Coronavirus InfectionPhase 2/3NCT04642638
Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure
A Phase 2/3 study testing INO-4800 and CELLECTRA® 2000 in people with Coronavirus Infection and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by Inovio Pharmaceuticals at 27 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), COVID-19 Disease
- What is being tested?
- INO-4800 and CELLECTRA® 2000
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,307 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 30 Nov 2020to 13 Sep 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
United States16 sites
Synexus Clinical Research US, Inc - Phoenix Southeast
Chandler, Arizona, 85224
AMR South Florida
Coral Gables, Florida, 33134
Ascension St. John Hospital
Detroit, Michigan, 48236
AMR Kansas City
Kansas City, Missouri, 64114
AMR, Clinical Research Consortium- Las Vegas
Las Vegas, Nevada, 89119
AMR Lexington
Lexington, Kentucky, 40509
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Central Phoenix Synexus Clinical Research
Phoenix, Arizona, 85020
Tekton Research
San Antonio, Texas, 78229
Optimal Research, LLC
San Diego, California, 92108
Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
Clinical Research Trials of Florida, Inc
Tampa, Florida, 33607
AMR Tempe
Tempe, Arizona, 85283
DM Clinical Research
Tomball, Texas, 78229
Advanced Clinical Research
West Jordan, Utah, 84088
Mexico6 sites
BRCR Global Mexico
Guadalajara, Jalisco, 44600
Clinstile, SA de CV
Mexico City, 06700
Eukarya Pharmasite SC
Monterrey, Nuevo León, 64718
SMIQ, S. de R. L. de C.V.
Querétaro, 76070
Unidad de Medicina Especializada SMA
San Juan del Río, Querétaro, 76800
FAICIC S. de R.L. de C.V.
Veracruz, 91900
Colombia5 sites
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, Atlántico, 800001
Clinica de la Costa LTDA
Barranquilla, Atlántico, 80002
Corazon IPS S.A.S
Barranquilla, Atlántico, 80020
Ips Centro Cientifico Asistencial Sas
Barranquilla, Atlántico, 80020
Centro de Investigaciones Clinicas IPS Cardiomet Pereira
Pereira, Risaralda Department, 660003
About this study
Official title: 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 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 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.
- Conditions
- Coronavirus Infection, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), COVID-19 Disease
- Being tested
- INO-4800, CELLECTRA® 2000, Placebo
- Keywords
- DNA vaccine, Electroporation, Healthy, COVID-19
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-4800Drug
INO-4800 was administered ID on Day 0 and Day 28.
CELLECTRA® 2000Device
EP using the CELLECTRA® 2000 device was administered following ID delivery of INO-4800 on Day 0 and Day 28.
PlaceboDrug
Also called SSC-0001, Placebo for INO-4800
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID on Day 0 and Day 28.
CELLECTRA® 2000Device
EP using the CELLECTRA® 2000 device was administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.
| Study group | Role | What they receive |
|---|---|---|
| Phase 2: INO-4800 Dose Group 1 | Experimental | Participants received one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Receives: Drug: INO-4800; Device: CELLECTRA® 2000 |
| Phase 2: INO-4800 Dose Group 2 | Experimental | Participants received two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Receives: Drug: INO-4800; Device: CELLECTRA® 2000 |
| Phase 2: Placebo Dose Group 1 | Placebo comparator | Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Receives: Drug: Placebo; Device: CELLECTRA® 2000 |
| Phase 2: Placebo Dose Group 2 | Placebo comparator | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Receives: Drug: Placebo; Device: CELLECTRA® 2000 |
| Phase 3: INO-4800 Dose Group (2.0mg per dosing visit) | Experimental | Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Receives: Drug: INO-4800; Device: CELLECTRA® 2000 |
| Phase 3: Placebo Dose Group | Placebo comparator | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Receives: Drug: Placebo; Device: CELLECTRA® 2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay
Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 was measured in spot-forming units per million peripheral blood mononuclear cells (SFU/10^6, PBMC) using ELISpot. No samples collected after Week 6 were analyzed.
Measured: Baseline up to Week 6
Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay
The immune responses to INO-4800 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial timepoints. No samples collected after Week 6 were analyzed.
Measured: Baseline up to Week 6
Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Virologically-confirmed COVID-19 Disease
Participants were virologically-confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. Participants with no prior exposure to COVID-19 at baseline were considered for the analysis.
Measured: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Secondary outcomes (13)
Phase 2 and 3: Percentage of Participants With Solicited Injection Site Reactions
Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' (Food and Drug Administration [FDA] Guidance for Industry, September 2007). Participants were provided a diary to record the solicited injection site reactions. Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were recorded. Injection site reactions were evaluated starting 30 minutes following the injection. The solicited injection site reactions were recorded for 7 days after each dose.
Measured: 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35)
Phase 2 and 3: Percentage of Participants With Unsolicited Injection Site Reactions
Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' FDA Guidance for Industry, September 2007. Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were reported. Injection site reactions were evaluated starting 30 minutes following the injection. Unsolicited injection site reactions were recorded for up to 28 days after administration of dose 2.
Measured: From first dose of study drug up to Day 56
Phase 2 and 3: Percentage of Participants With Solicited Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants were provided a diary to record the solicited systemic AEs. The solicited AEs were recorded for 7 days after each dose.
Measured: 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35)
Phase 2 and 3: Percentage of Participants With Unsolicited AEs
An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AEs were recorded for up to 28 days after administration of dose 2.
Measured: From first dose of study drug up to Day 56
Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly or birth defect.
Measured: Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126
Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs)
An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.
Measured: Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126
Phase 3: Number of Participants With Death From All Causes
Measured: Baseline up to Day 126
Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Non-Severe COVID-19 Disease
The efficacy of INO-4800 in the prevention of COVID-19 disease was evaluated according to the degrees of COVID-19 disease severity in participants. Participants were confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. The case definition of severe COVID-19 was participants with COVID-19 having clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to an intensive care unit, or death. The case definition for non-severe COVID-19 was participants with confirmed COVID-19, and which did not meet the case definition of severe COVID-19.
Measured: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Severe COVID-19 Disease
The efficacy of INO-4800 in the prevention of COVID-19 disease was evaluated according to the degrees of COVID-19 disease severity in participants. Participants were confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. The case definition of severe COVID-19 was participants with COVID-19 having clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to an intensive care unit, or death.
Measured: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Death From COVID-19 Disease
Measured: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Percentage of Participants (SARS-CoV-2 Seropositive at Baseline) With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease
Participants were virologically-confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. Participants with prior exposure to COVID-19 at baseline were considered for the analysis.
Measured: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay
Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 were measured using ELISpot.
Measured: Baseline up to Day 126
Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay
The immune responses to INO-4800 were measured using assays that included a pseudovirus-based neutralization assay.
Measured: Baseline up to Day 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start30 Nov 2020
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Why it stopped: The study was terminated to prioritize Inovio's COVID-19 efforts to advance a heterologous booster strategy and optimize potential impact on global public health.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inovio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jose Suaya, Study director, Inovio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642638
- Sponsor's protocol ID
- COVID19-311
- Other IDs
- INNOVATE, WHO UTN: U1111-1266-9952
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2020
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Adults at High Risk of SARS-CoV-2 Exposure
- ClinicalTrials.gov ID
- NCT04642638
- Acronym / sponsor ID
- COVID19-311
- Conditions
- Coronavirus Infection, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), COVID-19 Disease
- Keywords
- DNA vaccine, Electroporation, Healthy, COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated to prioritize Inovio's COVID-19 efforts to advance a heterologous booster strategy and optimize potential impact on global public health.
- Enrolment
- 1,307 participants (actual)
- Lead sponsor
- Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase 2: INO-4800 Dose Group 1 | Experimental | Drug: INO-4800, Device: CELLECTRA® 2000Participants received one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| Phase 2: INO-4800 Dose Group 2 | Experimental | Drug: INO-4800, Device: CELLECTRA® 2000Participants received two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| Phase 2: Placebo Dose Group 1 | Placebo comparator | Drug: Placebo, Device: CELLECTRA® 2000Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| Phase 2: Placebo Dose Group 2 | Placebo comparator | Drug: Placebo, Device: CELLECTRA® 2000Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| Phase 3: INO-4800 Dose Group (2.0mg per dosing visit) | Experimental | Drug: INO-4800, Device: CELLECTRA® 2000Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| Phase 3: Placebo Dose Group | Placebo comparator | Drug: Placebo, Device: CELLECTRA® 2000Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INO-4800INO-4800 was administered ID on Day 0 and Day 28. | Drug | Phase 2: INO-4800 Dose Group 1, Phase 2: INO-4800 Dose Group 2, Phase 3: INO-4800 Dose Group (2.0mg per dosing visit) |
| CELLECTRA® 2000EP using the CELLECTRA® 2000 device was administered following ID delivery of INO-4800 on Day 0 and Day 28. | Device | Phase 2: INO-4800 Dose Group 1, Phase 2: INO-4800 Dose Group 2, Phase 3: INO-4800 Dose Group (2.0mg per dosing visit) |
| PlaceboAlso: SSC-0001, Placebo for INO-4800Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID on Day 0 and Day 28. | Drug | Phase 2: Placebo Dose Group 1, Phase 2: Placebo Dose Group 2, Phase 3: Placebo Dose Group |
| CELLECTRA® 2000EP using the CELLECTRA® 2000 device was administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28. | Device | Phase 2: Placebo Dose Group 1, Phase 2: Placebo Dose Group 2, Phase 3: Placebo Dose Group |
Primary outcome
Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay
Time frame: Baseline up to Week 6
Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 was measured in spot-forming units per million peripheral blood mononuclear cells (SFU/10^6, PBMC) using ELISpot. No samples collected after Week 6 were analyzed.
Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay
Time frame: Baseline up to Week 6
The immune responses to INO-4800 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial timepoints. No samples collected after Week 6 were analyzed.
Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Virologically-confirmed COVID-19 Disease
Time frame: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Participants were virologically-confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. Participants with no prior exposure to COVID-19 at baseline were considered for the analysis.
13 secondary outcomes
Phase 2 and 3: Percentage of Participants With Solicited Injection Site Reactions
Time frame: 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35)
Phase 2 and 3: Percentage of Participants With Unsolicited Injection Site Reactions
Time frame: From first dose of study drug up to Day 56
Phase 2 and 3: Percentage of Participants With Solicited Adverse Events (AEs)
Time frame: 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35)
Phase 2 and 3: Percentage of Participants With Unsolicited AEs
Time frame: From first dose of study drug up to Day 56
Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126
Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126
Phase 3: Number of Participants With Death From All Causes
Time frame: Baseline up to Day 126
Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Non-Severe COVID-19 Disease
Time frame: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Severe COVID-19 Disease
Time frame: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Death From COVID-19 Disease
Time frame: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Percentage of Participants (SARS-CoV-2 Seropositive at Baseline) With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease
Time frame: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay
Time frame: Baseline up to Day 126
Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay
Time frame: Baseline up to Day 126
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Suaya study director
Inovio Pharmaceuticals
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing INO-4800 and CELLECTRA® 2000 in people with Coronavirus Infection and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by Inovio Pharmaceuticals at 27 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Mexico, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay (time frame: Baseline up to Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.