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INO-3605

Phase 1

Healthy | Monoclonal antibody | Other |Inovio Pharmaceuticals, Inc.|Last Updated: Mar 3, 2014

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment116

FDA Designations

No designations recorded

Clinical trial landscape

INO-3605 · 1 trial · 1 indication

Phase 1 1
NCT01405885A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza VirusHealthy
COMPLETED116 Analytics
PHASE1COMPLETED
A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza Virus
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Study Endpoints

Primary Endpoints

Safety and tolerability of nine different formulation of multiple combination of H1 and H5 HA plasmid administered ID followed by electroporation in healthy adult subjects
Day 0 through Month 12

Frequency and severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events

Secondary Endpoints

Humoral and cellular immune responses
Day 0 through Month 12
tolerability and immunogenicity of multiple formulations of H1 and H5 HA plasmids administered ID followed by electroporation to seasonal influenza vaccine
Day 0 through Month 12
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm A - 0.9mg of INO-3605EXPERIMENTAL -
Arm B - 0.9mg of INO-3609EXPERIMENTAL -
Arm C- 0.9mg of INO-3401EXPERIMENTAL -
Arm D- 0.3mg of INO-3609EXPERIMENTAL -
Arm E - 0.45mg each INO-3605 , INO-3609EXPERIMENTAL -
Arm F - 0.3mg each of INO-3401,INO-3605,INO-3609EXPERIMENTAL -
Arm G - 0.9mg of INO-3609EXPERIMENTAL -
Arm H - 0.9mg of INO-3609EXPERIMENTAL -
Arm I - Seasonal influenza vaccineACTIVE_COMPARATOR -
Arm J - 1.8mg of INO-3609EXPERIMENTAL -

Interventions

NameTypeDescription
INO-3605BIOLOGICAL0.9mg of INO-3605 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
INO-3609BIOLOGICAL0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
INO-3401BIOLOGICAL0.9mg of 3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
INO-3605 AND INO-3609BIOLOGICAL0.45mg each of INO-3605 AND INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
INO-3510BIOLOGICAL0.3mg each of INO-3605, INO-3609 AND INO-3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
Seasonal Influenza vaccineBIOLOGICAL0.5ml of vaccine delivered IM
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Written informed consent in accordance with institutional guidelines. If required by local law, candidates must also authorize the release and use of protected health information (PHI); * Adults of either gender 18-55 years of age at entry; * Healthy subjects as judged by the ...

Countries:United States
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Frequently asked questions about INO-3605

What is INO-3605?

INO-3605 is an investigational DNA vaccine being developed by Inovio Pharmaceuticals, Inc. (INO). It is designed for the prevention of disease caused by H1 and H5 influenza virus. The drug is currently in Phase 1 clinical development and has completed one trial.

What is INO-3605 used for?

INO-3605 is used for the prevention of disease caused by H1 and H5 influenza virus. It is being studied in healthy volunteers as a preventive measure against these influenza strains. The drug is currently in Phase 1 clinical development.

Who makes INO-3605?

INO-3605 is developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded under the ticker symbol INO. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational DNA vaccine.

What phase is INO-3605 in?

INO-3605 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under evaluation for the prevention of H1 and H5 influenza.

What clinical trials is INO-3605 in?

INO-3605 has been studied in one completed Phase 1 clinical trial, NCT01405885, titled 'A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza Virus.' The trial enrolled 116 healthy volunteers in the United States.

Is INO-3605 the same as a DNA vaccine with electroporation?

INO-3605 is a DNA vaccine that is administered with electroporation, as described in the clinical trial NCT01405885. The trial evaluates the vaccine's ability to prevent disease caused by H1 and H5 influenza virus when delivered via this method.