Date: 2017-05-04
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the CMV 2017 Conference
Company: Hookipa Biotech (Austria)
Product: HB-101
Action
mechanism:
- vaccine. HB-101 is a bivalent cytomegalovirus vaccine candidate based on Vaxwave® vectors expressing two human CMV antigens, the tegument protein pp65 and a truncated isoform of the fusion protein gB.
- Vaxwave® is based on lymphocytic choriomeningitis virus (LCMV) and in this vector the gene encoding the LCMV envelope protein, normally responsible for virus entry into target cells, has been deleted and replaced with a target gene of interest. The resulting vectors infect target cells and stimulate very potent and long-lasting immune responses, however they can no longer replicate and are therefore non-pathogenic and inherently safe.
Disease: cytomegalovirus infections
Therapeutic
area: Infectious diseases
Country: Belgium
Trial
details: The objectives of this first-in-human is to evaluate the safety and the immunogenicity of three administrations of a bivalent vaccine candidate against human cytomegalovirus, at three different dose levels. The safety and immunogenicity of HB-101 were evaluated in a randomized, placebo-controlled, double-blind phase I dose-escalating trial. Three cohorts of 18 subjects per cohort were enrolled. In each cohort, 14 subjects received a high, medium or low dose of the vaccine, respectively, and four received placebo. Vaccine and placebo were administered on day zero, and one and three months after first injection. Safety and reactogenicity data were collected and reviewed by an independent data and safety monitoring board. Immunogenicity readouts included humoral and cellular responses against gB, cellular responses against pp65, as well as humoral and cellular responses against the vector. (NCT02798692)
Latest
news:
- • On May 4, 2017, Hookipa Biotech presented the un-blinded safety and immunogenicity data through month four from its phase 1 first-in-human trial of HB-101, a vaccine against human cytomegalovirus (CMV), based on Hookipa's proprietary Vaxwave® platform. The data was presented at the CMV 2017 Conference in Leeuwenhorst, The Netherlands.
- Three cohorts of 18 subjects per cohort were enrolled. In each cohort, 14 subjects received a high, medium or low dose of the vaccine, respectively, and four received placebo. Vaccine and placebo were administered on day zero, and one and three months after first injection. Safety and reactogenicity data were collected and reviewed by an independent data and safety monitoring board. Immunogenicity readouts included humoral and cellular responses against gB, cellular responses against pp65, as well as humoral and cellular responses against the vector. Over all three dose groups, 98% of the subjects who received vaccine, and zero percent of the subjects who received placebo, showed detectable CMV-neutralizing antibody titers after three doses (93% of the subjects in the lowest dose group and 100% of the subjects in the medium and high dose groups). In the highest dose group, 100% seroconversion was already observed after the second vaccination and 79% of the subjects who received vaccine in this group, showed titers within the range of seropositive controls. Similarly, all three dose groups of the vaccine induced robust and statistically significant cellular immune responses when compared to placebo. When looking specifically at pp65-specific CD8+ T cells, a key biomarker for cellular immunity against cytomegalovirus, the medium and high dose groups induced clinically and statistically significant responses when compared to placebo.
- Further follow-up safety and immunogenicity results through month 12 of the study are expected in November 2017.
Is
general: Yes
