safety, immunogenicity, and efficacy of ino-4800 for covid-19 in adults at high risk of sars-cov-2 exposure

Conditions: Coronavirus Infection; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); COVID-19 Disease

Summary: this is a phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of ino-4800 administered by intradermal (id) injection followed by electroporation (ep) using cellectra® 2000 device to prevent coronavirus disease 2019 (covid-19) in participants at high risk of exposure to severe acute respiratory syndrome coronavirus - 2 (sars-cov-2). the phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. safety and immunogenicity information from the phase 2 segment will be used to determine the dose level for the phase 3 efficacy segment of the study involving approximately 7116 participants.


Eligibility criteria:
key inclusion criteria: * working or residing in an environment with high risk of exposure to sars-cov-2 for whom exposure may be relatively prolonged or for whom personal protective equipment (ppe) may be inconsistently used, especially in confined settings. * phase 2 only: screening laboratory results within normal limits for testing laboratory or are deemed not clinically significant by the investigator. * be post-menopausal or be surgically sterile or have a partner who is sterile or use medically effective contraception with a failure rate of \< 1% per year when used consistently and correctly from screening until 3 months following last dose (phase 2) or until last dose (phase 3). key exclusion criteria: * acute febrile illness with temperature higher than or equal to 100.4°f (38.0°c) or acute onset of upper or lower respiratory tract symptoms (e.g., cough, shortness of breath, sore throat). * positive serologic or molecular (reverse transcription polymerase chain reaction (rt-pcr)) test for sars-cov-2 at screening (this criterion applies to all phase 2 participants and only applies after approximately 402 participants positive for sars-cov-2 serologic test are randomized in the phase 3 segment of the study). * pregnant or breastfeeding or intending to become pregnant or intending to father children within the projected duration of the trial starting from the screening visit until 3 months following the last dose (phase 2) or until last dose (phase 3). * known history of uncontrolled human immunodeficiency virus (hiv) based on clusters of differentiation (cd4) count less than 200 cells per cubic millimeter (/mm\^3) or a detectable viral load within the past 3 months. * is currently participating or has participated in a study with an investigational product within 30 days preceding day 0. * previous or planned receipt of an investigational (including emergency use authorization (eua) or local equivalent authorization) or licensed vaccine for prevention or treatment of covid-19, middle east respiratory syndrome (mers), or severe acute respiratory syndrome (sars) (documented receipt of placebo in previous trial would be permissible for trial eligibility). * respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease) requiring significant changes in therapy or hospitalization for worsening disease during the 6 weeks prior to enrolment. * immunosuppression as a result of underlying illness or treatment. * lack of acceptable sites available for id injection and ep. * blood donation or transfusion within 1 month prior to day 0. * reported alcohol or substance abuse or dependence, or illicit drug use (excluding marijuana use). * any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.

Keywords: dna vaccine electroporation healthy covid-19