NCT02464670

Open-Label Study of INO-4212 With or Without INO-9012, Administered IM or ID Followed by Electroporation in Healthy Volunteers

Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of INO-4212 and Its Components, INO-4201 and INO-4202, Given With or Without INO-9012, Administered IM or ID Followed by Electroporation in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Inovio Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This 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 Ebola vaccine under study will be tested in approximately 240 healthy adult volunteers.

Conditions

• Ebola Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	INO-4201	INO-4201 delivered IM followed by Electroporation
BIOLOGICAL	INO-4202	INO-4202 delivered IM followed by Electroporation
BIOLOGICAL	INO-4201	INO-4201 delivered ID followed by Electroporation
BIOLOGICAL	INO-4212	INO-4212 delivered IM followed by Electroporation
BIOLOGICAL	INO-4212 + INO-9012	INO-4212 + INO-9012 delivered IM followed by Electroporation
BIOLOGICAL	INO-4201 + INO-9012	INO-4201 + INO-9012 delivered ID followed by Electroporation

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-05-24
• Completion: 2018-05-24
• First posted: 2015-06-08
• Last updated: 2019-06-28

Locations

3 sites across 1 country: United States