Date: 2016-08-11
Type of
information: update on patient enrollment
phase: 1
Announcement: update on patient enrollment
Company: Inovio Pharmaceuticals (USA - PA) GeneOne Life Science (South Korea)
Product: INO-4212
Action
mechanism: vaccine. Inovio’s Ebola vaccine was designed using the SynCon technology to provide broad protective antibody and T cell responses against multiple strains of Ebola virus.
Disease: Ebola fever
Therapeutic
area: Infectious diseases
Country: USA
Trial
details:
- This study evaluates whether INO-4212 and its components INO-4201 and INO-4202 administered intramuscularly (IM) or intradermally (ID) followed by electroporation (EP) will be well tolerated and immunogenic. The study will test the safety, tolerability, and immunogenicity of the DNA vaccine, INO-4212 and its components INO-4201 and INO-4202 in healthy volunteers. INO-4201 contains the DNA sequence that codes for past Ebola Zaire virus outbreak strains, and INO-4202 contains the DNA sequence that codes for the current Ebola virus outbreak strain. When given together, the DNA vaccine is called INO-4212 and contains the DNA sequence of both the previous and the current outbreak strain. Another ingredient called INO-9012 which contains the DNA sequence for interleukin-12, will be given in a subset of subjects to help boost the body's immune response when given with the vaccine. Following administration of vaccine, a specialized medical device, CELLECTRA®, will deliver brief electrical pulses in a process known as electroporation (EP), to help move more DNA into cells more efficiently. The study will evaluate whether INO-4212 and its components may be able to generate protective immunity against Ebola Zaire, evaluate the relative ability of IM versus ID administration to elicit immune responses and evaluate whether vaccine administered with INO-9012 can generate greater immune responses.
- The study is being conducted by an Inovio-led consortium which was selected and awarded $45 million by the U.S. Defense Advanced Research Projects Agency (DARPA) in 2015 to take a multi-faceted approach to prevent and treat Ebola infection. (NCT02464670)
Latest
news:
- • On August 11, 2016, Inovio Pharmaceuticals announced that the company is more than doubling study enrollment to further characterize and identify in humans the most optimal immunization regimen using intradermal delivery of its preventive Ebola DNA vaccine. Inovio is enrolling 125 subjects in a second stage of its phase I trial of INO-4212 after generating positive initial safety and immune response data in the first set of 75 healthy volunteers. The study will assess immune response characteristics generated with fewer intradermal administrations, lower doses, and with and without its DNA-based IL-12 immune activator.
- The initial 75-subject stage of the trial evaluated INO-4212 in muscle and skin in five study arms in two and three doses, one including Inovio’s DNA-based IL-12 immune activator. In a study arm using intradermal administration, 100% (13/13) of subjects generated antigen-specific antibody responses after only two doses. Similarly, in a study arm receiving the vaccine with intramuscular administration in combination with plasmid IL-12, 12 of 13 evaluable subjects (92%) demonstrated strong antibody responses after only two immunizations and 100% produced strong antibody responses after three immunizations. A majority of vaccinated subjects in each of the five cohorts produced strong Ebola antigen-specific T-cell responses.
- To date INO-4212 has been well tolerated and not demonstrated systemic serious adverse effects, such as fever, severe joint pain, and low white blood cell counts, reported in association with some viral vector based Ebola vaccines currently in development. Moreover, unlike viral vectored vaccines, which must be kept frozen, INO-4212 was formulated in a refrigerated solution (2-8 C).
- • On May 12, 2015, Inovio Pharmaceuticals announced that the company has initiated a phase I trial to evaluate safety, tolerability and immune responses of Inovio’s DNA immunotherapy for Ebola. In previously published preclinical testing, Inovio's DNA-based Ebola immunotherapy protected 100% of immunized animals from death and sickness after being exposed to a lethal dose of the Ebola virus. This initial trial will evaluate Inovio’s Ebola immunotherapy (INO-4212) in five groups of healthy subjects receiving INO-4212 and its components (INO-4201 and INO-4202) alone or in combination with INO-9012, delivered into muscle or skin using Inovio’s proprietary DNA delivery technology. The Ebola vaccine under study will be tested in approximately 75 healthy adult volunteers.
- • On September 24, 2014, Inovio Pharmaceuticals announced it will advance its DNA vaccine for Ebola into a phase I clinical trial in a collaboration with GeneOne Life Science, an international DNA vaccine manufacturer in which Inovio holds a minority interest. In the collaboration Inovio and GeneOne will co-develop Inovio’s DNA-based Ebola vaccine through a phase I clinical trial. The companies are currently conducting pre-IND activities and plan to start the clinical study in the first half of 2015. Upon successful completion of the phase I, the companies will jointly seek additional third party support and resources to further develop and commercialize this product. In published preclinical testing of its Ebola vaccine, Inovio observed that 100% of vaccinated guinea pigs and mice were protected from death after being exposed to the Ebola virus. Unlike the non-vaccinated animals, vaccinated animals were also protected from weight loss, a measure of morbidity. Researchers found significant increases in neutralizing antibody titers and strong and broad levels of vaccine-induced T-cells, including \"killer\" T-cells, suggesting that this product could provide both preventive and treatment benefits.
Is
general: Yes
