Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03805984
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations (CEPI)
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Brief Summary:
This is a dose finding trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adult volunteers.

Condition or disease Intervention/treatment Phase
Lassa Fever Drug: INO-4500 Device: CELLECTRA® 2000 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: INO-4500 Group A
Participants will receive 2 ID injections of 0.1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
Drug: INO-4500
INO-4500 will be administered ID on Day 0 and Week 4. Only the dose group judged to have the optimal response will receive a third dose at Week 48.

Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID drug administration.

Experimental: INO-4500 Group B
Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
Drug: INO-4500
INO-4500 will be administered ID on Day 0 and Week 4. Only the dose group judged to have the optimal response will receive a third dose at Week 48.

Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID drug administration.

Experimental: INO-4500 Group C
Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
Drug: INO-4500
INO-4500 will be administered ID on Day 0 and Week 4. Only the dose group judged to have the optimal response will receive a third dose at Week 48.

Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID drug administration.




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Week 68 ]
  2. Percentage of Participants with Injection Site Reactions [ Time Frame: Day 0 up to Week 68 ]

Secondary Outcome Measures :
  1. Change from Baseline in Antigen Specific Binding Antibody titers [ Time Frame: Day 0 up to Week 6 ]
  2. Change from Baseline in Lassa Virus (LASV) Neutralizing Antibodies [ Time Frame: Day 0 up to Week 6 ]
  3. Change from Baseline in Interferon-Gamma Response Magnitude [ Time Frame: Day 0 up to Week 6 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening;
  • Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody;
  • Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings;
  • Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 6 months following last dose or be post-menopausal or be surgically sterile or have a partner who is sterile.

Exclusion Criteria:

  • Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 6 months following last dose;
  • Administration of an investigational product within 30 days of Day 0;
  • Previous receipt of an investigational vaccine product for prevention of Lassa Fever;
  • Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
  • Current or anticipated concomitant immunosuppressive therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805984


Contacts
Layout table for location contacts
Contact: Inovio Call Center (267) 440-4237 clinical.trials@inovio.com

Locations
Layout table for location information
United States, Missouri
The Center for Pharmaceutical Research Not yet recruiting
Kansas City, Missouri, United States, 64114
Principal Investigator: John E Ervin, MD         
Sponsors and Collaborators
Inovio Pharmaceuticals
Coalition for Epidemic Preparedness Innovations (CEPI)
Investigators
Layout table for investigator information
Study Director: Scott White, MD Inovio Pharmaceuticals

Layout table for additonal information
Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03805984     History of Changes
Other Study ID Numbers: LSV-001
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study.
Access Criteria: Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Inovio Pharmaceuticals:
Healthy volunteer

Additional relevant MeSH terms:
Layout table for MeSH terms
Lassa Fever
Arenaviridae Infections
RNA Virus Infections
Virus Diseases
Hemorrhagic Fevers, Viral