Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT03805984 |
Recruitment Status :
Completed
First Posted : January 16, 2019
Last Update Posted : November 23, 2020
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Condition or disease | Intervention/treatment | Phase |
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Lassa Fever | Drug: INO-4500 Drug: Placebo Device: CELLECTRA® 2000 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | The Sponsor will be blinded up to Week 6; at that time the Sponsor will become group-level unblinded. |
Primary Purpose: | Prevention |
Official Title: | Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers |
Actual Study Start Date : | May 9, 2019 |
Actual Primary Completion Date : | October 21, 2020 |
Actual Study Completion Date : | October 21, 2020 |

Arm | Intervention/treatment |
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Experimental: INO-4500 Group A
Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
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Drug: INO-4500
INO-4500 will be administered ID on Day 0 and Week 4. Device: CELLECTRA® 2000 EP using the CELLECTRA® 2000 device will be administered following ID drug administration. |
Placebo Comparator: Placebo Comparator Group A
Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
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Drug: Placebo
Placebo will be administered ID on Day 0 and Week 4.
Other Name: SSC-0001 Device: CELLECTRA® 2000 EP using the CELLECTRA® 2000 device will be administered following ID drug administration. |
Experimental: INO-4500 Group B
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. Device: CELLECTRA® 2000 EP using the CELLECTRA® 2000 device will be administered following ID drug administration. |
Placebo Comparator: Placebo Comparator Group B
Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
|
Drug: Placebo
Placebo will be administered ID on Day 0 and Week 4.
Other Name: SSC-0001 Device: CELLECTRA® 2000 EP using the CELLECTRA® 2000 device will be administered following ID drug administration. |
- Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Week 48 ]
- Percentage of Participants with Injection Site Reactions [ Time Frame: Day 0 up to Week 48 ]
- Incidence of adverse events of special interest [ Time Frame: Baseline up to Week 48 ]
- Change from Baseline in Antigen Specific Binding Antibody titers [ Time Frame: Day 0 up to Week 48 ]
- Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies [ Time Frame: Day 0 up to Week 48 ]
- Change from Baseline in Interferon-Gamma Response Magnitude [ Time Frame: Day 0 up to Week 48 ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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 (e.g. Wolff-Parkinson-White syndrome);
- 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 1 month following last dose;
- Is currently participating in or has participated in a study with an investigational product within 30 days preceding 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;
- Audiometry testing that demonstrates a hearing level threshold of 30 dB or greater for any frequency tested between 250 Hz - 8000 Hz;
- Recent (within 6 months) or planned travel to Lassa-endemic region;
- Current or anticipated concomitant immunosuppressive therapy.

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
United States, Missouri | |
The Center for Pharmaceutical Research | |
Kansas City, Missouri, United States, 64114 |
Study Director: | Mammen Mammen, MD, FACP, FIDSA | Inovio Pharmaceuticals |
Responsible Party: | Inovio Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03805984 |
Other Study ID Numbers: |
LSV-001 |
First Posted: | January 16, 2019 Key Record Dates |
Last Update Posted: | November 23, 2020 |
Last Verified: | November 2020 |
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. |
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 |
Healthy volunteer |
Lassa Fever Arenaviridae Infections RNA Virus Infections |
Virus Diseases Infections Hemorrhagic Fevers, Viral |