaccine also includes a third plasmid encoding the highly immunogenic CMV immediate early 1 (IE1) gene product. In laboratory animal testing, both formulated plasmid DNA vaccines demonstrated potent and specific immune responses against the encoded CMV immunogens.
The multi-centre, randomised, open-label clinical trial will evaluate the safety and immunogenicity of Vical's trivalent CMV immunotherapeutic vaccine in up to 40 healthy subjects. Subjects will follow either a three- or four- dose regimen of the formulated trivalent vaccine at either a 1 mg or 5 mg dose. All subjects will be followed for three months after the last immunisation. CMV seronegative and CMV seropositive subjects will be monitored primarily for safety. Secondary endpoints in this trial will include the immunogenicity of the various vaccine doses and regimens.