Clinical trial NCT04336410: Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers
Official title: Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronavirus Infection
Keywords: DNA vaccine
Electroporation
Lead sponsor: Inovio Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Coalition for Epidemic Preparedness Innovations
First posted: 2020-04-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This is an open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at screening.
* Able and willing to comply with all study procedures.
* Screening laboratory results within normal limits or deemed not clinically significant by the Investigator.
* Body Mass Index of 18-30 kg/m\^2, inclusive, at screening.
* Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody at screening.
* 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 3 months following last dose, be post-menopausal, 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 from screening until 3 months following last dose.
* Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0.
* Previous exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or receipt of an investigational product for the prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS).
* In a current occupation with high risk of exposure to SARS-CoV-2 (e.g., health care workers or emergency response personnel having direct interactions with or providing direct care to patients).
* Current or history of the following medical conditions:

  * Respiratory diseases
  * Hypersensitivity or severe allergic reactions to vaccines or drugs
  * Diagnosis of diabetes mellitus
  * Hypertension
  * Malignancy within 5 years of screening
  * Cardiovascular diseases
* Immunosuppression as a result of underlying illness or treatment including:

  * Primary immunodeficiencies
  * Long term use (≥7 days) of oral or parenteral glucocorticoids
  * Current or anticipated use of disease-modifying doses of anti-rheumatic drugs and biologic disease-modifying drugs
  * History of solid organ or bone marrow transplantation
  * Prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease
* Fewer than two acceptable sites available for intradermal (ID) injection and electroporation (EP) considering the deltoid and anterolateral quadriceps muscles.
* Reported smoking, vaping, or active drug, alcohol or substance abuse or dependence.
* Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
measure: Percentage of Participants with Administration (Injection) Site Reactions
timeFrame: Day 0 up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
measure: Percentage of Participants with Adverse Events of Special Interest (AESIs)
timeFrame: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
measure: Change from Baseline in SARS-CoV-2 Spike Glycoprotein Antigen-Specific Binding Antibody Titers
timeFrame: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
measure: Change from Baseline in Antigen-Specific Cellular Immune Response
timeFrame: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Inovio Pharmaceuticals
name: Dr. Ning Jiang, MD PhD
role: STUDY_DIRECTOR
References:
citation: Kraynyak KA, Blackwood E, Agnes J, Tebas P, Giffear M, Amante D, Reuschel EL, Purwar M, Christensen-Quick A, Liu N, Andrade VM, Diehl MC, Wani S, Lupicka M, Sylvester A, Morrow MP, Pezzoli P, McMullan T, Kulkarni AJ, Zaidi FI, Frase D, Liaw K, Smith TRF, Ramos SJ, Ervin J, Adams M, Lee J, Dallas M, Shah Brown A, Shea JE, Kim JJ, Weiner DB, Broderick KE, Humeau LM, Boyer JD, Mammen MP. SARS-CoV-2 DNA Vaccine INO-4800 Induces Durable Immune Responses Capable of Being Boosted in a Phase 1 Open-Label Trial. J Infect Dis. 2022 Jun 1;225(11):1923-1932. doi: 10.1093/infdis/jiac016.
citation: Tebas P, Yang S, Boyer JD, Reuschel EL, Patel A, Christensen-Quick A, Andrade VM, Morrow MP, Kraynyak K, Agnes J, Purwar M, Sylvester A, Pawlicki J, Gillespie E, Maricic I, Zaidi FI, Kim KY, Dia Y, Frase D, Pezzoli P, Schultheis K, Smith TRF, Ramos SJ, McMullan T, Buttigieg K, Carroll MW, Ervin J, Diehl MC, Blackwood E, Mammen MP, Lee J, Dallas MJ, Brown AS, Shea JE, Kim JJ, Weiner DB, Broderick KE, Humeau LM. Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, Phase 1 clinical trial. EClinicalMedicine. 2021 Jan;31:100689. doi: 10.1016/j.eclinm.2020.100689. Epub 2020 Dec 24.