Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure
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 COVID-19 disease in participants at high risk of exposure to 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 6178 participants.
Extraído de clinicaltrials.gov
Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure
Criterios de Inclusión y Exclusión
Extraído de clinicaltrials.gov
Para participar del ensayo, es muy importante que cumplas con todos los criterios de inclusión y que no cuentes con ninguno de los criterios de exclusión. Si tenés dudas, podés consultar a tu médico o al investigador responsable del ensayo. A continuación hacé click y conocé algunos de estos criterios.
- 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.
- 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.
- Acute febrile illness with temperature higher than 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.
- 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.
- Known history of uncontrolled HIV based on a 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 receipt of an investigational 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.