Ebola Vaccine Clinical Trial
Official title:
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
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05959421 -
Immunity Induced by VSV-EBOV and Assessment of a Booster Dose in Individuals at Potential Occupational Risk for Exposure
|
Phase 3 |