HOOKIPA Doses First Patient in a Phase 2 Clinical Trial of Prophylactic Vaccine Candidate HB-101 against Cytomegalovirus

The clinical trial will be conducted at approximately 35 centers worldwide and will include a total of 150 male and female patients.

Hookipa announced that it has dosed the first patient in its randomized, placebo-controlled, Phase 2 clinical trial to evaluate the safety and efficacy of HB-101, a bivalent prophylactic vaccine for cytomegalovirus (CMV), in CMV-negative patients awaiting kidney transplantation from living CMV-positive donors.

HB-101 is based on HOOKIPA┬┤s non-replicating Vaxwave┬«* technology and expresses two human CMV antigens, the tegument protein pp65, which induces CMV-specific T cells and a truncated isoform of the fusion protein gB, which elicits the production of CMV-neutralizing antibodies.

The clinical trial will be conducted at approximately 35 centers worldwide and will include a total of 150 male and female patients, aged 18 years or older. The patients will be randomized to receive either HB-101 or placebo at a ratio of 2:1 prior to kidney transplantation. Patients enrolled will be scheduled to have a living donor kidney transplantation after receiving two to three doses of HB-101.

*Registered in Europe; Pending in the US.

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