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

NCT03805984 — Phase 1, Completed, 60 participants, Inovio Pharmaceuticals

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Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers

RegistryNCT03805984
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, sequential, masking: triple, prevention
Enrollment60 (Actual)
SponsorInovio Pharmaceuticals (Industry); collaborators: Coalition for Epidemic Preparedness Innovations
ConditionsLassa Fever
InterventionsINO-4500, Placebo, CELLECTRA® 2000 (Drug, device)
Datesstart 2019-05-09, primary completion 2020-10-21, completion 2020-10-21, first posted 2019-01-16, last updated 2020-11-23
Locations1 site in United States

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-Summary

This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers.

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+Arms and interventions

ArmTypeInterventionsDescription
INO-4500 Group AExperimentalDrug: INO-4500; Device: CELLECTRA® 2000Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
Placebo Comparator Group APlacebo comparatorDrug: Placebo; Device: CELLECTRA® 2000Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
INO-4500 Group BExperimentalDrug: INO-4500; Device: CELLECTRA® 2000Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device
Placebo Comparator Group BPlacebo comparatorDrug: Placebo; Device: CELLECTRA® 2000Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
  • INO-4500 (Drug): INO-4500 will be administered ID on Day 0 and Week 4.
  • Placebo (Drug), also known as SSC-0001: Placebo will be administered ID on Day 0 and Week 4.
  • CELLECTRA® 2000 (Device): EP using the CELLECTRA® 2000 device will be administered following ID drug administration.

+Outcome measures

Primary outcomes

  • Percentage of Participants with Adverse Events (AEs) [Baseline up to Week 48]
  • Percentage of Participants with Injection Site Reactions [Day 0 up to Week 48]
  • Incidence of adverse events of special interest [Baseline up to Week 48]

Secondary outcomes

  • Change from Baseline in Antigen Specific Binding Antibody titers [Day 0 up to Week 48]
  • Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies [Day 0 up to Week 48]
  • Change from Baseline in Interferon-Gamma Response Magnitude [Day 0 up to Week 48]

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
The Center for Pharmaceutical ResearchKansas City, MissouriUnited States

+Investigators

My Notes