Date: 2017-06-15
Type of
information: Completion of patient enrollment
phase: 1
Announcement: completion of patient enrollment
Company: Inovio Pharmaceuticals (USA - PA)
Product: GLS-5700
Action
mechanism:
- DNA vaccine. GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. Inovio is developing its synthetic Zika vaccine with GeneOne Life Sciences and academic collaborators. Inovio synthetically generated DNA vaccine constructs targeting multiple Zika virus antigens using its SynCon vaccine technology. These SynCon constructs were administered using Inovio's CELLECTRA® electroporation delivery technology.
- Preclinical data published in the peer-reviewed journals npg Vaccines (2016) and Nature Communications (2017) showed that GLS-5700 generated single-dose protection in 100% of mice and non-human primates from death as well as neurologic or testicular effects of the Zika virus.
Disease: Zika virus infection
Therapeutic
area: Infectious diseases
Country: Puerto Rico
Trial
details: ZIKA-002 study, initiated in 3Q 2016, is a placebo-controlled, double-blind trial involving 160 healthy adult volunteers (80 subjects received vaccine and 80 subjects received placebo) to evaluate GLS-5700 administered with Inovio’s skin delivery system. Along with safety and immune responses, the study is also assessing differences in Zika infection rates in participants given either placebo or vaccine as part of an exploratory endpoint being evaluated over one year. (NCT02887482)
Latest
news:
- • On June 15, 2017, Inovio Pharmaceuticals announced that it has completed enrollment of its phase 1 clinical trial in Puerto Rico evaluating its Zika vaccine, GLS-5700. This second phase 1 study (ZIKA-002) was designed to assess safety, tolerability, and immune responses in the setting of potentially ongoing disease transmission.
- Another trial (ZIKA-001) phase 1 trial was conducted in the US and Canada in 40 healthy volunteers. In February 2017 Inovio reported positive clinical data: high levels of binding antibodies were measured in 100% (39 of 39) of evaluated subjects; two doses or a single dose of vaccine generated a robust antibody response in 95% (37 of 39) and 40% (16 of 40) of evaluated subjects, respectively. The vaccine was well tolerated and no significant safety concerns were noted.
- • On August 29, 2016, Inovio Pharmaceuticals announced it has initiated a clinical study of its preventive Zika vaccine (GLS-5700) in 160 subjects in Puerto Rico, where the Zika virus outbreak has been declared a public health emergency. The CDC estimates Zika will infect more than 25% of the Puerto Rican population by year end, providing the potential for this study’s placebo control design to provide exploratory signals of vaccine efficacy. In June, Inovio was the first to commence a human Zika trial, with sites in the U.S. and Canada. All 40 subjects for the first clinical study have been fully enrolled and dosed. Inovio expects to report results before the end of this year. This second clinical study is a placebo-controlled, double-blind trial involving 160 healthy adult volunteers (80 subjects will receive vaccine and 80 subjects will receive placebo) to evaluate the safety, tolerability and immunogenicity of GLS-5700 administered with Inovio’s CELLECTRA®-3P device. This proprietary intradermal DNA vaccine delivery device has been shown to maximize antigen expression and immune responses in multiple human studies. Inovio will also assess differences in Zika infection rates in participants given either placebo or vaccine as part of an exploratory endpoint. In preclinical testing, this synthetic vaccine induced robust antibody and T cell responses - the immune responses necessary to fight viral infections - in small and large animal models.
Is
general: Yes
