Date: 2017-04-11
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the World Vaccine Congress in Washington
Company: Inovio Pharmaceuticals (USA - PA)
Product: INO-4201
Action
mechanism:
Disease: Ebola fever
Therapeutic
area: Infectious diseases
Country: USA
Trial
details: (NCT02464670)
Latest
news:
- • On April 11, 2017, Inovio Pharmaceuticals announced preliminary results from the expanded stage of its phase I study, EBOV-001. The expanded study examined different regimens of its Ebola DNA vaccine INO-4201 using intradermal (skin) administration. The results across both stages of the trial, including both intramuscular and intradermal delivery, demonstrated that 95% (170/179) of evaluable subjects generated an Ebola-specific antibody immune response, with the mean antibody titer comparable or superior to those reported from viral vector-based Ebola vaccines.
- Inovio’s Ebola vaccine was well-tolerated with a favorable safety profile compared to viral vector-based Ebola vaccines, some of which have been associated with serious adverse events including myalgia, arthralgia, fever, and rash. Furthermore, their faster construct design, ability to continue to boost immune responses and protection with additional administrations, easier scalability of manufacturing, and better product thermal stability make DNA vaccines an attractive platform to rapidly respond to emerging global infectious diseases.
- Previously, Inovio reported positive safety and immune response data in the first set of 75 healthy volunteers administered with INO-4212 (60 delivered intramuscularly and 15 intradermally). Based on that result Inovio enrolled an additional 125 subjects in a second stage of this trial to further characterize and optimize immunization regimens using intradermal delivery, which is well-suited for this preventive Ebola DNA vaccine. Across the two stages, 88% (50/57) of evaluable intramuscular subjects generated an Ebola-specific antibody immune response; 97% (119/122) of evaluable intradermal subjects generated an Ebola-specific antibody immune response.
- In an accompanying preclinical study, INO-4201 protected 100% of rhesus monkeys challenged with a lethal dose of the Ebola virus following vaccination with two intradermal doses of INO-4201.
- Dr. Scott White, Inovio’s Vice President of Clinical Development, is presenting this data at the World Vaccine Congress in Washington.
- Inovio’s Ebola vaccine program is funded by a $45 million contract received from DARPA to develop an Ebola vaccine and DNA-based monoclonal antibody therapy. A more detailed data set and analysis from this study is being prepared for publishing in a peer-reviewed journal.
Is
general: Yes
